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Enlivex Receives Approval from Danish Regulatory Agency for Phase I/II Trial Investigating Allocetra in Patients with Knee Osteoarthritis

Wednesday, April 17, 2024

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has received authorization from the Danish Medicines Agency (DKMA) to expand its Phase I/II trial for Allocetra™ into Denmark. This development follows the initial approval from the Israeli Ministry of Health earlier this year, marking a significant milestone in the company's efforts to develop a novel treatment for moderate to severe knee osteoarthritis.

The trial comprises two stages: a safety run-in phase followed by a randomized, placebo-controlled phase. The safety run-in phase aims to establish the safety and tolerability of Allocetra™ injections, while the subsequent phase evaluates its efficacy compared to a placebo. This double-blind stage is statistically-powered to assess joint-pain and joint-function improvements over a period of three, six, and twelve months post-treatment.

Oren Hershkovitz, Ph.D., CEO of Enlivex, expressed excitement for advancing Allocetra™ in osteoarthritis treatment. He emphasized Denmark's role as a leading recruitment country, noting the country's experience and expertise in conducting osteoarthritis studies.

Osteoarthritis affects millions worldwide, with symptomatic knee osteoarthritis being particularly prevalent and disabling. Current treatments fail to address the underlying structural damage in joints, making the need for effective therapies urgent.

Allocetra™ offers a promising approach as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. By restoring macrophage balance, Allocetra™ presents a potential breakthrough in addressing various diseases, including life-threatening conditions such as solid cancers and sepsis, where macrophage dysfunction plays a significant role.

 

Source: globenewswire.com

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