Successful Completion of First half of ApoGraft™ Phase I/II Clinical Trial Shows 100% Engraftment and No Related Adverse Effects
TEL AVIV, Israel, March 27, 2019 /PRNewswire/ -- Further validating its ApoGraft™ technology, Cellect Biotechnology Ltd. (APOP), a developer of a novel stem cell production technology, announced positive mid-study data from the Company's Phase I/II study of its ApoGraft™ technology. The first half of patients planned for the study have completed the 180 day follow up, and 8 out of 12 planned subjects have been enrolled.
All patients transplanted using the ApoGraft™ process were engrafted and time to engraftment was similar to the standard of care. To date, there have not been any safety concerns during the study and patient enrollment is continuing. Both, the principal investigator (PI) and independent data safety monitoring board (DSMB) agree that no serious adverse events (SAEs) reported during the course of the study were related to the ApoGraft™ process.
The following is the mid-study results overview of the first six patients at 180 days:
- Patients' average age is 45.8 years of age (21-64), 50% males, the primary disease is AML (63% of total patients) and 25% suffer from MDS and 12% from ALL
- Safety and dose escalation were monitored by the DSMB. No safety concerns were identified during the study and enrollment has continued as planned
- All patients transplanted with ApoGraft were engrafted. Mean time to neutrophil and platelet engraftment was 15.8 and 16.9 respectively. These results are fully compatible with the standard of care in patients undergoing bone marrow transplantations
- There were no serious adverse events reported during the ApoGraft study that were considered related to the ApoGraft process by either the study principal investigator or the sponsor
- Eleven SAEs were reported during the ApoGraft study in six patients - all defined as not related to the ApoGraft procedure
"We are encouraged that the data for the Phase I/II study continues to validate our ApoGraft technology – and the data at this point fully met our expectations," commented Dr. Shai Yarkoni, Chief Executive Officer. "As we enroll the remaining patients, we believe the results strengthen our plans to initiate the next trial in the U.S. during the first half of the year and begin to monetize Cellect's proof of concept as we seek partnerships and collaborations with academics and corporate customers."
The Phase I/II, open-label, proof of concept, staggered 4-cohort clinical study is designed to evaluate safety and tolerability of ApoGraft™ in patients with haemato-oncology disorders undergoing allogenic HLA-matched hematopoietic stem cell transplant (HSCT). The primary endpoint of the study is to evaluate the overall incidence, frequency, and severity of adverse events potentially related to ApoGraft™ at 180-days post-transplant.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (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 researchers, clinical community 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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Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer