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BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinson’s Disease – Yahoo Finance

Posted: July 21, 2021 at 2:45 am

CAMBRIDGE, Mass., July 19, 2021 /PRNewswire/ -- BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly owned subsidiary of Bayer AG, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DA01 for advanced Parkinson's disease (PD). DA01, BlueRock's pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase 1 study.

BlueRock Therapeutics (PRNewsfoto/BlueRock Therapeutics)

The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for accelerated approval and priority review.

"Receiving Fast Track Designation from the FDA is an important step, which will help us further accelerate clinical development of our DA01 cell therapy approach for Parkinson's disease," says Joachim Fruebis, Ph.D., BlueRock's Chief Development Officer. "This is another critical step in the BlueRock mission to create authentic cellular medicines to reverse devastating diseases, with the vision of improving the human condition."

About the TrialThe trial will enroll ten patients in the United States and Canada. The primary objective of the Ph1 study is to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. The secondary objectives of the study are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant, to evaluate continued safety and tolerability at two years, and to assess feasibility of transplantation.

More information about this trial is available at clinicaltrials.gov (NCT#04802733).

About Parkinson's DiseaseParkinson's disease is a progressive neurodegenerative disorder caused by nerve cell damage in the brain, leading to decreased dopamine levels. The worsening of motor and non-motor symptoms is caused by the loss of dopamine-producing neurons. At diagnosis, it is estimated that patients have already lost 60-80% of their dopaminergic neurons. Parkinson's disease often starts with a tremor in one hand. Other symptoms are rigidity, cramping and dyskinesias. Parkinson's disease is the second most common neurodegenerative disorder, impacting more than 7.5 million people, including 1.3 million people in North America.

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About BlueRock TherapeuticsBlueRock Therapeutics is an engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. The company's cell+gene platform enables the creation, manufacture, and delivery of authentic cell therapies with engineered functionality by simultaneously harnessing pluripotent cell biology and genome editing. This enables an approach where, in theory, any cell in the body can be manufactured and any gene in the genome can be engineered for therapeutic purposes. The platform is broadly applicable, but the company is focused today in neurology, cardiology, immunology, and ophthalmology. In August 2019, the company was acquired by Bayer Pharmaceuticals, for an enterprise value of $1B in upfront and milestone payments. For BlueRock this marks the next step in the journey to prove degenerative disease is reversible, and to bring our revolutionary new medicines to the patients who desperately need them. For more information, visit http://www.bluerocktx.com.

About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to http://www.bayer.com.

Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. These forward-looking statements are based on BlueRock's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing of our clinical trial for DA01; our results regarding the safety, tolerance and efficacy of DA01 cell transplantation for patients with Parkinson's disease; and ongoing FDA and other regulatory requirements regarding the development of DA01. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, BlueRock does not undertake an obligation to update or revise any forward-looking statement. All of the Company's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

Cision

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BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinson's Disease - Yahoo Finance

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Creative Medical Technology Holdings Announces MyeloCelz The Company’s Second Regenerative Immunotherapy Product – PRNewswire

Posted: July 21, 2021 at 2:45 am

PHOENIX, July 20, 2021 /PRNewswire/ -- (OTC CELZ)Creative Medical Technology Holdings Inc. announced today the launching of its second Regenerative Immunology product, MyeloCelz.

In contrast to the Company's ImmCelz product, which utilizes primarily T cells and B cells to induce activation of the body's own stem cells and healing processes, MyeloCelz utilizes the innate immune system, particularly cells of the monocyte/macrophage lineage.

"Immunotherapy is the future of medicine. In the field of oncology immunotherapy it has saved thousands of lives and resulted in the Nobel Prize in Medicine." Said Thomas Ichim, Ph.D, Chief Scientific Officer, and Co-Founder of the Company. "We believe that in using ImmCelz and MyeloCelz, we are in the position to advance immunotherapy for treatment of degenerative conditions, an approach that we term "Regenerative Immunotherapy". This is a first-in-class therapeutic direction that leverages the specificity, amplification, and memory of the immune system in order to accelerate the body to restore its function."

"The unique thing about MyeloCelz, like ImmCelz, is that the cellular product is personalized and the patient is receiving their own cells back into themselves. This not only significantly increases the safety of the procedure, but also conceptually may increase efficacy because the body's own cells know best how to interact with the body." Said Dr. Courtney Bartlett, Director of Clinical Development.

"Having recently joined the Scientific Advisory Board of the Company, I am astonished at the expedience, innovation, and productivity of the team assembled by Dr. Thomas Ichim, Chief Scientific Officer of the Company." Said Dr. Camillo Ricordi. "MyeloCelz, which is a parallel immunotherapy approach to ImmCelz, is another paradigm shifting product and to my knowledge, is covered by one of the most comprehensive patent applications in cell therapy."

The Company's first regenerative immunotherapy product, ImmCelz was demonstrated effective in numerous animal models of autoimmunity and is the subject of a filed and pending FDA IND for use in stroke. ImmCelz was featured at the international stem cell conference, The World Stem Cell Summit, with the presentation available at this link https://www.youtube.com/watch?v=LTHUxz_xN5w .

