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AIVITA Biomedical Publishes Study Comparing Immune Responses and Associated Survivals Induced by Dendritic and Tumor Cell Vaccines – BioSpace

Posted: April 23, 2020 at 12:53 pm

Findings confirmed that patient-specific autologous dendritic cell vaccines (DCV) induced a different immune response associated with longer survival than autologous tumor cell vaccines (TCV)

IRVINE, Calif.--(BUSINESS WIRE)-- AIVITA Biomedical, Inc., a biotechnology company specializing in innovative cell therapy applications, announced today the publication of a paper titled, Cytokine network analysis of immune responses before and after autologous dendritic cell and tumor cell vaccine immunotherapies in a randomized trial, in the Journal of Translational Medicine. Robert O. Dillman, M.D., chief medical officer at AIVITA, and Gabriel I Nistor, M.D., chief scientific officer at AIVITA, authored the article.

The publication provides insight into the innate and adaptive immune responses induced by patient-specific autologous dendritic cell vaccines (DCV) and autologous tumor cell vaccines (TCV), and their impact on survival. DCV was associated with a multipronged innate and adaptive immune response and correlated with improved survival compared to TCV.

In a randomized Phase 2 trial conducted in patients with melanoma, blood samples were obtained at one week before and one week after a course of three weekly injections, which either included dendritic cells loaded ex vivo with antigens from autologous irradiated tumor-initiating cells (DCV), or autologous irradiated tumor-initiating cells alone (TCV). Cytokine network analysis techniques used to analyze the serologic immune responses generated by each immunotherapy confirmed they triggered differing responses. The results help provide insight into a potential underlying immunologic mechanism of action that contributes to improved survival in DCV-treated patients.

This analysis reinforces conclusions from our patient-specific cancer vaccine survival data, which suggested that ex-vivo processing of the same tumor antigens by autologous dendritic cells induces a more advantageous immune response than antigen-only based tumor cell vaccines, said Dr. Nistor. This is reassuring as we continue to further optimize our unique approach in which we use enhanced autologous dendritic cells for targeting each patients own tumor.

AIVITA is currently conducting three independent clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the development of its cancer therapeutic pipeline.

About AIVITAS Clinical Trials

OVARIAN CANCER

AIVITAs ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITAs AVOVA-1 trial patients can visit: http://www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITAs glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITAs AV-GBM-1 trial please visit: http://www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITAs melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITAs tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITAs AV-MEL-1 trial please visit: http://www.clinicaltrials.gov/ct2/show/NCT03743298

About AIVITA Biomedical

AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITAs skin care products support the treatment of people with cancer.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200423005260/en/

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AIVITA Biomedical Publishes Study Comparing Immune Responses and Associated Survivals Induced by Dendritic and Tumor Cell Vaccines - BioSpace

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Regenerative Medicine Products Market Analysis by Size, Share, Top Key Manufacturers, Demand Overview, Regional Outlook And Growth Forecast to 2026 -…

Posted: April 23, 2020 at 12:53 pm

Bellicum Pharmaceuticals

Global Regenerative Medicine Products Market Segmentation

This market was divided into types, applications and regions. The growth of each segment provides an accurate calculation and forecast of sales by type and application in terms of volume and value for the period between 2020 and 2026. This analysis can help you develop your business by targeting niche markets. Market share data are available at global and regional levels. The regions covered by the report are North America, Europe, the Asia-Pacific region, the Middle East, and Africa and Latin America. Research analysts understand the competitive forces and provide competitive analysis for each competitor separately.

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Global Regenerative Medicine Products Market Regions and Countries Level Analysis

The regional analysis is a very complete part of this report. This segmentation highlights Regenerative Medicine Products sales at regional and national levels. This data provides a detailed and accurate analysis of volume by country and an analysis of market size by region of the world market.

The report provides an in-depth assessment of growth and other aspects of the market in key countries such as the United States, Canada, Mexico, Germany, France, the United Kingdom, Russia and the United States Italy, China, Japan, South Korea, India, Australia, Brazil and Saudi Arabia. The chapter on the competitive landscape of the global market report contains important information on market participants such as business overview, total sales (financial data), market potential, global presence, Regenerative Medicine Products sales and earnings, market share, prices, production locations and facilities, products offered and applied strategies. This study provides Regenerative Medicine Products sales, revenue, and market share for each player covered in this report for a period between 2016 and 2020.

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We offer state of the art critical reports with accurate information about the future of the market.

Our reports have been evaluated by some industry experts in the market, which makes them beneficial for the company to maximize their return on investment.

We provide a full graphical representation of information, strategic recommendations and analysis tool results to provide a sophisticated landscape and highlight key market players. This detailed market assessment will help the company increase its efficiency.

The dynamics of supply and demand shown in the report offer a 360-degree view of the market.

Our report helps readers decipher the current and future constraints of the Regenerative Medicine Products market and formulate optimal business strategies to maximize market growth.

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Table of Contents:

Study Coverage: It includes study objectives, years considered for the research study, growth rate and Regenerative Medicine Products market size of type and application segments, key manufacturers covered, product scope, and highlights of segmental analysis.

Executive Summary: In this section, the report focuses on analysis of macroscopic indicators, market issues, drivers, and trends, competitive landscape, CAGR of the global Regenerative Medicine Products market, and global production. Under the global production chapter, the authors of the report have included market pricing and trends, global capacity, global production, and global revenue forecasts.

Regenerative Medicine Products Market Size by Manufacturer: Here, the report concentrates on revenue and production shares of manufacturers for all the years of the forecast period. It also focuses on price by manufacturer and expansion plans and mergers and acquisitions of companies.

Production by Region: It shows how the revenue and production in the global market are distributed among different regions. Each regional market is extensively studied here on the basis of import and export, key players, revenue, and production.

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Mustang Bio Receives Advanced Therapy Medicinal Product Classification from European Medicines Agency for MB-107 Lentiviral Gene Therapy for X-Linked…

Posted: April 23, 2020 at 12:53 pm

NEW YORK, April 20, 2020 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (Mustang) (MBIO), a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that the European Medicines Agency (EMA) has granted Advanced Therapy Medicinal Product (ATMP) classification to MB-107, Mustangs lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease. The U.S. Food and Drug Administration (FDA) previously granted Regenerative Medicine Advanced Therapy (RMAT) designation to MB-107 for the treatment of XSCID in August 2019.

EMA grants ATMP classifications to new therapeutics that are based on genes or cells and intended as long-term or permanent therapeutic solutions to acute or chronic human diseases at a genetic, cellular or tissue level. The ATMP program provides specific regulatory guidelines for preclinical development, manufacturing and product quality testing of ATMPs and offers incentives, including fee reductions for regulatory advice, recommendations and evaluation and certification of quality and non-clinical data.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, We are extremely encouraged that the EMA has granted MB-107 with ATMP classification, an important step in establishing our path to market approval and commercialization in Europe. This classification complements the RMAT designation we received last year from the FDA and brings us closer to realizing our goal of commercializing MB-107 for XSCID patients, as these patients are in desperate need of innovative and potentially curative treatment options.

