Tuesday September 15, 2020 0 comments
GOLDEN -- Reven Holdings, a privately held clinical stage biotechnology and pharmaceutical company dedicated to the discovery and development of novel treatment platforms for cancer, viral illnesses—including COVID-19—announced its product for treatment of COVID-19 has received an initial green light from the FDA.
Reven recently submitted a Pre-Investigational New Drug (Pre-IND) application to the FDA to obtain feedback and guidance for its clinical evaluation of the anti-inflammatory/anti-oxidant investigational drug product Rejuveinix (RJX) in the treatment of COVID-19.
Reven announced the FDA has responded favorably to its Pre-IND application.
Following the FDA guidance, as the next step Reven said it is planning to promptly submit an Investigational New Drug (IND) application and clinical protocol to the Agency.
The clinical study will be a randomized, double-blind, placebo-controlled, multi-institutional trial comparing a combination of the standard of care with a placebo to a combination of the standard of care with RJX for the treatment of COVID-19.
The clinical trial design, mechanism of action and the rationale for developing RJX as a treatment modality for prevention of cytokine storm and other complications of COVID-19 are all discussed in a published article in the current issue (Volume 10, Issue 3, 2020) of the peer-reviewed medical journal Clinical Investigation.
“We are grateful to the FDA for their valuable guidance in the pre-IND process,” said Fatih Uckun, Reven’s chief medical officer.
“We hope that the diligent and careful clinical development of RJX ultimately contributes to a better survival and faster recovery in COVID-19.”
“I am delighted to have the opportunity to work with Dr. Uckun as part of Reven’s leadership team as we diligently advance the RJX clinical trial program with the vision of bringing a new treatment option to high-risk COVID-19 patients who are in urgent need for therapeutic innovations,” said Michael Volk, Reven’s co-founder and chief strategy officer.