"I am grateful for our team of scientific advisors and collaborators, who have worked diligently and ingeniously to develop a cellular therapy that leverages aspects of the innate immune system in stimulating the body to heal itself naturally. The addition of MyeloCelzto our Regenerative Immunotherapy portfolio, which includes ImmCelz and multiple patent filings on the treatment of specific indications, clearly demonstrates our dedication to the immunotherapy space." Said Timothy Warbington, President and CEO of the Company.

About Creative Medical Technology HoldingsCreative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking StatementsOTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

Creativemedicaltechnology.comwww.StemSpine.comwww.Caverstem.comwww.Femcelz.com http://www.MyeloCelz.comwww.OvaStem.comwww.ImmCelz.com

SOURCE Creative Medical Technology Holdings, Inc.

http://creativemedicaltechnology.com

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Developmental Interest in Allogeneic PlacentaDerived Cell Therapies Expands – OncLive

Posted: July 21, 2021 at 2:45 am

After closing a merger with GX Acquisition Corp., Celularity Inc., a clinical-stage cellular medicine company, is taking the next step in its evolution to enable further development of novel, off-the-shelf allogeneic placentaderived cellular therapies.1

Celularity aims to transform the way we approach the treatment of cancer and other diseases by harnessing the versatility, unique immune biology, and innate stemness of placental-derived cells, Robert J. Hariri, MD, PhD, found, chairperson, and chief executive officer of Celularity, stated in a press release. We are immensely proud of our clinical development results so far as well as the state-of-the-art manufacturing capabilities we built to support rapid scaling and a competitive cost structure for our placental-derived cell therapeutics. We believe off-the-shelf, allogeneic cell therapies will drive a paradigm shift in how clinicians approach the treatment of cancer and other serious diseases.

CYNK-001, the companys lead product candidate, is the only cryopreserved, allogeneic, off-the-shelf natural killer (NK) cell therapy to be developed from placental hematopoietic stem cells. The agent expresses perforin and granzyme B, has showcased cytotoxic activity against hematological tumors and solid tumor cell lines, and can secrete immunomodulatory cytokines in the presence of tumor cells.

The novel therapy is under investigation as a potential option in multiple myeloma, acute myeloid leukemia (AML), and glioblastoma multiforme; it is also being evaluated in infectious diseases like COVID-19 (NCT04365101).

An ongoing, open-label, multi-dose, phase 1 trial (NCT04310592) is examining the maximum-tolerated dose (MTD) or maximum planned dose of CYNK-001 in an estimated 22 patients with acute myeloid leukemia (AML).2 To participate, patients need to have primary or secondary AML and be in first or second morphological clinical response (CR), morphological CR with incomplete hematologic recovery, or a morphologic leukemia-free state per European LeukemiaNet recommendations for AML Response Criteria.

Patients also need to have MRD positivity, be aged between 18 and 80 years old, have an ECOG performance status of 0 to 2, and be able to be off immunosuppressive therapy for at least 3 days before infusion with the therapy. Patients who previously had central nervous system involvement are allowed to enroll if they had been treated and their cerebral spinal fluid is clear for at least 2 weeks before undergoing lymphodepletion.

Exclusion criteria include significant medical conditions, laboratory abnormalities, bi-phenotypic acute leukemia, acute promyelocytic leukemia, unacceptable organ function, autoimmune disease, uncontrolled graft-vs-host disease (GVHD), and GVHD that requires corticosteroids.

Participants are first given cyclophosphamide plus fludarabine. Then, they are administered CYNK-001 at 3 varying dose levels1.8 billion, 3.6 billion, and 5.4 billion CYNK-001 cellson days 0, 7, and 14. The primary objectives of the research include dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), and frequency and severity of adverse effects. Important secondary objectives include the number of patients who convert from MRD-positive to -negative status; time to, and duration of, MRD response; progression-free survival; time to progression; duration of morphologic complete remission; and overall survival.

In June 2021, the study was expanded to include patients with relapsed/refractory AML following a case of conversion to MRD negativity, when the therapy was delivered at its highest dose level.3

The decision to expand the trial followed observations of a patient with NPM-1positive, FLT3-negative AML and good-risk cytogenetics who had been administered 5.4 billion CYNK-001 cells. The patient converted from MRD-positive to -negative status, without experiencing any DLTs.

For this patient, primary induction treatment with 7+3 chemotherapy had failed, and so they had gone on to receive second induction therapy followed by high-dose cytarabine consolidation. At this time point, the patient achieved a complete CR, but MRD was found to be persistent; it did not clear following 4 months of treatment with azacitidine. MRD positivity was confirmed on a marrow biopsy.

The patient went on to enter the phase 1 trial, where they received lymphodepletion, and then received 1.8 billion CYNK-001 cells on days 0, 7, and 14 in the outpatient setting, which totaled to 5.4 billion CYNK-001 cells. On day 28, the patient had converted from MRD positivity to negativity. CYNK-001 cells were present in both the peripheral blood and bone marrow.

Notably, no DLTs have been observed with the therapy at any of the dose levels examined thus far.

The company also shared plans to continue dose escalation with the therapy in the MRD indication up to 9.0 billion CYNK-001 cells. To strengthen the persistence of the treatment, the expansion arms of MRD and relapsed/refractory AML will include an augmented lymphodepletion protocol comprised of cyclophosphamide at 3600 mg and fludarabine at 120 mg over 4 days vs cyclophosphamide at 900 mg plus fludarabine at 75 mg over 3 days.

