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Foundation Medicine and Dana-Farber Present Data at ASCO20 Showing that Comprehensive Genomic Profiling Identified Co-Occurring Alterations that May…

Posted: June 4, 2020 at 9:31 am

Alterations that cause skipping of exon 14 on the MET gene (METex14) are drivers of a type of lung cancer with a poor prognosis, but that is treatable with a recently approved MET inhibitor

Foundation Medicine, Inc. and Dana-Farber Cancer Institute presented new data highlighting the utility of comprehensive genomic profiling (CGP) to guide treatment decisions in patients with advanced non-small cell lung cancer (NSCLC) whose tumors also have an alteration that leads to MET exon 14 skipping (METex14). The results underscore the feasibility of tissue and liquid biopsy CGP to characterize common alterations that may be critical for predicting responses to MET inhibitors in patients with NSCLC. These data were presented in a clinical science symposium at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program.

NSCLC accounts for approximately 85% of lung cancer diagnoses, approximately 3% of which have MET exon 14 skipping.1,2 While METex14-altered NSCLC is sensitive to MET inhibition, alterations that co-occur with METex14 may cause treatment resistance to MET inhibitors.

In this analysis of more than 60,000 cases of advanced NSCLC, researchers characterized a subset of 1,387 of patients (2.3%) with METex14-altered NSCLC a prevalence consistent with previous research and identified multiple co-occurring alterations that may cause resistance to MET inhibitors.3,4,5,6 The study also identified six different subclasses of METex14 skipping alterations based on their location, illustrating the complexity of this cancer, which has a poor prognosis.7

"Diverse, co-occurring alterations in METex14 non-small cell lung cancer may correlate with primary or acquired resistance to treatment, so detecting these various alterations using comprehensive genomic profiling may be critical to predicting response to MET inhibitors," said lead study author Mark Awad, M.D., assistant professor of medicine at Harvard Medical School and clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. "These data underscore the urgent need to identify effective strategies to delay or overcome resistance to targeted therapies in METex14 mutant NSCLC."

Among 36 patients with paired tissue and liquid samples, potential resistance mechanisms to MET inhibition included 25% of patients with secondary MET alterations, 8% of patients with MET amplification and individual cases with acquired alterations in the EGFR, ERBB2, KRAS and the PI3K pathway were identified. Co-alterations and potential acquired resistance mechanisms appear largely independent of primary METex14 alteration subtype.

"This study emphasizes the importance of comprehensive genomic profiling in patients with METex14-altered NSCLC to facilitate precision medicine both earlier and throughout a patients treatment," said Brian Alexander, M.D., M.P.H, chief medical officer at Foundation Medicine and study co-author. "The study also adds more evidence that genomic testing through both tissue and liquid biopsy can be an important tool for monitoring for resistance alterations during treatment."

A full list of data being presented by Foundation Medicine and its collaborators, and more information about Foundation Medicines portfolio of CGP tests are available at http://comprehensivegenomicprofiling.com.

About METex14-altered Non-Small Cell Lung Cancer

NSCLC accounts for 80-85% of lung cancer diagnoses.1 Mutations that lead to skipping METex14, called skipping alterations, are oncogenic drivers in NSCLC. Approximately 3% of patients with NSCLC have MET exon 14 skipping.2 These tumors produce an altered form of the MET protein, which is a receptor tyrosine kinase that activates a wide range of cellular signaling pathways that can lead to cancer growth.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Story continues

Foundation Medicine is a registered trademark of Foundation Medicine, Inc.

Source: Foundation Medicine

1 American Cancer Society. About Lung Cancer. Available at https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed May 11, 2020.2 G.M. Frampton, S.M. Ali, M. Rosenzweig, et al.Activation of MET via diverse exon 14 splicing alterations occurs in multiple tumor types and confers clinical sensitivity to MET inhibitors. Cancer Discov, 5 (2015), pp. 850-8593 Characterization of 1,387 NSCLCs with MET exon 14 (METex14) skipping alterations (SA) and potential acquired resistance (AR) mechanisms. Abstract 9511.4 Sadiq AA, Salgia R. MET as a possible target for non-small-cell lung cancer. Journal of Clinical Oncology. 2013;31:1089-1096.5 Smyth EC, et al. Emerging molecular targets in oncology: clinical potential of MET/hepatocyte growth-factor inhibitors. Onco Targets and Therapy. 2014;7:1001-1014.6 Salgia R. MET in Lung Cancer: Biomarker Selection Based on Scientific Rationale. Molecular Cancer Therapeutics. 2017;16(4):555-565.7 Tong JH, et al. MET Amplification and Exon 14 Splice Site Mutation Define Unique Molecular Subgroups of Non-Small Cell Lung Carcinoma with Poor Prognosis. Clin Cancer Res 2016;22:3048-56.

