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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 (Nasdaq: ENLV) has received authorization from the Israeli Ministry of Health to begin a Phase I trial evaluating Allocetra™ in patients with temporomandibular joint (TMJ) osteoarthritis. The investigator-initiated trial will be conducted at Sheba Medical Center, recently ranked among the world's top 10 hospitals by Newsweek.
The study aims to recruit six patients who haven't responded adequately to conventional TMJ osteoarthritis treatments. The trial will assess safety through monitoring adverse events, while efficacy endpoints will evaluate changes in TMJ pain, joint functionality, and other disease parameters for up to 12 months post-treatment.
Enlivex Therapeutics announced positive interim efficacy data from its Phase I/II Allocetra™ trial for moderate to severe knee osteoarthritis. The Phase I stage showed statistically significant results (p-value < 0.0007, n=12) with marked improvements in key efficacy endpoints. The treatment demonstrated a 50% reduction in average knee joint pain, 42% improvement in knee joint function, and 37% reduction in knee joint stiffness after three months. Among participants, 83% were responders to Allocetra™, showing >40% pain reduction from baseline. The trial is now enrolling patients for the Phase II stage, which is double-blind, randomized, and placebo-controlled.
Enlivex Therapeutics (Nasdaq: ENLV) announces an exclusive live investor webinar and Q&A session scheduled for December 3, 2024, at 11:00 a.m. ET. CEO Oren Hershkovitz will discuss the company's lead product Allocetra™, its clinical status, and planned catalysts for 2025. Allocetra™ is an off-the-shelf cell therapy that reprograms macrophages to optimal functioning state, addressing conditions like osteoarthritis, sepsis, and psoriatic arthritis. Phase I/II trials have shown promising results in these multi-billion-dollar markets. Investors can pre-submit questions to ENLV@redchip.com or participate in the live Q&A.
Enlivex Therapeutics (Nasdaq: ENLV) announced its Board of Directors has approved the purchase of up to $1 million of Bitcoin as part of its cash management strategy. The clinical-stage macrophage reprogramming immunotherapy company views Bitcoin as a strong and diversifying treasury reserve asset, citing growing demand, increased acceptance as a medium of exchange, recent Bitcoin ETF approvals, and institutional investor support. The company believes Bitcoin can serve as a potential store of value and inflation hedge against standard currencies.
Enlivex Therapeutics has initiated a Phase I clinical trial evaluating Allocetra™ in patients with psoriatic arthritis. The first patient has completed dosing and initial follow-up with no safety concerns reported. The trial aims to recruit six patients who haven't responded adequately to conventional therapies. The study will assess safety through monitoring adverse events, and measure changes in pain and disease activity for up to 12 months post-treatment. This trial complements Enlivex's ongoing osteoarthritis study, targeting high-grade inflammatory joint disease with potential market opportunities.
Enlivex Therapeutics (Nasdaq: ENLV) announced the enrollment and dosing of the first 10 patients in the randomized Phase II stage of its Allocetra™ trial for moderate to severe knee osteoarthritis. This follows the successful completion of Phase I safety run-in stage and approval from the Danish Medicines Agency. The Phase II stage is designed as a double-blind, randomized, placebo-controlled study, focusing on evaluating both safety and efficacy of Allocetra™ knee injections. The trial will assess joint-pain and joint-function compared to placebo at three, six, and 12 months post-treatment. Initial dosing showed no safety concerns.
Enlivex Therapeutics (Nasdaq: ENLV) has received a notice of allowance from the Japanese Patent Office for patent application 2022-512861, titled 'THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS'. The patent, expected to be formally issued by Q2 2025, will protect Enlivex's intellectual property rights for Allocetra™ in Japan through at least 2040. This development supports the company's global IP strategy and their efforts to develop Allocetra™ as a next-generation cell therapy for osteoarthritis, addressing an unmet medical need with current treatment options.
Enlivex Therapeutics (Nasdaq: ENLV) has received authorization from the Danish Medicines Agency to initiate the Phase II stage of its Phase I/II trial for Allocetra™ in patients with moderate to severe knee osteoarthritis. This approval follows a recommendation by the independent Data and Safety Monitoring Board (DSMB) to proceed to Phase II. The trial consists of two stages: a Phase I safety run-in, open-label dose escalation phase, and a Phase II double-blind, randomized, placebo-controlled stage.
The Phase II stage will evaluate both safety and efficacy of Allocetra™ injections into the knee, with primary measurements assessing joint-pain and joint-function compared to placebo at three, six, and 12 months post-treatment. Dr. Einat Galamidi, Medical Vice President of Enlivex, expressed satisfaction with Allocetra™'s safety profile following three sequential intra-articular knee injections in the first twelve patients of the Phase I stage.
Enlivex Therapeutics (Nasdaq: ENLV) announced positive results from the Phase I safety run-in stage of its Phase I/II clinical trial for Allocetra™ in patients with moderate to severe knee osteoarthritis. The independent Data and Safety Monitoring Board (DSMB) recommended proceeding to the Phase II stage after reviewing the safety data. Key points include:
1. No serious adverse reactions reported during or after treatment
2. DSMB confirmed Allocetra™'s safety profile allows progression to Phase II
3. Phase II will use the highest dose tested in Phase I
4. The trial will involve up to 160 patients
5. Phase II is a double-blind, randomized, placebo-controlled study
6. Primary measurements will assess joint pain and function at 3, 6, and 12 months post-treatment
RedChip Companies will air interviews with GreenPower Motor Company Inc. (Nasdaq:GP) and Enlivex Therapeutics on the RedChip Small Stocks, Big Money™ show on Bloomberg TV on August 31, 2024, at 7 p.m. ET. The show reaches an estimated 73 million homes across the U.S.
In his interview, GreenPower's CEO Fraser Atkinson provides a corporate update. GreenPower manufactures all-electric, zero-emission medium and heavy-duty vehicles for various markets. The company has delivered over 700 vehicles to date and maintains a significant order book. GreenPower's competitive positioning and market dynamics suggest potential for sustained growth in the EV industry.
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