In April 2021, the FDA granted an orphan drug designation to CYNK-001 as a potential therapeutic option for patients with malignant gliomas.4 As such, the therapy is also under investigation in patients with glioblastoma multiforme as part of another phase 1 trial (NCT04489420).5

To be eligible for enrollment, patients need to have historically confirmed disease at first or second relapse, measurable disease, a Karnofsky performance status of 60 or higher, and acceptable organ function, among other criteria.

Patients who previously received radiation within 12 weeks of their screening MRI; those who were on growth factors with less than 4 weeks of a washout period; those treated with radiotherapy, chemotherapy, or other investigational drugs within 4 weeks; those who received prior cellular or gene therapy; and those with active autoimmune disease, were excluded.

Cohort 1A of the trial will enroll up to 6 patients with recurrent glioblastoma multiforme who will receive intravenous CYNK-001 at a dose of 1.2 x 109 cells on days 0, 7, and 14. From the initial infusion of therapy, patients will be followed for a 42-day DLT period. No other interventions are planned between the last day of treatment.

If DLTs are experienced, cohort 1C, the de-escalation cohort, will include up to 6 patients with recurrent glioblastoma multiforme who will receive the therapy at a dose of 600 x 106 cells on days 0, 7, and 14. These patients will also be followed for DLTs for 42 days post infusion. Cohort 1B, the surgical cohort, will also enroll up to 6 patients, who will be given CYNK-001 at a maximum safe dose of either 1.2 x 109 cells or 600 x 106 cells at days 0, 7, and 14. Patients in this cohort will undergo resection following the last dose of the therapy in the DLT period.

Treatment of cohorts 2A or 2C will only begin after the safety data from cohorts 1A or 1C are determined to be acceptable. Here, patients will first have the Ommaya catheter placement in accordance with institutional policy within 1 week before CYNK-001 infusion on day 0. Cohort 2A will enroll up to 6 patients with recurrent glioblastoma multiforme who will be given the therapy at a dose of 200 x 106 cells +/- 50 x 106 cells intratumorally on day 0, 7, and 14.

Cohort 2C will also include up to 6 patients with recurrent disease who will receive the product at a dose of 200 x 106 cells +/- 50 x 106 cells intratumorally on day 0 and day 7. Lastly, cohort 2B, the surgical intratumoral cohort, will include 6 patients with glioblastoma multiforme who will receive the cellular therapy at a maximum safe dose of either 200 x 106 cells +/- 50 x 106 cells on day 0 and 7.

The primary objectives of the trial are to examine the number of patients who report DLTs with the therapy and toxicities. Important secondary objectives are to evaluate the overall response rate, duration of response, progression-free survival, time to progression, and overall survival.

The safety and efficacy of the cell therapy is also being explored in newly diagnosed patients with multiple myeloma after autologous stem cell transplant, as part of another phase 1 trial (NCT04309084).6 The objective of the program is to achieve durable responses with the therapy in these patients with multiple myeloma who are eligible for transplant in the first-line setting.

Another novel agent in the pipeline is CYNK-101, which is manufactured from NK cells extracted from postpartum placentas. The cells are then genetically engineered to boost cell-killing activity when given with a monoclonal antibody.7 Preclinical data with the product in combination with an antibody showed that the regimen resulted in cell-killing activity when administered to lymphoma cells in vitro.

Additionally, CYNK-CAR products are being developed as allogeneic, off-the-shelf strategies by modifying genes of the human placental hematopoietic stem cellderived NK cells. Several CAR constructs that are designed to target hematologic and solid tumor indications are currently under investigation.

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Brooklyn ImmunoTherapeutics Completes Acquisition of Novellus Therapeutics – GlobeNewswire

Posted: July 21, 2021 at 2:45 am

Acquisition Advances Transformation Into Platform Company Focused on Cell, Gene Editing and Cytokine Therapy

Company to hold Conference Call Today, July 19, 2021, at 4:15PM ET to Discuss the Transaction and Future Plans

NEW YORK, July 19, 2021 (GLOBE NEWSWIRE) -- Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) (Brooklyn), a biopharmaceutical company focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases, today announced that it had completed, on July 16, 2021, its acquisition of Novellus Therapeutics Limited (Novellus). Novellus is developing next-generation engineered mesenchymal stem cell (MSC) therapies using extensively patented mRNA-based cell reprogramming and gene editing technologies licensed from Factor Bioscience (Factor). The transaction advances Brooklyns evolution into a platform company with a pipeline of next-generation engineered cellular, gene editing and cytokine programs.

Key Transaction Highlights:

We are confident that the Novellus transaction will provide significant forward momentum in the gene editing and mRNA spaces, said Brooklyns Chief Executive Officer and President Howard J. Federoff, M.D., Ph.D. The addition of Novellus will accelerate our research and development efforts, potentially facilitating faster development of clinical products for orphan diseases such as sickle cell anemia, familial amyloidosis and cell therapies for cancer. We believe the transaction makes it possible for us to enter first-in-human trials as early as 2023 and positions Brooklyn to become a leader in stem cell therapies, gene editing and mRNA therapeutics, with the ability to develop multiple therapeutic candidates rapidly.

We look forward to continuing to update our stockholders on our progress and to speaking with them to provide additional details on this transformative transaction, concluded Dr. Federoff.

