- Addressing serious neutropenia side effect may allow wider use of "7+3" induction chemotherapy
- Presented at European Hematology Association (EHA) 23RD Congress
San Carlos, CA June 18, 2018 - Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, presented results from its randomized controlled Phase 2 clinical trial of CLT-008 (romyelocel-L, human myeloid progenitor cells), an off-the-shelf cell therapy which does not require HLA matching intended to prevent bacterial and fungal infections during neutropenia. As part of the Phase 2 trial, CLT-008 was evaluated in newly diagnosed acute myeloid leukemia (AML) patients who underwent standard "7+3" (cytarabine and an anthracycline) induction chemotherapy. One of the major side effects of 7+3 and other myelosuppressive chemotherapies is neutropenia, which leaves patients at high risk of serious infections. Results from the Phase 2 study showed that CLT-008 reduced the incidence of serious infections by 73% and reduced hospital length of stay by three days in patients who received 7+3 chemotherapy. The data were presented on Saturday, June 16, at the European Hematology Association (EHA) 23rd Congress in Stockholm.
AML is an aggressive cancer of the blood and bone marrow that disproportionately afflicts older patients (median age at diagnosis in the United States is 68 years). Older patients, those 65 years and older, have a significantly lower overall survival rate than younger patients in large part because of the risk of infection and infection-related morbidity and mortality which arise from neutropenia induced by induction chemotherapy.
"Infection is one of the main reasons for morbidity and mortality in AML patients receiving induction chemotherapy. The exciting results from this study show that this innovative approach to treatment of infections could allow more patients to safely survive optimal induction chemotherapy treatment and survive longer, particularly many elderly patients who are not offered induction chemotherapy due to the risk of infection," said Dr. Pinkal Desai, Assistant Professor of Medicine, Weill Cornell Medicine and one of the Phase 2 study's principal investigators.
"CLT-008 is designed to provide innate immunity until the patient's own immune system recovers. Prolonged neutropenia commonly occurs with most myelosuppressive treatments such as AML induction therapy, and these results demonstrate the potential of CLT-008 to mitigate the effects of neutropenia by bridging patients to neutrophil recovery, resulting in improved outcomes," added Ram Mandalam, President and CEO of Cellerant.
EHA Abstract #1405: Desai, et al., Decreased incidence of infection, use of antibacterials and days in hospital after administration of CLT-008 myeloid progenitor cells to subjects receiving AML induction therapy: Phase 2 Study Results. Oral presentation on June 16, 2018, 4:45-5:00pm CEST. Presenting author: Pinkal Desai, M.D., M.P.H., Assistant Professor of Medicine, Weill Cornell Medicine, New York.
Cellerant Therapeutics is a clinical-stage company developing innovative cell- and antibody-based immunotherapies for hematologic malignancies and other blood-related disorders. Cellerant's CLT-008 (romyelocel-L) is a universal cell therapy intended to prevent infections during neutropenia. Neutropenia is a severe side effect of many chemotherapy regimens, particularly for acute myeloid leukemia (AML) and other hematologic malignancies, and is also a serious condition in acute radiation syndrome. Cellerant has completed a randomized, controlled Phase 2 clinical trial of CLT-008 in patients with AML which showed that CLT-008 significantly reduces infections, use of antimicrobials and days in hospital compared to control. Cellerant's CLT-008 program has been supported by federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services, under contract HHSO100201000051C. Cellerant is also developing a novel antibody drug-conjugate (ADC) product, CLT030, to treat AML by selectively targeting and killing leukemic stem and blast cells.
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