TMCnet News
Enlivex: After Expedited Review, Israeli Ministry of Health Authorizes Initiation of Phase II Clinical Trial Evaluating Allocetra in COVID-19 Severe and Critical PatientsNes Ziona, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage immunotherapy company, today reported that the Israeli Ministry of Health authorized the initiation of a proposed investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients. The planned COVID-19 study is a multi-center investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition, and is designed to assess AllocetraTM in combination with standard of care treatment. The trial plans to evaluate safety, tolerability, cytokine profile and efficacy parameters. Enlivex recently reported positive top-line results of a previously announced Phase Ib investigator-initiated clinical trial of AllocetraTM in COVID-19 patients in severe and critical condition in Hadassah Hospital, one of the largest hospitals in Israel. Enlivex was scheduled to provide the Israeli Ministry of Health with a full summary of the completed Phase Ib study following a 28-day observational period for each of the five patients treated in that study, which period is scheduled to lapse in late October. However, based on the positive Phase Ib top-line results and the release from the hospital of all patients treated in that study, after having tested negative for COVID-19, the Israeli Ministry of Health requested expedited submission by Enlivex of its COVID-19 AllocetraTM Phase Ib clinical trial summary prior to the completion of the full 28-day period for the last patient in order to expedite the regulatory review process. The Phase Ib clinical trial included five COVID-19 patients, three in severe condition and two in critical condition. All five patients completely recovered from their respective severe/critical condition and were released from the hospital after an average of 5 days (severe) and 9 days (critical), following administration of AllocetraTM, at which time they were all COVID-19 PCR negative. There were no reported severe adverse events relating to the administration of AllocetraTM in the patients, and the therapy was well-tolerated. Oren Hershkovitz, Ph.D., CEO of Enlivex, and Prof. Dror Mevorach, Chief Medical Officer of Enlivex, stated in a joint comment: “We would like to thank the Israeli Ministry of Health for its unprecedented expedited review and for authorizing a Phase II clinical trial of AllocetraTM in COVID-19 patients in severe and critical condition.” ABOUT THE ALLOCETRA COVID-19 PHASE II CLINICAL TRIAL ABOUT THE ALLOCETRA COVID-19 PHASE Ib CLINICAL TRIAL 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 INVESTOR RELATIONS CONTACT |