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BioSight Completed Treatment of Patients in Astarabine™ Phase I/IIa Clinical Trial

Tuesday, April 19, 2016 Clinical Trials News J E 4
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Results to date indicate superior safety and efficacy in secondary AML and newly-diagnosed AML and ALL patients unfit for conventional chemotherapy

KARMIEL, Israel, April 19, 2016 /PRNewswire/ -- BioSight, Ltd, a pharmaceutical development company focused on the development of chemotherapy pro-drugs with reduced toxicity, today announced completion of patient treatment in its ongoing Phase I/IIa clinical study of Astarabine™ in acute leukemia patients. The company expects to report the final results in the coming months.

Astarabine™ is a non-toxic conjugate of the chemotherapy drug cytarabine (Ara-C) and the amino acid asparagine. Cytarabine is the first-line treatment for Acute Myeloid Leukemia (AML) and relapsed/refractory Acute Lymphoblastic Leukemia (ALL), however it is highly toxic with severe side effects such as cerebellar toxicity and bone marrow suppression. While the average age AML patients is almost 70 years, cytarabine doses are significantly attenuated for older patients due to its severe toxicity, and administration of high-dose cytarabine is precluded in patients with hepatic or renal dysfunction. Hence, the toxicity significantly limits its use, especially for older patients.

Unlike cytarabine, the toxicity of Astarabine™ is mostly specific to leukemia cells, as it is preferentially taken up by leukemia cells where it triggers cellular mechanisms which lead to their death.

The Phase I/IIa study is an open-label study to evaluate the safety and efficacy of Astarabine™ as single agent in adults with AML or ALL. The results to date demonstrate safety in all patients, with no significant drug-related adverse events, including in 80 and 90 years old patients. Moreover, Astarabine™ treatment lead to high response rates in newly-diagnosed AML and ALL patients, as well as in secondary AML patients.

"We are very pleased and encouraged by the results obtained to date with Astarabine™ treatment for AML and ALL patients, especially in light of the unmet medical need for these patients today. We are looking forward to continuing the development of Astarabine™ to further evaluate and establish its safety and efficacy in a larger study. We truly believe that Astarabine™ can bring hope to many patients and their families and provide an answer to unmet needs in the treatment of both AML and ALL" said Dr. Ruth Ben Yakar, CEO of BioSight.

About Astarabine:

Astarabine™ is a new pharmaceutical composition pro-drug of cytarabine (Ara-C), the first line chemotherapy drug for acute myeloid leukemia (AML) and relapsed acute lymphoblastic leukemia (ALL), also used for treatment of chronic myeloid leukemia (CML) and non-Hodgkin's lymphoma (NHL). Unlike cytarabine, Astarabine™ is non-toxic, hence addressing unmet medical needs and enabling treatment of patients who are unfit for conventional intensive chemotherapy, with minimal or no side effects. Astarabine™ is currently under clinical development for treatment of acute leukemia.

About BioSight:

BioSight is a private Israeli clinical-stage drug development company, founded by Dr. Stela Gengrinovitch.

BioSight focuses on development of chemotherapy pro-drugs with reduced toxicity, based on its proprietary technology S2DOT for chemotherapy pro-drug design and 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. Its lead proprietary product Astarabine™ is in clinical stages for treatment of leukemia. Additional products are in pre-clinical stages, addressing unmet medical needs and multi-billion dollar markets.

Contact: Dr. Ruth Ben Yakar, CEOinfo@biosight-pharma.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/biosight-completed-treatment-of-patients-in-astarabine-phase-iiia-clinical-trial-300253764.html

SOURCE BioSight Ltd.

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