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Contacts

Lee-Ann Murphy, 617-245-3077pr@foundationmedicine.com

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Foundation Medicine and Dana-Farber Present Data at ASCO20 Showing that Comprehensive Genomic Profiling Identified Co-Occurring Alterations that May...

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First-in-Class Antipsychotic Linked to Lower Cardiometabolic Risk – Medscape

Posted: June 4, 2020 at 9:31 am

A recently approved first-in-class antipsychotic appears to have fewer adverse cardiometabolic effects compared with standard care with risperidone, new research suggests.

In post hoc analyses of two short-term randomized controlled trials plus an open-label long-term study, patients with schizophrenia on lumateperone (Caplyta, Intra-Cellular Therapies Inc) had reduced rates of metabolic syndrome compared with their counterparts taking placebo or the antipsychotic risperidone.

In the short-term studies, rates of metabolic syndrome were similar between groups at baseline, but by the end of 4 and 6 weeks of treatment, 25% of patients taking lumateperone no longer met criteria for metabolic syndrome. A similar finding occurred in 36% of patients in the 1-year open label study.

Dr Andrew Satlin

"One of the major advantages that we found during the drug's development was that it has a very favorable profile with regard to changes in weight, and other [parameters] associated with cardiovascular disease risk, such as elevated glucose and lipids," study investigator Andrew Satlin, MD, chief medical officer at Intra-Cellular Therapies, New York City, told Medscape Medical News.

"So we went back to our data and looked to see whether the changes that we saw had an impact on either the development or the resolution of metabolic syndrome in the patients who came into our studies," he said.

The findings were presented at the American Society of Clinical Psychopharmacology (ASCP) 2020 Virtual Conference.

As reported by Medscape Medical News, lumateperone was approved in December by the US Food and Drug Administration (FDA). The drug acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.

The short-term studies included 511 patients randomly assigned to receive lumateperone 42 mg (n = 256 patients) or risperidone 4 mg (n = 255 patients).

At baseline, rates of metabolic syndrome were 16% in the lumateperone group and 19% in the risperidone group. At the end of treatment, metabolic syndrome was less common in the lumateperone group (13%) vs those receiving risperidone (25%).

In addition, 46% of lumateperone patients with metabolic syndrome at baseline no longer had it at the end of the study period. This compared with 25% of patients on risperidone.

More patients taking risperidone than on lumateperone developed metabolic syndrome during treatment (13% vs 5%).

The differences in metabolic syndrome conversion rates appeared to be driven by greater reductions in total cholesterol with lumateperone compared with risperidone (2.8 mg/dL with lumateperone vs 4.8 mg/dL with risperidone) and triglycerides (0.7 mg/dL with lumateperone vs 20.4 mg/dL with risperidone).

Greater increases in blood glucose were also seen with risperidone (7.7 mg/dL) than with lumateperone (0.9 mg/dL).

The long-term study included 602 patients with stable schizophrenia. All received lumateperone 42 mg, and 197 patients (33%) had metabolic syndrome at baseline.

At the end of the 1-year study, 72 of these patients (36%) no longer met criteria for metabolic syndrome.

"Lumateperone seems to be the safest antipsychotic we have seen so far," Christoph Correll, MD, professor of child and adolescent psychiatry, Charit Universitatsmedizin, Berlin, Germany, who was also involved in clinical trials of lumateperone, told Medscape Medical News.

Dr Christoph Correll

"It seems to be very safe when it comes to cardiometabolic parameters, and it shows similar reduction in symptoms as risperidone. It is certainly an agent one should consider, particularly when a patient cannot tolerate other medications or may not be in full adherence," said Correll, who has a joint appointment as professor of psychiatry and molecular medicine at the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York.

The drug's safety and efficacy profile would make it a good candidate in patients initiating antipsychotic treatment, but reimbursement issues may be a barrier, at least for now, he added.

He said that the drug may prevent the onset of metabolic side effects and added that once payers are willing to reimburse the drug it should become the "first-line standard of care."

It is well known that atypical antipsychotics are associated with adverse and rapid metabolic changes. Correll noted that particularly early-phase and first-episode patients can be "very sensitive" to the side effects of these drugs and often experience rapid weight gain and other adverse metabolic changes. Lumateperone, he added, may help avoid some of this cardiometabolic risk.

Commenting on the findings for Medscape Medical News, Jessica M. Gannon, MD, a psychiatrist at the University of Pittsburgh in Pennsylvania, said the drug's favorable metabolic profile has previously been reported.

She also noted that there has been some interest in lumateperone due to possible "downstream effects on NMDA-type glutamate receptor activity, a larger binding ratio at D2:5HT1A receptors than other atypical antipsychotics, and presynaptic D2 partial agonism and a postsynaptic D2 antagonism."

