StemCell Therapy

Oct. 5, 2020 11:30 UTC

GOLDEN, Colo.--(BUSINESS WIRE)-- Reven Holdings, Inc. (Reven) is a privately held clinical stage biotechnology and pharmaceutical company dedicated to the discovery and development of novel treatment platforms for cancer, viral illnessesincluding COVID-19and inflammatory disorders.

Reven is planning to initiate a randomized, double-blind, placebo-controlled, multi-institutional clinical trial of its lead anti-inflammatory/anti-oxidant investigational drug product Rejuveinix (RJX) in the treatment of COVID-19. The upcoming clinical trial is designed to evaluate the safety and efficacy of RJX in COVID-19 patients.

Reven today announced that three new members with extensive experience and knowledge in clinical research and quality assurance have joined its multi-disciplinary team to work on the COVID-19 clinical project:

Nancy Oehlke has assumed the role of Manager of Regulatory Affairs and Quality Assurance. Nancy has 20+ years of experience in drug development, Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP) compliance, regulatory aspects of drug product manufacturing and testing, and clinical research.

Renae Townsend has assumed the role of Director of Clinical Operations and Jenny Daniels has assumed the role of Director of Clinical Quality Assurance. Both Renae and Jenny have 15+ years of Good Clinical Practice (GCP), clinical research and clinical monitoring experience.

These new team members will help us provide sponsor oversight for the services rendered by the clinical research organizations (CRO) and other vendors who will support our clinical RJX program and execution of the clinical trial. I am excited to welcome these very experienced new members to Reven. I look forward to the opportunity to work side by side with them as we try to diligently advance the clinical development of RJX, said Fatih Uckun, MD PhD, Chief Medical Officer and Chief Scientific Officer of Reven.

Our IND (Investigational New Drug) application package for COVID-19 is completed and we are planning to roll out our clinical program against COVID-19 in the coming month, said Michael Volk, Director and Chief Strategy Officer of Reven.

Our new team members each will have a very important role in our efforts aimed at evaluating the clinical impact potential of RJX, added Peter Lange, CEO of Reven.

About Rejuveinix (RJX) RJX is an intravenous (IV) formulation of a patented first-in-class pharmaceutical composition containing a specific mixture of anti-oxidant and anti-inflammatory ingredients that is being developed for more effective treatment of patients with inflammatory disorders, including COVID-19 patients with viral sepsis and acute respiratory distress syndrome (ARDS). The clinical safety and tolerability of RJX was confirmed in a recently completed double blind, placebo-controlled Phase 1 dose-escalation study in healthy volunteers (ClinicalTrials.gov Identifier: NCT03680105).

About Reven Holdings, Inc. Reven Holdings, Inc., a Delaware corporation, through its Golden/Colorado-based operating company Reven, LLC, is developing new drugs for difficult-to-treat diseases. As a clinical stage biopharmaceutical company, Revens overarching goal is to develop effective treatments for serious health conditions caused by infectious, inflammatory, cardiovascular, and metabolic diseases. Its lead product, RJX, is being developed as a treatment platform against complications of COVID-19, sepsis, cardiovascular diseases, and diabetes.

About Dr. Fatih Uckun, M.D., Ph.D, Chief Medical Officer of Reven. Dr. Uckun is an Active Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He earned his doctoral degrees at University of Heidelberg in Germany and completed his residency training in Pediatrics, fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation, as well as postdoctoral research training in immunology and microbiology at the University of Minnesota in the US.

Dr. Uckun has more than 30 years of professional experience in developmental therapeutics and biopharmaceuticals in oncology/immuno-oncology as well as infectious diseases and immunology. In addition, Dr. Uckun has deep knowledge and 20+ years of experience in treatment of infectious diseases and their complications. In particular, he has extensive experience in viral, fungal, and bacterial infections of immunocompromised hosts, septic shock, ARDS as well as systemic capillary leak syndrome and cytokine release syndrome (CRS). Dr. Uckun served as a Defense Advanced Research Projects Agency (DARPA)-funded principal investigator and directed a universal virus neutralizer program project as part of a countermeasures initiative against viruses that can be used as bioweapons and therefore pose a biothreat for our national security. Prior to joining Reven, Dr. Uckun was a Vice President, Clinical Strategy Lead, Oncology-Hematology and Member of the COVID-19 Task Force at Worldwide Clinical Trials.

Dr. Uckun worked 11 years as a Professor of Bone Marrow Transplantation, Therapeutic Radiology-Radiation Oncology, Pharmacology, and Pediatrics as well as Director of the Biotherapy Institute at the University of Minnesota, where he became the first recipient of the Endowed Hughes Chair in Biotherapy. He worked 6 years as a Professor and Head of Translational Research in Leukemia and Lymphoma of the CCBD and a Principal Investigator of the Stem Cell-Regenerative Medicine Initiative at the at the University of Southern California. During that time, Dr. Uckun served as the Chair of the Biotargeting Working Group for the National Cancer Institute (NCI)s Nanotechnology Alliance in Cancer.

He has held executive positions in multiple biotechnology companies and has extensive regulatory experience. He has published more than 500 peer-reviewed papers, received numerous awards, and served as a member of several medical journal editorial boards and NIH grant review/special emphasis panels. Website: https://www.linkedin.com/in/fatihuckun/

Revens Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as may, on-track, expect, anticipate hope, vision, optimism, design, exciting, promising, will, conviction, estimate, intend, believe and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the companys product candidates and the potential use of the companys product candidates to treat various disease indications. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing market competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates, and unexpected litigation or other disputes. These risks are not exhaustive; the company faces known and unknown risks, including the risk factors described in the companys periodic SEC filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information regarding future events, or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201005005298/en/

See more here:
Reven Strengthens Its Clinical Team With Three New Members - BioSpace

This entry was posted on October 6, 2020 at 4:54 am and is filed under Regenerative Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |