SAN CARLOS, CA - September 22, 2008 Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has been awarded a contract valued at $13.5 million dollars from the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services for the development of a treatment for acute radiation syndrome (ARS). Under terms of the contract, Cellerant will receive $3.4 million in the first year and, depending on development progress, up to $10.1 million in additional funds over three years. Funds will be used to move Cellerant’s lead program, a human Myeloid Progenitor Cell product (CLT-008) from advanced preclinical studies to Phase 1 and Phase 2 clinical trials, and to conduct preclinical radiation efficacy studies.
“We are honored to have been awarded this important contract from BARDA,” said Dr. Ram Mandalam, President and CEO of Cellerant Therapeutics. “Cellerant is proud to develop CLT-008 as an effective nuclear countermeasure and to support our national security interests with a solution for this unmet medical need. This contract not only provides validation to Cellerant’s technology platform, but also enables us to significantly accelerate CLT-008’s safety and efficacy evaluation, including FDA approval. We expect to file an IND for CLT-008 later this year.”
CLT-008 is intended to provide hematopoietic cellular support after radiation exposure to ARS patients. Various preclinical studies conducted to date suggest that a single dose of CLT-008 could provide effective treatment for ARS in an emergency situation, and can be administered up to five days post-exposure to radiation. In addition to the BARDA contract, Cellerant has received grant funding from the Department of Defense through its partnership with the Joint Program Executive Office for Chemical and Biological Defense, Chemical Biological Medical Systems Joint Project Management Office as well as funding from the National Institutes of Health for study of the potential use of CLT-008 as a viable method of reducing the damage caused by radiation exposure.
CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Myeloid Progenitor Cells derived from adult stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In pre-clinical models, CLT-008 has been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival with a high degree of efficiency. Cellerant is developing CLT-008 as an effective treatment for chemotherapy induced neutropenia, protection from exposure to acute radiation and facilitating cord blood transplantation.
Cellerant Therapeutics is a product-focused biotechnology company with a portfolio of advanced and development stage preclinical compounds based on the regulation of the hematopoietic (blood-forming) system. Cellerant focuses on human stem cell and antibody therapies for oncology applications and blood-related disorders. Cellerant is developing a novel, cell-based medicine (Myeloid Progenitors) as a treatment for chemotherapy- and radiation-induced neutropenia (CLT-008) as well as for Acute Radiation Syndrome. The antibody program is focused on identifying novel drug targets, and therapeutic antibodies and small molecules aimed at cancer stem cells. For more information on Cellerant, please visit http://www.cellerant.com.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield. In addition, BARDA manages the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).
For more information on Cellerant, please contact:
Ram Mandalam, Ph.D.
President and CEO
Cellerant Therapeutics, Inc.
Cellerant Therapeutics, Inc.