MB-107 is currently being assessed in two Phase 1/2 clinical trials for XSCID: the first in newly diagnosed infants under the age of two at St. Jude Childrens Research Hospital (St. Jude), UCSF Benioff Childrens Hospital in San Francisco and Seattle Childrens Hospital and the second in patients over the age of two who have received prior hematopoietic stem cell transplantation at the National Institutes of Health. Under a licensing partnership with St. Jude, Mustang intends to develop the lentiviral gene therapy for commercial use as MB-107.

About Mustang BioMustang Bio, Inc. (Mustang) is a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for XSCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission. Mustang was founded by Fortress Biotech, Inc. (FBIO). For more information, visit http://www.mustangbio.com.

ForwardLooking StatementsThis press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on managements current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

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Dr. Wellness The Manila Times – The Manila Times

Posted: April 23, 2020 at 12:53 pm

DR. JOEL LOPEZMedical Director, J.Lopez, M.D. Medical Group

Treating the root of the illness, and not the symptoms, is key to enduring healthcare that is his prescriptionA strong and healthy immune system is definitely our bodys first line of defense [against] Covid-19 (coronavirus disease 2019) and other illnesses, declares Dr. Joel Lopez, medical director of the J. Lopez, M.D. Medical Group.

Dr. Lopez was about to start a two-hour webinar (online seminar) for medical professionals and laymen on How to Fortify your Immune System and Vitamin C when Boardroom Watch reached him on April 6.

Holistic treatmentsPending the availability of a safe and effective vaccine for Covid-19, Dr. Lopez recommends nutritional supplements to boost ones immune system. Vitamin C should be given to high-risk individuals, such as frontliners, the elderly and the frail, to help boost [their] innate natural immunity, he says.

American chemist, biochemist and chemical engineer Linus Carl Pauling, a double Nobel laureate for his extensive studies on the benefits of Vitamin C, is Dr. Lopez role model.

There are numerous studies showing that vitamins A, C, D3 and E, as well as minerals such as magnesium, selenium and zinc, can be effective prophylaxis against any type of infection, Dr. Lopez says, adding some wry advice: To cope with stress during the Covid-19 [pandemic], lessen the time watching or listening to news you find upsetting.

Dr. Lopez, who has set up clinics in Alabama, Florida, Indiana, Illinois and California, is now based in the Philippines, caring for his aged mother and giving back to his countrymen. He still maintains his San Francisco office, though. My mom (Dr. Adelina San Juan-Lopez) is a dentist, but most of her siblings are doctors, while several cousins on both sides of the family are medical doctors who practice locally and in the US. Im the only specializing in integrative, biological and regenerative medicine, he says.

Hi dad Tomas, an accountant who sold medical supplies and equipment, passed away two years ago.

NATURES WAY Dr. Lopez (back row, far left) with colleagues during his residency at Mercy Hospital & Medical Center. Below is him sweating it out at the gym. CONTRIBUTED PHOTOS

Back on home ground in 2013, Dr. Lopez opened a clinic at The Medical City on Ortigas Avenue, Pasig City, followed last year by a 28-story outpatient facility in Poblacion, Makati City that deals with integrative, holistic, functional, biological and orthomolecular (right molecules in the right amounts) medicine. His mission statement is to transform, boost, and maintain patients overall wellness.

Filipinos are very receptive to this type of medicine, Dr. Lopez says. Growth can be achieved by educating the public about the basics of nutrition/prevention. He has been practicing holistic medicine for 16 years. To be able to train more medical professionals in this field is his long-term goal.

I prefer that they shadow me while Im seeing clients, Dr. Lopez says. For more theoretical training, I share my textbooks and recommend conferences that I [attended], such as the American Academy of Anti-Aging Medicine, the Institute of Functional Medicine and the Orthomolecular (right molecule) Medicine Group.

Dr. Lopez, who is 54, emphasizes that his biological age is younger, and more important

For optional results, he partners with the client to heal the body, mind, spirit and emotions. He addresses premature aging factors, such as nutritional deficiencies, chronic inflammation, hormonal imbalance, oxidative stress (fatigue, cramps, pain) and poor detoxification mechanisms.

We treat the underlying causes of illness, rather than just treating symptoms. My practice is based on the 7Ps: Personalized, Predictive, Precise, Preventive, Proactive, Partnership and Pharmaceutical grade supplements, he says.

He uses natural remedies (macro and micronutrients, herbals), along with bioidentical (man-made) hormones, peptides, (short strings of amino acids), cell extracts and homeopathy (treatment using natural substances). He applies medication only in an emergency.

Leave it to natureDr. Lopez says integrative medicine allows him to harvest the wisdom of traditional practices and fused with the continued growth of modern science. He also uses a four-step series, called Methodical Dynamics, to furnish a systematic approach to treatments.

Health should be approached holistically since the body and mind are connected, says Dr. Gracielle Consing, The Medical Groups operations manager.

Dr. Daniel J. Dunphy, The Medical Groups visiting practitioner, adds: The good physician cures illness, while the excellent physician prevents it. Harvie Baron, the Medical Groups nutrition coach and food educator, lives by this principle: Transform your health through the healing power of food.

As vice president and founding member of the Preventive Regenerative, Integrative Medical Association since 2014, Dr. Lopez aims to bring optimizing health for a youthful life practice into the mainstream and set up practice standards.

The aging process starts at 30 when our body doesnt produce enough hydrochloric acid to digest food protein, resulting in less less amino acid supplying the brain, he says. One or two teaspoons of apple cider before meals can help the body digest food better. It mimics the effect of hydrochloric acid in the body and is a treatment for indigestion.

Sometimes, you just have to go back to nature to solve nagging health problems and live longer, says Dr. Lopez. Walnuts prevent memory from declining. Fish, especially the small ones like the humble dilis (anchovies), have fatty acids that prevent inflammation. Clean water, air, sleep, exercise, stress reduction, detoxification and nutritional supplements are daily prevention practices.

Because diet influences aging, Dr. Lopez says he eats organic, in-season produce. These contain no hormones that destroy cells. When I wake up in the morning, that means Im still around for a purpose: To glorify Him in all things I do, in my professional and personal life. I read the Bible. He drinks a healthy milkshake for breakfast, as well as nutritional supplements. He exercises at the gym in the late afternoon or early evening. Exercise is one of the best anti-aging tools. It improves the muscle mass and lessens body fat, he says.