"This latter feature may explain the reported low extrapyramidal symptom incidence in the clinical trials," she said .

"While I think future studies and clinical use can help determine how clinically efficacious this medication will be for our patients when compared to others on the market, its favorable metabolic and EPS profile do make it of interest," added Gannon, who was not involved in researching the drug.

The study was funded by Intra-Cellular Therapies. Satlin is chief medical officer of Intracellular Therapies. Correll has been a consultant or advisor to and has received honoraria from Acadia, Alkermes, Allergan, Angelini, Axsome, Gedeon Richter, Gerson Lehrman Group, Intra-Cellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, Medscape, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Sumitomo Dainippon, Sunovion, Supernus, Takeda, and Teva.

American Society of Clinical Psychopharmacology (ASCP) 2020: Abstract 3002348. Presented May 30, 2020.

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Ferring and Igenomix Collaborate to Advance Care in Reproductive Medicine and Maternal Health – Business Wire

Posted: June 4, 2020 at 9:31 am

SAINT-PREX, Switzerland & VALENCIA, Spain--(BUSINESS WIRE)--Ferring Pharmaceuticals and Igenomix today announced a two-year research collaboration aimed at the discovery of novel targets and disease mechanisms in infertility and pregnancy-related conditions, including preeclampsia, with the goal of developing innovative diagnostic and therapeutic strategies in these areas of high unmet need.

A new research hub will be created in Boston, bringing together scientists and expertise from both companies. The hub will focus on investigating molecular signatures, developing novel functional genomic systems and creating translational tools to study for embryo implantation, endometrial microbiome interaction and decidualization biology to drive innovative solutions for patients.

Today, 1 in 6 couples worldwide are affected by fertility issues, with embryo implantation being a critical step to improving success rates in assisted reproduction technologies (ART) such as IVF. Furthermore, between 3 and 5% of all pregnancies are affected by preeclampsia,1 a severe complication which increases the morbidity and mortality of both mother and baby, said Joan-Carles Arce, Senior Vice President of Reproductive Medicine and Maternal Health, Ferring. Through this collaboration, we aim to advance diagnostic testing and the discovery of candidate drug targets in these areas of high unmet need and ultimately help more people build healthy families worldwide.

This new research hub will connect Igenomixs unique diagnostic capabilities with Ferrings deep therapeutic expertise, said Professor Carlos Simn, Head of Scientific Board of Igenomix Foundation and Project Lead for the new hub. We believe this collaboration will accelerate scientific findings and improve conception rates at a time when significant progress is needed in preimplantation science to help more women and families experience healthy pregnancies.

ENDS

About Fertility Issues

The World Health Organization defines infertility as a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. Today, 1 in 6 couples worldwide are affected by fertility issues. Assisted Reproductive Technologies (ART) such as In Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI) can help couples who have problems conceiving naturally.

About Preeclampsia

Preeclampsia is a common and severe complication of pregnancy characterised by high blood pressure and multiple organ failure. It affects between 3% and 5% of all pregnancies in the US.1 There is a significant unmet need for an effective treatment for preeclampsia; currently the only treatment is delivery of the baby.

Preeclampsia is responsible for approximately 20% of all preterm births2 and increases the morbidity and mortality of both mother and baby, especially in developing countries. An effective treatment would bring significant improvements in global infant and maternal health.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at http://www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

About Igenomix

Igenomix is a biotech company based in Valencia, Spain, specialized in reproductive genetics. Its expertise in fertility and its advanced research capacity situates the company as a worldwide referent in this area. Igenomix has 23 laboratories across the world and employs more than 400 professionals. Since the company launch in 2010, Igenomix has published more than 450 scientific papers and its communications have taken place during high level congresses such as ESHRE (European Society of Human Reproduction) or ASRM (American Society for Reproductive Medicine). Igenomix researchers have received numerous awards recognizing research and many of them share their knowledge and knowhow in leading US universities such as Stanford or Harvard.

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Structural Biology and Molecular Modeling Techniques Market Size, Application, Region and Growth Forecast 2017-2025 – 3rd Watch News

Posted: June 4, 2020 at 9:31 am

Structural Biology and Molecular Modeling Techniques Market: Overview

The global structural biology and molecular modeling techniques market is a novel conception in the global healthcare sector and has already made key contributions in obtaining remedies to a number of diseases. The structural biology and molecular modeling field is concerned with how various molecules in biological compounds are arranged and how the peculiarity of the arrangement affects the nature of the compound. The field also studies how alterations in the structure of the compounds affect their nature and how the position of each part of the structure is linked to the overall nature of the compound.

