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Cellerant $13.5M Contract Will Fund Lead Program(BioWorld Today Via Acquire Media NewsEdge) Cellerant Therapeutics Inc. has received a $13.5 million U.S. government contract to develop a treatment for acute radiation syndrome (ARS) to counteract the effects of nuclear terrorism. Under the contract, the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services will provide the company with $3.4 million in the first year and, depending on development progress, up to $10.1 million in additional funds over three years. The BARDA funds will be used to move Cellerant's lead program, a human myeloid progenitor cell product (CLT-008), from advanced preclinical studies to Phase I and Phase II clinical trials in cord blood transplantation, and to conduct preclinical radiation efficacy studies. Based on animal data, CLT-008 could be given four to five days after radiation exposure compared to 24 to 48 hours for similar products in development, CEO Ram Mandalam told BioWorld Today. The BARDA funds are expected to accelerate the CLT-008 program, moving it into the clinic faster than the company could have done with current investor funding alone, Mandalam said. As required in the biodefense contract, Cellerant would need to demonstrate the safety of CLT-008 in any clinical trial it is conducting on the product, and it has chosen the cord blood setting. Cord blood transplantation is the lead setting in which Cellerant will seek approval for CLT-008. The San Carlos, Calif.-based biotech expects to file an investigational new drug (IND) application for that indication later this year. Cellerant also is studying CLT-008 to treat chemotherapy- and radiation-induced neutropenia, a condition in which white blood cells drop to an abnormally low level. Chemotherapy-induced neutropenia is potentially a bigger market opportunity than the cord blood setting, Mandalam said. However, the BARDA funding will not cover the cost of the company's neutropenia trials, he noted. Cellerant is still in the process of raising money and expects its current cash to last to the end of 2009, he said. To date, Cellerant has secured government funding of $7.4 million for the CLT-008 program from the Defense Department and the National Institutes of Health. The company was started by Irv Weissman in 2003 by acquiring hematopoietic stem cell (HSC, CLT-001) purification technology from SyStemix Inc., which was purchased by Novartis AG. Cellerant subsequently in-licensed two other key technologies: myeloid progenitors (CLT-008) and cancer stem cells (CSC) from licenses from Stanford University. Mandalam joined the company in 2005 and previously worked for Geron Corp., where he managed the development and manufacturing of cell-based therapies for treatment of degenerative diseases and cancer. The company has shifted focus recently from stem cell purification services to a product-focused firm, he said. Even though the company has had a "strategic change in direction," Mandalam said, the company has remained focused on the same hematopoietic system. n ? ? Copyright ? 2008 Thomson BioWorld, All Rights Reserved. |