GOLDEN, Colo.--(BUSINESS WIRE)--Reven Holdings, Inc. (“Reven”), 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, today announced the publication of two peer-reviewed expert articles authored by its Chief Medical Officer & Chief Scientific Officer, Fatih Uckun M.D. Ph.D., and other members of the Reven team and their academic collaborators in the medical journal, Clinical Investigation (London).
Dr. Uckun provides an overview of the development status, mechanism of action, and clinical potential of the RJX platform for the treatment of COVID-19 in the article, “Clinical Impact Potential Of Rejuveinix (RJX) For Prevention Of Fatal Acute Respiratory Distress Syndrome (ARDS) And Multi-Organ Failure In COVID-19 Patients.” The article also discusses the potential for the prevention of life-threatening complications from COVID-19 with RJX based on data obtained from clinical and non-clinical studies. This has provided the medical-scientific rationale for Reven’s clinical development strategy for RJX and a randomized, double-blinded clinical study in COVID-19 patients.1
One of the crucial questions with regard to COVID-19 seems to be the prevention of progression of mild disease. Kristina Cabala explains how RJX could favorably affect the patient journey in the article, “Rationale for a randomized, placebo-controlled, Phase 2 study of Rejuveinix (RJX) in COVID-19 patients with acute lung injury and hypoxemic respiratory failure.” She provides the critical design elements for a two-cohort, two-part placebo-controlled, double-blind Phase 2 study of RJX in COVID-19 patients.
In addition to the possible prevention of progression of mild disease, the paper discusses how RJX could have a positive impact on the faster resolution of ARDS, prevention of multiple-organ failure, and a reduction of case mortality during respiratory failure. The article also describes how RJX could potentially promote long-term healing after patient recovery from COVID-19.2
“These articles emphasize our commitment to advance our investigational product RJX which shows high clinical impact potential to address unmet needs in COVID-19 therapy,” stated Peter Lange, Chief Executive Officer.
1 Fatih M. Uckun, Jim Ervin, Kazim Sahin, Joy Powell, Natalie Pizzimenti, Jackie Earabino, Hendrik van Wyk, Mariette van Wyk, Peter Pacult, Taha Koray Sahin, Kristina Cabala. “Clinical Impact Potential Of Rejuveinix (RJX) For Prevention Of Fatal Acute Respiratory Distress Syndrome (ARDS) And Multi-Organ Failure In Covid-19 Patients.” Clinical Investigation (London) 2020; 10(2): 177-184
2 Kristina Cabala, Jackie Earabino, Peter Pacult, Fatih M. Uckun. Rationale For A Randomized, Placebo-Controlled, Phase 2 Study Of Rejuveinix (RJX) in COVID-19 Patients With Acute Lung Injury And Hypoxemic Respiratory Failure. Clinical Investigation (London) 2020; 10(2): 185-189
About Rejuveinix (RJX)
RJX is an intravenous (IV) formulation of known physiologically compatible compounds that is being developed for more effective supportive therapy of patients with sepsis, including COVID-19 patients with viral sepsis and acute respiratory distress syndrome (ARDS). The RJX formulation is a solution of buffered acid products, electrolyte components, and vitamins, including ascorbic acid, cyanocobalamin, thiamine hydrochloride, riboflavin 5’ phosphate, niacinamide, pyridoxine hydrochloride, and calcium d-pantothenate, and magnesium sulfate heptahydrate, a mineral with a negative oxidation-reduction potential. The components of RJX exhibited promising activity in clinical studies involving ARDS patients and/or non-clinical studies in animal models of ARDS. The published data from these clinical and non-clinical studies provided the medical-scientific rationale for Reven’s clinical development strategy for RJX and a clinical study in COVID-19 patients. The clinical 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, Rejuveinix (RJX), targets patients suffering from COVID-19, sepsis, vascular and metabolic related diseases as well as specific patient populations suffering 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.
