|Q&A with Cell Source CEO, Itamar Shimrat – transition from preclinical to human clinical trials|
|Wednesday, 05 November 2014 08:35|
Overcoming graft rejection is the main obstacle when it comes to allogeneic stem cell regeneration and organ transplantation. Current treatment includes the use of systemic immunosuppression, which leaves the patient at risk for opportunistic infections.Recent breakthroughs from Cell Source (OTC: CLCS) in Veto Cell technology, which selectively tunes immune response, may change how immunologists treat blood cancers and bone marrow transplants, as well as the process of how organs are repaired and new ones are regenerated.
Itamar Shimat, Cell Source’s CEO, who recently took part in the Life Sciences Summit in New York, sat down with BiomedReports to discuss the potential breakthroughs using Veto Cell technology.
BioMedReports:Can you give us some history about the technology?
Shimrat: It started when renowned Professor Yair Reisner and his team at the internationally renowned Weizmann Institute of Science in Rehovot, one of Israel’s leading research institutions, found the holy grail of the field of immunology: a cell that can selectively tune immune response so that it tolerates (doesn’t reject) desirable foreign incursions (e.g. life-saving transplantations) while continuing to actively reject all other incursions (i.e. threats). The team developed the breakthrough Central Memory T Cell (TCM)_technology which we coin as “Veto Cell Technology,” which is now licensed by Cell Source, an immunotherapy and regenerative medicine company, based in Tel Aviv.
BioMedReports:How do these Veto Cells eradicate hematological cancers?
Shimrat: Our cells locate, attack and destroy lymphoma, leukemia and multiple myeloma cells by traveling throughout the body and attacking only those cancer cells. Our Veto Cells then live on to kill more cancer cells until the cancer is eradicated. In a preclinical study conducted at the Weizmann Institute, mice with lymphoma that were treated with the Veto Cells all lived, as compared to the control group of mice that did not receive treatment which all died. The results of this study were published in peer-reviewed journals including the Journal of Immunology in July 2012 and also in Blood in February 2013.
BioMedReports:How do your Veto Cells create safe and accessible bone marrow transplantation which is often used to treat cancers of the blood?
Shimrat: Veto Cells safely neutralize rejection by disabling the immune system’s attack on only the transplantation so it can be accepted by the body, without compromising the rest of the immune system. This technology enables greater use of “mismatched” bone marrow donors, and opens up the use of safer Bone Marrow Transplantation ( BMT) for not only blood cancers, but potentially for the treatment of non-malignant hematological conditions such as sickle cell anemia. In another preclinical study at the Weizmann Institute, mice that had received mismatched BMT with very low levels of immune suppression and were treated with Veto Cells had a 70% survival rate, whereas all of the mice in the control group died. Results of this study were published in the scientific journal Blood in both the December 2012 issue and the February 2013 issue.
BioMedReports:You are also entering the organ space. Can you give us more color on the Organsource technology?
Shimrat: We have the option to license an organ regeneration technology that can potentially treat disease by “repairing” damaged organs. In the past this platform was used to effectively treat Type 1 diabetes in both mice and monkeys by regenerating a new pancreas in the host’s body from embryonic tissue taken from a pig fetus. Today we are focusing on using embryonic cells to “repair” damaged lung tissue in mice.
BioMedReports:When do you go into human trials?
Shimrat: Our Megadose + Drug Combination cell therapy treatment is expected to enter human clinical trials by end of 2014. Megadose + Drug cell therapy uses a combination of an established cell therapy with FDA approved drugs to enable a breakthrough in the use of mismatched BMT. The Megadose + Drug Combination is expected to dramatically increase BMT success and survival rates. Preclinical studies show that this novel combination of accepted and approved clinical treatments enables the coexistence of host and donor DNA. The human clinical study will be conducted at a hospital in Italy. The hospital, on its own initiative, plans to conduct the trial for Megadose + Drug Combination on a self-directed basis. The hospital, which applied for approval in May 2014, recently received final written approval from the Italian Medicine Association (AIFA), which is the Italian equivalent of the United States FDA, to begin a trial with a small number of patients. Although this trial is not being conducted by nor on behalf of Cell Source, because it involves the same treatment protocol that we plan to use in our future trials, successful results in the Italian hospital’s trial can act as a springboard for our planned company sponsored study.
BioMedReports:How important was it to present at the Life Science Summit?
Shimrat: The conference allowed us to bring our company story to business development executives from some of the big major pharma brands such as Takeda (OTC:TKPHF), Shire (NASDAQ:SHPG) and Merck (NYSE:MRK), who were looking for novel technology platforms in disease states such as diabetes and oncology. While we are initialy developing fully personalized treatments, our aspiration is to eventually complement this approach be developing a sort of “off-the-shelf" cell therapy.
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