Dr. Lopez graduated with a bachelor of science in medical technology in 1986, followed by a doctor of medicine degree in 1990 from Far Eastern University. As a volunteer physician in 1992, he taught holistic healthcare in isolated rural areas in Palawan province, as well as on medical missions in Thailand. He later completed his degree in internal medicine at the University of Illinois at Chicago and his residency at the Mercy Hospital & Medical Center in Chicago.

In 1996, he trained with one of Americas well-known pioneers in alternative medicine, Dr. Gus Prosch. He also taught yoga and chi gong (exercises for cultivating healing energy) on the side.

Dr. Lopez is a very good, compassionate and innovative physician. He is a very dedicated and tireless medical researcher who is always looking for new ways to holistically heal his patients, says Dr. Chiedu J. Nchekwube of Merrillville, Indiana, under whom Dr. Lopez worked directly in 2010.

But perhaps, the best testimonies come from those whom Dr. Lopez has treated. These are recorded on The Medical Groups website.

Joel is not going to throw a bunch of pharmaceuticals at you. He will get to the root cause of why your body is not in balance, and work to adjust it naturally, as much as possible, says Jaye Wittaker, a US-based patient.

Avegay L. from Fremont, California, adds: Dr. Lopez will not just treat the symptom of the disease, but will also treat the root and cause of the problem. I want to age gracefully and to look and feel healthy. Even my boyfriend is now being treated by Dr. Lopez.

He explains all tests so we can understand everything. He takes the time to answer our emails and phone calls when we need advice or help, say Sandi and Fred Herrera, a Filipino couple living in Manila.

Through diagnosis, detoxification, healing and rejuvenation, Dr. Lopez regularly reaches his ultimate goal. And that is to have patients take active control of their health and wellness.

* * *

WHOS AFRAID OF AGING?

Dr. Joel Lopezs individual approach in managing clients nutritional concerns is reflected through four Methodical Dynamics pillars. Your body is a home that you will live in forever, he says. Embrace, love and take care of it. Its the best thing you can ever do for yourself.

Step 1: Early Detection allows us to see what the body needs and how it can be better aided. This describes a 360 degree-approach to your consultation. Strategically designed questions are combined with the test results from the Medical Groups Integrative Innovations. This process allows the physician to find the best approach to the clients current concerns or preventive treatment.

Step 2: System Destress tackles the symptoms and possible causes that prevent the individual from reaching optimal health. It aids in body detoxification to allow the body to best receive the recommended treatments. Our bodies go through so much because of the environment and diets alone. This step in the Methodical Dynamics series helps the body to purify itself for better absorption of nutrients.

Step 3: Restore brings the body into a state of health that allows its very self to maximize its very potentials. Restore allows the body to regain its optimal state. Innovations in the practice of Integrative Medicine are used to allow the body to heal itself naturally.

Step 4: Regenerate stabilizes the foundations of the body with the support needed for the patients goals. Regenerate helps rebuild healthy cells as the person ages. With J. Lopez, M.D. Medical Group, Inc., regeneration supports these building blocks using the recommended nutrients and minerals each individual needs. This approach supports clients ageing process for the long term.

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The Proto-Communist Plan to Resurrect Everyone Who Ever Lived – VICE

Posted: April 22, 2020 at 6:46 pm

Is there anything that can be done to escape the death cult we seem trapped in?

One of the more radical visions for how to organize human society begins with a simple goal: lets resurrect everyone who has ever lived. Nikolai Fedorov, a nineteenth-century librarian and Russian Orthodoxy philosopher, went so far as to call this project the common task of humanity, calling for the living to be rejuvenated, the dead to be resurrected, and space to be colonized specifically to house them. From the 1860s to the 1930s, Fedorovs influence was present throughout the culturehe influenced a generation of Marxists ahead of the Russian Revolution, as well as literary writers like Leo Tolstoy and Fyodor Dostoevsky, whose novel, The Brothers Karamazov, directly engaged with Federov's ideas about resurrection.

After his death, Federovs acolytes consolidated his ideas into a single text, A Philosophy of the Common Task, and created Cosmism, the movement based on his anti-death eschatology. Federov left the technical details to those who would someday create the prerequisite technology, but this did not stop his disciples: Alexander Bogdanov, who founded the Bolsheviks with Lenin, was an early pioneer of blood transfusions in hopes of rejuvenating humanity; Konstantin Tsiolkvosky, an astrophysicist who was the progenitor of Russia's space program, sought to colonize space to house the resurrected dead; and Alexander Chizhevsky, a biophysicist who sought to map out the effects of solar activity on Earth life and behavior, thought his research might help design the ideal society for the dead to return to.

The vast majority of cosmists were, by the 1930s, either murdered or purged by Stalin, muting the influence of their ambitious project but also leaving us with an incomplete body of work about what type of society resurrection requires or will result in, and whether that wouldas some cosmists believe nowbring us closer to the liberation of the species. Now, I think it is obvious thatdespite what todays transhumanists might tell youwe are in no position, now or anytime soon, to resurrect anyone let alone bring back to life the untold billions that have existed across human history and past it into the eons before civilizations dawn.

To be clear, I think cosmism is absolute madness, but I also find it fascinating. With an introduction to Cosmism and its implications, maybe we can further explore the arbitrary and calculated parts of our social and political order that prioritize capital instead of humanity, often for sinister ends.

**

What? Who gets resurrected? And how?

At its core, the Common Task calls for the subordination of all social relations, productive forces, and civilization itself to the single-minded goal of achieving immortality for the living and resurrection for the dead. Cosmists see this as a necessarily universal project for either everyone or no one at all. That constraint means that their fundamental overhaul of society must go a step further in securing a place where evil or ill-intentioned people cant hurt anyone, but also where immortality is freely accessible for everyone.

Its hard to imagine how that worldwhere resources are pooled together for this project, where humans cannot hurt one another, and where immortality is freeis compatible with the accumulation and exploitation that sit at the heart of capitalism. The crisis heightened by coronavirus should make painfully clear to us all that, as J.W. Masonan economist at CUNYrecently put it, we have a system organized around the threat of withholding people's subsistence, and it "will deeply resist measures to guarantee it, even when the particular circumstances make that necessary for the survival of the system itself." Universal immortality, already an optimistic vision, simply cannot happen in a system that relies on perpetual commodification.

Take one small front of the original cosmist project: blood transfusions. In the 1920s, after being pushed out of the Bolshevik party, Bogdanov focused on experimenting with blood transfusions to create a rejuvenation process for humans (theres little evidence they do this). He tried and failed to set up blood banks across the Soviet Union for the universal rejuvenation of the public, dying from complications of a transfusion himself. Today, young blood is offered for transfusion by industrious start-ups, largely to wealthy and eccentric clientsmost notably (and allegedly) Peter Thiel.