Brooklyn will be conducting a conference call at 4:15PM ET on July 19, 2021 to discuss the transaction and future plans. Participants can register for the call here and will receive dial-in information to put them directly into the call. Those who are unable to register may access the conference by calling 1-866-777-2509 (toll free U.S.) or 1-412-317-5413 (internationally) and then asking the operator to join them into the Brooklyn ImmunoTherapeutics conference call. The conference will also be webcast, which can be accessed here. A replay of the call will be available via the webcast link as well as on Brooklyns website in the investor relations section, for one week following the call.

About Brooklyn ImmunoTherapeutics

Brooklyn is focused on exploring the role that cytokine, gene editing, and cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases.

Brooklyns most advanced program is IRX-2, a human cell-derived cytokine therapy, studying the safety and efficacy of IRX-2 in patients with head and neck cancer in Phase 2B. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

Brooklyn has multiple next-generation cell and gene-editing therapies in preclinical development for various indications including acute respiratory distress syndrome, solid tumor indications, as well as in vivo gene-editing therapies for rare genetic diseases. For more information about Brooklyn and its clinical programs, please visit http://www.BrooklynITx.com.

Forward-Looking Statements

The third bullet under, and the paragraph immediately following, Key Transaction Highlights contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are any statements that are not statements of historical fact and may be identified by terminology such as believe, plan, possible, potential, project, or will or other similar words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those stated or implied in any forward-looking statement as a result of various factors, including, but not limited to, uncertainties related to: (i) the evolution of Brooklyns business model into a platform company focused on cellular, gene editing and cytokine programs; (ii)Brooklyns ability to successfully, cost-effectively and efficiently develop its technology and products; (iii)Brooklyns ability to successfully commence clinical trials of any products on a timely basis or at all; (iv)Brooklyns ability to successfully fund and manage the growth of its development activities; (v)Brooklyns ability to obtain regulatory approvals of its products for commercialization; and (vi) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of Brooklyn, including on the timing and cost of its clinical trials. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this communication speak only as of the date on which they were made, and Brooklyn does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as may be required by applicable law or regulation.

Investor Relations Contact:CORE IR516-222-2560investors@brooklynitx.com

Media Contact:Jules AbrahamCORE IR917-885-7378julesa@coreir.com

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Stem Cell Therapy Market Analysis of Key Players, End User, Demand and Consumption By 2026 26 Sports – 2×6 Sports

Posted: July 21, 2021 at 2:45 am

The report published on the Stem Cell Therapy Market Analysis of Key Players, End User, Demand and Consumption By 2026 by Zion Market Research facilitates a closer outlook on opportunities, revenue growth, and current market trends. The report is focused to offer qualitative and quantitative analysis of dynamics and market opportunities prevailing during the forecast period. Also, the report encompasses an in-depth study on the prominent leaders in theStem Cell Therapy Market.

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Anterogen Co., Ltd., RTI SurgicalInc., Pharmicell Co., Ltd., MEDIPOST Co., Ltd., JCR Pharmaceuticals Co., Ltd., Holostem Terapie Avanzate S.r.l., NuVasiveInc., and AlloSource.

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The overview section reveals the potential, opportunities, and scope of the Stem Cell Therapy Market along with its market size and volume. Also, the section encompasses an in-depth study on value chain analysis and the core working of the market. The growth factor segment elaborates the financial position, technology dynamics, and product portfolio expected in the forthcoming year. Also, the segmentation section bifurcates the whole market landscape into different classes to identify the market size and volume of each segment. However, the regional analysis segment reveals the extensive potential of each region in the global Stem Cell Therapy Market along with its size and volume.

Our analysts have tried to maintain the highest level of transparency and accuracy in the report. Also, the report offers business intelligence solutions for helping our clients to achieve a competitive edge in the global Stem Cell Therapy Market. Moreover, it will help our users to curate effective business strategies to promulgate the growth rate of their business in the forthcoming years. However, all the statistical and quantitative analysis mentioned in the report reflects the real-time data. It covers all the market landscapes to help users understand the present positioning of the global Stem Cell Therapy Market along with the probable market trends in the future.

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Moving to the drivers and restraints, one will be given all factors that are indirectly or directly helping the development of the global Stem Cell Therapy Market. To get to know the markets development measurements, it is important to evaluate the drivers of the market. Furthermore, the report likewise analyses the current patterns alongside new and plausible growth openings for the global market. Additionally, the report incorporates the components that can restrict the market growth during the forecast period. Understanding these elements is also mandatory as they help in grasping the markets shortcomings.

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Stem Cell Therapy Market Analysis of Key Players, End User, Demand and Consumption By 2026 26 Sports - 2x6 Sports

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Roswell Park Team Shows Dendritic-Cell Vaccines Can Be Paired With Standard Therapy for Breast Cancer – Newswise

Posted: July 21, 2021 at 2:45 am

Newswise BUFFALO, N.Y. A research team led by Fumito Ito, MD, PhD, FACS, of Roswell Park Comprehensive Cancer Center reports new data on the promise of combining standard treatment for breast cancer with a particular form of cancer immmunotherapy dendritic-cell (DC) treatment vaccines. This study, published in the Journal for ImmunoTherapy of Cancer, is the first to demonstrate that in situ dendritic-cell vaccines can improve the effectiveness of radiation therapy for some aggressive and treatment-resistant forms of breast cancer.

