AIRPORT CITY, Israel, December 14, 2017 /PRNewswire/ --
BioSight Ltd, a pharmaceutical development company,
The study enrolled 26 acute leukemia patients, including 10 relapsed/refractory acute myelocytic leukemia (AML) patients and 16 newly-diagnosed older patients unfit for standard induction therapy (median age 78, range 70-90). Of the newly-diagnosed patients, 3 were diagnosed with de novo AML, 8 with AML secondary to myelodysplastic syndrome (MDS), the majority of them progressed to AML while under hypomethylating agent treatment, 3 with AML secondary to myeloproliferative neoplasms, and 2 were newly-diagnosed with acute lymphoblastic leukemia (ALL).
BST-236 was safe and well tolerated at all doses. The maximal dose explored was 6 g/mē/d, the molar equivalent of 4.1 g/mē/d of cytarabine. BST-236 was administrated as a 1-hour infusion for 6 consecutive days. Adverse events included mainly "on-target" hematological events and related infections. No cerebellar toxicity, no mucositis, no renal failure, and no alopecia events were reported.
Forty-five percent of the newly diagnosed AML patients (de novo and secondary to MDS) responded to BST-236, and 36% reached a durable complete remission (CR) after 1 or 2 induction courses. The median age of the responding patients was 80 years, 60% of them had secondary AML, 40% of responders were azacitidine resistant, and 60% and 40% had adverse or intermediate ELN score, respectively. In addition, 1 of the 2 ALL patients, a 90-year old man, reached a durable CR.
All CRs were durable, accompanied by survival of 6.5 to currently 20 months (median not reached). The median overall survival of the entire subgroup of newly-diagnosed AML (responders and non-responders) was 6.5 months, with a 27% 1-year survival rate.
Based on these encouraging results, BioSight intends to launch a multi-center Phase IIb study in the US and Israel in the coming months. The study will enroll 65 newly-diagnosed AML patients, age ?75 or with comorbidities, who are unfit for standard induction therapy.
Dr. Ruth Ben Yakar, BioSight's CEO said: "We are very excited with the results achieved in the BST-236 Phase I/II study. We are especially encouraged by the good safety and efficacy of BST-236 in older and unfit patients with poor baseline characteristics and prognosis. BST-236 activity was demonstrated to be targeted, enabling safe delivery of high cytarabine doses to older patients, up to 90 years old, achieving approximately 3-fold higher response rates compared to currently available treatments. Importantly, the remissions were durable, correlating with significantly prolonged survival. We intend to launch a multi-center Phase IIb study in the coming months to confirm these encouraging results".
BST-236, a novel proprietary compound under development for the treatment of hematological malignancies, is composed of cytarabine covalently bound to asparagine. BST-236 acts as a cytarabine pro-drug, releasing cytarabine inside target cells with reduced non-specific systemic toxicity, thus enabling delivery of high cytarabine doses to leukemia cells with relative sparing of normal tissues.
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.
Contact: Dr. Ruth Ben Yakar, CEO, firstname.lastname@example.org
SOURCE BioSight, Ltd
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