In a book of conversations on cosmism published in 2017 titled Art Without Death, the first dialogue between Anton Vidokle and Hito Steyerl, living artists and writers in Berlin, drives home this same point. Vidokle tells Steyerl that he believes Death is capital quite literally, because everything we accumulatefood, energy, raw material, etc.these are all products of death. For him, it is no surprise were in a capitalist death cult given that he sees value as created through perpetual acts of extraction or exhaustion.

Steyerl echoes these concerns in the conversation, comparing the resurrected dead to artificial general intelligences (AGIs), which oligarch billionaires warn pose an existential threat to humanity. Both groups anticipate fundamental reorganizations of human society, but capitalists diverge sharply from cosmists in that their reorganization necessitates more extraction, more exhaustion, and more death. In their conversation, Steyerl tells Vidokle:

Within the AGI Debate, several solutions have been suggested: first to program the AGI so it will not harm humans, or, on the alt-right/fascist end of the spectrum, to just accelerate extreme capitalisms tendency to exterminate humans and resurrect rich people as some sort of high-net-worth robot race.

These eugenicist ideas are already being implemented: cryogenics and blood transfusions for the rich get the headlines, but the breakdown of healthcare in particularand sustenance in generalfor poor people is literally shortening the lives of millions ... In the present reactionary backlash, oligarchic and neoreactionary eugenics are in full swing, with few attempts being made to contain or limit the impact on the living. The consequences of this are clear: the focus needs to be on the living first and foremost. Because if we dont sort out societycreate noncapitalist abundance and so forththe dead cannot be resurrected safely (or, by extension, AGI cannot be implemented without exterminating humankind or only preserving its most privileged parts).

One of the major problems of todays transhumanist movement is that we are currently unable to equally distribute even basic life-extension technology such as nutrition, medicine, and medical care. At least initially, transhumanists vision of a world in which people live forever is one in which the rich live forever, using the wealth theyve built by extracting value from the poor. Todays transhumanism exists largely within a capitalist framework, and the countrys foremost transhumanist, Zoltan Istvan, a Libertarian candidate for president, is currently campaigning on a platform that shutdown orders intended to preserve human life during the coronavirus pandemic are overblown and are causing irrevocable damage to the capitalist economy (Istvan has in the past written extensively for Motherboard, and has also in the past advocated for the abolition of money).

Cosmists were clear in explaining what resurrection would look like in their idealized version of society, even though they were thin on what the technological details would be. Some argue we must not only restructure our civilization, but our bodies so that we can acquire regenerative abilities, alter our metabolic activity so food or shelter are optional, and thus overcome the natural, social, sexual, and other limitations of the species as Arseny Zhilyaev puts it in a later conversation within the book.

Zhilyaev also invokes Federovs conception of a universal museum, a radicalized, expanded, and more inclusive version of the museums we have now as the site of resurrection. In our world, the closest example of this universal museum is the digital world which also doubles as an enormous data collector used for anything from commerce to government surveillance. The prospect of being resurrected because of government/corporate surveillance records or Mormon genealogy databases is sinister at best, but Zhilyaevs argumentand the larger one advanced by other cosmistsis that our world is already full of and defined by absurd and oppressive institutions that are hostile to our collective interests, yet still manage to thrive. The options for our digital worlds development have been defined by advertisers, state authorities, telecom companies, deep-pocketed investors, and the likewhat might it look like if we decided to focus instead on literally any other task?

All this brings us to the question of where the immortal and resurrected would go. The answer, for cosmists, is space. In the cosmist vision, space colonization must happen so that we can properly honor our ethical responsibility to take care of the resurrected by housing them on museum planets. If the universal museum looks like a digital world emancipated from the demands of capital returns, then the museum planet is a space saved from the whims of our knock-off Willy Wonkasthe Elon Musks and Jeff Bezos of the world. I am not saying it is a good or fair idea to segregate resurrected dead people to museum planets in space, but this is what cosmists suggested, and its a quainter, more peaceful vision for space than what todays capitalists believe we should do.

For Musk, Mars and other future worlds will become colonies that require space mortgages, are used for resource extraction, or, in some cases, be used as landing spots for the rich once we have completely destroyed the Earth. Bezos, the worlds richest man, says we will have "gigantic chip factories in space where heavy industry is kept off-planet. Beyond Earth, Bezos anticipates humanity will be contained to O'Neill cylinder space colonies. One might stop and consider the fact that while the cosmist vision calls for improving human civilization on Earth before resurrecting the dead and colonizing space, the capitalist vision sees space as the next frontier to colonize and extract stupendous returns fromtrillions of dollars of resource extraction is the goal. Even in space, they cannot imagine humanity without the same growth that demands the sort of material extraction and environmental degradation already despoiling the world. Better to export it to another place (another country, planet, etc.) than fix the underlying system.

Why?

Ostensibly, the why behind cosmism is a belief that we have an ethical responsibility to resurrect the dead, much like we have one to care for the sick or infirm. At a deeper level, however, cosmists not only see noncapitalist abundance as a virtue in of itself, but believe the process of realizing it would offer chances to challenge deep-seated assumptions about humanity that might aid political and cultural forms hostile to the better future cosmists seek.

Vidokle tells Steyerl in their conversation that he sees the path towards resurrection involving expanding the rights of the dead in ways that undermine certain political and cultural forms,

The dead ... dont have any rights in our society: they dont communicate, consume, or vote and so they are not political subjects. Their remains are removed further and further from the cities, where most of the living reside. Culturally, the dead are now largely pathetical comical figures: zombies in movies, he said. Financial capitalism does not care about the dead because they do not produce or consume. Fascism only uses them as a mythical proof of sacrifice. Communism is also indifferent to the dead because only the generation that achieves communism will benefit from it; everyone who died on the way gets nothing.

In another part of their conversation, Steyerl suggests that failing to pursue the cosmist project might cede ground to the right-wing accelerationism already killing millions:

There is another aspect to this: the maintenance and reproduction of life is of course a very gendered technologyand control of this is on a social battleground. Reactionaries try to grab control over lifes production and reproduction by any means: religious, economic, legal, and scientific. This affects womens rights on the one hand, and, on the other, it spawns fantasies of reproduction wrested from female control: in labs, via genetic engineering, etc.

In other words, the failure to imagine and pursue some alternative to this oligarchic project has real-world consequences that not only kill human beings, but undermine the collective agency of the majority of humanity. In order for this narrow minority to rejuvenate and resurrect themselves in a way that preserves their own privilege and power, they will have to sharply curtail the rights and agency of almost every other human being in every other sphere of society.

Elena Shaposhnikova, another artist who appears later in the book, wonders whether the end of deathor the arrival of a project promising to abolish itmight help us better imagine and pursue lives beyond capitalism:

It seems to me that most of us tend to sublimate our current life conditions and all its problems, tragedies, and inequalities, and project this into future scenarios, she said. So while its easy to imagine and represent life in a society without money and with intergalactic travel, the plot invariably defaults to essentialist conflicts of power, heroism, betrayal, revenge, or something along these lines.

