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Enlivex Therapeutics Ltd. (NASDAQ: ENLV) is an Israel-based clinical-stage immunotherapy company focused on developing innovative allogeneic drugs to rebalance the immune system. The company's flagship product candidate, Allocetra™, is under development for multiple severe and critical conditions.
Allocetra™ is currently in a Phase IIB clinical trial targeting patients with severe sepsis, a life-threatening condition caused by the body's response to infection. Additionally, it is being investigated in a Phase II clinical trial for the treatment of COVID-19 patients with severe and critical conditions. The company is also exploring Allocetra™ in a Phase IIA trial for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplants (HSCT).
Enlivex is advancing Allocetra™ as a potential treatment for complications associated with bone marrow transplants, acute multiple organ failure, and as a combination therapy with various anti-cancer treatments to enhance efficacy. The immunotherapy works by reprogramming macrophages to their homeostatic state, thus rebalancing the immune system.
Recently, the Israeli Ministry of Health authorized a new trial for Allocetra™ targeting osteoarthritis, a chronic inflammatory condition affecting millions worldwide. This multi-country, double-blind, placebo-controlled Phase I/II trial aims to evaluate the safety and efficacy of Allocetra™ injections in knee osteoarthritis patients.
The company has shown promising results in its Phase II study of Allocetra™ in sepsis patients, demonstrating a favorable safety profile and potential effectiveness. With approvals from the Danish Medicines Agency and other international regulators, Enlivex is extending its clinical trials across multiple countries to further evaluate Allocetra™'s broad therapeutic potential.
Enlivex Therapeutics Ltd. announced peer-reviewed data showing remarkable safety and efficacy of Allocetra in treating severe sepsis. In a Phase Ib trial, patients receiving Allocetra exhibited a 0% mortality rate over 28 days, notably better than the 27% rate in matched controls. Key outcomes included shorter ICU stays and improved organ function. The study validates Allocetra's mechanism in managing cytokine storms. Enlivex is currently progressing into Phase IIb trials for pneumonia-associated sepsis and COVID-19 related acute respiratory distress syndrome.
Enlivex Therapeutics (Nasdaq: ENLV) announced its participation in the Reuters Events' Cell & Gene Therapy USA 2021 event, taking place virtually on September 28-29, 2021. Enlivex will present on September 29 at 11:30 a.m. EDT, discussing Allocetra's large-scale manufacturing process. AllocetraTM is an innovative cell therapy aimed at reprogramming macrophages, critical in addressing severe diseases like solid cancers and COVID-19. The event will feature various industry leaders sharing insights on gene therapies.
Enlivex Therapeutics (Nasdaq: ENLV) has initiated a Phase IIb clinical trial to evaluate AllocetraTM in patients with severe COVID-19 experiencing acute respiratory distress syndrome (ARDS). The trial aims to recruit up to 152 patients across Israel and Europe, with the primary endpoints being ventilation-free survival and recovery. Enlivex anticipates top-line results by Q2 2022. Previous trials showed a 0% mortality rate among 21 patients treated with AllocetraTM, with 90.5% recovering within an average of 5.6 days. This trial represents a crucial step toward addressing severe COVID-19 cases.
Enlivex Therapeutics (Nasdaq: ENLV) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The company focuses on macrophage reprogramming immunotherapy aimed at treating sepsis, COVID-19, and solid tumors. An on-demand presentation will be accessible starting 7:00 AM Eastern Time on September 13, 2021, through the provided link. Enlivex is advancing Allocetra™, a novel therapy designed to restore macrophage homeostasis, crucial for immune system balance.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has received authorization from the Israeli Ministry of Health to initiate a Phase IIb clinical trial of AllocetraTM for severe COVID-19 patients with ARDS. The trial will enroll up to 152 patients across Israel and Europe, focusing on safety and efficacy alongside standard treatment. Previous trials showed AllocetraTM achieved a 0% mortality rate and 90.5% recovery in severe cases within 28 days. The Phase IIb trial aims to evaluate ventilation-free survival and long-COVID symptoms.
Enlivex Therapeutics (ENLV) announced its Q2 2021 financial results and key clinical updates. The ongoing Phase IIb trial for AllocetraTM in sepsis is anticipated to report top-line results in Q2 2022, with 120-160 patients expected in the study. A Phase IIb trial for AllocetraTM in severe COVID-19 patients is set to start in Q3 2021. Enlivex also plans a Phase Ib trial to evaluate AllocetraTM combined with chemotherapy for solid tumors. Financially, the company posted a net loss of $3.108 million, with cash and marketable securities of $90.6 million to fund operations through 2023.
Enlivex Therapeutics has announced the appointment of Tzvi Palash as Project Lead for the construction of its new cGMP AllocetraTM manufacturing plant. With over 35 years of experience, including roles at Gamida Cell and Protalix Biotherapeutics, Palash is expected to enhance manufacturing capacity for upcoming clinical trials and potential commercialization. AllocetraTM aims to reprogram macrophages, addressing critical health needs in conditions like sepsis and COVID-19, aligning with Enlivex’s goal of leading in cell therapies.
Enlivex Therapeutics (Nasdaq: ENLV) announced that its CEO, Dr. Oren Hershkovitz, will participate in the Improvate Life-Saving Technologies International Conference 2021 on July 22, 2021. Dr. Hershkovitz's interview, scheduled for 5:15 AM EDT, will focus on the company's AllocetraTM macrophage reprogramming cell therapy platform, aimed at addressing life-threatening unmet medical needs. Attendees can access the live broadcast by registering on the conference's website.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its participation in the ARDS Drug Development Summit on July 15, 2021. The Company will present AllocetraTM, a promising therapy for acute respiratory distress syndrome (ARDS), a condition with limited effective treatments. The inaugural summit aims to address drug development challenges for both COVID-19 and non-COVID-19 related ARDS. AllocetraTM is designed to reprogram macrophages to restore immune balance, potentially serving life-threatening conditions.
Enlivex Therapeutics has announced the initiation of design and construction for a new cGMP manufacturing plant in Israel, aimed at expanding production capacity for its immunotherapy product Allocetra. This facility, initially planned to be 17,000 square feet with potential expansion to 21,500 square feet, will support ongoing and future clinical trials, along with initial commercial production upon regulatory approvals. CEO Oren Hershkovitz emphasized that this expansion is crucial for advancing clinical readiness for sepsis and COVID-19 treatments.
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