- Company’s innovative cell selection product may dramatically reduce bone marrow transplantation risks
- Patient enrollment expected to begin in the next few weeks
TEL AVIV, Israel, Sept. 13, 2016 (GLOBE NEWSWIRE)—Cellect Biotechnology Ltd. (NASDAQ:APOP) (TASE:APOP), a developer of innovative technology which enables the functional selection of stem cells, today announced that the Company has received the Israeli Ministry of Health’s approval to begin a Phase I/II clinical trial in leukemia patients. The trial, which Cellect expects will be initiated in a few weeks, is planned to be conducted in the bone marrow transplantation (“BMT”) unit of Rambam Hospital, and led by Clinical Assistant Professor, Zila Zuckerman, the Director of the unit.
This trial is the first of its kind in leukemia patients in need of BMT, and will evaluate Cellect’s cell selection technology, “Powered by Cellect”, with the aim of assessing the technology’s safety and efficacy. Cellect’s cell selection process is designed to prevent severe adverse effects resulting from mature cells, including patient death. These adverse effects occur due to the interaction between the donor’s immune system and the recipient’s immune system. Cellect’s technology may enable controlled destruction of those mature immune system cells, thereby preventing the adverse effects.
Dr. Shai Yarkoni, the Company’s Chief Executive Officer, noted: “We are excited to have the opportunity to initiate this clinical trial and look forward to beginning to recruit patients shortly. The comprehensive preparations, which included extensive studies in healthy volunteers, demonstrated an impressive success in bone marrow transplants, with neither adverse effects nor mortality. We believe Cellect’s transformative approach to cell selection represents a significant breakthrough in the ability to produce selective destruction of mature cell populations, thus reducing the significant risks associated with BMT.”
The approval granted by the Ministry of Health to conduct the trial in leukemia patients may facilitate other clinical trial approvals in additional indications in both the US and Europe, which the Company is currently pursuing. Once the safety of Cellect’s cell selection technology is established in clinical trials, it will be validated for use in other applications, such as stem cell research and manufacturing processes of stem cell-based therapies.
Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ:APOP) (TASE:APOP). The Company develops an innovative technology which enables the functional selection of stem cells based on their sensitivity to apoptosis. This functional-based selection is a breakthrough technology in the ability to isolate stem cells from any given tissue, and may improve a variety of stem cells applications.
The Company’s first planned product line is expected to include unique containers for cell selection in an apoptosis-inducing microenvironment. Cellect’s first planned commercial product candidate is a medical kit designed for the cancer treatment bone marrow transplantations market, as well as other markets which require cell selection. The Company plans that in the future its technology will be integrated in many production procedures of stem cell-based products.
pt and validate the usability of its products and the description of its technology and its proposed uses in other applications.
Cellect Biotechnology Ltd.
Chief Financial Officer and Deputy Chief Executive Officer
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