In a conversation with Shaposhnikova, Zhilyaev offers that cosmism might help fight the general fear of socialism as he understands it:

According to Marx, or even Lenin, socialism as a goal is associated with something elsewith opportunities of unlimited plurality and playful creativity, wider than those offered by capitalism. ... the universal museum producing eternal life and resurrection for all as the last necessary step for establishing social justice.

In the conversations that this book, cosmism emerges not simply as an ambition to resurrect the dead but to create, for the first time in human history, a civilization committed to egalitarianism and justice. So committed, in fact, that no part of the human experienceincluding deathwould escape the frenzied wake of our restructuring.

Its a nice thought, and something worth thinking about. Ours is not that world but in fact, one that is committed, above all else, to capital accumulation. There will be no resurrection for the deadthere isnt even healthcare for most of the living, after all. Even in the Citadel of Capital, the heart of the World Empire, the belly of the beast, the richest country in human history, most are expected to fend for themselves as massive wealth transfers drain the public treasuries that mightve funded some measure of protection from the pandemic, the economic meltdown, and every disaster lurking just out of sight. And yet, for all our plumage, our death cult still holds true to Adam Smith's observation in The Wealth of Nations: "All for ourselves, and nothing for other people, seems, in every age of the world, to have been the vile maxim of the masters of mankind."

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A Novel Class of Long Non-coding RNAs May Help Explain Increased Susceptibility of Females to Depression – Newswise

Posted: April 22, 2020 at 4:47 am

Newswise (New York, NY April 21, 2020) Researchers at Mount Sinai have found that a novel class of genes known as long non-coding RNAs (lncRNAs) expressed in the brain may play a pivotal role in regulating mood and driving sex-specific susceptibility versus resilience to depression. In a study published online, in the journal Neuron on April 17, the team highlighted a specific gene, LINC00473, that is downregulated in the cerebral cortex of women only, shedding light on why depression affects females at twice the rate of men.

Our study provides evidence of an important new family of molecular targets that could help scientists better understand the complex mechanisms leading to depression, particularly in women, says Orna Issler, PhD, a postdoctoral researcher in the Nash Family Department of Neuroscience and The Friedman Brain institute, Icahn School of Medicine at Mount Sinai, and lead author of the study. These findings into the biological basis of depression could promote the development of more effective pharmacotherapies to address a disease thats the leading cause of disability worldwide.

Past research has shown that about 35 percent of the risk for depression in both sexes can be traced to genetic factors, and the remainder to environmental factors, primarily stress exposure. Long non-coding RNAs fall into a third category: epigenetic factors, which are biological processes that lead to changes in gene expression not caused by changes in the genes themselves. While research focusing on the role of lncRNAs in mood and depression is in its infancy, Mount Sinai has pushed the boundaries of the science by showing the robust regulation of this class of molecules linked to depression in a brain-region and sex-specific manner.

Our work suggests that the complex primate brain especially uses lncRNAs to facilitate regulation of higher brain function, including mood, explains Dr. Issler, and that malfunction of these processes can contribute to pathologies like depression and anxiety in a sex-specific manner. Researchers found, for example, that the LINC00473 gene is a female-specific driver of stress resilience that is impaired in female depression. They also learned it is a key regulator of mood in females, in whom it acts on the prefrontal cortex of the brain by regulating gene expression, neurophysiology, and behavior.

To evaluate the contribution of lncRNAs to depression, the Mount Sinai team screened thousands of candidate molecules, and using advanced bioinformatics narrowed the field to LINC00473. Through viral-mediated gene transfer, researchers expressed LINC00473 in adult mouse neurons, and showed that it induced stress resilience solely in female mice. They found that this sex-specific phenotype was accompanied by changes in synaptic function and gene expression selectively in female mice. That discovery, along with studies of human neuron-like cells in culture, led to selection of LINC00473 as the lead candidate. Other genes considered strong candidates are also being actively investigated.

Our study opens the window to a whole new class of molecular targets that could help explain the mechanisms governing depression susceptibility and resilience, particularly in females, says corresponding author Eric J. Nestler, MD, PhD, Nash Family Professor of Neuroscience at Icahn School of Medicine, Director of The Friedman Brain Institute, and Dean for Academic and Scientific Affairs. Long non-coding RNAs could guide us toward better, more effective ways to treat depression and, just as importantly, to diagnose this debilitating condition. Much work remains, but weve provided a very promising roadmap to follow moving forward.

Researchers from the University of Pittsburgh, University of Texas Southwestern Medical Center, and Massachusetts General Hospital contributed to this research.

The study was supported by grants from National Institute of Mental Health (NIMH), Hope for Depression Research Foundation (HDRF) and Brain & Behavior Research Foundation (NARSAD).

About the Mount Sinai Health SystemThe Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality carefrom prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty by U.S. News & World Report.

For more information, visithttps://www.mountsinai.orgor find Mount Sinai onFacebook,TwitterandYouTube.

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COVID-19 Vax Efforts Aim to Balance Speed, Efficacy in Race to Market – Xconomy

Posted: April 22, 2020 at 4:47 am

XconomyNational

If Peter Marks had a magic wand to perfect the sophisticated process that takes a new vaccine from idea to reality, the US could have a way to prevent some people from COVID-19 infection in nine months to one year.

In the real world, the journey to a vaccine OKd under emergency guidelines is more likely to take 12 to 18 months, said Marks, who runs the FDAs Center for Biologics Evaluation and Research, on a Friday teleconference hosted by the Commonwealth Fund and the Alliance for Health Policy Teleconference for Media and Policymakers.

Marks said factors that will play a role in FDAs issuance of an emergency use authorizationnot an approvalwill include the level of coronavirus circulating, how well the vaccine works, and how safe it appears. Some of the data to back up safety and efficacy claims are likely to come from less traditional sources, such as adaptive trials, or those designed to allow changes along the way in response to early results, and real-world evidence.

Facilitating the development of a vaccine for COVID-19 is an agency priority now and for the foreseeable future since the US will likely see a second wave or even third wave [of infections] if we dont get it right and get it right quickly, he said.

The agency aims to ensure vaccine makers move forward the candidates with the most potential, he said.

What that will really mean from the FDA perspective is working with the various sponsors of the vaccines to most efficiently look at their preclinical data, understand as much as we can about the characteristics of these vaccines, (and) help people develop plans that are most efficient at understanding whether their candidates will get to the level of protection that would really warrant carrying them forward, because, frankly, vaccine candidates that have very low efficacy or not tremendous efficacy, in this particular case, could just distract from capacity for more robust candidates to come forward, he said.

Marks described the careful calculus of ensuring that any vaccine distributed is safe and effective while removing roadblocks to the fastest possible authorization and distribution.

