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Find Clinical Drug Pipeline Developments & Deals by Pluri
Through the agreement, Pluri will focus on the development of PLX-PAD cells (emiplacel), that exhibit immune-modulating capabilities, for the treatment of patients with cocaine addictions.
The net funding will be used to advance the development of its PLX-R18 cell therapy as a potential novel treatment for Hematopoietic Acute Radiation Syndrome (H-ARS).
The goal of the PROTO project is to utilize Pluri’s PLX-PAD cells in a Phase I/IIa study for the treatment of mild to moderate knee osteoarthritis (OA).
Patients treated with PLX-PAD (allogeneic PLX-PAD Cell) showed an increase of 2.3kg from reference (week 6) to week 26 compared to 0.51kg in the placebo group, a 1.8kg difference (p=0.073).
Results show the potential in the use of PLX-R18 for meaningful advantage over other existing and proposed treatments in post hematopoietic cell transplantation (HCT) patients. PLX-R18 reduced mortality from 29% to 18%1
and was well-tolerated with a favorable safety profile.
PLX-PAD cells demonstrated statistically significant superiority, in ability to increase muscle strength and volume for patients who have undergone total hip replacement surgery due to osteoarthritis.
The analysis will be based on 89 patients enrolled in the previously announced two Phase II studies, which investigated the safety and efficacy of Pluristem’s PLX cells as a treatment for severe COVID-19 cases complicated by ARDS.
The results demonstrate that PLX-R18 has the potential to stimulate the implanted hematopoietic cells to realize their therapeutic potential and generate improved blood counts over the long term in all three blood cell lineages at once.
Based on the review, the DMC concluded that the CLI study is unlikely to meet the primary endpoint by the time of the final analysis. Company to terminate the CLI study of PLX-PAD to focus on different therapeutic areas in its pipeline.
Pluristem Therapeutics has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for its COVID-19 Phase II clinical trial, under the protocol that was approved by Germany’s regulatory agency.