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Enlivex Announces Positive Final Safety and Efficacy Data From Clinical Trial of Off-The-Shelf Allocetra in Patients with Severe Sepsis– Final Analysis Comparing 10 AllocetraTM-Treated Patients with 37 Matched Controls Showed Significant Positive Responses in State of Organ Failure, ICU Hospitalization and Mortality in a Highly Fragile and Extremely Difficult to Treat Population with Severe Sepsis – Nes Ziona, Israel, March 18, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced positive final safety and efficacy data from the Company’s completed Phase Ib clinical trial in patients with severe sepsis. The final analysis compared the clinical data of 10 patients admitted to the intensive care unit with sepsis who were administered off-the-shelf AllocetraTM (“Allocetra-OTS”) upon their admission, with 37 patients who were matched controls (matched by age, gender, Sequential Organ Failure Assessment (SOFA) score, and infection source) who received only the standard of care treatment at the same hospital during 2014-2019 but did not receive Allocetra-OTS. The clinical trial was conducted at Hadassah Medical Center, which is one of the largest and most prestigious hospitals in Israel (“Haddasah”). The primary aim of the clinical trial was to determine the safety profile and tolerability of . In addition, effects on, mortality, organ dysfunction and number of hospitalization days in general and in the intensive care unit (ICU) were measured. Mortality Sepsis & Organ Failure Duration of ICU Hospitalization Safety Prof. Dror Mevorach, Chief Medical Officer of Enlivex, commented, “We were excited to observe such deep and durable responses at a well-tolerated dose in this highly fragile and extremely difficult to treat septic population, and obtaining statistically-significant differences from the matched historical controls group. We believe that Allocetra-OTS is positioned as a potentially clinically viable option for treatment of sepsis, which is a clinical condition that has poor clinical outcomes and no currently effective therapy.” Oren Hershkovitz, CEO of Enlivex, stated, “Allocetra-OTS is a significant product candidate for Enlivex, and the robust results of this study are highly encouraging. We are compiling patient’s cytokine storm data in an effort to analyze the potential of Allocetra-OTS in other clinical indications whose pathophysiology is highly correlated with cytokine storms and exaggerated immune responses.” Study design Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated immune response to infection. Sepsis has been identified by the World Health Organization as a global health priority and currently has no FDA-approved pharmacologic treatment. Sepsis is the third leading cause of mortality in the United States after cardiovascular and cancer diseases and affects approximately 1.7 million adults in the United States each year. Various studies have estimated that up to 50% of severe sepsis hospitalizations culminate in death. AllocetraTM is an experimental therapy being investigated for treatment of patients with organ failure associated with sepsis, a syndrome whose lethal pathophysiology – hyper stimulation of the immune response and cytokine storm followed by organ failure – that may be similar to that of the coronavirus (COVID-19) associated with the newly recognized virus SARS-CoV-2. ABOUT ENLIVEX 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”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements 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 in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. 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: |