TEL AVIV, Israel, Nov. 13, 2014 /PRNewswire/ -- Cell Source, Inc.
(OTCQB: CLCS) ("Cell Source") an immunotherapy and regenerative
medicine company, announced today its Megadose Drug Combination has
been cleared for human clinical trials in Italy. Cell Source's proprietary Megadose Drug
Combination is expected to increase bone marrow transplantation
(BMT) success and survival. By combining an established cell
therapy with U.S. Food and Drug Administration (FDA) approved
drugs, Megadose Drug Combination, based on preclinical results to
date, may have the potential to enable an improvement in the
effectiveness and safety of use of mismatched BMT. BMT is most
often used for the treatment of blood cancers and is currently
reserved mostly for patients with life threatening diseases, due to
complications including transplant rejection. Should BMT
become safer, the procedure's use may well be expanded beyond
cancer to other indications including genetic and autoimmune
disease.
A leading Italian university hospital with extensive BMT
experience, an independent third party organization, has on its own
initiative chosen to conduct a human clinical trial of Megadose
Drug Combination on a self-directed basis. While Cell Source is not
a sponsor of the trial, a positive outcome could be
encouraging.
The Italian university filed an investigational new drug
application (IND) with the Italian Medicine Association, the
Italian equivalent of the U.S. FDA, to conduct human clinical
trials using the Megadose Drug Combination in the first half of
2014. The Italian Medicine Association granted approval for the IND
and commencement of the study with a small number of patients on
October 23, 2014.
"We are very pleased that independent researchers at this
Italian university have found our Megadose Drug Combination
compelling enough to initiate their own study. The treatment
protocol the university intends to implement for the study is the
same protocol we intend to use in our own future Phase I/II study.
Therefore, the data resulting from their study will be an important
indicator for Cell Source's future trials and positive results
would serve as an additional springboard," stated Cell Source
President and CEO Itamar
Shimrat.
In preclinical studies Megadose Drug Combination has shown
success in inducing immune tolerance. The drug has shown to enable
the coexistence of host and donor DNA, thus significantly reducing
transplant rejection.
Cell Source is the exclusive worldwide licensee of a variety of
progressive cell therapy technologies invented at the Weizmann
Institute of Science, one of Israel's and the world's leading research
institutes.
For further information, please visit
www.cell-source.com or contact Itamar
Shimrat, President and CEO (646) 416-7896.
About Cell Source, Inc.
Cell Source is an immunotherapy and regenerative medicine
company whose primary breakthrough is the regulation of immune
tolerance. In preclinical studies Cell Source's therapies have
demonstrated the ability to directly address a number of severe
medical conditions including blood cancers such as non-Hodgkins
lymphoma, multiple myeloma, and chronic lymphocytic leukemia.
Cell Source's organ regeneration platform holds the potential
to repair organs and to grow entire organs inside the patient's
body. Growing or regenerating organs and using cell therapy to
tolerize the immune system can each revolutionize the treatment of
numerous severe diseases that today kill hundreds of thousands of
patients annually.
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SOURCE Cell Source, Inc.