Although immunotherapy with primary conventional dendritic cells is a promising approach, obtaining a sufficient number of circulating conventional dendritic cells has proved difficult, says Dr. Ito, who is Associate Professor of Surgical Oncology at Roswell Park. Use of induced pluripotent stem cells (iPSCs) has been proposed to overcome that limitation, but the feasibility of this approach had not previously been demonstrated.

The teams results show that intratumoral administration of iPSC-DCs significantly enhanced antitumor efficacy of local irradiation, which is commonly incorporated into treatment plans for patients with breast cancer.To better understand the potential of this approach, Dr. Ito and colleagues conducted laboratory studies to assess the antitumor efficacy of intratumoral injection of iPSC-DCs, or dendritic cells derived from iPSCs, and radiotherapy in models of triple-negative breast cancer that have shown resistance to anti-PD-L1 checkpoint inhibition immunotherapy.

The researchers demonstrate that radiation therapy increased the trafficking of intratumorally injected iPSC-DCs to the tumor-draining lymph nodes and augmented the activation of tumor-specific T cells. Their work shows that this multimodal intralesional therapy can control growth of distant tumors and render some breast cancers responsive to anti-PD-L1 therapy

While our work to develop this strategy is at an early stage and will need to be studied further, we show that these two approaches, radiotherapy and intratumoral iPSC-DC administration, can work synergistically to control not only local tumor growth but also distant tumors. And we saw evidence of systemic tumor-specific immunological memory, suggesting a potential for long-term tumor control, says Dr. Ito.

This study sheds light on the antitumor efficacy of in situ administration of iPSC-DCs when integrated with radiotherapy against poorly immunogenic tumors. These findings align with another study from Dr. Ito and his team, recently published in Nature Communications, that showed potent systemic antitumor immunity caused by combinational multimodal intralesional therapy.

Currently, efficacy of immunotherapy against breast cancer is limited, adds Dr. Ito. Our hope is to improve clinical outcomes for patients with advanced unresectable and metastatic breast cancer.

This work, In situ delivery of iPSC-derived dendritic cells with local radiotherapy generates systemic antitumor immunity and potentiates PD-L1 blockade in preclinical poorly immunogenic tumor models, was supported by several grants from the National Cancer Institute (project numbers P30CA016056, K08CA197966, and R50CA211108), as well as the Melanoma Research Alliance, Sarcoma Foundation of America and Uehara Memorial Foundation.

###

For an online version of this release, please visit: https://www.roswellpark.org/newsroom/202107-roswell-park-team-shows-dendritic-cell-vaccines-can-be-paired-standard-therapy

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancers grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at http://www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or [emailprotected].

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Hormone replacement therapy (HRT) – NHS

Posted: July 21, 2021 at 2:44 am

Hormone replacement therapy (HRT) is a treatment to relieve symptoms of themenopause. It replaces hormones that are at a lower level as you approach themenopause.

The main benefit of HRT is that it can help relieve most of the menopausal symptoms, such as:

Many of these symptoms pass after a few years, but they canbe unpleasant and taking HRT can offer relief for many women.

Itcan also help prevent weakening of the bones (osteoporosis), which is more common after the menopause.

Some types of HRT can increase your risk of breast cancer.

The benefits of HRT are generally believed to outweigh the risks. But speak to a GP if you have any concerns about taking HRT.

Read more abouttherisks of HRT.

Speak to a GP if you're interested in starting HRT.

You can usually begin HRT as soon asyou start experiencing menopausal symptoms and will not usually need to have any tests first.

A GP can explain thedifferent types of HRTavailable and help you choose one that's suitable for you.

You'll usually start with a low dose, which may be increased at a later stage. It may take a few weeks to feel the effects of treatment and there may be someside effects at first.

A GP will usually recommend trying treatment for 3 months to see if it helps. If it does not, they may suggest changing your dose, or changing the type of HRT you're taking.

Most women can have HRT if they're having symptoms associated with the menopause.

ButHRT may not be suitable if you:

Inthese circumstances,alternatives to HRTmay be recommended instead.

There are many different types of HRT and finding the right 1 for you can be difficult.

There are different:

A GP can give you advice to help you choose which type is best for you.You may need to try more than 1 type before you find 1 that works best.

Find out more about the different types ofHRT.

There's no limit on how long you can take HRT, but talk to a GP about how long they recommend you take the treatment.

Most womenstop takingitonce their menopausal symptoms pass, which is usually after a few years.

Women who take HRT for more than 1 year have a higher risk of breast cancer than women who never use HRT. The risk is linked to all types of HRT except vaginal oestrogen.

The increased risk of breast cancer falls after you stop taking HRT, but some increased risk remains for more than 10 years compared to women who have never used HRT.

When you decide to stop, you can choose to do so suddenly or gradually.

Gradually decreasing your HRT dose is usually recommended because it's less likely to cause your symptoms to come back in the short term.

Contact a GP if you have symptoms that persist for several months after you stop HRT, or if you have particularly severe symptoms. You may need to start HRT again.

As with any medicine, HRT can cause side effects. But these will usually pass within 3 months of starting treatment.

Common side effects include:

If you're unable totake HRT or decide not to,you may want to consider alternativeways of controlling your menopausal symptoms.

Alternatives to HRT include:

Several remedies (such as bioidenticalhormones) are claimed to help withmenopausal symptoms, but these are not recommended because it's not clear how safe and effective they are.

