AIRPORT CITY, Israel, July 11, 2018 /PRNewswire/ — BioSight Ltd., a pharmaceutical development company focused on the development of targeted oncology drugs, announced today that it has received the FDA and the Israeli Ministry of Health clearance to launch a Phase 2b clinical trial of BST-236 for treatment of Acute Myeloid Leukemia (AML).
The trial, which will be launched in the upcoming month, will be conducted in 25 medical centers in the US and Israel. BST-236 will be administered as a single agent treatment for newly-diagnosed AML patients, either de novo or secondary to myelodysplastic disorder (MDS) who are unfit for standard chemotherapy due to its severe toxicity. This population is estimated to account for a third to half of the AML patients.
In the Phase 1/2 study, presented at the Annual American Society of Hematology (ASH) Meeting and Exposition on December 2017, 26 acute leukemia patients were treated with BST-236 as a single agent. The study enrolled mainly older patients with poor prognosis baseline characteristics, including prior treatment with hypomethylating agents for MDS. BST-236 was found to be safe and well tolerated at high doses, with no neurological or gastrointestinal toxicities or renal failure, all of which are life-threatening toxicities associated with the existing chemotherapy and which often attenuate or prevent its use in older patients. This encouraging safety profile allowed the treatment of older and medically unfit patients with high doses of BST-236 and led to 2-3-fold higher response rates compared to currently approved treatments for this patient population. The aim of the Phase 2b study is to repeat the results of the Phase 1/2 study in a larger number of patients in the US and Israel.
Dr. Ruth Ben Yakar, BioSight’s CEO said: “We are excited to launch this Phase 2b clinical trial of BST-236 for treatment of newly-diagnosed AML patients who are unfit for standard chemotherapy. The encouraging results of the Phase 1/2 study suggest that BST-236 may serve as an improved treatment option compared to the approved drugs available today for this population, including for patients at the age of 75 years or more. We think it is very important to approach these patients, mainly due to the general increase in the population’s age and quality of life, and we believe we can provide them with a safer and more effective treatment.”
BST-236 is a novel pro-drug of the chemotherapeutic drug cytarabine. Cytarabine has been the backbone of first-line therapy for AML for the past 40 years, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities which significantly limit its use, especially in older and medically unfit patients. BST-236 is designed to enable delivery of high cytarabine doses to leukemia cells with lower systemic exposure to the free drug and relative sparing of normal tissues. As such, BST-236 may serve as an ideal therapy for leukemia, particularly for delivering high doses of cytarabine to medically unfit or older adults.
About BioSight Ltd.
BioSight is a private Israeli clinical-stage pharmaceutical development company, founded by Dr. Stela Gengrinovitch and headed by Dr. Ruth Ben Yakar. BioSight focuses on the development of novel caner-targeted pro-drugs. BioSight’s lead product BST-236 is under clinical development for acute leukemia.
SOURCE BioSight, Ltd
Posted: July 2018