Reven Selects eClinical Services Provider DSG for Clinical Data Management Services to Accelerate the Clinical Development of Reven’s Investigational Drug Product RJX as a Treatment Against COVID-19

·5-min read

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 illnesses—including COVID-19—and 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 it selected DSG, Inc., a leading global eClinical services provider, for all aspects of clinical trial data management during its upcoming COVID-19 study. DSG will work directly with the Reven team, facilitating the real-time process optimizations needed to make data management more efficient in a proactive electronic data capture (EDC) environment. DSG, with its eCaseLink platform, will provide the data management tools for Reven to achieve its high-quality data collection, management and analysis goals. Reven will also utilize the Interactive Response Technology (IRT) of DSG to manage randomization in the upcoming study.

"I have worked with DSG in several of my previous clinical projects, and I look forward to working once again side by side with their excellent team. We are confident that using the DSG platforms will enhance the quality of data collection and management during the COVID-19 clinical study," stated Fatih Uckun MD PhD, Reven’s Chief Medical Officer. "The quality of the clinical trial data is of utmost importance for its reliability and interpretability. Therefore, we selected DSG as our eClinical provider for data management services," added Michael Volk, Reven’s Chief Strategy Officer.

"The DSG team is thankful for the opportunity to partner with Reven, collaborating with a most effective, practical and talented clinical trial leader, Dr. Fatih Uckun, on systems design, and to be part of the solution in finding a treatment for COVID-19," said Tony Varano, CEO at DSG. "This continues the 28-year DSG tradition of continual process improvement and tech innovation for the clinical trials community. We believe the eCaseLink unified platform sets the standard for ease of use and flexibility our partners, system users, and stakeholders demand."

About DSG

DSG, Inc. is a leading global eClinical provider with a unified suite of innovative technology solutions for the global clinical research community and life sciences industry. DSG's eClinical software platform provides competitive advantage that is cost-effective and quickest to build. DSG’s award-winning eCaseLink solutions are used in thousands of clinical trials around the globe. DSG launched its clinical data management services division back in 2006, offering a wide range of data management services. This unique data management model has been a proven success for a large number of DSG’s EDC clients. DSG was awarded the Society for Clinical Data Management (SCDM)’s Data Driven Innovation Award for clinical data quality control implementation at Human Genome Sciences.

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 a biopharmaceutical company. Reven’s vision is to make a difference in the world by making its products accessible to everyone suffering the effects of vascular and metabolic related diseases. Reven is committed to being the premier, research-intensive biopharmaceutical company that advances the health and well-being of people around the world. Its primary product, RJX, targets patients suffering from COVID-19, sepsis, vascular and metabolic related diseases as well as specific patient populations suffering Peripheral Arterial Disease (PAD) and other cardiovascular related medical conditions.

Reven’s 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 company’s product candidates and the potential use of the company’s 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 company’s 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/20200930005288/en/

Contacts

Natalie Pizzimenti, Medical Scientific Liaison
+1 (586) 242-9590
natalie.pizzimenti@reven.com