Solidarity trial

Codagenix Announces Late-Breaking Presentation of Positive Clinical Immunogenicity Data For COVID-19 Vaccine Candidate CoviLiv™ at IDWeek 2023

Retrieved on: 
Wednesday, October 11, 2023

FARMINGDALE, N.Y., Oct. 11, 2023 /PRNewswire/ -- Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for viral vaccines and immuno-oncology therapeutics, today announced the late-breaking presentation of positive clinical data for its CoviLiv™ COVID-19 vaccine candidate at the upcoming IDWeek 2023 annual meeting, taking place in Boston on October 11-15, 2023.

Key Points: 
  • Data show that participants who received two doses of 5x106 PFU of CoviLiv showed robust induction of both humoral and cellular immune responses.
  • T cell reactivity was demonstrated to be specific for multiple viral antigens beyond the frequently mutating spike protein.
  • The vaccine was designed using the Codagenix platform technology that re-codes the genetic material of a virus – converting the virus from a disease-causing pathogen into a stable and safe, live-attenuated vaccine.
  • SIIPL, the world's largest vaccine manufacturer by number of doses produced and sold globally, is manufacturing the vaccine for this clinical study.

Castor Appoints Digital Leader Milind Kamkolkar to Board of Directors

Retrieved on: 
Tuesday, November 9, 2021

Castor , a leading provider of decentralized and hybrid clinical trial solutions, today announced the appointment of industry veteran Milind Kamkolkar to its Board of Directors.

Key Points: 
  • Castor , a leading provider of decentralized and hybrid clinical trial solutions, today announced the appointment of industry veteran Milind Kamkolkar to its Board of Directors.
  • Milind is currently Senior Advisor to Cellarity, a Flagship Pioneering Company, after his tenure as Chief Digital & Data Officer.
  • He brings to Castor more than 20 years of experience in healthcare AI and digital health, from startup, management consulting to Fortune 500 enterprises.
  • The adoption of decentralized clinical trials has seen exponential growth, catalyzing an industry in critical need of modernization, said Milind.

Phase III North American Clinical Trial for COVID-19 Treatment begins after FDA & Health Canada approval

Retrieved on: 
Monday, June 14, 2021

The clinical trial will test the use of PULM-001 in patients in the early stages of COVID-19.

Key Points: 
  • The clinical trial will test the use of PULM-001 in patients in the early stages of COVID-19.
  • The is one of very few phase III clinical trials for COVID therapies to obtain approval from both the U.S. Food and Drug Administration (FDA) and Health Canada.
  • This Canada-led phase III clinical trial could change the course of the global pandemic, especially for developing countries that have little access to vaccines.
  • With the endorsement of federal health regulators in the US and Canada now in place, we can begin the trial.

CASTOR Continues Rapid Growth and Momentum Powering COVID-19 Studies with Global Decentralized Clinical Trial Platform

Retrieved on: 
Wednesday, May 26, 2021

Castor , a leading provider of clinical trial technology to Democratize Clinical Research, announced today continued rapid adoption of its decentralized clinical trial platform to power COVID-19 studies globally.

Key Points: 
  • Castor , a leading provider of clinical trial technology to Democratize Clinical Research, announced today continued rapid adoption of its decentralized clinical trial platform to power COVID-19 studies globally.
  • At the start of the pandemic, Castor joined the global fight against the COVID-19 by offering its user-friendly, globally scalable Decentralized Clinical Trial (DCT) platform for free for all COVID-19 research projects.
  • Examples of COVID-19 studies powered by Castors eClinical suite:
    World Health Organizations Solidarity trial , the largest adaptive COVID-19 clinical trial ever conducted, with database support, adaptive randomization, and customized offline data capture.
  • Castor is a leading provider of decentralized and hybrid clinical trial solutions to democratize research.

BetterLife Subsidiary, Altum Pharmaceuticals, to Conduct Randomized Placebo-controlled COVID-19 Trial Using AP-003

Retrieved on: 
Thursday, March 11, 2021

The trial is projected to start in Q2 of this year and be completed by end of Q3.

Key Points: 
  • The trial is projected to start in Q2 of this year and be completed by end of Q3.
  • Multiple clinical analyses show a significant link between deficiency in Type 1 interferon and development of severe COVID-19 disease.
  • The goal of the IN2COVID trial is to confirm the benefit of inhaled IFN-a2b in early stage COVID-19 patients.
  • The IN2COVID trial will have a randomized placebo Phase 1 portion in healthy subjects followed by a randomized placebo-controlled Phase 2 portion in early stage COVID-19 patients (

Innovative drug, Carrimycin, Receives FDA Approval for International, Multi-country Phase III Clinical Trial for the treatment of severe COVID-19 in hospitalized patients

Retrieved on: 
Wednesday, December 23, 2020

The International trial will enrol 300 hospitalized patients 18 years including 150 patients in the experimental group and 150 patients in the control group.

Key Points: 
  • The International trial will enrol 300 hospitalized patients 18 years including 150 patients in the experimental group and 150 patients in the control group.
  • Anticipated to last about six months, an interim analysis is planned to be conducted when half (~150) patients have completed the 28-day assessment period.
  • It is the only FDA-approved synthetic biology drug in the world for phase III clinical studies of severe coronavirus disease.
  • It has now received written approval from the FDA for the Carrimycin phase III clinical study against severe coronavirus disease in the United States.

DGAP-News: Apogenix AG: COVID-19 targeted treatment trial launched in Vienna

Retrieved on: 
Tuesday, December 22, 2020

(Vienna/Heidelberg/Cologne/London, 22 December 2020) A phase II clinical trial of a treatment for COVID-19 patients is currently starting at the Medical University of Vienna as a sub-study of the Austrian CoronaVirus Adaptive Clinical Trial (ACOVACT).

Key Points: 
  • (Vienna/Heidelberg/Cologne/London, 22 December 2020) A phase II clinical trial of a treatment for COVID-19 patients is currently starting at the Medical University of Vienna as a sub-study of the Austrian CoronaVirus Adaptive Clinical Trial (ACOVACT).
  • ACOVACT is a randomised, controlled, multi-centre, open-label clinical trial sponsored by MedUni Vienna.
  • Apogenix develops innovative immunotherapeutic agents for the treatment of cancer and viral diseases such as Covid-19.
  • This phase II clinical trial complements another stand-alone phase II clinical trial by Apogenix with the same therapeutic in patients with severe COVID-19 being conducted in Spain and Russia.

VA San Diego Healthcare System Joins the Phase II Trial of LSALT Peptide for the Treatment of Complications in Hospitalized COVID-19 Patients

Retrieved on: 
Thursday, December 10, 2020

a pulmonary and critical care physician at the VASDHS and site principal investigator for the LSALT Phase II trial.

Key Points: 
  • a pulmonary and critical care physician at the VASDHS and site principal investigator for the LSALT Phase II trial.
  • The VASDHS is the fifth hospital to be activated into the trial, joining sites in Florida and Louisiana, as well as two hospital sites in Turkey.
  • Arch is currently exploring opportunities to add Canadian clinical sites into the trial as the number of hospitalized COVID-19 patients has grown significantly in Alberta and Ontario in recent weeks.
  • Additional information about the Phase II trial can be found at:
    The Phase II results will be used to design the Phase III trial, including greater patient numbers to more fully evaluate efficacy and safety in COVID-19 patients.

Enlivex Reports Positive Interim Results From Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients

Retrieved on: 
Thursday, December 3, 2020

The Phase II patients that have been discharged from the hospital are currently healthy.

Key Points: 
  • The Phase II patients that have been discharged from the hospital are currently healthy.
  • Oren Hershkovitz, Ph.D., CEO of Enlivex commented, We are pleased with the interim results of this COVID-19 Phase II clinical trial.
  • We believe that AllocetraTM, if approved, could potentially cover the void that currently exists in treatments for severe or critical COVID-19 patients.
  • The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals.

RedHill Biopharma Completes Enrollment for COVID-19 U.S. Phase 2 Study with Opaganib - Data Expected in the Coming Weeks

Retrieved on: 
Monday, November 16, 2020

Phase 2 study with opaganib (Yeliva, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has completed enrollment of the last patient in the study.

Key Points: 
  • Phase 2 study with opaganib (Yeliva, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has completed enrollment of the last patient in the study.
  • We are compiling a robust data set to support the planned emergency use applications, expected as early as next quarter, subject to study success."
  • Phase 2 study and look to rapidly complete the global Phase 2/3 development program for opaganib toward potential emergency use authorization applications."
  • Reporting of topline data, safety analysis and of unblinded futility interim analysis for the global Phase 2/3 study with opaganib.