Bioidentical hormones are not the same as body identical hormones. Body identical hormones, or micronised progesterone, can be prescribed to treat menopausal symptoms.

Read more about alternatives to HRT.

Page last reviewed: 09 September 2019Next review due: 09 September 2022

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Transgender hormone therapy – Wikipedia

Posted: July 21, 2021 at 2:44 am

Transgender hormone therapy, also sometimes called cross-sex hormone therapy, is a form of hormone therapy in which sex hormones and other hormonal medications are administered to transgender or gender nonconforming individuals for the purpose of more closely aligning their secondary sexual characteristics with their gender identity. This form of hormone therapy is given as one of two types, based on whether the goal of treatment is feminization or masculinization:

Some intersex people may also undergo hormone therapy, either starting in childhood to confirm the sex they were assigned at birth, or later in order to align their sex with their gender identity. Non-binary people may also undergo hormone therapy in order to achieve a desired balance of sex hormones or to pass as a desired gender. [1]

The formal requirements for hormone therapy vary widely.

Historically, many health centers required a psychiatric evaluation and/or a letter from a therapist before beginning therapy. Many centers now use an informed consent model that does not require any routine formal psychiatric evaluation but instead focuses on reducing barriers to care by ensuring a person can understand the risks, benefits, alternatives, unknowns, limitations, and risks of no treatment.[2] Some LGBT health organizations (notably Chicago's Howard Brown Health Center[3] and Planned Parenthood[4]) advocate for this type of informed consent model.

The Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People (SOC) require that the patient be referred by a mental health professional who has diagnosed the patient with persistent gender dysphoria. The Standards also require that the patient give informed consent, in other words, that they consent to the treatment after being fully informed of the risks involved.[5]

The World Professional Association for Transgender Health (WPATH) Standards of Care, 7th edition, note that both of these approaches to care are appropriate.[6]

The World Professional Association for Transgender Health (WPATH) and the Endocrine Society formulated guidelines that created a foundation for health care providers to care for transgender patients.[7] UCSF guidelines are also used.[8][citation needed] There is no generally agreed-upon set of guidelines, however.[citation needed]

Feminizing hormone therapy usually includes medication to suppress testosterone production and induce feminization. Types of medications include estrogens, antiandrogens (testosterone blockers), and progestogens.[9] Most commonly, an estrogen is combined with an antiandrogen to suppress and block testosterone. This allows for demasculinization and promotion of feminization and breast development.

Masculinizing hormone therapy usually includes testosterone to produce masculinization and suppress the production of estrogen.[10] Treatment options include oral, parenteral, subcutaneous implant, and transdermal (patches, gels). Dosing is patient-specific and is discussed with the physician.[11] The most commonly prescribed methods are intramuscular and subcutaneous injections. This dosing can be weekly or biweekly depending on the individual patient.[citation needed]

Hormone therapy for transgender individuals has been shown in medical literature to be generally safe, when supervised by a qualified medical professional.[12] There are potential risks with hormone treatment that will be monitored through screenings and lab tests such as blood count (hemoglobin), kidney and liver function, blood sugar, potassium, and cholesterol.[11][9] Taking more medication than directed may lead to health problems such as increased risk of cancer, heart attack from thickening of the blood, blood clots, and elevated cholesterol.[11][13]

Transgender hormone therapy may limit fertility potential.[14] Should a transgender individual choose to undergo sex reassignment surgery, their fertility potential is lost completely.[15] Before starting any treatment, individuals may consider fertility issues and fertility preservation. Options include semen cryopreservation, oocyte cryopreservation, and ovarian tissue cryopreservation.[14][15]

A study due to be presented at ENDO 2019 (the Endocrine Society's conference) reportedly shows that even after one year of treatment with testosterone, a transgender man can preserve his fertility potential.[16]

Many providers use informed consent, whereby someone seeking hormone therapy can sign a statement of informed consent and begin treatment without much gatekeeping. For other providers, eligibility is determined using major diagnostic tools such as ICD-10 or the Diagnostic and Statistical Manual of Mental Disorders (DSM). Psychiatric conditions can commonly accompany or present similar to gender incongruence and gender dysphoria. For this reason, patients are assessed using DSM-5 criteria or ICD-10 criteria in addition to screening for psychiatric disorders. The Endocrine Society requires physicians that diagnose gender dysphoria and gender incongruence to be trained in psychiatric disorders with competency in ICD-10 and DSM-5. The healthcare provider should also obtain a thorough assessment of the patient's mental health and identify potential psychosocial factors that can affect therapy.[17]

The ICD-10 system requires that patients have a diagnosis of either transsexualism or gender identity disorder of childhood. The criteria for transsexualism include:[18]

Individuals cannot be diagnosed with transsexualism if their symptoms are believed to be a result of another mental disorder, or of a genetic or chromosomal abnormality.[citation needed]

For a child to be diagnosed with gender identity disorder of childhood under ICD-10 criteria, they must be pre-pubescent and have intense and persistent distress about being the opposite sex. The distress must be present for at least six months. The child must either:

The DSM-5 states that at least two of the following criteria must be experienced for at least six months' duration for a diagnosis of gender dysphoria:[19]

In addition, the condition must be associated with clinically significant distress or impairment.[19]

