Enlivex Therapeutics Provides Clinical Update on Positive Safety Profile of Its Off-The-Shelf Cell Therapy Product in First Three Severe Sepsis Patients
Nes Ziona, Israel, June 06, 2019 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today provided a clinical update on the positive safety profile of its off-the-shelf cell therapy, AllocetraTM, in the first three severe sepsis patients, as part of its ongoing Phase Ib clinical trial.
This is the first infusion of off-the-shelf AllocetraTM (“OTS Allocetra”) in human subjects. Enlivex has developed OTS Allocetra as a second-generation cell therapy to the matched-donor Allocetra product, which has demonstrated a robust safety and clinical efficacy profile in a Phase IIa clinical trial for the prevention of GvHD in patients following bone-marrow transplantation. Enlivex designed OTS Allocetra to eliminate the need to find matched donors as the source of the therapeutic cells and allow Enlivex to manufacture therapeutic product inventory that could be used, post regulatory approval, for additional clinical indications that require swift infusion of the immunotherapeutic product to patients. The first such indication Enlivex is currently targeting is prevention of cytokine storms and organ dysfunction associated with sepsis.
The three patients in the Phase Ib clinical trial of OTS Allocetra had severe sepsis at the time of OTS Allocetra infusion. All three patients tolerated the infusion without serious adverse events. All three patients demonstrated swift clinical improvement after administration of both the standard-of-care and OTS Allocetra, and were released from the hospital after the condition of severe sepsis has been eliminated.
Following the results of the first three patients, Enlivex obtained regulatory approval for continued recruitment of patients into the Phase Ib clinical trial.
Prof. Dror Mevorach, Chief Medical Officer of Enlivex, commented, “We are pleased with the robust safety profile of OTS Allocetra in the first three sepsis patients in our ongoing Phase 1b clinical trial. Patients with severe sepsis are typically in highly-fragile clinical states, and it is encouraging that we have observed no serious adverse events associated with OTS in our ongoing trial. A potential clinically viable option of an off-the-shelf formulation could be of great importance for the commercialization of Allocetra for various clinical indications without the need to find a matched donor as the source of the infused cells.”
Shmuel Hess, CEO of Enlivex, stated, “We are encouraged by these initial results and the regulatory approval for recruitment of additional sepsis patients. OTS Allocetra is a significant product for Enlivex, and we look forward to obtaining additional clinical data”.
The ongoing Phase Ib clinical trial is expected to recruit up to 10 sepsis patients and study the safety and tolerability profile of OTS Allocetra. Subject to the study results, Enlivex is planning to initiate a Phase II of OTS Allocetra in up to 40 patients with sepsis, studying the clinical effect on amelioration of cytokine storms and prevention of organ dysfunction associated with severe sepsis.
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 hyper-expression of cytokines (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.
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 opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, 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 in Enlivex’s Annual Report on Form 20-F for the year ended December 31, 2018. 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.
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
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