System Independent Data Format

Vasomune and AnGes Announce Drug Candidate AV-001 Receives Positive Recommendation from the IDSMB for AV001-004 Phase 2a Study

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Tuesday, November 14, 2023
Health, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, Safety, Therapy, System Independent Data Format, Patient, Trial of the century, Pharmaceutical industry

Vasomune Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of diseases associated with vascular dysfunction, announced today that their lead drug candidate AV-001 has received a positive recommendation from the Independent Data and Safety Monitoring Board (IDSMB) of the AV001-004 Phase 2a Study.

Key Points: 
  • Vasomune Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of diseases associated with vascular dysfunction, announced today that their lead drug candidate AV-001 has received a positive recommendation from the Independent Data and Safety Monitoring Board (IDSMB) of the AV001-004 Phase 2a Study.
  • “We are pleased to announce that the Independent Data and Safety Monitoring Board recommended the continuation of the Phase 2a trial (NCT05123755) evaluating the efficacy, safety, and tolerability of AV-001 in patients suffering with Acute Respiratory Distress Syndrome (ARDS),” said Dr. Brian E. Jahns, President and Chief Operating Officer.
  • “We believe outcomes for patients with ARDS can be significantly improved through restoration of Tie2 signaling to promote endothelial stability, enhance barrier defense and block vascular leak.
  • The Phase 2a trial, AV001-004, is a hallmark of our focused and collaborative efforts with our investigators, which has been catalyzed by two prestigious US Department of Defence grants.”
    Ei Yamada, President & CEO of AnGes, said that “Data gained in this important clinical study will inform the treatment of ARDS, and the clinical development of AV-001 is expected to accelerate with this milestone.”

View Launches Partner Marketplace to Accelerate Digital Transformation of Real Estate

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Thursday, November 17, 2022
Cloud, API, Egunyu Janepher Nantume, Environment, Workplace, Glass, ESG, Silicon, IAQ, Hospital, Partnership, MIT Media Lab, System Independent Data Format, School, Airport, IOT, Lighting, Smart, HVAC, Carbon, Health, Atmosphere, Intelligence, Marketplace, Safety, View, Inc., Mobile phone, Cryptocurrency, Heating, ventilation, and air conditioning, Indonesia AirAsia, Bing Maps

The View Partner Marketplace enables View customers to deploy popular real estate applications, sensors, and software platforms with a single click, making it easier than ever for real estate owners and operators to quickly and securely digitize their real estate portfolios.

Key Points: 
  • The View Partner Marketplace enables View customers to deploy popular real estate applications, sensors, and software platforms with a single click, making it easier than ever for real estate owners and operators to quickly and securely digitize their real estate portfolios.
  • With the launch of the View Partner Marketplace, View is adding turnkey integrations with platforms and applications that make buildings healthier, more sustainable, more efficient, and easier to operate.
  • Sonu Panda, CEO of Prescriptive Data, said: Partnering with View will help building owners accelerate towards ESG targets of improving energy efficiency and sustainability within their real estate portfolios.
  • Shaun Cooley, Founder CEO, Mapped, said: Were thrilled to partner with View and make building data more accessible, actionable, and secure.

Ocugen Announces Completion of Dosing in OCU400 Phase 1/2 Cohort 2

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Wednesday, October 12, 2022
Schepens Eye Research Institute, LinkedIn, U.S. Securities and Exchange Commission, Retina, Nuclear, SEC, Retinal degeneration, Hope, Retinitis pigmentosa, Vaccine, NR2E3, Private Securities Litigation Reform Act, NASDAQ, Patient, DSMB, Research, Twitter, Security (finance), Rhodopsin, Infection, Efficacy, RHO, Company, Doctor of Philosophy, Health, Safety, GLOBE, Clinical trial, System Independent Data Format, Risk, Public health, Pharmaceutical industry

MALVERN, Pa., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Independent Data and Safety Monitoring Board (DSMB) for the OCU400 Phase 1/2 clinical trial completed a review of safety data for subjects enrolled in Cohort 2 and recommends proceeding to enroll subjects in Cohort 3. The Company expects to complete Cohort 3 enrollment in Q4 2022 as planned. 

