Golden, Colorado, Thursday, June 11, 2020 1:00am MDT – Reven, LLC, a biopharmaceutical company that is developing Rejuveinix (RJX) for patients with cardiovascular and other health conditions, announced today that it recently completed an animal study in connection with its Coronavirus Treatment Acceleration Program (CTAP) submission to the FDA. Reven conducted the study in response a recent FDA request to provide additional pre-clinical support specific to the COVID-19 related Acute Respiratory Distress Syndrome (ARDS) clinical trial advice request from last month.
We are happy to report that RJX successfully and effectively treated animals with ARDS induced through otherwise lethal injection of lipopolysaccharide (LPS) and galactosamine (GaIN). This is a commonly used model in pre-clinical development of pharmaceutical products for this type of indication. The RJX treated animals showed a controlled inflammatory response over the non-treated animals. All of the non-treated animals died within 6.5 hours while several of the RJX treated animals remained alive for the 48-hour duration of the study, at which time they were euthanized and examined.
Histological samples and blood were taken from the mice to increase the understanding of how RJX is working to improve survival in ARDS induced mice. In each of the four RJX treatment groups, we observed a reduction in the thickening of the lungs when compared to the LPS group. The damage to the lungs occurs due to an immune response that aligns with an elevation of inflammatory markers. In order to determine if RJX is able to reduce the damage in the lungs through balancing the inflammatory system, pro-inflammatory markers including interleukin-6 (IL-6), tumor necrosis factor alpha (TNFα), and lactate dehydrogenase (LDH, a marker of tissue damage associated with anerobic metabolism and higher lactate production) were measured. There was a significant reduction in both the levels of IL-6 and TNFα in the RJX treatment groups compared to LPS alone. There was also a significant reduction in the LDH levels with RJX treatment, suggesting an increase in oxidative metabolism and reduced lactate production. The data suggest that RJX may aid in the reduction of fibrin deposition in the lungs and septic shock in an ARDS model.
These important pre-clinical findings were submitted to the FDA this week. In addition, the Reven team has drafted a submission to several industry publications to introduce RJX as a new entry in the fight against COVID-19 related ARDS. Based on these breakthrough clinical findings, Reven hopes to gain approval to proceed with Phase II trials of RJX for Covid-19 patients. Additional updates will be provided upon further advice by the FDA in the upcoming weeks.
About Cardiovascular Disease
Cardiovascular disease (CVD) is a class of diseases that involve the heart or blood vessels. Cardiovascular disease includes coronary artery diseases such as angina and myocardial infarction. Other CVDs include stroke, heart failure, rheumatic heart disease, cardiomyopathy, heart arrhythmia, congenital heart disease and more. Cardiovascular diseases are the leading cause of death globally, of which coronary artery disease and stroke account for 80% of CVD deaths in males and 75% of CVD deaths in females. In the United States, 11% of people between 20 and 40 have CVD, while 37% between 40 and 60, 71% of people between 60 and 80, and 85% of people over 80 have CVD.
About Reven, LLC
Reven, LLC is a Golden, Colorado based biopharmaceutical company. Reven’s vision is to make a difference in the world by making its products accessible to everyone suffering the effects of cardiovascular disease. 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 Critical Limb Ischemia patients facing amputation as well as a larger patient population suffering PAD and other vascular related medical conditions.
This announcement may contain forward-looking statements. These statements are based on Reven management’s current estimates and expectations of future events as of the date of this announcement. Furthermore, the estimates are subject to risks and uncertainties that could cause actual results to differ materially and adversely from those indicated or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with our ability to continue to operate as a going concern; our ability to raise sufficient additional funds to continue operations and to conduct clinical trials of RJX in the United States and elsewhere; our ability to enlist clinical trial sites and enroll patients; the risk that the FDA stops RJX early as a result of the occurrence of certain safety events or does not approve an expansion of RJX; obtaining and maintaining regulatory approvals required to market and sell our products; the possibility that future clinical trials will not be successful or confirm earlier results; the timing and costs of clinical trials; the timing of regulatory submissions; the timing, receipt and maintenance of regulatory approvals; the timing and amount of other expenses; the timing and extent of third-party reimbursement; intellectual-property risk; risks related to assumptions regarding the size of the available market; the benefits of our products; product pricing; timing of product launches; future financial results; and other factors. Given these uncertainties, one should not place undue reliance on these forward-looking statements. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, unless we are required to do so by law.
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Golden, CO 80401, USA