Clinical Trial News Archive - April 2020

April 1, 2020

• ImmunityBio Combines Supercomputing Power with Microsoft Azure to Target Infection “Doorway” of the Coronavirus

April 2, 2020

• Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients
• Vanda Pharmaceuticals Announces the Initiation of ODYSSEY, an FDA Approved Clinical Study of Tradipitant in Hospitalized Patients with Severe COVID-19 Pneumonia
• FDA Approves Emergency IND Use of Humanigen’s Lenzilumab for Compassionate Use in COVID-19 Patients

April 6, 2020

• INOVIO Initiates Phase 1 Clinical Trial Of Its COVID-19 Vaccine
• First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency IND and Two Patients Have Already Extubated
• FDA Clears IND for Remestemcel Use in COVID-19 ARDS Patients
• FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19

April 7, 2020

• FDA Grants Fast Track Designation to Sacituzumab Govitecan for Metastatic Urothelial Cancer
• Genentech Provides Regulatory Update on Risdiplam for the Treatment of Spinal Muscular Atrophy (SMA)
• Relief Therapeutics' Drug Aviptadil Enters FDA Trial at University of Miami to Treat COVID-19-Induced Respiratory Distress
• CytoDyn Collaborating with U.K.’s Department of Health to Provide Emergency Access to Leronlimab for Severe and Critically Ill COVID-19 Patients

April 9, 2020

• Theravance Biopharma Responds to COVID-19 Pandemic by Advancing TD-0903 to Treat Hospitalized Patients with Acute Lung Injury
• Fujifilm Announces the Start of a Phase II Clinical Trial of its Influenza Antiviral Drug “Avigan® Tablet” for COVID-19 Patients in the U.S.
• Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development
• BioCryst Begins Clinical Trial with Galidesivir for Treatment of Patients with COVID-19
• Relief Therapeutics Drug Aviptadil Enters FDA Trial at Thomas Jefferson University Hospital in Philadelphia, to treat COVID-19-Induced Acute Respiratory Distress

April 10, 2020

• Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine
• Lilly Begins Clinical Testing of Therapies for COVID-19

April 14, 2020

• Sanofi and GSK to Join Forces in Unprecedented Vaccine Collaboration to Fight COVID-19
• AstraZeneca Initiates CALAVI Clinical Trial with Calquence Against COVID-19
• Aldeyra Announces Positive Top-Line Phase 1 Clinical Trial Results and Clinical Development Plans for ADX-629
• Sinovac Announces Approval of Human Clinical Trial for a Vaccine Candidate Against COVID-19
• Alnylam Receives Fast Track Designation for Vutrisiran for the Treatment of the Polyneuropathy of hATTR Amyloidosis
• NantKwest and ImmunityBio Announce Therapeutics and Vaccines for Combatting Covid-19; Clinical Trials Anticipated to Begin This Quarter

April 15, 2020

• FDA Approves Initiation of Humanigen’s Phase III Study of Lenzilumab in COVID-19 Patients
• Oragenics, Inc. Announces Early Top-Line Results of Phase 2 Clinical Trial of AG013 for Oral Mucositis in Chemoradiation Treatment of Head and Neck Cancer
• Roivant Doses First Patient in Pivotal BREATHE Clinical Trial Evaluating Gimsilumab in COVID-19 Patients for the Prevention and Treatment of Acute Respiratory Distress Syndrome
• First Patient Treated with Leronlimab in Phase 2b/3 Trial for COVID-19

April 16, 2020

• Mayne Pharma Submits NDA for E4/DRSP to the FDA
• FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola

April 17, 2020

• Sinovac Announces Commencement of Phase I Human Clinical Trial for Vaccine Candidate Against COVID-19

April 20, 2020

• ERYTECH Provides Update on the TRYbeCA-1 Phase 3 Clinical Trial of Eryaspase in Second Line Pancreatic Cancer

April 21, 2020

• Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma Announce Positive Results From Global KALM-2 Pivotal Phase 3 Trial of Korsuva Injection in Hemodialysis Patients with Pruritus

April 22, 2020

• ObsEva Announces Publication of Abstracts from Phase 2b EDELWEISS Trial of Linzagolix in Endometriosis
• BioNTech and Pfizer Announce Regulatory Approval from German Authority Paul-Ehrlich-Institut to Commence First Clinical Trial of COVID-19 Vaccine Candidates

April 23, 2020

• AstraZeneca and Saint Luke’s Mid America Heart Institute Initiate Phase III DARE-19 Trial with Farxiga in COVID-19 Patients
• Theravance Biopharma Announces First Subject Dosed in Phase 1 Study of TD-0903, in Development for the Treatment of Hospitalized Patients with Acute Lung Injury Caused by COVID-19

April 24, 2020

• Tonix Pharmaceuticals Achieves 50 Percent Enrollment in Phase 3 RELIEF Study of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for Management of Fibromyalgia

April 27, 2020

• Genentech’s Risdiplam Shows Significant Improvement in Survival and Motor Milestones in Infants With Type 1 Spinal Muscular Atrophy (SMA)
• Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

April 28, 2020

• GSK Presents New Data from the GARNET Study Demonstrating Potential of Dostarlimab to Treat a Subset of Women with Recurrent or Advanced Endometrial Cancer
• Sanofi and Regeneron Provide Update on U.S. Kevzara Phase 2/3 Adaptive-Designed Trial in Hospitalized COVID-19 Patients
• Bergenbio’s Bemcentinib Selected To Be Fast-Tracked As Potential Treatment For Covid-19 Through New National UK Government Clinical Trial Initiative
• First Patient Dosed in Avdoralimab Phase II Clinical Trial in COVID-19 Patients With Severe Pneumonia

April 29, 2020

• BioNTech and Pfizer Announce Completion of Dosing for First Cohort of Phase 1/2 trial of COVID-19 Vaccine Candidates in Germany
• Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19
• Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19

April 30, 2020

• AstraZeneca and Oxford University Announce Landmark Agreement for COVID-19 Vaccine
• CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries
• INOVIO Expands Manufacturing of COVID-19 DNA Vaccine INO-4800 With New Funding from CEPI
• Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15