Imago BioSciences Receives FDA Approval of IND Application for the Treatment of Myeloid Malignancies
SAN CARLOS, Calif., Feb. 1, 2018 /PRNewswire/ -- Imago Biosciences, a clinical-stage pharmaceutical company developing novel therapies for hematological and inflammatory diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted their Investigational New Drug (IND) application providing clearance to proceed with the clinical development of IMG-7289 in the U.S. The IND supports the company's ongoing Phase 1/2 clinical trial of IMG-7289 for myelofibrosis (MF).
"There is a pressing need for novel approaches to the treatment of myeloproliferative disorders including myelofibrosis," said Hugh Young Rienhoff, Jr. M.D., Imago's Chief Executive Officer. "We are pleased to have received FDA acceptance of our clinical trial protocol and look forward to the imminent expansion of this study into the United States."
This Phase 1/2 open-label clinical trial is designed to assess the pharmacodynamics of IMG-7289, an oral inhibitor of the epigenetic enzyme lysine-specific demethylase 1 (LSD1) in high-risk myelofibrosis patients aged 18 or older (www.clinicaltrials.gov Identifier NCT03136185). Assessments include measuring changes in spleen volume, patient reported total symptom scores, mutant allele burden, inflammatory cytokines and bone marrow fibrosis over the course of the treatment period. The trial commenced in Australia in 2017 and will add multiple sites in the United States in 2018.
This is the second clinical trial of IMG-7289 sponsored by Imago BioSciences, Inc. The first, evaluating IMG-7289 for the treatment of high-risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), was initiated in 2016 (www.clinicaltrials.gov Identifier NCT02842827) and continues to enroll patients.
IMG-7289, an investigational agent currently being evaluated in ongoing clinical trials, is a small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating gene expression in hematopoietic cells. In non-clinical models, the inhibition of LSD1 has been shown to limit self-renewal in neoplastic stem cells such as those in acute myeloid leukemia and myelofibrosis. Across a range of malignancy and inflammatory models, IMG-7289 demonstrated robust in vivo activity as a single agent and in combination with other agents.
About Imago BioSciences
Imago BioSciences is a clinical-stage pharmaceutical company, funded by Clarus Ventures, Frazier Healthcare Partners, Amgen Ventures, and Merck Research Laboratories Ventures Fund. Imago is focused on discovering and developing novel anti-cancer therapeutics. These include a range of hematologic malignancies including AML, MDS and the myeloproliferative neoplasms. The company is based in California with offices in Boston and Somerset, England.
Please see the website at www.imagobio.com for additional information.
SOURCE Imago BioSciences