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The structural biology and molecular modeling techniques market has significant potential due to the rising prevalence of chronic diseases. Improving the quality of medicine and healthcare in general has been a key focus of governments across the world in recent years due to the rising volume of patient demographics and the growing geriatric population. This has driven consistent investment in the medical research in recent years, making steady development of the structural biology and molecular modeling techniques market likely in the near future.

North America is likely to remain the leading regional market for structural biology and molecular modeling techniques in the coming years due to the strong emphasis on the widespread incorporation of healthcare IT and the presence of strong investment channels for the medical research field as well as several key healthcare industry players. The presence of advanced technological framework supporting research in complementary areas of the structural biology and molecular modeling techniques market, such as genomics, is also likely to be a key driver for the North America structural biology and molecular modeling techniques market in the coming years.

Global Structural Biology and Molecular Modeling Techniques Market: Snapshot

The global structural biology and molecular modeling techniques market has been thriving due to the high prevalence of chronic diseases. The market is also gaining a strong foothold across the globe as treating these diseases is becoming increasingly difficult due to the acquired drug resistance. In the light of these developments, research and development activities using structural biology and molecular modeling techniques have been in full swing. The increasing focus on improving the quality of medicines and ensuring patient recovery and safety has augmented the demand for various structural biology and molecular modeling techniques. The demand for these techniques is projected to soar as the need to reduce drug failure is an immense one amongst healthcare institutes.

The report answers questions pertaining to the size of the global market by the end of the forecast period, leading segments, and players amongst others. The report is a comprehensive outlook of the global market and it presents key market insights for readers with absolute objectivity.

Global Structural Biology and Molecular Modeling Techniques Market: Drivers and Trends

The rapid pace of technological developments and innovations have been exceptionally supportive of the global market over the past few years. Both these aspects have authenticated the sophisticated models that help in the accurate determination of cellular interactions and function, which in turn helps in identifying the problem area and a subsequent solution. The wide range of structural biology and molecular modeling techniques are expected to find tremendous scope in the area of drug discovery. These techniques will prove to be important in identifying the missing pieces that limit the process of drug discovery, thereby resulting in high success rates.

Adoption of these techniques in pharmacogenomics and pharmacogenetics are also expected to prove beneficial to the overall growth of the market. Analysts project that increasing incidences of diseases where several drugs cannot be administered to the patient will prove to be a lucrative ground for the global structural biology and molecular modeling techniques market.

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Global Structural Biology and Molecular Modeling Techniques Market: Regional Outlook

Spread over regions such as North America, Asia Pacific, the Middle East and Africa, Europe, and Latin America, the global structural biology and molecular modeling techniques market has truly made its market in North America. The higher understanding of diseases and empathy toward managing them with supportive regulatory policies has been North Americas winning strategy for the past few years. Increasing funding for research and development of novel drugs is expected to favor this regional markets growth in the coming years as well.

On the other hand, increasing expenditure on IT, healthcare infrastructure, and research organizations in Asia Pacific is also expected to open up new avenues for growth for the overall market. Furthermore, the rising standard of living of people in developing countries, improving GDPs, and better access to healthcare are also expected to fuel the demand for structural biology and molecular modeling techniques in Asia Pacific.

Global Structural Biology and Molecular Modeling Techniques Market: Competitive Landscape

The key players identified by the research analysts are Dassault Systemes, Agile Molecule, Acellera Ltd., Bioinformatic LLC, Affymetrix, Agilent Technologies, Inc., Illumina, Bruker Daltonics Inc., Biomax Informatics AG, Chemical Computing Group, and CLC bio. The report points out that the global market is expected to witness intense competition in the coming years. However, to stay ahead of the competition, several players are expected to focus on mergers and acquisitions, investments for novel drug development, and technological advancements.

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About TMR Research

TMR Research is a premier provider of customized market research and consulting services to busi-ness entities keen on succeeding in todays supercharged economic climate. Armed with an experi-enced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Structural Biology and Molecular Modeling Techniques Market Size, Application, Region and Growth Forecast 2017-2025 - 3rd Watch News

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ViralClear to Host Conference Call on June 9th to Discuss Upcoming and Recent Developments for Phase II Human Clinical Trials of its Broad-Spectrum…

Posted: June 4, 2020 at 9:31 am

Westport, CT, June 01, 2020 (GLOBE NEWSWIRE) --

BioSig Technologies, Inc. (Nasdaq: BSGM) (BioSig” or the Company”) and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it will host a call to discuss the Phase II clinical trials of merimepodib, its broad-spectrum oral anti-viral candidate for the treatment of COVID-19 in adult patients.

The format will be a management presentation updating recent developments followed by a Q&A session with select call attendees.

