Cellect Announces Positive Clinical Results
Oct 15, 2018, 07:16 ET
- One-month assessment of half of the planned patients in the ApoGraft™ study show complete engraftment and zero related adverse events
- First cohort of patients completed the full study showing safety and tolerability (zero Related Adverse Events -primary endpoint) and engraftment before 28 days post-transplant
- Independent Data Safety Monitoring Board approves dose escalation for next group of Patients
TEL AVIV, Israel, Oct. 15, 2018 /PRNewswire/ -- Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of a novel stem cell production technology, announced today further data from a Phase I/II study of its ApoGraft™ technology. With half of the patients planned for the study having finished first month follow up, all such patients have shown 100% engraftment with no procedure related adverse events reported. Further to the six patients' one month data detailed above, Cellect reports that the first three patients of the trial (cohort I) have completed the study period (180 days) with full safety and tolerability.
Up to 50% of stem cell transplantation procedures result in life-threatening rejection disease and other immune responses such as Graft-versus-Host-Disease (GvHD). These adverse reactions stem from the inability of current practice to select between cells needed for successful transplant and those which cause the adverse effects. Cellect's ApoGraft™ technology aims to turn stem cell transplantations into a simple and safe yet cost-effective procedure by proper selection of the needed cells and elimination of the toxicity causing cells thereby reducing the associated severe side effects and consequently the outcome of the patients.
The Phase I/II, dose escalating, 4-cohort, open label clinical trial of twelve patients is designed to evaluate the safety and tolerability of the ApoGraft™ process in patients with hematological malignancies in an allogeneic hematopoietic stem cell transplantation (HSCT). The primary endpoint of the study is overall incidence, frequency and severity of adverse events potentially related to ApoGraft™ at 180 days from transplantation.
An independent Data Safety Monitoring Board (DSMB) has reviewed the study results and approved dose escalation to 50 ng/ml FasL. The first cohort in the study was dosed with 10 ng/ml FasL and the second was dosed with 25 ng/ml FasL. Based on the DSMB's recommendation, Cellect is proceeding with enrolling and dosing the third cohort of the study.
"The data is very encouraging and points to the potential of ApoGraft™ to make stem cell usage safe and effective. Eliminating the cells that cause the adverse events in Bone Marrow Transplants validates the ability of the Apograft's selection process. This proof of concept combined with the effect in Fat derived Stem cells further supports the generic use of Cellect's technology from a variety of cell sources and widens the scope of applications within Regenerative Medicine", stated Cellect CEO Dr. Shai Yarkoni.
Cellect's simple process selects and eliminates immune reaction-causing cells from the donor sample and delivers an improved cell batch comprising enriched stem cells. The ApoGraft™ is intended to result in recovery of the patient's new immune system with reduced related safety concerns in contrast to the significant morbidity or even death that happens a lot in currently standard BMT.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (NASDAQ: APOP) has developed a breakthrough technology for the selection of stem cells from any given tissue that aims to improve a variety of stem cell-based therapies.
The Company's technology is expected to provide research, hospitals and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.
Forward Looking Statements
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Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
+972-9-974-1444
SOURCE Cellect Biotechnology Ltd.