Cell Source, an immunotherapy and regenerative medicine company, announced 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 US Food and Drug Administration (US 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 organisation, 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 US 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 chief executive officer, 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 licencee 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.