Reven Holdings Announces Publication of Peer-Reviewed Article in Prestigious Medical Journal Frontiers in Oncology

Reven Holdings also reports that Part 1 of 12 patients has been completed along with 10 patients already enrolled and treated in Part 2 of the multi-institutional, randomized, double-blind Phase 2 clinical trial evaluating the leading antiseptic drug candidate of Reven, RJX, in hospitalized patients at high risk COVID-19 patients

WESTMINSTER, Colorado, November 5, 2021– (COMMERCIAL THREAD) – Reven Holdings, Inc. (“Reven”) is a privately-held biotechnology and clinical-stage pharmaceutical company dedicated to the discovery and development of new treatment platforms for cancer, viral diseases, including COVID -19 – and inflammatory disorders.

Reven today announced the publication of a peer-reviewed article in the prestigious medical journal Frontiers in Oncology. The article reports a systematic analysis of antibody responses to COVID-19 vaccination in cancer patients. This analysis was performed in collaboration with the team at Hacettepe University Cancer Institute in Ankara / Turkey and Ares Pharmaceuticals, LLC in St. Paul, MN. COVID-19 vaccine seroconversion rates (i.e. successful antibody development) were significantly lower in patients with hematologic malignancies (example: leukemias and lymphomas) and cancer patients receiving chemotherapy or immunosuppressive treatments than controls who did not have cancer.

The article, “Antibody responses to COVID-19 vaccination in cancer: a systematic review, ”Was published in Frontiers in Oncology, and is available online. To view the publication online, click here: http://journal.frontiersin.org/article/10.3389/fonc.2021.759108/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalinName=9 Frontiers

Quote: Guven DC, Sahin TK, Kilickap S and Uckun FM (2021) Antibody responses to COVID-19 vaccination in cancer: a systematic review. Before. Oncol. 11: 759108. doi: 10.3389 / fonc.2021.759108

Corresponding author, Executive Vice President for Global Medical Affairs and Medical Director of Reven, Dr Fatih Uckun MD PhD, explained: “We report the challenges for oncology patients in achieving adaptive immunity against COVID-19. This report illustrates the importance of developing effective treatments for high-risk COVID-19 and the cytokine release syndrome (CRS) associated with COVID-19 given the poor performance of vaccinations in cancer patients. Reven’s clinical development efforts for our lead drug candidate COVID-19 RJX ​​aim to reduce the risk of life-threatening complications from COVID-19 and accelerate full recovery in high-risk patients, such as those with cancer .

This article illustrates the importance of our randomized trial to address unmet need in COVID-19 therapy“, added Peter Lange, CEO of Reven.

Reven had recently announced the successful completion of Part 1 of the two-part, two-cohort, multicenter Phase I / II trial of RJX in hospitalized patients at high risk of COVID-19. 12 hospitalized adult patients with high-risk symptomatic COVID-19 pneumonia and abnormally high markers of inflammation in the blood were treated with daily intravenous infusions of RJX in combination with standard care. Nine (9) of 12 patients, including 3 patients with hypoxemic respiratory failure, experienced rapid clinical recovery with normalization of abnormally high markers of inflammation in the blood and were able to discharge from hospital after a median of 5 days . All patients tolerated their RJX infusions without any side effects. An independent Data and Safety Oversight Board (DSMB) that oversees and acts independently of the Reven project team reviewed the clinical data of 12 patients and approved the initiation of the randomized, double-blind part 2 of the phase 2 study.

10 patients have already been recruited and treated in the randomized, double-blind, placebo-controlled part 2 of the phase 2 study (ClinicalTrials.gov Identifier: NCT04708340; https://clinicaltrials.gov/ct2/show/NCT04708340). This FDA-approved controlled clinical trial aims to evaluate the efficacy and safety of RJX in side-by-side comparison with placebo as an adjunct to standard care in hospitalized COVID-19 patients. Michael Volk, Director and Chief Strategy Officer of Reven, said: “We are excited about the rapid progress of our COVID-19 clinical program.

We expect the first data from this very important study by the end of 2021,said Brian Denomme, president of Reven.

We are diligently advancing the clinical development of RJX“said Fatih Uckun, MD PhD.

RJX is an intravenous (IV) formulation of a patented first-class pharmaceutical composition containing a specific blend of antioxidant and anti-inflammatory ingredients which is under development for more effective treatment of patients with inflammatory disorders, including patients with COVID-19 sepsis, multisystem inflammation, cytokine release syndrome (CRS), shock, ARDS, and multiple organ failure. The FDA-approved clinical trial aims to assess the efficacy and safety of RJX as an adjunct to standard care in hospitalized COVID-19 patients, who have features at high risk for progression to serious disease and an ARDS and patients with hypoxemic respiratory failure receiving either noninvasive positive pressure ventilation (NPPV) or high flow oxygen, who have not yet developed ARDS to require mechanical ventilation. Since RJX is a potent antioxidant and anti-inflammatory agent that reduces oxidative stress at the tissue level in multiple organs in animal models of severe systemic inflammation, shock, cytokine storm, and multiple organ failure, Reven hopes that ‘it help prevent the progression of COVID-19 and resolve it more quickly in high-risk patients.

About Rejuveinix (RJX)

RJX is an intravenous (IV) formulation of physiologically compatible compounds that is under development for more effective treatment of patients with sepsis, including COVID-19 patients with viral sepsis and acute respiratory distress syndrome (ARDS) .

About Reven Holdings, Inc.

Reven Holdings, Inc., a Delaware corporation, through its Westminster, 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 all those who suffer from the effects of vascular and metabolic diseases. Reven is committed to being the first research-intensive biopharmaceutical company advancing the health and well-being of people around the world. Its lead product, Rejuveinix (RJX), targets patients with COVID-19, sepsis, vascular and metabolic diseases, as well as specific populations of patients with PAD and other cardiovascular medical conditions.

Reven Caution Regarding 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 fact, included in this communication concerning strategy, future operations, future financial condition, prospects , management’s plans and objectives are forward-looking statements. Words such as “may”, “on track”, “expect”, “anticipate”, “hope”, “vision”, “optimism”, “conception”, “exciting”, “promising”, “will” “,” belief “,” estimate “,” intend “,” believe “and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained in this press release include, without limitation, statements regarding future plans, progress, timing, clinical development, scope and success of future clinical trials, disclosure of clinical data for the Company’s product candidates, and the potential use of the Company’s product candidates to address 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 can cause actual expectations to differ. actual and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, activation of clinical trial sites or lower than expected recruitment rates, expected changes in competition or existing in the market, changes in environmental regulations, the inability of employees to support or advance collaborations or product candidates, and unforeseen litigation or other disputes. These risks are not exhaustive; the company faces known and unknown risks, including risk factors described in the company’s periodic filings with the SEC. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information regarding future events or otherwise.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20211105005307/en/

Contacts

Michael Volk, Chief Strategy Officer
[email protected]


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