Cellect Announces Positive Results From BMT Safety Test
TEL AVIV, Israel, Dec. 9, 2015 (GLOBE NEWSWIRE) -- Cellect Biomed Ltd. (TASE:CLBD) ("Cellect" or the "Company"), a developer of innovative technology which enables the functional selection of stem cells, announced today the results of its primary toxicology test conducted using its unique stem cell selection platform. The 9-week test, which concludes overall preparations for the Company's first clinical trial was conducted under internationally-recognized Good Laboratory Practices (GLP) guidelines, and included a full clinical and histopathological analysis of both the treatment and the control animal groups.
The test examined the safety of bone marrow transplantations (BMT) in an aggressive model with expected mortality rates of 40% to 50%. This is the preferred model of all companies developing BMT treatments because the aggressive control group represents a superior comparison model. The test was designed to analyze the safety of Cellect's cell selection method by examining toxicity parameters and comparing results to a control group, in which the same cells were transplanted without Cellect's treatment.
While the control group demonstrated a 50% mortality rate as predicted, the treatment group, which received bone marrow samples that were transplanted with Cellect's methodology, demonstrated zero mortality. Moreover, no toxicity was observed in other parameters, such as clinical signs and body weight. The Company is conducting analyses of observations collected outside the framework of the test, and expects to receive a histological report in the coming months that will include the relevant statistical analysis. However, even at this early stage, the results have exceeded the expectations of Cellect's management team.
Professor Dov Zipori, a globally renowned expert in the stem cell field, noted: "The fact that no mortality was observed in the treatment group, combined with the substantial mortality rate demonstrated in the control group, offers significant support for the safety of this system. Furthermore, it is important to emphasize the receipt of human cells in the bone marrow of 95% of the group treated through Cellect's method, two months after the transplantation. These results are extremely encouraging as we approach the upcoming human clinical trials."
Dr. Shai Yarkoni, Cellect's CEO, said: "The results have exceeded our expectations and they even surpassed the successful results we have previously achieved. This is a real breakthrough, and has the potential to help millions of patients suffering from cancer and those undergoing organ transplantations worldwide. Cellect's technology may indeed open a new path to 21st century medicine."
About Cellect
Cellect develops an innovative technology which enables the functional selection of stem cells based on their sensitivity to apoptosis. This functional-based selection is an international breakthrough in the ability to isolate stem cells from mature cells, thereby improving a variety of stem cells applications.
The company's first product line will include unique containers for cell selection in apoptosis-inducing microenvironment. Cellect has proved in extensive lab studies that the use of apoptosis can largely increase the stem cell concentration in samples taken from bone marrow donors, as well as umbilical cord blood. The first commercial product of the company is a medical kit designed for the cancer treatment bone marrow transplantations market, as well as other markets which require cell selection. The company estimates that in the future its technology will be integrated in many production procedures of stem cell-based product.
Forward-Looking Statements
This press release may contain forward-looking statements, about Cellect's expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Cellect or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Cellect with the TASE, press releases or oral statements made by or with the approval of one of Cellect's authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Cellect's actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Cellect's actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements, including, but not limited to, the factors summarized in Cellect's filings with the TASE. In addition, Cellect operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Cellect does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: U.S. Investor Contact: Stephen Kilmer (647) 872-4849 stephen@kilmerlucas.com