News & Events
August 4, 2020, Airport City, Israel
Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced that that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BST-236 (aspacytarabine) for the treatment of acute myeloid leukemia (AML) in adults who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. BST-236, Biosight’s lead product candidate, is a novel antimetabolite, designed to provide the benefit of intensive chemotherapy while avoiding much of its toxicity. The company is currently enrolling patients in its Phase 2b study, evaluating BST-236 as a single-agent first-line AML therapy for patients unfit for standard chemotherapy,
July 21, 2020, Airport City, Israel
Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced that it has entered into a clinical trial agreement with the French Study Group of the European Myelodysplastic Syndromes (MDS) Cooperative Group (EMSCO) led by Dr. Pierre Fenaux, the Groupe Francophone des Myélodysplasies (GFM). GFM is a non-profit organization comprised of most French hematology centers that conducts and sponsors clinical trials and translational research and coordinates diagnostic and therapeutic guidelines for MDS. Under the terms of the collaboration, GFM will sponsor a Phase 2 clinical trial to evaluate BST-236, Biosight’s proprietary antimetabolite, as a second line treatment for patients with relapsed or refractory MDS or acute myeloid leukemia (AML). The study is expected to begin in Q4 2020.
May 26, 2020, Airport City, Israel
Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced that Dr. Ruth Ben Yakar, Chief Executive Officer of Biosight, will present at the Jefferies 2020 Virtual Healthcare Conference taking place from June 2-4, 2020. The company will also be available for one-on-one meetings.
Date: Wednesday, June 3
Time: 10 am EDT
May 18, 2020, Airport City, Israel
Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced the appointment of Gary Gordon, M.D., Ph.D., the former Vice President of Oncology Development at AbbVie, to its Board of Directors.
March 11, 2020, Airport City, Israel
Proceeds support clinical advancement of BST-236, a proprietary anti-metabolite enabling high-dose chemotherapy with reduced systemic toxicity.
The investment is led by Israel Biotech Fund (IBF) with participation by SBI JI Innovation Fund, Arkin Bio Ventures, and additional new and existing investors. The new capital will advance the clinical development of Biosight’s lead asset BST-236 (aspacytarabine), currently being investigated in a Phase 2b study as a single-agent, first-line treatment of acute myeloid leukemia (AML).
November 6, 2019, Airport City, Israel
Results from an ongoing Phase 2b clinical trial of BST-236 (aspacytarabine) for treatment of acute myeloid leukemia (AML), will be presented during an oral session at the 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, FL.
The data, to be presented by Dr. Jessica K. Altman, Northwestern University, Chicago IL, will include integrated results from a Phase 1/2a study and an ongoing Phase 2b study, of BST-236 as a first-line single-agent treatment for AML patients who are unfit to receive standard intensive chemotherapy.
Oral presentation details:
Title: Aspacytarabine (BST-236) Is Safe and Efficacious As a Single-Agent, First-Line Therapy for Patients with Acute Myeloid Leukemia Unfit for Standard Chemotherapy. Integrated Results from a Phase 1/2a and an Ongoing Phase 2b
Presenter: Jessica K. Altman MD
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Treatment Strategies
Session Date: Saturday, December 7, 2019
Session Time: 12:00 PM - 1:30 PM
Presentation Time: 1:00 PM
Room: Orange County Convention Center, Chapin Theater (W320)
June 4, 2019, Airport City, Israel
Biosight, a pharmaceutical development company focused on the development of novel oncology therapeutics, announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to BST-236, an investigational novel antimetabolite, for the treatment of acute myeloid leukemia (AML). BST-236 is being developed for the treatment of hematological malignancies and disorders, and is currently in Phase 2b development for front-line treatment of AML.
July 11, 2018, Airport City, Israel
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.
Dec 14, 2017, Airport City, Israel
Biosight Announces Phase I/II Results of Its Cytarabine Pro-Drug BST-236 For Treatment of Acute Leukemia. Results of the Phase I/II Study were Presented at the 59th Annual Meeting of the American Society of Hematology
Biosight Ltd, a pharmaceutical development company focused on the development of targeted oncology drugs, reports positive final results in a Phase I/II multi-center, open label, dose-escalating study of its lead product BST-236, a novel cytarabine pro-drug, as a single agent for induction therapy in acute leukemia patients. The results, presented at the 59th Annual American Society of Hematology Meeting and Exposition by Dr. Tsila Zuckerman of the Rambam Healthcare Center, demonstrated safety and efficacy of BST-236 as a single agent in treatment of newly-diagnosed acute leukemia patients, unfit for standard induction therapy.
Aug 09, 2017, Airport City, Israel
Biosight Ltd., a pharmaceutical development company, focused on the development of targeted oncology therapeutics with reduced toxicity, today announced completion of last patient treatment in its extended Phase I/II clinical study of BST-236 (Astarabine) in acute leukemia patients. The company expects to report top-line results of the study in the coming months.
Dec 03, 2016, San Diego, CA
BST-236 (Formerly Astarabine), a Novel Leukemia-Targeted Cytarabine Composition Allows, for the First Time, the Delivery of High Cytarabine Doses for Older or Unfit Patients with Acute Leukemia. Results of an Ongoing Phase I/IIa Study
BioSight reports positive interim results of an initial efficacy trial for its Leukemia treatment product.
The company's product, BST-236 (Astarabine), had been tested on 15 Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) patients unfit for chemotherapy. Results indicate a good response to treatment in the examined group, with minimum side effects. In three out of 15 patients, for whom no treatment could earlier be provided, complete remission was noted for 4-10 months, to date; in two further patients a partial remission was reported for 3-7 months.
May 16, 2016, Karmiel, Israel
Biosight announced today the closing of an investment of $13M led by the Mori Arkin's pharmaceutical investment firm, Arkin Holdings, and the US based venture firm Primera Capital. Proceeds of the financing will be used to fund a multi-center phase IIb clinical trial with the company's lead product, Astarabine™, for the treatment of Acute Myeloid Leukemia (AML).
Dec 7, 2015, Orlando, FL
BioSight reported positive interim results in an abstract at the 2015 ASH meeting from a Phase 1/2a clinical study of Astarabine in leukemia patients.
The aim of the study was to evaluate the safety and optimal dose of Astarabine in refractory/relapsed or medically unfit patients with acute leukemia.
In the first three cohorts of nine patients, eight had acute myeloid leukemia (AML), of which four were refractory/relapsed and four were newly diagnosed secondary AML unfit for intensive therapy, while one patient had newly diagnosed relapsed acute lymphoblastic leukemia (ALL).
The study demonstrated that Astarabine was safe and well tolerated, including in patients over 80 years of age, resulting in remission in three of nine patients with acute leukemia.
BioSight is planning a Phase 2 to confirm the encouraging Phase 1/2a results and define the use of Astarabine for patients otherwise unable to receive high doses of cytarabine.
October 26, 2015, Tel Aviv, Israel
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.