Results presented at American Society of Clinical Oncology (ASCO) 2018 Annual Meeting
San Carlos, CA June 4, 2018 - Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, today announced results from a randomized controlled Phase 2 clinical trial of CLT-008 (romyelocel-L, human myeloid progenitor cells), a universal, off-the-shelf cell therapy intended to prevent 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 newly diagnosed with acute myeloid leukemia (AML) who underwent induction chemotherapy. Key results of the Phase 2 study show that CLT-008 significantly reduced the incidence of serious infections, the number of days in hospital, and the use of antimicrobial drugs compared to control. These updated results were presented today at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting.
"These results indicate that CLT-008 could meaningfully benefit AML patients undergoing induction chemotherapy," 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. "The high risk of infections in these patients is an impediment to effective treatment as it leads to reduction or delay in treatment. The 76% reduction in the incidence of infections observed in the CLT-008 arm compared to control is clinically meaningful and may result in better outcomes in these patients."
"Even with current therapy, infections in AML patients undergoing induction chemotherapy lead to serious morbidity and risk of death," said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant. "CLT-008 transiently restores patients' innate immunity and helps them fight these infections. By bridging these patients to recovery of their own immune systems, we may be able to help them receive optimal treatment. We look forward to advancing CLT-008 to a pivotal Phase 3 trial."
The Phase 2 study was conducted in patients aged 55 years or older newly diagnosed with AML who received either "7+3" (cytarabine and an anthracycline) or "HiDAC" (high-dose cytarabine) induction chemotherapy. A total of 163 patients were enrolled and randomized 1:1 to receive either CLT-008 plus granulocyte colony stimulating factor (G-CSF) (the treated group) or G-CSF alone (the control group). CLT-008 was administered to the treated group approximately nine days after initiation of induction chemotherapy (Day 9), and G-CSF was administered to both groups approximately 14 days after initiation of chemotherapy (Day 14). The biological effect of CLT-008 is expected to be observed starting on Day 15. Patients were followed for 42 days following initiation of chemotherapy and a total of 120 patients were evaluable for analysis of efficacy.
Efficacy was analyzed over the time period Day 15 to Day 28 as patients typically recover their neutrophil counts by Day 28. During this time period:
- the incidence of serious infection was 76% less in the treated group compared to the control group (one sided p = 0.001)
- the total number of days in hospital was 3.2 days less for the treated group than the control group (one-sided p = 0.001),
- the proportion of patients receiving antimicrobial agents for treatment of a diagnosed infection was 29% less in the treated group compared to the control group (one-sided p=0.028), and
- there were no safety concerns and the incidence of serious adverse events (SAEs) were similar in the treated group compared to the control group.
ASCO Abstract #7043: Abboud, et al., A randomized controlled open label exploratory trial of CLT-008 myeloid progenitor cells (MPC) to decrease infections during induction for AML. Poster discussion on June 4, 2018, 8:00-11:30am CDT. Presenting author: Farhad Ravandi, M.D., University of Texas MD Anderson Cancer Center.
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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