KARMIEL, Israel, October 26, 2015 /PRNewswire/ --
BioSight Ltd. announced today it shall report interim results from an ongoing Phase 1/2a clinical study of Astarabine™ in leukemia patients, at the ASH Annual Meeting on December 5-8, 2015 in Orlando, FL. The results will be presented by Dr. Tsila Zuckerman, Head of the Bone Marrow Transplantation Unit at Rambam Healthcare Campus, Technion, Israel.
Astarabine™ is a pro-drug of the chemotherapy drug cytarabine (Ara-C), the first-line treatment for acute myeloid leukemia (AML) and relapsed acute lymphoblastic leukemia (ALL), and is also used for treatment of chronic myeloid leukemia and lymphomas. Cytarabine is highly toxic with severe side effects including cerebellar toxicity and bone marrow suppression. Moreover, while the median age of AML patients is 68 years, administration of high-dose cytarabine is precluded in older patients and in patients with hepatic or renal dysfunctions. Hence, cytarabine's toxicity significantly limits its use, resulting in sever unmet medical need.
Unlike cytarabine, Astarabine's toxicity is expected to be specific to leukemia cells, suggesting that Astarabine could potentially enable treatment for patients otherwise unfit for conventional chemotherapy.
BioSight consulted with FDA regarding a phase 2b study for treatment of newly diagnosed AML patients unfit for standard chemotherapy. FDA and BioSight agreed regarding the study design and the data required for an IND application, and FDA confirmed that the application would be considered as a 505(b)(2). The agency also indicated that the proposed trial in patients with AML in the study population could potentially support a Breakthrough Therapy Designation request.
"We are excited with the results obtained to date with treatment of AML and ALL patients with Astarabine" said Dr. Ruth Ben Yakar, CEO of BioSight, "These patients would have otherwise had very limited treatment options. We are optimistic that Astarabine could bring real hope to many patients and an answer to unmet needs in the treatment of hematologic malignancies", she added.
BioSight is a private Israeli pharmaceutical development company founded in 2000, focus on development of chemotherapy pro-drugs with reduced toxicity, based on its proprietary S2DOT™ technology for chemotherapy pro-drug synthesis. BioSight develops a pipeline of targeted chemotherapy pro-drugs with reduced toxicity, thus, aiming to revolutionize the treatment for cancer patients, to enable safe and effective treatment to cancer patients around the world.
Dr. Ruth Ben Yakar, CEO
SOURCE BioSight Ltd.