Some organizations but fewer than in the past require that patients spend a certain period of time living in their desired gender role before starting hormone therapy. This period is sometimes called real-life experience (RLE). The Endocrine Society stated in 2009 that individuals should either have a documented three months of RLE or undergo psychotherapy for a period of time specified by their mental health provider, usually a minimum of three months.[20]

Transgender and gender non-conforming activists, such as Kate Bornstein, have asserted that RLE is psychologically harmful and is a form of "gatekeeping", effectively barring individuals from transitioning for as long as possible, if not permanently.[21]

Gender-affirming care is health care that affirms people to live authentically in their genders, no matter the gender they were assigned at birth or the path their gender affirmation (or transition) takes. It allows each person to seek only the changes or medical interventions they desire to affirm their own gender identity, and hormone therapy (HRT or gender-affirming hormone therapy) may be a part of that. [22]

Some transgender people choose to self-administer hormone replacement medications, often because doctors have too little experience in this area, or because no doctor is available. Others self-administer because their doctor will not prescribe hormones without a letter from a psychotherapist stating that the patient meets the diagnostic criteria and is making an informed decision to transition. Many therapists require at least three months of continuous psychotherapy and/or real-life experience before they will write such a letter. Because many individuals must pay for evaluation and care out-of-pocket, costs can be prohibitive.

Access to medication can be poor even where health care is provided free. In a patient survey conducted by the United Kingdom's National Health Service in 2008, 5% of respondents acknowledged resorting to self-medication, and 46% were dissatisfied with the amount of time it took to receive hormone therapy. The report concluded in part: "The NHS must provide a service that is easy to access so that vulnerable patients do not feel forced to turn to DIY remedies such as buying drugs online with all the risks that entails. Patients must be able to access professional help and advice so that they can make informed decisions about their care, whether they wish to take the NHS or private route without putting their health and indeed their lives in danger."[23] Self-administration of hormone replacement medications may have untoward health effects and risks.[24]

A number of private companies have attempted to increase accessibility for hormone replacement medications and help transgender people navigate the complexities of access to treatment. Plume is building a healthcare service specifically for the transgender community.[25] In September of 2020, Plume partnered[26] with Solace to expand accessibility and awareness of Gender-Affirming Hormone Therapy (GAHT). Solace is a mobile application focused on providing access to credible, relevant transition information and allowing users to create a custom transition roadmaps and goals.[27]

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Estrogen and Hormone Replacement Therapy: Is it Right for You?

Posted: July 21, 2021 at 2:44 am

Menopause is a natural biological process that all women experience at some point in their lives. During this time, your body goes through numerous changes as it adjusts to fluctuating hormone levels. The hormones that once existed in such vast amounts begin to dwindle as you pass childbearing years, and theyll continue to decrease throughout the rest of your life. These changes can cause symptoms, such as hot flashes, mood swings, and even depression.

Hormone replacement therapy (HRT) can make a big difference in counteracting these symptoms by replacing the diminished hormones in a natural way. However, HRT isnt without risks. In fact, it has been linked to an increased risk of breast cancer, heart disease, and stroke. You should carefully consider these risks before deciding if HRT is the best treatment option for your symptoms.

In the early years of HRT, doctors most often prescribed it in the form of synthetic prescription medications. These drugs are made from a blend of hormones isolated from a pregnant horses urine. Premarin is the synthetic form of estrogen, while Provera is the synthetic version of progesterone. Though synthetic drugs used to be the preferred HRT theyve become less popular in recent years. Some risks were identified in clinical trials that led many women to seek out an alternative form of HRT called bioidentical HRT.

In bioidentical HRT, a pharmacist mixes a special blend of hormones intended to replace the depleted hormones in your body. Bioidentical hormones are generally extracted from elements found in nature. Its believed that your body is unable to differentiate between these hormones and the natural hormones your body creates. This way of tricking your body into its former state has been shown to be successful in many women. However, medical researchers dont yet know exactly how much of each hormone is needed. As a result, bioidentical HRT may involve multiple doctor visits and frequent tests to find the level of HRT dosing thats right for you.

Since each dose varies from person-to-person, bioidentical hormones are difficult to test for safety and effectiveness on an overall basis. The lack of information on the risks of bioidentical hormones causes many women to assume that these natural hormones are better or safer than synthetic hormones.

However, the word natural is open to interpretation. Bioidentical hormones arent found in this form in nature. Rather, theyre made, or synthesized, from a plant chemical extracted from yams and soy. This same chemical is used in soy supplements, so bioidentical hormones are technically categorized as natural supplements. As a result, the U.S. Food and Drug Administration regulates them under a different set of rules than those covering prescription and over-the-counter drugs. This means that bioidentical hormones dont need to be rigorously tested in humans, making it hard to know whether theyre safe or effective. Though theres no definitive answer, most experts believe bioidentical HRT involves the same risks as synthetic HRT. Neither type of HRT is considered to be safer than the other.

In your childbearing years, your ovaries produce estrogen and progesterone. These hormones regulate your reproductive cycle and promote the bodys use of calcium. The ovaries decrease their production of these hormones as you age, which often results in:

HRT replenishes estrogen and progesterone levels in the body, helping to reduce these effects. This type of treatment comes with other benefits as well. In addition to easing the symptoms of menopause, HRT may also reduce your risk for diabetes, tooth loss, and cataracts. Many women are able to live a more productive and comfortable life after successful HRT treatments.