Conference Call Details: Date: Tuesday, June 9, 2020 Time: 11:00 AM Eastern Time (ET) Dial in Number for U.S. Callers: 1-877-407-8293 Dial in Number for International Callers: 1-201-689-8349

A replay will be available for two weeks starting on June 9, 2020 at approximately 2:00 PM ET. To access the replay, please dial 1-877-660-6853 in the U.S. and 1-201-612-7415 for international callers. The conference ID# is 13704617.

On May 14, 2020, an article titled, "The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro" was published by F1000 Research, an online peer-reviewed life sciences journal publishing program in biology and medicine. The article cites that merimepodib in combination with remdesivir decreases viral production of SARS-CoV-2 to undetectable levels in pre-clinical testing.

On May 18, 2020, ViralClear announced the FDA’s clearance of its IND to proceed with a proposed Phase II study of merimepodib in COVID-19 patients. The human clinical trial is planned to be conducted under the leadership of Dr. Andrew D. Badley, Professor and Chair of the Department of Molecular Medicine and the Enterprise Chair of the COVID-19 Task Force at Mayo Clinic.

About BioSig Technologies BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

About Merimepodib (MMPD) Merimepodib, a broad-spectrum anti-viral candidate, has demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials conducted (including 315 chronic hepatitis C patients, 24 psoriasis patients, and 98 healthy volunteers) and an extensive preclinical safety package completed.

A manuscript titled, The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro”, was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. (ViralClear”) as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch.

About ViralClear BioSig’s subsidiary, ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical to treat COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against COVID-19 in cell cultures. Merimepodib has been previously studied in 12 clinical trials, including 5 in patients with hepatitis C (1 Phase 1b, 1 Phase 2, 2 Phase 2a, and 1 Phase 2b), 1 in patients with psoriasis (Phase 2), and six in healthy volunteers (Phase I).

Forward-looking Statements This press release contains forward-looking statements.” Such statements may be preceded by the words intends,” may,” will,” plans,” expects,” anticipates,” projects,” predicts,” estimates,” aims,” believes,” hopes,” potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

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Molecular Medicine Spa hits 52w high but will it continue? – Stockopedia

Posted: June 4, 2020 at 9:31 am

It's a good time to be a shareholder inMolecular Medicine Spa (BIT:MLM): as the share approaches its 52-week high, holdersmay be wonderingwhether to sell and take the profit,or buy more and ride the uptrend.

Shares inMolecular Medicine Spaare currently trading close to a 52 week high, with the share price up by around2.75%to0.503over the past month.

For investors holding the stock (or considering buying it), the question is: what now?

52-week highs are a popular market indicator. But research shows investors can be left wondering what to do when it happens when a 52-week high is hit. Heres a primer on what the academic research says...

GET MORE DATA-DRIVEN INSIGHTS INTO BIT:MLM

52 week highs are always good news. But surprisingly, the prices of high performing shares can be slow to move when they publish positive earnings news.

Research shows thishappens because investors are cautious about bidding high performing shares any higher (even if they deserve it). Psychologists call thisanchoring. As humans, we tend to take our time when it comesto changing our opinions in the face of new information - even when it's good news.

This emotional tug-of-war often ends with the new high stock drifting higher in price over the coming weeks and months.The upward trend is called post earnings announcement drift. As the news sinks in, momentum takes over and the price moves higher.

A look at Molecular Medicine Spas StockReport could offer more insight into whats driving the momentum in its share price - and whether that might continue.

WithMolecular Medicine Spa trading close to its52 week high, its possible that investors in the market are uncertain about whether to buy, hold or sell it. This uncertainty can cause erratic pricing in the short-term before momentum takes over - and its worth considering this before making your own trading decision.

To find more stocks that are trading close to their 52 week highs, you can explore this constantly updated 52 Week Highs screen, which covers all the new highs in the market.

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Molecular Medicine Spa hits 52w high but will it continue? - Stockopedia

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Excellent growth of Human Embryonic Stem Cells Market- Comprehensive study by key players: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell…

Posted: June 4, 2020 at 9:30 am

Ample Market Research has recently published a report Human Embryonic Stem Cells Market . The key objective of this report is to highlight various trends and dynamics, new and innovative technology and mergers and acquisitions that are expected to make a positive impact on the overall industry. This report studies the Human Embryonic Stem Cells market size (value and volume) by players, regions, product types and end industries, history data 2014-2018 and forecast data 2019-2025; This report provides a detailed analysis of the prospects for the global Human Embryonic Stem Cells industry up to 2024, including an assessment of the impact of COVID-19.

