Nes-Ziona, Israel, Oct. 10, 2019 — Enlivex Therapeutics Ltd. (Nasdaq:ENLV), a clinical-stage immunotherapy company, today announced today that the European and Int’l Shock Societies selected, for an oral presentation, “Pathogen- and damage-associated molecular patterns are immune modified by apoptotic cell adjuvant therapy for acute sepsis in a cecal ligation and puncture mice model, and avoids multi-organ failure and improves survival” to be presented at the XVIIIth Congress of the European Shock Society and IXth Congress of the Int’l Federation of Shock Societies, on October 11, 2019, 11:40am, held at the Avra Imperial Hotel & Conference Center, Chania, Crete, Greece.
The presentation details results of preclinical studies, which were designed to evaluate the effect of Allocetra-OTS immunotherapy on subjects with highly-severe sepsis. The data showed ten-fold (10x) increased survival for study subjects who were treated with Allocetra-OTS therapy and antibiotics and fluids, as compared to subjects treated solely with antibiotics and fluids. Specifically, the levels of cytokine storms and organ failures were dramatically lower in the Allocetra-OTS group, leading to improved survival.
“Enlivex previously reported positive interim safety and tolerability of Allocetra-OTS in six patients with severe sepsis as part of an ongoing Phase Ib clinical trial. These interim safety results, taken together with the efficacy profile of improved survival and reduced cytokine storms and organ damage, present Allocetra-OTS as a potential candidate to become the first therapy ever to be approved for severe sepsis,” stated Dror Mevorach, M.D., Chief Scientific and Medical Officer of Enlivex.
The XVIIIth Congress of the European Shock Society and IXth Congress of the Int’l Federation of Shock Societies is focused on hot topic key notes provided by world-known experts. Current topics with focus on trauma/hemorrhagic shock/sepsis discussed during the conference include immune and organ responses, novel pathways, trauma modelling, comorbidities, novel therapies, long term effects, precision modeling, international shock research.
ALLOCETRATM by Enlivex was designed to provide a novel immunotherapy mechanism of action that targets life-threatening clinical indications that are defined as “unmet medical needs”, including prevention or treatment of complications associated with bone marrow transplantations (BMT) and/or hematopoietic stem cell transplantations (HSCT); organ dysfunction and acute multiple organ failure associated with sepsis; and enablement of an effective treatment of solid tumors via immune checkpoint rebalancing.
ABOUT ENLIVEX
Enlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve an out of control immune system (e.g. Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs), as well as solid tumors immune-checkpoint rebalancing. For more information, visit http://www.enlivex.com.
ABOUT THE EUROPEAN SHOCK SOCIETY
The primary objective of the European Shock Society is to advance understanding of the pathophysiology and to improve treatment of shock, trauma and sepsis and/or allied disciplines. For more information, visit https://www.europeanshocksociety.org/
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunitiesfor the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunitiesfor, ALLOCETRATM programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including under the heading “Risk Factors” contained in Enlivex’s most recently filed Annual Report on Form 20-F. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
ENLIVEX CONTACT:
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
shachar@enlivex-pharm.com
