DSMB Approves Enrollment of Final Conort In Phase 1 Hematological Study.
First Two Cohorts Show Primary Safety Endpoint Met, Plus Early Signs Of Efficacy
HAIFA, Israel, March 12, 2019 -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) announced full enrollment of the second cohort of six patients in an ongoing Phase 1 clinical study evaluating PLX-R18 for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT)
The company said it has received Data and Safety Monitoring Board (DSMB) approval to continue to the final cohort of the study.
Pluristem is developing placenta-based cell therapy products,
Results from the first two cohorts demonstrate PLX-R18 is safe and well tolerated, with early signals of efficacy in improving blood counts.
The third and final cohort will comprise 15 patients who will receive two administrations of four million PLX-R18 cells/kg, one week apart, considered as the target dose for these patients.
Incomplete hematopoietic recovery poses a significant risk to HCT recipients who fail to respond to the usual standards of care, making them vulnerable to severe complications and potentially resulting in their incurring significant related costs.
The company believes PLX-R18 can address the unmet need in this patient population by reviving the regenerative potential of the bone marrow and blood cell growth where other treatments have proven ineffective, and we look forward to final results from this study.
The Phase 1 study is designed as a multicenter, open-label, dose-escalating study to evaluate the safety of intra-muscular (IM) injections of PLX-R18 cells in 24 patients with incomplete hematopoietic recovery persisting for at least four months after HCT. The follow up period for safety is 12 months.
Patients in the study are enrolled into three chronological treatment groups: two administrations of one million PLX-R18 cells/kg (n=3), two administrations of two million PLX-R18 cells/kg (n=G) and two administrations of 4 million PLX-R18 cells/kg (n=15).
The primary endpoint is safety which is assessed, at the end of each cohort, by an external DSMB.
In addition, exploratory evaluations are made, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life and changes in the serum immunological parameters.
PLX-R18 cell therapy for the treatment of incomplete hematopoietic recovery following HCT was granted Orphan Drug Designation by the FDA.
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|Title Annotation:||In The Clinic...|
|Publication:||Stem Cell Research News|
|Date:||Mar 25, 2019|
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