San Carlos, CA September 4, 2012 - 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 $36.4 million under an option exercised by the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services, for the advanced development of CLT-008, a first-in-class, allogeneic, cell-based therapy for the treatment of Acute Radiation Syndrome (ARS). This third year of funding is in addition to the $80 million committed under the two year base period and is part of a five-year award valued at up to $169.9 million.
This additional funding will continue to support Cellerant's CLT-008 development strategy by providing funds for its ongoing clinical trials, process development and manufacturing activities and the nonclinical studies required for approval in ARS. If licensed by the U.S. Food and Drug Administration (FDA), the federal government could buy CLT-008 for the Strategic National Stockpile under Project Bioshield. Project Bioshield is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.
"We are pleased that the federal government continues to support our biodefense efforts to advance CLT-008," said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. "Our collaboration with BARDA over the past two years has been productive and this option exercise demonstrates BARDA's continued endorsement and satisfaction with the development and progress of CLT-008 as a potential medical countermeasure."
As part of BARDA's commitment to supporting multi-use products that have both commercial and biodefense applications, this third year of funding also allows Cellerant to continue its ongoing clinical trials with CLT-008 for cancer applications. Cellerant's first Phase 1 study is evaluating CLT-008 in patients undergoing cord blood transplants for the treatment of hematological malignancies. CLT-008 is intended to rapidly produce neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation. Cellerant's second Phase 1/2 study is evaluating CLT-008 in acute leukemia patients with chemotherapy-induced neutropenia. CLT-008 may shorten the time to neutrophil recovery and decrease the risks of febrile neutropenia and infection.
In ARS applications, CLT-008 is intended to provide hematopoietic cellular support after exposure to ionizing radiation such as from a nuclear or radiological weapon, or from a nuclear accident. 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 could be administered up to five days post-exposure to radiation. CLT-008 is being developed under the U.S. Food and Drug Administration's Animal Efficacy Rule for ARS. This approval pathway requires demonstration of efficacy in representative animal models and safety and metabolism testing in human clinical trials. There is currently no FDA approved medical countermeasure to treat ARS.
CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human myeloid progenitor cells derived from adult hematopoietic stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In preclinical models, cryopreserved, allogeneic mouse myeloid progenitor cells have 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 efficacy. Cellerant is developing CLT-008 as a treatment for chemotherapy-induced neutropenia, protection following exposure to acute radiation, and facilitating engraftment of cord blood transplantation.
Cellerant Therapeutics is a clinical stage biotechnology company focused on the regulation of the hematopoietic (blood-forming) system. The Company is developing human stem cell and antibody therapies for oncology applications and blood-related disorders. Cellerant's lead product, CLT-008, is currently in two Phase 1 clinical trials in patients with hematological malignancies. The Company also has a cancer stem cell (CSC) antibody discovery program focused on therapies for acute myelogenous leukemia, multiple myeloma and myelodysplastic syndrome.
For more information on Cellerant, please contact:
Cellerant Therapeutics, Inc.
Executive Director, Corporate Development