Cellerant Announces Publication Demonstrating Significant Survival Benefits and Preclinical Proof of Concept With …


Cellerant Therapeutics, Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced the publication of a radiation countermeasure study demonstrating that cryopreserved, allogeneic mouse myeloid progenitor cells significantly improved survival in mice irradiated with lethal doses of radiation. The study, published on May 4, 2012 in the scientific journal, Radiation Research, represents the first report of an effective radiation countermeasure for Acute Radiation Syndrome (ARS) across a broad range of lethal radiation doses when administered as late as seven (7) days after irradiation. These results show that myeloid progenitor cells are one of the most promising radiation countermeasures among all therapeutics currently under development with respect to efficacy, timing and practicality of administration.

The work was carried out in collaboration with scientists at the Armed Forces Radiobiology Research Institute (AFRRI) and is entitled Myeloid Progenitors: A Radiation Countermeasure that is Effective when Initiated Days after Irradiation which appears online ahead of print on the website http://www.rrjournal.org/doi/abs/10.1667/RR2894.1?journalCode=rare.

The publication describes the use of Cellerants cryopreserved, allogeneic myeloid progenitor cells developed in mice to elucidate its potential as a radiomitigator against lethal doses of ionizing radiation in various strains of mice. Pooled allogeneic myeloid progenitor cells were transfused into unmatched recipients irradiated with lethal doses of ionizing radiation known to cause ARS in hematopoietic tissues. Survival benefit was dose dependent and significant even when administration of the product was delayed up to seven (7) days post-irradiation. The ability to delay the administration of a radiomitigator by 24 to 48 hours is critical to allow for the time it takes disaster teams to respond to radiation victims in an emergency situation.

"These study results exceed our expectations of the potential survival benefits of myeloid progenitor cells, said Ram Mandalam, President and CEO of Cellerant. "We are excited about the data as it represents demonstration of proof of concept for our CLT-008 human myeloid progenitor therapy as a radiation medical countermeasure. We continue to work closely with AFFRI in performing further studies and with the government in advancing our product closer to approval for therapeutic use.

Cellerant is developing CLT-008, human myeloid progenitor cells, for the treatment of ARS under a United States Government contract awarded on September 1, 2010 and valued up to $170 million over five years with 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.

In ARS applications, CLT-008 is intended to provide hematopoietic cellular support after exposure to ionizing radiation from a nuclear weapon or from a nuclear accident. Cellerant has conducted various preclinical studies to evaluate whether a single administration of myeloid progenitor cells has the potential to provide effective treatment for ARS in an emergency situation when administered up to seven days post-exposure to radiation. CLT-008 is being developed under the U.S. Food and Drug Administrations Animal Rule for ARS. This approval pathway is available when human efficacy studies are neither ethical nor feasible and requires demonstration of efficacy in representative and well-characterized animal models along with safety and pharmacokinetic testing in human clinical trials. There is currently no FDA-approved medical countermeasure to treat ARS. If licensed by the FDA, the federal government could purchase 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.

About CLT-008

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, 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 efficacy. Cellerant is developing CLT-008 as an effective treatment for chemotherapy-induced neutropenia, protection following exposure to acute radiation, and facilitating engraftment of cord blood transplantation.

CLT-008 is currently in a Phase 1 study 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. A second Phase I/II 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.

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