Cellect Biotechnology Reports Top Line Data from Phase 1/2 Clinical Trial
Cellect Biotechnology (NASDAQ: APOP) announced positive results from its Phase 1/2 clinical trial of ApoGraft technology, conducted on 11 patients with hemato-oncology disorders. All patients successfully underwent transplantation, meeting the primary objective of safety and tolerability, with no adverse events reported. Following a merger with Quoin Pharmaceuticals, the development of ApoGraft will continue under EnCellX in San Diego. CEO Dr. Shai Yarkoni highlighted the data's validation of previous results and its potential to expedite further clinical development.
- Successful transplantation for all 11 patients in the trial.
- No procedure-related adverse events reported.
- Positive validation of earlier trial results.
- The company requires additional capital due to a history of losses.
- Uncertainty regarding future regulatory approvals.
- Potential difficulties in patient enrollment for future studies.
Results Support Ongoing Clinical Development of ApoGraft in U.S.
Tel Aviv, Israel, April 19, 2021 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (NASDAQ: "APOP"), a developer of innovative technology that enables the functional selection of stem cells, today announced positive data from the Company's open label Phase 1/2 clinical trial of its ApoGraft™ technology in Israel. All eleven patients enrolled for the trial were transplanted using the ApoGraft product and were engrafted in a timely manner. The primary objective, safety and tolerability of ApoGraft administered to patients with hemato-oncology disorders, was met and there were no procedure related adverse events (AEs) reported during the course of the study.
As previously announced last month, following the anticipated closing of the merger with Quoin Pharmaceuticals, the development of the ApoGraft technology is expected to be pursued by San-Diego based EnCellX, led by Adi Mohanty.
“The data validates earlier results and supports the ongoing development of our products,” commented Dr. Shai Yarkoni, Chief Executive Officer. “I remain committed and believe that the human data from this study will expedite the clinical development of the ApoGraft.”
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 cell-based therapies.
The Company's technology is expected to provide researchers, clinicians and pharmaceutical companies with the tools to rapidly isolate specific cells in quantity and quality, allowing 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
This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; or maintain its current operations; uncertainties involving any strategic transaction the Company may decide to enter into as the result of its current efforts to explore new strategic alternatives; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company's periodic filings with the SEC.
Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
www.cellect.co
+972-9-974-1444
Or
EVC Group LLC
Michael Polyviou
(732) 933-2754
mpolyviou@evcgroup.com
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