We may not have the long-term data that we normally might like, so we may be putting real-world evidence into practice in this case by vaccinating relatively larger populations of individualsit may be individuals at higher risk for things like thisthen gathering data in the real world, he said.

Choosing which candidates to advance is an especially necessary and high-stakes effort in the face of a pandemic, Marks said.

My unique perspective on this is that its time to really mobilize as best we can in our animal modeling to try and compare things, to the extent that we can, and try and sort things out before we get to humans, knowing its never perfect to make that transition There is an opportunity cost to taking any candidate forward, and so you want to take your best candidates forward because, by definition, they will occupy capacity over one another, he said.

Esther Krofah, who heads the Milken Institutes FasterCures center, said drug companies appear to be operating with a similar timeline in mind, given some recent announcements about plans to ramp up manufacturing of their vaccine candidates in the event they prove safe and efficacious.

In recent weeks Johnson & Johnson (NYSE: JNJ) announced it had selected a lead vaccine candidate to advance against the novel coronavirus, and committed to boosting its manufacturing capacity to be able to make more than one billion doses of such a vaccine. The company anticipates human tests of its candidate to start at the latest by September, and said it expects batches could be ready for use under emergency guidelines in early 2021.

Thats a substantially accelerated timeframe in comparison to the typical vaccine development process, the company noted. Krofah says Milken is tracking 86 active vaccine projects, including six clinical trials; two dozen more are slated to enter the clinic in summer or early fall.

LJ Tan, chief strategy officer at the Immunization Action Coalition, emphasized the speed at which COVID-19 vaccine development is occurring compared to typical timelines for new vaccine innovation.

Tan previously spent about 16 years in leadership roles at the American Medical Association, most recently as director of medicine and public health and as director of infectious disease, immunology, and molecular medicine for more than a decade.

Traditional vaccine development, through all its phases, can take 10, 15, sometimes 20 years, and can cost at least $800 million dollars or even more, Tan said. When you build in all the costs to build the manufacturing facility, the equipment, the quality control that goes into this, the figure can go way over $1 billion to bring a vaccine from development all the way through to market.

Moderna (NASDAQ: MRNA), whose vaccine candidate was the first to start human testing in the US, said Thursday that it anticipated the start of a Phase 2 study this quarter, if safety data from the National Institutes of Health-led Phase 1 trial supports continuation. The Cambridge, MA-based biotech also announced that the US Biomedical Advanced Research and Development Authority (BARDA) had agreed to award it up to $483 million to fund the vaccines development through FDA review and ramp up its manufacturing to allow it to be produced at scale this year.

The company said it plans to add as many as 150 new employees by 2021.

Some vaccine candidates are being advanced in multiple geographies. This week Inovio Pharmaceuticals (NASDAQ: INO) announced a $6.9 million award from the Coalition for Epidemic Preparedness to move its vaccine into a Phase 1/2 trial in South Korea. Working with International Vaccine Institute and the Korea National Institute of Health, the trial will parallel Inovios ongoing Phase 1 in the US, which started April 6.

Remember, ultimately, were not talking about just vaccinating a few hundred thousand individuals, were taking about vaccinating a few hundred million people in this country alone and a few billion people globally, so one really would like to try to get it right to the extent they can, obviously working at a very rapid pace, Marks said.

Image: iStock/Nastco

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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Find the Best Stem Cell Clinics in New Hampshire – Stem …

Posted: April 22, 2020 at 4:42 am

With a motto of Live Free or Die it is no wonder that New Hampshire has happily taken to the idea of stem cell therapy and does not really have any legislation that would hinder researchers in their state from making breakthroughs in the fledgling medical field. The state currently has 9 stem cell clinics, which is surprisingly a lot considering the small population of the state. While stem cell therapy in New Hampshire is fairly new when compared with other states, it is growing and will probably continue to do so in the near future.

If you are thinking about getting stem cell therapy in New Hampshire, then you have two choices for the type of stem cell therapy that you can get. Currently, in the state, autologous bone marrow and autologous adipose-derived stem cells are the only stem cells that are being offered, but this does not mean that you wont be able to get the treatment that you need. A majority of the treatments that are offered throughout the country are based on these stem cells, so there is a fairly good chance that you will be able to get the treatment that you desire in New Hampshire.

Some of the stem cell therapies that are available in New Hampshire are:

Pain managementAchilles TendinitisAchilles TearsAnkle SprainsArthritisBack PainCarpal Tunnel SyndromeCartilage DefectsDegenerative Disc DiseaseElbow TendonitisFailed Back Surgery SyndromeFractures Golfers ElbowPhantom Limb PainPlantar FasciitisPost-herpetic NeuralgiaPost-laminectomy SyndromeRheumatoid ArthritisRotator Cuff TendonitisTension HeadachesTrigeminal Neuralgia

After looking at the list of treatments above if you do not see the particular treatment that you are looking for, dont fret, as it might just not be listed. Putting forth a list of every single stem cell treatment offered in the state would be untenable and so our list represents only a cross-section of what is offered in the state. Be sure to reach out to us so that we can offer you more complete information and if need be refer you to a clinic near you.

The only law that is currently enforceable in New Hampshire in regard to stem cell research or therapy is that researchers are not allowed to maintain an unfrozen fertilized embryo for more than 14 days. This means that for the most part researchers who are interested in studying embryonic stem cells are able to do so as long as they operate within the confines of that piece of legislation.

Even though there are a number of new and exciting stem cell therapies available in New Hampshire it is always important to remember that most of these treatments are not FDA approved. As of now the only stem cell therapies that are FDA approved are a few related to certain types of bone and blood cancers. Outside of this, all therapies are considered to be experimental and as such your insurance company will more than likely not cover the costs of the treatment.

If you are looking to better educate yourself on the benefits of stem cell therapy in New Hampshire, then call Stem Cell Authority toll-free today. Since there is so much information and misinformation out there in regard to stem cells it is important to get all of the facts before you make a decision to undergo treatment. At Stem Cell Authority we can help you do just that, so give us a call today.

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How Propanc Biopharma Is Joining the Fight with Cancer Patients Who Are Increasingly Vulnerable to the COVID-19 Global Pandemic – Business Wire

Posted: April 22, 2020 at 4:42 am

MELBOURNE, Australia--(BUSINESS WIRE)--Propanc Biopharma, Inc. (OTC: PPCB) (Propanc or the Company), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, announced today that its Chief Executive Officer, Mr James Nathanielsz, predicts a significant and unmet need for need for new cancer treatments that are not only more effective and less toxic, but critically, also enhance the immune response of patients. As a direct result of the COVID-19 pandemic, the risk of infection for cancer sufferers undergoing chemotherapy or radiation is life threatening. Propanc Biopharmas lead product candidate, PRP, not only stops the cancer from returning and spreading, but also enhances the bodys own immune system, which is considered a key to overcoming cancer.

According to the World Health Organization over 18.1 million cancer cases were diagnosed and 9.6 million cancer related deaths were recorded in 2018, globally. The threat of the global pandemic penetrating this vulnerable and significantly large patient group, globally, whilst undergoing treatment is extremely high. Recently, there were a number of instances where COVID-19 infections have been discovered among staff and patients in oncology wards in hospitals, such as the Alfred Hospital in Melbourne, Australia.

I am gravely concerned for cancer sufferers worldwide during this global crisis and it especially came to my attention when three COVID-19 positive patients from the Alfred hematology and oncology ward, died as a result of exposure. My heart goes out to those families, said James Nathanielsz, Propancs Chief Executive Officer. There is no doubt this group of patients are particularly vulnerable, and we need to put all our resources into every avenue of healthcare to ensure a better quality of life for human kind. Now that we have the backing of our institutional investor, financially, we are expending every effort to fast track PRP into the clinic so we can determine its effectiveness as a less toxic, targeted therapy for the treatment and prevention of metastatic cancer from solid tumors, where patients can enjoy a better quality of life.

Professor Klaus Kutz, Chief Medical Officer for Propanc Biopharma, recognizes the need for more effective and less toxic treatments, but also recognizes that supporting immune function will become an imperative for his medical colleagues, who are not only battling cancer, but the risk of secondary infection from treatment, often resulting in patients admitted to critical care and many dying from infection.

When I first joined the Propanc Scientific Advisory Board, my first task was to assess a small number of terminal cancer patients treated on the grounds of compassionate use, and what I observed was not only an overall improvement in life expectancy, but also no severe, or even serious side effects from treatment, no hair loss, no nausea and no immune suppression, said Professor Kutz, Propancs Chief Medical Officer. After more than ten years of research, I am keen to see the positive effects from treatment in a First-In-Human study for advanced cancer patients, a vulnerable, at risk patient group who need better treatments for a sustained, better quality of life.

Dr Julian Kenyon, who serves as Chief Scientific Officer at Propanc Biopharma, whilst also Medical Director of his clinic in Hampshire, UK, has focused his expertise on looking after patients who are at risk from COVID-19 infection due to underlying health conditions, by helping improve their innate and acquired immunities. He believes this gives his patients the best possible chance of overcoming this global pandemic.

My clinical expertise over the years in treating chronic diseases, including cancer, often focuses on how I can improve the immune function of my patients, as we know that adequate immune function means that any patient with COVID-19 has increased chances of surviving, and also those without COVID-19 are less likely to develop a positive infection, said Dr Kenyon. Our lead product candidate, PRP, has the potential to not only treat cancer patients, but improve their immune response towards fighting against the cancer, as well as secondary infection. This is something we have long understood as a medical need, but COVID-19 has brought this to the forefront as a pressing issue for these vulnerable patients. I believe a product which can achieve this objective in clinical trials will likely see significant and rapid uptake among healthcare practitioners.

About Propanc Biopharma, Inc.

Propanc Biopharma, Inc. (the Company) is developing a novel approach to prevent recurrence and metastasis of solid tumors by using pancreatic proenzymes that target and eradicate cancer stem cells in patients suffering from pancreatic, ovarian and colorectal cancers. For more information, please visit http://www.propanc.com.

The Companys novel proenzyme therapy is based on the science that enzymes stimulate biological reactions in the body, especially enzymes secreted by the pancreas. These pancreatic enzymes could represent the bodys primary defense against cancer.

To view the Companys Mechanism of Action video on its anti-cancer lead product candidate, PRP, please click on the following link: http://www.propanc.com/news-media/video

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements, which may often, but not always, be identified by the use of such words as may, might, will, will likely result, would, should, estimate, plan, project, forecast, intend, expect, anticipate, believe, seek, continue, target or the negative of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements. These factors include uncertainties as to the Companys ability to continue as a going concern absent new debt or equity financings; the Companys current reliance on substantial debt financing that it is unable to repay in cash; the Companys ability to successfully remediate material weaknesses in its internal controls; the Companys ability to reach research and development milestones as planned and within proposed budgets; the Companys ability to control costs; the Companys ability to obtain adequate new financing on reasonable terms; the Companys ability to successfully initiate and complete clinical trials and its ability to successful develop PRP, its lead product candidate; the Companys ability to obtain and maintain patent protection; the Companys ability to recruit employees and directors with accounting and finance expertise; the Companys dependence on third parties for services; the Companys dependence on key executives; the impact of government regulations, including FDA regulations; the impact of any future litigation; the availability of capital; changes in economic conditions, competition; and other risks, including, but not limited to, those described in the Companys Registration Statement on Form S-1, Amendment No. 1, filed with the U.S. Securities and Exchange Commission (the SEC) on January 24, 2020, and in the Companys other filings and submissions with the SEC. These forward-looking statements speak only as of the date hereof and the Company disclaims any obligations to update these statements except as may be required by law.

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Can genetics explain the degrees of misery inflicted by the coronavirus? – Genetic Literacy Project

Posted: April 21, 2020 at 12:44 am

The single biggest threat to mans continued dominance on the planet is thevirus. Joshua Lederberg, Nobel Prize in Physiology or Medicine, 1958

One of the most terrifying aspects of the COVID-19 pandemic is that we dont know what makes one person die, another suffer for weeks, another have just a cough and fatigue, and yet another have no symptoms at all. Even the experts are flummoxed.

Ive been puzzled from the beginning by the sharp dichotomy of who gets sick. At first it was mostly older people with chronic disease, and then a young person with low risk would show up. It can be devastating and rapid in one individual but mild in another, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease on a media webinar.

What lies behind susceptibility to COVID-19? Gender? Genetics? Geography? Behavior? Immunity? All of these factors may be at play, and they overlap.

Comedian Bill Maher blames poor immunity on eating too much sugar, and a thriving industry pitches immune-boosters, but much of the strength or weakness of an individuals immune response arises from specific combinations of inherited gene variants. Thats my take as a geneticist, and Dr. Faucis. Perhaps genetics and the immune response play a role in why one person has a mild response, yet another rapidly deteriorates into viral pneumonia and respiratory failure, he said.

During the first weeks of the pandemic, the observation that many victims were either older, had certain chronic medical conditions, or both, fed a sense of denial so widespread that young people flocked to Spring Break beaches as older folks boarded cruise ships in Florida as recently as early March. And then the exceptions began to appear among the young people.

While clinicians on the front lines everywhere are saving as many lives as possible, researchers are racing to identify factors that the most vulnerable, and the most mildly affected, share, especially the asymptomatic carriers. And as the numbers continue to climb and more familiar possible risk factors are minimized or dismissed age, location, lifestyle habits genetics is emerging as an explanation for why otherwise young, strong, healthy people can die from COVID-19.