To know How COVID-19 Pandemic Will Impact This Market/Industry -Request a sample copy of the report: https://www.amplemarketreports.com/sample-request/global-human-embryonic-stem-cells-market-1731516.html

Human Embryonic Stem Cells Market Latest Research Report 2018- 2025 covers a complete market structure across the world with a detailed industry analysis of major key factors. This report provides strategic recommendations consulted by the industrial experts including market forecasts, profit, supply, raw materials, manufacturing expenses, the proportion of manufacturing cost structure, latest market trends, demands and much more.

Global Human Embryonic Stem Cells Market is valued approximately USD XX billion in 2019 and is anticipated to grow with a healthy growth rate of more than XX% over the forecast period 2020-2026. Due to COVID-19 pandemic, the market is facing challenges because of government protocols to stay at home across the world. Human Embryonic Stem Cells (hESCs) are derived from blastocyst and are capable of differentiating into number of cell types that make up the human body as well as it replicates indefinitely and produce non-regenerative tissues such as neural and myocardial cells. They are used in treating a number of blood and genetic disorders related to the immune system, cancers, and disorders as well as used in investigational studies of early human development, genetic diseases and toxicology testing. The technological advancement involving stem cells therapy, rising demand for regenerative medicines, R&D in toxicology testing, technological advancements for the production of embryonic stem cells through alternative methods and increasing prevalence of genetic disorders are the few factors responsible for growth of the market over the forecast period. Furthermore, the introduction of innovative products and other strategic advancements by market players will create lucrative opportunities for the market. For instance, as per companys news release in January 2019, Stemcell Technologies Inc. launched mTeSRl Plus, an enhanced version of mTeSR1. mTeSR Plus is the stabilized feeder-free maintenance medium for human embryonic stem (ES) and induced pluripotent stem (iPS) cells. However, ethical concern related to stem cell research is the major factor restraining the growth of global Vegetable Chips market during the forecast period.

The regional analysis of global Human Embryonic Stem Cells market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. Asia Pacific is the leading/significant region across the world due to the presence of several prominent entities incorporated in the U.S. Whereas, Asia-Pacific is also anticipated to exhibit highest growth rate / CAGR over the forecast period 2020-2026.

This report discusses the key drivers influencing Human Embryonic Stem Cells market growth, demand, the challenges and the risks faced by key players and the market as a whole. It also analyzes key emerging trends and their impact on current and future development.

Human Embryonic Stem Cells market report presents the market competitive landscape and a corresponding detailed analysis of the major vendor/manufacturers in the market.

Key players analyzed in the Human Embryonic Stem Cells Insight Report: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell Technologies Inc., Biotime, Inc. / Cell Cure Neurosciences LTD, Thermo Fisher Scientific, Inc., CellGenix GmbH, ESI BIO, PromoCell GmbH, Lonza Group AG, Kite Pharma, Cynata Therapeutics Ltd.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.

Browse Detailed TOC, Tables, Figures, Charts And Companies Mentioned In Human Embryonic Stem Cells Market Research Report At: https://www.amplemarketreports.com/report/global-human-embryonic-stem-cells-market-1731516.html

Strategic Points Covered in Table of Contents

Study Coverage: It includes key manufacturers covered, key market segments, the scope of products offered in the global Conductive Nylon market, years considered, and study objectives. Additionally, it touches the segmentation study provided in the report on the basis of the type of product and application.

Executive Summary: It gives a summary of key studies, viz. production, market growth rate, competitive landscape, market drivers, trends, and issues, and macroscopic indicators.

Production by Region: Here, the report provides information related to import and export, revenue, production, and key players of all regional markets studied.

Profile of Manufacturers: Each player profiled in this section is studied on the basis of SWOT analysis, their products, production, value, capacity, and other vital factors.

Market Size by Manufacturer

Consumption by Region

Market Size by Type,by Application

Production Forecast and Consumption Forecast

Industry Chain, Upstream, and Downstream Customers Analysis

Key Findings, Opportunities and Challenges, Threats, and Affecting Factors

Appendix

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In the end, this report additionally presents product specification, producing method, and product cost structure. Production is separated by regions, technology, and applications. The Human Embryonic Stem Cells Market report includes investment come analysis and development trend analysis. The key rising opportunities of the fastest growing international Human Embryonic Stem Cells industry segments are coated throughout this report. This report provides information about the import, export, consumption and consumption value. The report then provides one of the most crucial aspects of the Human Embryonic Stem Cells Market the forecast for the next five to six years based on the previous as well as current data.

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Excellent growth of Human Embryonic Stem Cells Market- Comprehensive study by key players: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell...

