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 Small Business Innovation Research (SBIR) Phase 1 contract and a Phase 2 option from the National Cancer Institute (NCI) valued up to $1,683,503. The SBIR Contract funds the development of CLT-009, a first-in-class, human allogeneic Megakaryocyte Progenitor Cell therapy for the treatment of thrombocytopenia in cancer patients and allows the Company to conduct studies to enable an Investigational New Drug (IND) Application to be filed with the FDA in the next two years.
“We are delighted to receive this contract from NCI to support the development of our novel, off-the-shelf, platelet product and address a high unmet need”
Thrombocytopenia is characterized as a significant reduction in the concentration of circulating platelets. Platelets are crucial in the process of coagulation to stop bleeding, and thrombocytopenia can increase the risk of severe bleeding in patients. It is becoming an increasingly common problem among oncology patients and a significant dose-limiting toxicity, especially in the treatment of hematological malignancies. Chemotherapy and radiation therapy are the most common causes of thrombocytopenia because the platelet-producing cells, megakaryocytes, and their precursors are highly sensitive to myelosuppressive cytotoxics and ionizing radiation. Thrombocytopenia typically occurs during the initial cycles of high-dose chemotherapy and radiation therapy, usually 6-14 days after administration. According to Datamonitor, the estimated incidence of cancer patients who suffer from significant chemotherapy-induced thrombocytopenia worldwide was approximately 200,000 in 2008.
Occurrence of severe thrombocytopenia may require dose reductions for chemotherapy regimens which can impact subsequent disease control and survival, especially in the treatment of hematological malignancies such as acute leukemia and high-risk myelodysplastic syndrome. Current treatment options include platelet transfusions which are costly and labor intensive and are associated with risks such as contamination and transmission of viral and bacterial infections. Recombinant human interleukin-11 is the only approved agent for chemotherapy induced thrombocytopenia but its use is limited and has only modest efficacy and significant side effects. CLT-009, a human Megakaryocyte Progenitor Cell product, would be an alternative treatment option, providing the critical megakayocyte progenitor cellular support to rapidly produce platelets in vivo and shorten the duration of severe thrombocytopenia following chemotherapy treatment.
"We are delighted to receive this contract from NCI to support the development of our novel, off-the-shelf, platelet product and address a high unmet need," said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. "This contract allows us to not only leverage our experience in developing cellular therapies but also provides us with the ability to bring CLT-009 closer to the clinic. Our unique product portfolio, which now includes CLT-009, along with our CLT-008 - myeloid progenitor cell product and our therapeutic antibodies targeting cancer stem cells, demonstrates our continued commitment to developing novel products for the benefit of cancer patients."
In addition to this SBIR contract, Cellerant has previously received grants from the National Institute of Health (NIH) in 2008 - 2010 to conduct research studies in platelet recovery which it has successfully completed. In its previous studies, Cellerant demonstrated that megakaryocyte progenitor cells were able to produce human platelets in preclinical models with in vivo functionality similar to that of normal human platelets.
This program is funded with Federal funds from the National Institute of Health, Department of Health and Human Services, under Contract No.HHSN261201200076C.
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