Enlivex Initiates Groundbreaking Phase I TMJ Osteoarthritis Study
Enlivex's Innovative Clinical Trial Begins
Temporomandibular joint (TMJ) osteoarthritis is a degenerative and painful condition that affects a significant portion of the population, characterized by joint deterioration leading to limited mobility and discomfort. Globally, it impacts approximately 5% to 12% of individuals, making it a prevalent and challenging issue.
Importance of the Phase I Trial
Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a pioneering clinical-stage immunotherapy company, has marked a significant milestone by dosing the first patient in an important Phase I trial evaluating Allocetra™ for patients suffering from TMJ osteoarthritis. This groundbreaking study aims to assess not only the safety and tolerability of this innovative treatment but also its potential effectiveness in alleviating the severe symptoms associated with TMJ osteoarthritis.
This clinical trial is a critical step forward as there are currently no long-term effective treatments available for patients afflicted with this debilitating condition. The study is being conducted by the esteemed Rheumatology Unit at Sheba Medical Center in collaboration with its Department of Oral and Maxillofacial Surgery.
Evaluating Allocetra™
Dr. Einat Galamidi, the Chief Medical Officer of Enlivex, expressed enthusiasm about the trial, stating, "The initiation of this study represents a vital opportunity to evaluate the potential of Allocetra™ as a therapeutic option for TMJ osteoarthritis, which significantly hinders daily functioning. We are thrilled to report that the first injection into the patient's TMJ was completed successfully, with no reported complications."
The trial plans to enroll six patients who have not experienced adequate relief from conventional treatments. Key safety measures will track any adverse events, while the efficacy of Allocetra™ will be assessed through various endpoints, including pain assessment and joint functionality over a twelve-month period following administration.
Understanding Allocetra™
Allocetra™ is designed as a universal, off-the-shelf cell therapy that reprograms macrophages back to their homeostatic state. Macrophages play a crucial role in the immune response, and when they lose this balance, they can exacerbate conditions like TMJ osteoarthritis, leading to further degradation of the joint. By restoring normal function in these immune cells, Allocetra™ presents a novel therapeutic approach aimed at addressing critical medical needs.
Your Health and TMJ Osteoarthritis
TMJ disorders are a significant health concern, with treatment costs associated with the condition reaching approximately $4 billion annually. Osteoarthritis of the TMJ is noted as the predominant arthritis type in this joint, causing considerable pain and stiffness that can impair one's ability to eat properly or even speak comfortably. The progressive nature of this disease raises significant concerns, especially for younger individuals showing severe symptoms, as it may lead to more invasive interventions, including total joint replacement.
About Enlivex Therapeutics
As a leader in macrophage reprogramming immunotherapy, Enlivex is committed to developing innovative therapeutic solutions for unmet medical needs. The development of Allocetra™ signifies the company's ongoing mission to revolutionize treatments for various life-threatening conditions through its cutting-edge research and clinical endeavors.
If you have further questions or would like more information, you can reach out to:
Enlivex Contact:
Shachar Shlosberger, CFO
Email: shachar@enlivexpharm.com
Investor Relations Contact:
Dave Gentry, CEO, RedChip Companies Inc.
Phone: 1-407-644-4256
Email: ENLV@redchip.com
Frequently Asked Questions
What is the purpose of the Phase I trial for Allocetra™?
The trial aims to evaluate the safety, tolerability, and initial efficacy of Allocetra™ in treating TMJ osteoarthritis.
Who is conducting the trial?
The trial is being conducted by the Rheumatology Unit at Sheba Medical Center, working alongside the Department of Oral and Maxillofacial Surgery.
How many patients will be involved in the trial?
Six patients will be recruited for the trial, all of whom have had inadequate responses to existing treatments.
What is TMJ osteoarthritis?
TMJ osteoarthritis is a degenerative joint condition causing pain and dysfunction in the temporomandibular joint.
How does Allocetra™ work?
Allocetra™ aims to reprogram non-homeostatic macrophages back to their functional state, potentially improving immune responses and mitigating symptoms.
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