Clinical trials

Applied Biology and Corpometria Institute Receive National IRB Approval to Study a Potential Breakthrough Therapy for COVID-19

Tuesday, September 22, 2020 - 7:33pm

An Insight into a Potential New Therapy (doi: 10.1111/dth.13365), elucidates the possible role of androgens in controlling the infectivity of SARS-CoV-2 in human lung cells.

Key Points: 
  • An Insight into a Potential New Therapy (doi: 10.1111/dth.13365), elucidates the possible role of androgens in controlling the infectivity of SARS-CoV-2 in human lung cells.
  • The study on the effects of proxalutamide on COVID-19 has received national IRB approval and will be conducted in Brasilia, Brazil, in non-hospitalized patients with mild-to-moderate COVID-19 disease.
  • Founded in 2002, Applied Biology, Inc. ( www.appliedbiology.com ), headquartered in Irvine, California, is a biotechnology company specializing in hair and skin science.
  • Applied Biology develops breakthrough drugs and medical devices for the treatment of androgen mediated dermatological conditions.

Humanigen Announces Closing of Public Offering of Common Stock

Tuesday, September 22, 2020 - 7:00pm

Humanigen, Inc. (Nasdaq: HGEN), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate lenzilumab, announced today that it has completed its previously announced underwritten public offering of common stock.

Key Points: 
  • Humanigen, Inc. (Nasdaq: HGEN), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate lenzilumab, announced today that it has completed its previously announced underwritten public offering of common stock.
  • J.P. Morgan and Jefferies acted as joint book-running managers for the offering.
  • Bryan, Garnier & Co. acted as the European lead manager and National Securities Corporation, Roth Capital Partners and H.C. Wainwright & Co. acted as co-managers for the offering.
  • The offering was made only by means of the written prospectus and prospectus supplement that form a part of the registration statement.

Canada Exercises Increased Option for 20 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

Tuesday, September 22, 2020 - 5:22pm

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Canadian Government has increased its confirmed order commitment to 20 million doses of Modernas vaccine candidate against COVID-19, mRNA-1273.

Key Points: 
  • Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Canadian Government has increased its confirmed order commitment to 20 million doses of Modernas vaccine candidate against COVID-19, mRNA-1273.
  • This support, along with that of our stakeholders, drives us forward as we scale-up our global manufacturing and distribution network.
  • Moderna remains on track to be able to deliver up to 56 million doses of its COVID-19 vaccine to help protect Canadians beginning in 2021.
  • Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.

Geneva Biotech Announces SARS-CoV-2 Antiviral Pipeline Based on Ground-Breaking Discovery Published in Science Magazine

Tuesday, September 22, 2020 - 5:11pm

Geneva Biotech today announced a SARS-CoV-2 therapeutics platform, based on a ground-breaking discovery that revealed mechanisms driving the high infectivity, broad tissue tropism and severe pathology of the virus that causes COVID-19.

Key Points: 
  • Geneva Biotech today announced a SARS-CoV-2 therapeutics platform, based on a ground-breaking discovery that revealed mechanisms driving the high infectivity, broad tissue tropism and severe pathology of the virus that causes COVID-19.
  • The virus uses Spike to attach to human cells, allowing it to invade and start replicating, causing widespread damage.
  • An international team of scientists including Geneva Biotech co-founders Daniel Fitzgerald and Imre Berger now published a seminal study in Science Magazine demonstrating that the omega-6 fatty acid linoleic acid is a key component of the SARS-CoV-2 Spike, and that linoleic acid binding to Spike significantly decreases SARS-CoV-2 infectivity.
  • For more information on Geneva Biotechs SARS-CoV-2 therapeutics platform and associated intellectual property estate: Pipeline
    View source version on businesswire.com: https://www.businesswire.com/news/home/20200922005835/en/

ViralClear Expands Ongoing Phase 2 Trial Size for its Oral Anti-Viral for the Treatment of COVID-19, Expands Trial Locations and Appoints Contract Manufacturing Organization to Manufacture Phase 3 Supplies of Merimepodib Oral Solution

Tuesday, September 22, 2020 - 3:55pm

The size of the ongoing randomized, double-blind, placebo-controlled Phase 2 trial of merimepodib in combination with remdesivir is being increased from 40 to 80 subjects.

Key Points: 
  • The size of the ongoing randomized, double-blind, placebo-controlled Phase 2 trial of merimepodib in combination with remdesivir is being increased from 40 to 80 subjects.
  • However, based on a review of blinded data from the ongoing trial, subjects with scores of 3 and 4 are showing distinct differences.
  • The merimepodib monotherapy trial to be conducted in the outpatient setting will be initiated after the completion of the current Phase 2 combination trial.
  • Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133

TPG Forms Ellodi Pharmaceuticals to Continue Clinical Development of APT-1011 for Treatment of Eosinophilic Esophagitis

Tuesday, September 22, 2020 - 3:00pm

Ellodi Pharmaceuticals is dedicated to the clinical development of APT-1011, a novel therapy in Phase 3 development for the treatment of Eosinophilic Esophagitis (EoE) spun-out of Adare Pharmaceuticals (Adare).

