Enlivex Secures Danish Approval to Advance Allocetra Trials
Enlivex Gains Approval for Phase II Clinical Trial
Enlivex Therapeutics Ltd. (NASDAQ: ENLV), a visionary company specializing in macrophage reprogramming immunotherapy, has received significant news that the Danish Medicines Agency has authorized the initiation of the Phase II stage in its clinical trial for Allocetra, a treatment aimed at addressing moderate to severe knee osteoarthritis.
Details of the Phase I/II Trial
The clinical trial being conducted is a multi-center study, structured as two distinct phases. The Phase I section comprises a safety run-in and an open-label dose escalation. Its primary purpose is to assess the safety and tolerability of Allocetra injections in the knee joint, this helps to determine optimal dosing for future stages.
As Enlivex completes the safety confirmation from the Data and Safety Monitoring Board (DSMB), it is now ready to advance to the double-blind, randomized, placebo-controlled Phase II stage. This part of the study is meticulously designed not only to evaluate the safety of Allocetra but also to have a statistically powered assessment of its efficacy. The outcomes will focus on joint function and pain relief, comparing treatments over a 12-month period.
Expert Insights on Allocetra
Dr. Einat Galamidi, serving as the Medical Vice President, expressed enthusiasm about the journey thus far. She noted, "The safety profile of Allocetra after the initial twelve patients is promising, which allows us to proceed to a rigorous randomized trial of the product’s efficacy against a placebo. This development could mark a pivotal point in treating knee osteoarthritis.”
The Growing Burden of Knee Osteoarthritis
Knee osteoarthritis is a global concern, impacting millions. Approximately 32.5 million Americans are diagnosed, with the number projected to reach 78 million by 2040. This degenerative joint condition can be particularly debilitating, causing severe pain and limiting mobility, leading to significant social and economic challenges. Current treatment options remain inadequate, as there are no FDA or EMA approved medications that effectively stop or reverse joint damage.
The societal impact is profound, with routine healthcare services strained due to over a million hospitalizations per year in the U.S. due to osteoarthritis complications. Bridging the gap in therapeutic offerings is crucial as the demand for effective pain relief and improved life quality for patients continues to rise.
Enlivex’s Innovative Approach
Enlivex is pioneering a novel approach with Allocetra™, a cell therapy designed to correct the immune response by reprogramming macrophages to their homeostatic state. This groundbreaking treatment aims to empower the body’s immune system and potentially mitigate the severe impacts of multiple immunological disorders. The ability to provide off-the-shelf solutions like Allocetra places Enlivex at the forefront of therapeutic innovations in immunology.
Company Contact Information
For further inquiries or more information about Enlivex Therapeutics, interested parties can reach out to:
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
Email: shachar@enlivexpharm.com
Frequently Asked Questions
What is Allocetra?
Allocetra is a cell therapy developed by Enlivex designed to reprogram macrophages to help improve immune system response.
Who authorized the Phase II trial?
The Danish Medicines Agency granted the approval for the initiation of the Phase II trial for Allocetra.
What does the Phase II trial involve?
The Phase II trial consists of a randomized, placebo-controlled stage focusing on safety and efficacy of Allocetra injections in patients.
How prevalent is knee osteoarthritis?
Knee osteoarthritis affects over 32.5 million Americans and over 300 million individuals globally.
How does Enlivex aim to change treatment for knee osteoarthritis?
Enlivex seeks to offer a unique therapy that effectively addresses inflammation and joint damage associated with knee osteoarthritis.
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