SAN CARLOS, Calif.--(BUSINESS WIRE)--Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, presented additional results from its randomized controlled Phase 2 clinical trial of romyelocel-L (human myeloid progenitor cells, formerly referred to as CLT-008), an off-the-shelf cell therapy which does not require HLA matching intended to prevent bacterial and fungal infections during neutropenia. Neutropenia is a serious side effect of myelosuppressive chemotherapy that leaves patients at high risk of serious, potentially life-threatening infections. The Phase 2 trial was conducted in patients aged 55 years or older newly diagnosed with acute myeloid leukemia (AML) who received either “7+3” (cytarabine and an anthracycline) or “HiDAC” (high-dose Ara-C based chemotherapy) induction chemotherapy. Results of the Phase 2 study for the pooled and 7+3 cohorts were presented previously and showed that romyelocel-L significantly reduced the incidence of serious infections and the number of days in hospital compared to control. The results from the HiDAC cohort, which are broadly in line with the pooled and 7+3 cohort results, will be presented on Saturday, December 1 at the American Society of Hematology Annual Meeting in San Diego.
“AML patients who receive HiDAC induction therapy experience severe and prolonged neutropenia and thus are at high risk of infection and infection-related morbidity and mortality. These results show that romyelocel-L could meaningfully benefit AML patients by enabling them to receive optimal therapy and potentially increasing survival rates,” said Dr. Farhad Ravandi, Janiece and Stephen A. Lasher Professor of Medicine at the University of Texas MD Anderson Cancer Center and one of the Phase 2 study’s principal investigators.
“Cellerant is excited to advance romyelocel-L to a pivotal Phase 3 trial in de novo AML patients receiving 7+3 induction therapy. Most AML treatments, including the newly approved therapies, cause Grade 3 or higher neutropenia leading to serious infections,” added Ram Mandalam, President and CEO of Cellerant.
In the Phase 2 trial, patients were randomized to receive either romyelocel-L plus granulocyte colony stimulating factor (G-CSF) (the treated group) or G-CSF alone (the control group). Romyelocel-L was administered on Day 9, two days after the last dose of chemotherapy and G-CSF was administered on Day 14. The biological effect of romyelocel-L is expected to be observed starting on Day 15, which is when romyelocel-L derived neutrophils are likely to begin circulating.
In the HiDAC cohort, over the time period Day 15-28, the incidence of serious infection was 82% less in the treated group compared to the control group (p=0.03) and the total number of days in hospital was 3.1 days less for the treated group than the control group (p=0.03). There were no safety concerns and the incidence of serious adverse events was similar in the treated group compared to the control group.
ASH Poster #1407: Ravandi, et al., Evaluation of Romyelocel-L Myeloid Progenitor Cells to Decrease Infections in De Novo AML Patients Receiving High-dose Ara-C-based Induction Therapy.
Session Name: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I
Date: Saturday, December 1, 2018
Presentation Time: 6:15 PM - 8:15 PM
Location: San Diego Convention Center, Hall GH
Presenting author: Dr. Farhad Ravandi, University of Texas MD Anderson Cancer Center.
About Cellerant Therapeutics
Cellerant Therapeutics is a clinical-stage company developing innovative cell- and antibody-based immunotherapies for hematologic malignancies and other blood-related disorders. Cellerant’s 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. In a randomized, controlled Phase 2 trial in AML patients, romyelocel-L significantly reduced infections, use of antimicrobial drugs and days in hospital compared to control. Based on the Phase 2 data, the US Food and Drug Administration granted romyelocel-L Regenerative Medicine Advanced Therapy (RMAT) designation. Cellerant’s romyelocel-L 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. For more information, visit: www.cellerant.com