Key Points: 
  • Ellodi Pharmaceuticals is dedicated to the clinical development of APT-1011, a novel therapy in Phase 3 development for the treatment of Eosinophilic Esophagitis (EoE) spun-out of Adare Pharmaceuticals (Adare).
  • The formation of Ellodi Pharmaceuticals follows TPG Capitals sale of Adares specialty CDMO pharmaceutical technology and microbiome businesses to Thomas H. Lee Partners and Frazier Healthcare Partners.
  • Our clinical data provide diagnostic, histologic, and patient-reported evidence of safety and efficacy in the treatment of the eosinophilic esophagitis.
  • As part of the announcement, Adares Global Head of Specialty Pharma, Troy Hamilton, will assume the role of Ellodi Pharmaceuticals CEO.

Jasper Therapeutics Doses First Patient in Phase 1 Clinical Trial of JSP191 as Conditioning Agent for Patients with Myelodysplastic Syndromes/Acute Myeloid Leukemia Undergoing Hematopoietic Cell Transplantation

Tuesday, September 22, 2020 - 3:00pm

The trial is evaluating JSP191 as a conditioning agent in patients with two types of hematologic disorders myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) who are undergoing blood or hematopoietic cell transplantation.

Key Points: 
  • The trial is evaluating JSP191 as a conditioning agent in patients with two types of hematologic disorders myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) who are undergoing blood or hematopoietic cell transplantation.
  • JSP191 is also being evaluated in a Phase 1 study in patients with MDS or acute myeloid leukemia (AML) who are receiving hematopoietic cell transplant.
  • The companys lead compound, JSP191, is in clinical development as a conditioning antibody that clears hematopoietic stem cells from bone marrow in patients undergoing a hematopoietic cell transplant.
  • This first-in-class conditioning antibody is designed to enable safer and more effective curative hematopoietic cell transplants and gene therapies.

Global Mucopolysaccharidosis (MPS) Treatment Market to Surpass US$ 3,014.9 Million by 2027, Says Coherent Market Insights (CMI)

Tuesday, September 22, 2020 - 2:25pm

Key Trends and Analysis of the Global Mucopolysaccharidosis (MPS) Treatment Market:

Key Points: 
  • Key Trends and Analysis of the Global Mucopolysaccharidosis (MPS) Treatment Market:
    Key trends in the global mucopolysaccharidosis (MPS) treatment market include increasing research and development activities by market players, increasing product launches and approvals, and increasing merger, acquisitions, and partnerships by market players.
  • Market players are focusing on launching new therapeutics for the treatment of rare diseases, which is expected to boost growth of the global mucopolysaccharidosis (MPS) treatment market over the forecast period.
  • The global mucopolysaccharidosis (MPS) treatment market is expected to exhibit a CAGR of 9.8% over the forecast period.
  • Global Mucopolysaccharidosis (MPS) Treatment Market, By Treatment:
    Global Mucopolysaccharidosis (MPS) Treatment Market, By MPS Type:

Aural Analytics, Inc. Announces the Launch of A2E, A Software Development Kit for Clinical-Grade Speech Collection and Analytics

Tuesday, September 22, 2020 - 2:00pm

Aural Analytics A2E system is built to solve these industry challenges by enabling speech collection and analytics via embeddable short, simple speech tasks that lower patient burden and maximize clinical insight - all while seamlessly fitting into existing software and hardware offerings.

Key Points: 
  • Aural Analytics A2E system is built to solve these industry challenges by enabling speech collection and analytics via embeddable short, simple speech tasks that lower patient burden and maximize clinical insight - all while seamlessly fitting into existing software and hardware offerings.
  • Speech collection and analytics are highly complex and require very specific expertise, said Dr. Jim Gemmell, Aural Analytics chief technology officer.
  • Our extensive experience in speech neuroscience and product development enables us to deliver embedded, ubiquitous speech collection and analytics through A2E across the continuum of care and lifespan.
  • Aural Analytics is the industrys leading speech neuroscience company building the worlds most advanced clinical-grade speech analytics platform for health applications across the lifespan.

Promega Developing OncoMate™ MSI Assay as Companion Diagnostic for Endometrial Cancer Drug Candidate from Incyte

Tuesday, September 22, 2020 - 2:00pm

Promega Corporation announced today its intent to develop the Promega OncoMate microsatellite instability (MSI) Assay as a companion diagnostic test for retifanlimab, Incytes anti-PD-1 drug candidate, in endometrial cancer.

Key Points: 
  • Promega Corporation announced today its intent to develop the Promega OncoMate microsatellite instability (MSI) Assay as a companion diagnostic test for retifanlimab, Incytes anti-PD-1 drug candidate, in endometrial cancer.
  • Promega and Incyte intend to work together in the future to develop the Promega OncoMate MSI Assay as a companion diagnostic in other markets.
  • The OncoMate MSI Assay received CE marking in Europe earlier this year.
  • Promega intends to seek regulatory clearance for OncoMate MSI in the United States and China.