- First patient dosed with AllocetraTM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people
- Thumb osteoarthritis currently has no FDA-approved therapy and no effective long-term treatments
NESS-ZIONA, Israel I June 24, 2024 I Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated, randomized, placebo-controlled Phase I/II trial evaluating the efficacy and safety of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis, for which conventional therapies have failed.
This investigator-initiated Phase I/II trial plans to recruit up to 46 patients and is composed of two stages. The first stage is a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of an AllocetraTM injection in patients with osteoarthritis of the first basal thumb joint (first CMC joint) of the target thumb to identify the dose for the randomized stage. The second stage is a double-blind, randomized, placebo-controlled stage, which the Company expects to initiate following the completion of the safety run-in stage and selection of the safe and tolerable dose. Up to 40 patients will be randomized in a 1:1 ratio for treatment with either AllocetraTM at the selected dose or placebo. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and the efficacy endpoints will include assessments of change from baseline in pain and function for up to 12 months following treatment.
“This is the first injection of AllocteraTM into the basal thumb joint, and we are pleased with the swift enrollment of the first patient just a few weeks following regulatory approval to initiate this trial. The injection of AllocteraTM into the patient’s basal thumb joint was successfully completed with no complications.” stated Oren Hershkovitz, Ph.D., CEO of Enlivex.
ABOUT ALLOCETRA™
Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening and life-debilitating clinical indications that are defined as “unmet medical needs.”
ABOUT BASAL THUMB OSTEOARTHRITIS
Osteoarthritis of the thumb is a chronic condition causing pain, stiffness and occasional clicking and swelling in the joint at the base of thumb (also known as the carpometacarpal or CMC joint). Simple daily tasks can become painful and difficult. The prevalence of thumb osteoarthritis increases substantially with age and is more common in postmenopausal woman. The prevalence of radiographic base thumb OA was reported to be 5.8% and 7.3%, for 50-year-old males and females, respectively, while the respective prevalence for 80-year-old male and female participants was reported as 33.1% and 39.0%1. The overall estimated symptomatic prevalence is up to 15% in adults over 30 years of age2. Osteoarthritis of the thumb is a degenerative and progressive condition, and over time, conservative treatments and anti-inflammatory medication to reduce pain and swelling start losing their effectiveness. Currently, there are no effective long-term treatments for this disease.
ABOUT ENLIVEX
Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com.
SOURCE: Enlivex
Post Views: 1,359
- First patient dosed with AllocetraTM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people
- Thumb osteoarthritis currently has no FDA-approved therapy and no effective long-term treatments
NESS-ZIONA, Israel I June 24, 2024 I Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated, randomized, placebo-controlled Phase I/II trial evaluating the efficacy and safety of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis, for which conventional therapies have failed.
This investigator-initiated Phase I/II trial plans to recruit up to 46 patients and is composed of two stages. The first stage is a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of an AllocetraTM injection in patients with osteoarthritis of the first basal thumb joint (first CMC joint) of the target thumb to identify the dose for the randomized stage. The second stage is a double-blind, randomized, placebo-controlled stage, which the Company expects to initiate following the completion of the safety run-in stage and selection of the safe and tolerable dose. Up to 40 patients will be randomized in a 1:1 ratio for treatment with either AllocetraTM at the selected dose or placebo. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and the efficacy endpoints will include assessments of change from baseline in pain and function for up to 12 months following treatment.
“This is the first injection of AllocteraTM into the basal thumb joint, and we are pleased with the swift enrollment of the first patient just a few weeks following regulatory approval to initiate this trial. The injection of AllocteraTM into the patient’s basal thumb joint was successfully completed with no complications.” stated Oren Hershkovitz, Ph.D., CEO of Enlivex.
ABOUT ALLOCETRA™
Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening and life-debilitating clinical indications that are defined as “unmet medical needs.”
ABOUT BASAL THUMB OSTEOARTHRITIS
Osteoarthritis of the thumb is a chronic condition causing pain, stiffness and occasional clicking and swelling in the joint at the base of thumb (also known as the carpometacarpal or CMC joint). Simple daily tasks can become painful and difficult. The prevalence of thumb osteoarthritis increases substantially with age and is more common in postmenopausal woman. The prevalence of radiographic base thumb OA was reported to be 5.8% and 7.3%, for 50-year-old males and females, respectively, while the respective prevalence for 80-year-old male and female participants was reported as 33.1% and 39.0%1. The overall estimated symptomatic prevalence is up to 15% in adults over 30 years of age2. Osteoarthritis of the thumb is a degenerative and progressive condition, and over time, conservative treatments and anti-inflammatory medication to reduce pain and swelling start losing their effectiveness. Currently, there are no effective long-term treatments for this disease.
ABOUT ENLIVEX
Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com.
SOURCE: Enlivex
Post Views: 1,359