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Cell Expansion Market Worth $39.7 Billion by 2027 l CAGR 9.4%: Grand View Research, Inc. – PRNewswire

Posted: June 4, 2020 at 9:30 am

SAN FRANCISCO, June 3, 2020 /PRNewswire/ --The global cell expansion marketsize is expected to reach USD 39.7 billion by 2027 registering a CAGR of 9.4%, according to a new report by Grand View Research, Inc. Cell expansion techniques are increasingly employed for the development of cellular and gene therapies from a single cord blood collection. These techniques can also be used for the expansion of stored Stem Cells (SCs) for the development of cancer therapies. Therefore, significant developments in cord blood SCs expansion technologies are expected to boost market growth.

Key suggestions from the report:

Read 170 page research report with ToC on "Cell Expansion Market Size, Share & Trends Analysis Report By Product (Instruments, Consumables), By Cell Type (Mammalian, Animal), By Application, By End Use, And Segment Forecasts, 2020 - 2027" at: https://www.grandviewresearch.com/industry-analysis/cell-expansion-market

Companies have made heavy investments for the expansion of tissue-engineered products and the development of biologics. For instance, in March 2019, Merck KGaA invested USD 168 million for the expansion of its biologics manufacturing facility in Switzerland. Such initiatives are expected to boost the demand for solutions required for biologic development, thereby leading to market growth.

Bioreactors are fundamental tools in this market. Extensive research studies related to the applications of bioreactor engineering approaches have led to the incorporation of novel culture technologies. Moreover, the combined use of automated bioreactors with the microcarrier technology leads to an efficient expansion and enrichment of the cancer SCs. As a result, these approaches have gained immense traction in this market.

Grand View Research has segmented the global cell expansion market on the basis of product, cell type, application, end use, and region:

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About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

Contact:Sherry JamesCorporate Sales Specialist, USAGrand View Research, Inc.Phone: 1-415-349-0058Toll Free: 1-888-202-9519Email: [emailprotected] Web: https://www.grandviewresearch.com Follow Us: LinkedIn | Twitter

SOURCE Grand View Research, Inc.

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Highlights of Current Research on Leukemia, MDS, and Allotransplant – Pharmacy Times

Posted: June 4, 2020 at 9:30 am

At the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, speaker Leslie R. Ellis, MD, MSHPEd, FACP, associate professor of medicine, Wake Forest Baptist Health, Comprehensive Cancer Center Winston-Salem, discussed the results of studies in a session looking into current research on leukemia, myelodysplastic syndromes (MDS), and allotransplant.1

Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax

The first study discussed was the phase 1b/2 trial looking into the adverse effects and dosing of venetoclax when paired with ivosidenib, with or without being paired with azacitidine additionally. These treatments were used with participants in the study who had IDH1-mutated hematologic malignancies.1,2

The results demonstrated that venetoclax and ivosidenib may stop cancer cell growth by blocking some of the enzymes necessary for cell growth. In chemotherapy, drugs such as azacytidine work differently by hindering growth of cancer cells through either killing the cells, stopping them from dividing, or stopping them from spreading.1,2

The researchers found that treatment with ivosidenib and venetoclax with azacitidine may be more effective when treating patients with IDH1-mutated AML, compared with ivosidenib and venetoclax alone. Ellis added that the results demonstrated that further follow up and accrual would be ongoing in order to better define the duration and biomarkers of response in patients.1,2

OPTIC Study of Ponatinib for Chronic Phase-CML

The second study discussed in the session was the phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial evaluating response-based dosing regimens of ponatinib over a range of 3 starting doses (45 mg, 30 mg, 15 mg).1,3

The aim of the study was to optimize the treatments efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who were found to be resistant or intolerant to tyrosine kinase inhibitor therapy.1,3

With median follow-up time of approximately 21 months, data from the interim analysis demonstrated that the optimal benefit-risk profile for ponatinib in patients with CP-CML was observed at a daily starting dose of 45 mg followed by a reduction to 15 mg after achieving 1% BCR-ABL1. Following this dose reduction to 15 mg/day, the optimal benefit to treatment was demonstrated to be maintained by patients. This dosing regimen was also found to result in an adjudicated arterial occlusive event rate of 5.3%.1,3

Ellis explained that the complete primary analysis of the trial will occur after all patients are able to have at least 12 months of follow-up, with the resulting data being presented following this occurrence.1,3

Pediatric Disease Risk Index for Allogeneic Stem Cell Transplantation

In the final study discussed during the session, Ellis presented a recently developed validated pediatric disease risk index (p-DRI) for acute myeloid (AML) and acute lymphoblastic leukemia (ALL) that provides a stratification of children receiving allogeneic hematopoietic cell transplantation for prognostication.1,4

Characteristics such as disease, disease status, and cytogenetic abnormalities are known to effect relapse and survival in patients following transplantation for AML and ALL. It has previously been observed in adults that these attributes can be used to develop a disease risk index for survival. For this reason, the analysis conducted was aimed to develop and validate a p-DRI.1,4