Following are possible genetic explanations for why some people become sicker than others. These are hypotheses, the language of science: ideas eventually fleshed out with observations and data. Proof is part of mathematics; in science, conclusions can change with new data. The public is getting a crash course in the scientific method.

The most obvious genetic risk factor in susceptibility to COVID-19 is being male. The details of disease demographics change daily, but males are about twice as likely to die if theyre infected as are women: 4.7% versus 2.8%.

At first people blamed the sex disparity on stereotypes, like the riskier habits of many a male compared to females. But the sex difference comes down to chromosomes.

In humans, a gene, SRY, on the Y chromosome determines sex. Males have one X and a puny Y; females have two Xs. Fortunately, nature takes care of this fundamental inequality of the sexes, which I detailed hereand in every biology textbook Ive ever written.

To compensate for the X deficit of the male, one X in every cell of a female is silenced beneath a coating of methyl groups, an epigenetic change. But which X is silenced differs, more or less at random. In a liver cell, the turned off X might be the one that the woman inherited from her father; in a skin cell, the silenced X might be the one inherited from her mother.

The immune system seems to benefit from the females patchwork expression of her X-linked genes, with a dual response. Gene variants on one X may recognize viruses, while gene variants on the other X may have a different role, such as killing virally-infected cells.

Women also make more antibodiesagainst several viral pathogens. But some of us pay the price for our robust immune response with the autoimmune disorders that we are more likely to get.

People with type O blood may be at lower risk, and with type A blood at higher risk, of getting sick from SARS-CoV-2, according to results of a recent population-based study. But the idea of type O blood protecting against viral infections goes back years.

We have three dozen blood types. Theyre inherited through genes that encode proteins that dot red blood cell (RBC) surfaces, most serving as docks for sugars that are attached one piece at a time. The RBCs of people with type O blood do not have an extra bit of a sugar that determines the other ABO types: A, B, or AB.

The unadorned RBCs of people with type O blood, like me, are less likely to latch onto norovirus (which explains why I rarely throw up), hepatitis B virus, and HIV.

An investigation of ABO blood types from the SARS epidemic of 2002 to 2003 provides a possible clue to the differences. People with blood types B and O make antibodies that block the binding of the SARS viruss spikes to ACE2 receptors on human cells growing in culture. Since the novel coronavirus enters our cells through the same receptors, are people with type O blood less likely to become infected?

Thats what researchers from several institutions in China have found in the new study. They compared the blood types of 2,173 patients with COVID-19 from three hospitals in Wuhan and Shenzhen to the distribution of blood types in the general population in each area.

People with type A blood were at higher risk than people with type 0 blood for both infection and severity of the illness.

In the general population 31% of the people are type A, 24% are type B, 9% are type AB, and 34% are type O. But among infected individuals, type A is up to 38%, type B up to 26%, AB at 10%, and type O way down to 25%.

The researchers conclude that the findings demonstrate that the ABO blood type is a biomarker for differential susceptibility of COVID-19. I think thats a bit strong for a trend, considering the exceptions. But the researchers suggest that their findings, if validated for more people, can be used to prioritize limited PPE resources and implement more vigilant surveillance and aggressive treatment for people with blood type A.

Immunity and genetics are intimately intertwined. Links between mutations both harmful and helpful and immunity to infectious diseases are well known.

Mutations in single genes lie behind several types of severe combined immune deficiencies (SCIDs), like bubble boy disease. Sets of human leukocyte antigen gene variants (HLA types) have long been associated with increased risk of autoimmune conditions such as celiac disease, type 1 diabetes, and rheumatoid arthritis, and were for many years the basis of tissue typing for transplants.

In HIV/AIDS, two specific mutations in theCCR5 gene remove a chunk of a co-receptor protein to which the virus must bind to enter a human cell. The mutation has inspired treatment strategies, including drugs, stem cell transplants, and using CRISPRto recreate the CCR5 deletion mutation by editing out part of the gene.

Might variants of the gene that encodes ACE2, the protein receptor for the novel coronavirus, protect people in the way that a CCR5 mutation blocks entry of HIV? The search is on.

Another clue to possible genetic protection against the novel coronavirus may come from the SARS experience from years ago and parasitic worm diseases in Africa. (This hypothesis I came up with on my own so Im prepared to be shouted down.)

In a human body, the SARS virus disrupts the balance of helper T cells, boosting the number of cells that fight parasitic worms (the Th2 response) while depleting the cells that protect against bacteria and viruses (the Th1 response). The resulting Th2 immune bias, in SARS as well as in COVID-19, unleashes the inflammatory cytokine storm that can progress to respiratory failure, shock, and organ failure.

In subSarahan Africa alone, a billion people have intestinal infections of parasitic worms, the most common of which is schistosomiasis. Its also called snail fever because the worms are released into fresh water from snails and burrow into peoples feet when they wade in the water.

The worms mate inside our blood vessels, releasing eggs that leave in urine and feces into the water supply. Remaining eggs can inflame the intestines and bladder. The infection begins with a rash or itch, and causes fever, cough, and muscle aches in a month or two. A drug treatment is highly effective.

Genetics determines susceptibility, or resistance to, schistosomiasis. And thats what got me thinking about COVID-19.

People who resist the flatworm infection have variants of eight genes that ignite a powerful Th2 immune response that pours out a brew of specific interferons and interleukins. Could the Th2 immune bias of the novel coronavirus SARS-CoV-2 not be as devastating to people who already have the bias, to resist schistosomiasis? If so, then places in Africa where many people are immune to schistosomiasis might have fewer cases of COVID-19.

So far parts of Africa have reported low incidence of the new disease. On April 7, the World Health Organization reported approximately 10,000 cases in all of Africa. Thats similar to the number of deaths in New York City, although Africa could be on track for the exponential growth seen elsewhere. But if the lower number in Africa persists, then maybe those eight genes are protecting people. Adding to the evidence is that the 8-gene set varies more between West Africans and Europeans than do other sets of genes.

Like the ABO blood type study, if the 8-gene signature that protects against schistosomiasis protects against COVID-19, then the signature should be overrepresented among those exposed to the virus who do not get very sick, and underrepresented among those who do. However, its possible that Africa is just behindthe rest of the world in reporting COVID-19 cases. So, a thought experiment for now.

Before researchers zero in on a highly predictive genetic signature of COVID-19 risk, we can think about how the information would best be used:

I hope that discovery of a genetic basis for COVID-19 vulnerability or resistance will not inspire discrimination unfortunately, genetic information has had a legacy of misuse.

Ricki Lewis is the GLPs senior contributing writer focusing on gene therapy and gene editing. She has a PhD in genetics and is a genetic counselor, science writer and author of The Forever Fix: Gene Therapy and the Boy Who Saved It, the only popular book about gene therapy. BIO. Follow her at her website or Twitter @rickilewis

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Can genetics explain the degrees of misery inflicted by the coronavirus? - Genetic Literacy Project

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