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 – 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.