Patients who were younger than 18 years with AML and ALL transplanted between 2008 and 2017 in the United States were eligible for the p-DRI, with separate analyses performed for both AML and ALL. Each patient was randomly assigned to a training and validation cohort.1,4

In order to select significant variables, the researchers used the Cox proportional hazards model with stepwise selection. The primary outcome was leukemia-free survival (LFS).1,4

There were 4 risk groups identified for AML and 3 risk groups for ALL. The probabilities over 5 years of LFS for AML were 81%, 56%, 44%, and 21% for good, intermediate, high, and very high-risk groups, respectively. For ALL, the probabilities over 5 years of LFS for ALL were 68%, 50%, and 15% for good, intermediate, high risk groups, respectively.1,4

Ellis explained that based on these results, the researchers were able to validate that the p-DRI effectively stratified children with AML and ALL for prognostication undergoing allogeneic transplantation.1,4

REFERENCES

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MSC Therapy for Acute Respiratory Distress Syndrome; It’s Time to Accelerate Clinical Trials for COVID-19 Patients in Need – P&T Community

Posted: June 4, 2020 at 9:30 am

WASHINGTON, June 3, 2020 /PRNewswire/ --A new systematic review and meta-analysis of clinical studies using mesenchymal stromal cells (MSCs) led by a team at the Mayo Clinic, and including researchers from Emory, Duke, Case-Western, and the University of Miami, shows a trend toward improved outcomes and reduced mortality for patients with acute respiratory distress syndrome (ARDS), a major complication for patients with COVID-19. This studyand several othersalso have shown that MSCs are safe for patients.

Based on these findings, the authors call for the rapid commencement of large-scale, confirmatory clinical trials to build on the existing evidence base, which shows a trend toward improved pulmonary function and reduced severe lung inflammation for patients with ARDS, paving the way toward another treatment option for seriously ill patients with COVID-19.

To date, nearly two million Americans have tested positive for COVID-19 and more than 100,000 Americans have died. In its most severe form, COVID-19 leads to ARDSa life-threatening lung injury that allows fluid to leak into the lungs and makes it difficult for patients to breathe. More than 40 percent of individuals hospitalized for severe and critical COVID-19 develop ARDS, and 22 percent to 62 percent of those who are diagnosed and become critically ill, die from the disease. There is no effective treatment for ARDS today; MSCs potentially offer a unique therapeutic option to help patients in need.

"The analysis shows a positive trend in outcomes when treating ARDS patients with MSC therapy and represents the potential to save thousands of patients with COVID-19 induced ARDS," said Wenchun Qu, MD, PhD of the Mayo Clinic and first author of the paper. "The potential benefitcombined with the demonstrated safety of these therapiessupports the need for rapid commencement of more clinical trials."

"Acute respiratory distress syndrome is a rapidly progressive disease that can occur in critically ill patients," said Anthony Atala, MD, Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. "Having additional potential therapies, such as MSCs, could be highly beneficial to patients with COVID-19."

To date, the FDA has approved more than a dozen investigational new drug applications for the use of MSCs for COVID-19-related conditions. The National Institutes of Health (NIH) has also supported the use of MSCs and other regenerative cell therapies to help patients with other conditions. The bipartisan 21st Century Cures Act provided $30 million in funding to the NIH over three years for clinical research for such therapies. However, these limited investments expire in fiscal year 2020.

The Alliance for Cell Therapy Now and the Regenerative Medicine Foundation support the recommendation of the authors, who urge funding for larger studies that build on the results to date. Collaboration and funding are also needed to collect and analyze the evidence from multiple ongoing and new studies, to better evaluate outcomes and potential benefits of MSC therapy for COVID-19 patients in need. A portion of the more than $10 billion in funding directed by Congress to the Biomedical Advanced Research and Development Authority (BARDA) and the NIH for COVID-19 should be used to support these goals.

About the Alliance for Cell Therapy Now

Alliance for Cell Therapy Now (ACT Now) is an independent, non-profit organization devoted to advancing the availability of and access to safe and effective cell therapies for patients in need. ACT Now convenes experts and stakeholders to develop and advance sound policies that will improve the development, manufacturing, delivery, and improvement of regenerative cell therapies. See http://allianceforcelltherapynow.org/

About the Regenerative Medicine Foundation

The non-profit Regenerative Medicine Foundation (RMF) fosters strategic collaborations to accelerate the development of regenerative medicine to improve health and deliver cures. RMF pursues its mission by producing its flagship World Stem Cell Summit, honoring leaders through the Stem Cell and Regenerative Medicine Action Awards, and promoting educational initiatives. STEM CELLS Translational Medicine is RMF's official journal partner. See https://www.regmedfoundation.org/

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SOURCE Alliance for Cell Therapy Now

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