Key Points: 
  • The Company expects to complete Cohort 3 enrollment in Q4 2022 as planned.
  • Im very pleased with the progress of the clinical trial, said David Birch, PhD, Director, Retina Foundation of the Southwest, primary investigator of the study.
  • OCU400 clinical trial is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa Associated with NR2E3 (Nuclear Receptor Subfamily 2 Group E Member 3) and RHO (Rhodopsin) Mutations.
  • OCU400 is part of Ocugens Modifier Gene Therapy Platformtargeting inherited retinal disease and dry age-related macular degeneration.

Atara Biotherapeutics Announces Completion of the ATA188 Phase 2 EMBOLD Study Interim Analysis in Patients with Progressive MS

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Tuesday, July 12, 2022
Oncology, Health, Biometrics, Other Health, General Health, Clinical Trials, Biotechnology, EDSS, SEC, Security (finance), Safety, Canadian Aviation Regulations, EDT, U.S. Securities and Exchange Commission, EBV, Result, Interim analysis, Biology, System Independent Data Format, Intention, Epstein–Barr virus, Particle-size distribution, LinkedIn, Securities Act of 1933, Company, Lymphatic system, Multiple sclerosis, Northwest Biotherapeutics, Securities Exchange Act of 1934, Patient, Form, Review, Investor, COVID-19, Analysis, Data, Autoimmune disease, ATRA, HLA, Financial condition report, IA, Nasdaq, Form 10-K, Degenerative disease, Media, MTR, MS, Antigen, FDA, Research, Twitter, TCR, Cancer, Hematological Cancer Research Investment and Education Act, ID, Pharmaceutical industry, Medical imaging

The IA was planned to occur before enrolling patient 80 to enable an increased sample size if needed.

Key Points: 
  • The IA was planned to occur before enrolling patient 80 to enable an increased sample size if needed.
  • The IDSMC believes the six-month interim endpoint may be an inaccurate measure of the potential of this intervention in this condition.
  • The IDSMC recommended continuing the study without sample size adjustment until the final analysis of the primary endpoint of confirmed EDSS improvement at 12 months.
  • Following the EMBOLD IA, we are proceeding with the IDSMCs recommendation that the study continue to completion without sample size adjustment, said Jakob Dupont, M.D., Head of Global Research & Development at Atara.

Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19

Retrieved on: 
Wednesday, December 29, 2021
Psilocybin, Safety, Study, Infection, COVID-19, Population, Organ transplantation, Liver disease, Disorder, Omicron, FDA, City, Orphan drug, GLOBE, EUA, RVV, Company, Inflammation, System Independent Data Format, CEO, Hospital, Pfizer, Emergency Use Authorization, Research, Therapy, Viral load, Patient, Reperfusion injury, Autoimmune hepatitis, Drug development, CSE, Acquisition, Ischemia, Pharmaceutical industry, Bucillamine, CBD, Merck

The Independent Data and Safety Monitoring Board supported the continuation of the Study in its last meeting as there were no serious adverse events or safety concerns.

Key Points: 
  • The Independent Data and Safety Monitoring Board supported the continuation of the Study in its last meeting as there were no serious adverse events or safety concerns.
  • With the recent onset of the Omicron variant we have made some of the above adjustments to the trial.
  • Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19

Retrieved on: 
Tuesday, October 26, 2021
Psilocybin, Safety, Tablet, System Independent Data Format, Organ transplantation, Emergency Use Authorization, San Francisco, Vital signs, NIAID, Liver disease, COVID-19, Randomness, Acquisition, GLOBE, Heart rate, University of California, San Francisco, Death, Placebo, Research, EUA, Hematology, Autoimmune hepatitis, Company, Degenerative disease, Hospital, Temperature, Viral load, Ischemia, Drug development, CSE, Severe acute respiratory syndrome coronavirus 2, Reperfusion injury, Infection, CEO, Orphan drug, Inflammation, University, RVV, FDA, Review, Therapy, Coronavirus, Respiratory rate, Disorder, Dietary supplement, Pharmaceutical industry, Video game, Vaccine

Phase 3 clinical trial to incorporate viral load testing for a minimum of 300 patients.

Key Points: 
  • Phase 3 clinical trial to incorporate viral load testing for a minimum of 300 patients.
  • Engaged 46 clinical sites to date to complete the Phase 3 clinical trial.
  • Finalizing global manufacturing capabilities to support the production of at least 5 billion Bucillamine tablets for global commercialization in 2022.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.