Enlivex Therapeutics Ltd. Ordinary Shares - ENLV STOCK NEWS

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.

Enlivex Therapeutics (Nasdaq: ENLV) has received authorization from the Israeli Ministry of Health to initiate a Phase I clinical trial for Allocetra™ in patients with psoriatic arthritis. The trial aims to evaluate the safety and tolerability of Allocetra™ when injected into an affected joint. It plans to recruit six patients who have not responded adequately to conventional therapies.

The primary endpoint will assess the frequency and severity of adverse events, while secondary endpoints will measure changes in pain and disease activity for up to 12 months post-administration. This marks the first study of Allocetra™ in psoriatic arthritis, a chronic inflammatory condition affecting up to 30% of people with psoriasis. CEO Oren Hershkovitz expressed optimism about developing a potentially effective treatment option for patients with alternatives.

RedChip Companies will air interviews with Enlivex Therapeutics (Nasdaq:ENLV) and Biotricity, Inc. (Nasdaq:BTCY) on the RedChip Small Stocks, Big Money™ show on Bloomberg TV on July 20, 2024, at 7 p.m. ET. Oren Hershkovitz, Ph.D., CEO of Enlivex Therapeutics, will provide a corporate update on their clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Allocetra™ has the potential to address life-threatening and debilitating unmet medical needs in conditions like osteoarthritis and sepsis.

Enlivex Therapeutics announced the dosing of the first patient in a Phase I/II clinical trial evaluating AllocetraTM for thumb osteoarthritis. This condition, affecting millions, currently has no FDA-approved therapies. The trial, involving up to 46 patients, is divided into two stages: an open-label dose escalation phase to assess safety and tolerability, followed by a randomized, placebo-controlled stage. The primary endpoint is the frequency and severity of adverse events, while efficacy will be measured through changes in pain and function over 12 months. CEO Oren Hershkovitz highlighted the swift enrollment and successful dosing of the first patient.

Enlivex Therapeutics invites investors to a webinar on June 25, 2024, at 4:15 p.m. ET, hosted by RedChip Companies. The event will feature CEO Dr. Oren Hershkovitz, who will discuss Allocetra™, the company's leading product candidate, and share positive interim data from a Phase I/II trial in knee osteoarthritis showing reduced pain and a favorable safety profile. Updates on various clinical programs, expected milestones, and the company's financial status following a recent direct offering will also be presented. The event will include a live Q&A session. Register at https://redchip.zoom.us/webinar/register/WN_lwhHqyYNTJG7uIYzNc0tHA#/registration.