While some health benefits are linked to HRT, several risks are associated with it as well.

HRT has been connected to an increased risk for certain types of cancers, especially breast cancer. The studies that discovered a link between HRT and breast cancer refer to women being treated with synthetic HRT, not bioidentical HRT. However, there are no studies that show that bioidentical HRT is any safer than synthetic HRT. The risk of breast cancer increases the longer a woman engages in any type of HRT, and the risk decreases once HRT is stopped.

A higher risk for uterine cancer also exists when menopausal women with a uterus use estrogen HRT only. This is why doctors will generally prescribe progesterone along with estrogen. If youve had a hysterectomy, you can forego progesterone and simply take estrogen.

Other risks for women undergoing HRT include osteoporosis and stroke. Osteoporosis is particularly prevalent among postmenopausal women, which is why synthetic HRT is now mostly used for short-term relief of menopause symptoms. However, its important to note that the risks of osteoporosis exist in menopause without HRT.

Though there are risks involved with HRT, its still the best way to treat severe menopause symptoms and improve quality of life. You and your doctor can discuss the risks and benefits for you specifically and evaluate other treatment options. Its critical to work closely with your doctor so you can decide whats right for you.

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OPINION: Changing the myths, mystery and mortification around menopause – Atlanta Journal Constitution

Posted: July 21, 2021 at 2:44 am

ExploreMenopause affects both gray and white brain matter, study finds

By 2025, more than 1 billion women around the globe will be postmenopausal, according to the North American Menopause Society, and yet, while most women generally know what menopause is, the modern characterization of this transition as negative or mysterious has left them without a deeper understanding.

In some ways, that seems to be changing as conversation about menopause becomes more normalized. New products, books and communities are cropping up daily providing women with information and support through menopause. Dr. Jen Gunter, author of The Menopause Manifesto (Kensington, $18.95), said in an essay for The New York Times the time has come for a feminist menopause that rejects the patriarchal notion that a womans worth is tied to her ovarian function and that the end of her reproductive life represents the end of her productive life.

The femtech industry which refers to software and technology designed to address the health care needs of women is expected to reach almost $50 billion by 2025 and menopause management has high market potential as indicated by the explosion in startup companies focusing on the area.

Its hard to miss all the advertisements for products that claim to alleviate symptoms of menopause from the inside out. Supplements claiming to relieve hot flashes, sleep disturbances and mood swings are widely available but have little supporting evidence on their efficacy. Other products take a more general focus, such as skin creams or shampoos, specifically advertised to address the skin and hair concerns of women in perimenopause.

In the 1960s, estrogen replacement became the dominant regimen for treating menopause, but estrogen is not the wonder drug everyone thought it was, writes Susan Mattern, distinguished research professor of history at the University of Georgia and author of The Slow Moon Climbs (Princeton, $19.95), and while hormone replacement therapy may help with hot flashes, studies have revealed that it also comes with elevated risk of stroke, breast cancer, heart disease and more.

Most doctors advise short-term hormone replacement and only for severe symptoms, Mattern said, but when women are hyper-focused on physical symptoms that we attribute to menopause, they could be missing the bigger point.

Usually it is hard for me to listen to conversations about menopause because most of what people say about it is wrong, she said. We think of it as a medical condition and something you need to go to the doctor for. There has been an enormous amount of profit made off of menopause, selling drugs to women who think they are sick.

Because menopause can impact so many different systems in the body, addressing any concerns requires a multidisciplinary approach, one that doesnt place outsized importance on menopause as a physical transformation. I wish doctors would become more educated about what other disciplines are saying about menopause, said Mattern.

Menopause only became a subject of medical interest in Europe in the 18th century, said Mattern in her book, and our understanding of it rests on that most recent and somewhat faulty foundation. For most of human history, menopause has been seen as a developmental transition to an important stage of life something we should consider a solution rather than a problem, Mattern writes.

Why would animals outlive a time when they can reproduce copies of themselves? (Menopause) is something that has been important to the success of our species, said Mattern. Because women have a long post-reproductive life stage, humans across time have been able to rapidly populate while also controlling population size and managing resources.

So why do so many women seem to be in the dark about the changes to their bodies?

We dont talk about it because it is a mortifying subject, Mattern said. There is no reason to fear menopause and there is no reason to be embarrassed about it.

Part of changing the narrative means creating a space for women to talk about menopause in a more revolutionary manner than what has existed in the past.

About five years ago, Licia Freeman, a marriage and family therapist in Atlanta, created a 12-week menopause therapy group when she began attracting clients that mirrored what was happening in her own life.

It was not a group to just complain, Freeman said. It was about menopause but it merged into more existential topics what is going on in their lives outside of their bodies.

The women discuss careers and retirement, relationships, travel and how to manage it all during a perimenopausal and postmenopausal period that they are learning to reframe as a time and space for living life more passionately and freely. Freeman helps the women find skills to manage depression, anxiety and irrational thinking that may be exacerbated by the traditional messaging surrounding menopause.

There are so many necessary losses in life. We are constantly grieving something, said Freeman. The aim is to reach acceptance. (Menopause) is a stage of life with no limitation really.

Read more on the Real Life blog (www.ajc.com/opinion/real-life-blog/) and find Nedra on Facebook (www.facebook.com/AJCRealLifeColumn) and Twitter (@nrhoneajc) or email her at nedra.rhone@ajc.com

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