Cellerant Therapeutics, Inc. CLT-008 Phase 2 Results Show Significant Reduction in Infections and Days in Hospital in Severely Neutropenic AML Patients
Published: Jun 04, 2018
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.
Key Study Results:
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.
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 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. For more information, visit: www.cellerant.com
Cellerant Therapeutics, Inc.
Rodney Young, 650-232-2122
Chief Financial Officer
Source: Cellerant Therapeutics, Inc.