News & Events

May 11, 2021, Airport City, Israel

Biosight Completes Enrollment in Phase 2b Study of Aspacytarabine (BST-236) for First-Line Acute Myeloid Leukemia Therapy

 

Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced it has completed enrollment in the Company’s ongoing Phase 2b trial evaluating aspacytarabine (BST-236) as a single-agent first-line acute myeloid leukemia (AML) therapy for patients unfit for standard intensive chemotherapy.

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April 28, 2021, Airport City, Israel

Biosight to Present Updated Clinical Data from Ongoing Phase 2b Study of Aspacytarabine (BST-236) at the 2021 ASCO Annual Meeting

 

Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced an abstract has been accepted for an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting which will be held virtually from June 4-8, 2021.

 

Title: Efficacy and safety of aspacytarabine (BST-236) as a single-agent, first-line therapy for patients with acute myeloid leukemia unfit for standard chemotherapy.

Abstract Number: 7007

Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Presenter: Jessica K. Altman, M.D., Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL

Session Date and Time: June 4, 2021, 2:30 PM-5:30 PM EDT

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December 17, 2020, Airport City, Israel

Biosight Receives Orphan Medicinal Product Designation from the European Medicines Agency for Aspacytarabine (BST-236) for the Treatment of Acute Myeloid Leukemia

 

Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced the European Medicines Agency (EMA) has granted Orphan Medicinal Product Designation to aspacytarabine (BST-236) for the treatment of acute myeloid leukemia (AML). Aspacytarabine, Biosight’s lead product candidate, is a novel antimetabolite designed to provide the benefit of intensive chemotherapy while reducing the associated systemic toxicity. This new EMA designation, in combination with the Orphan Drug Designation granted last year by the U.S. Food and Drug Administration (FDA), provide Biosight with 7 and 10 years of market exclusivity in the U.S. and Europe, respectively.

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December 7, 2020, Airport City, Israel

Biosight Presents Updated New Clinical Data from Ongoing Phase 2b Study of Aspacytarabine (BST-236) at the 2020 ASH Annual Meeting

 

Biosight Ltd., 

a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced the presentation of updated clinical data from the Company’s ongoing Phase 2b trial evaluating aspacytarabine (BST-236) as a single-agent first-line acute myeloid leukemia (AML) therapy for patients unfit for standard chemotherapy at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

“These exciting data provide additional evidence that aspacytarabine has the potential to transform standard of care for AML patients,” said Jessica K. Altman M.D., Professor, Medicine, Feinberg School of Medicine of Northwestern University and Lead Study Investigator. “This larger data set supports our previous encouraging outcomes which are of particular interest given the challenging nature of the patient population treated. The 32% complete remission rate achieved in this population, comprised of mainly secondary AML patients including patients with prior hypomethylating agent therapy, is notable. Importantly, all responders achieved a complete hematological recovery and the MRD(-) rate by flow was 57%. And while still early, these results are important as in responders we are seeing a median duration of response not reached at 12 months, and median overall survival not reached at 24 months. These efficacy results are especially exciting to me as they are achieved in a monotherapy regimen with a limited duration of treatment of up to four courses, and a manageable safety profile.” 

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December 2, 2020, Airport City, Israel

Biosight Closes $46M Series C Financing to Advance Clinical Oncology Programs

 

Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced the deferred closing of its Series C financing, raising an additional $27M to the $19M announced earlier this year for total proceeds of $46M.

The round was led by Israel Biotech Fund (IBF) with participation from new investors, The Phoenix Insurance Company and Migdal Insurance Company, two of Israel's leading institutional investors, and Biotel, as well as existing investors including Arkin Bio Ventures and Primera Capital. These additional proceeds will be used to advance the clinical development of Biosight’s lead asset BST-236 (aspacytarabine), currently being investigated in a multi-center Phase 2b study in the U.S. and Israel as a single-agent, first-line treatment of acute myeloid leukemia (AML), and soon to be expanded to two additional Phase 2 trials, one in Europe and another in the U.S., to evaluate BST-236 in relapsed/refractory myelodysplastic syndrome (MDS) and AML.

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November 5, 2020, Airport City, Israel

Biosight to Present Updated Clinical Data from Ongoing Phase 2b Study of Aspacytarabine (BST-236) at the 2020 ASH Annual Meeting

Abstract selected for virtual Poster Walk panel discussion with leading KOLs

 

Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced an abstract has been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, which will be held virtually from December 5-8, 2020. The presentation will present updated clinical data from the Company’s ongoing Phase 2b trial evaluating aspacytarabine (BST-236) as a single-agent first-line AML therapy for patients unfit for standard chemotherapy.

In addition to being presented at the meeting by Jessica Altman, M.D., Professor of Medicine, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, the abstract has been selected by members of the Hematology and Aging Committee to be presented in a virtual Poster Walk which is a virtual session showcasing selected abstracts in a panel discussion featuring presentation authors and Key Opinion Leaders (KOL) in the field. An audience question and answer session will be held after the KOL panel discussion.

 

ASH 2020 Presentation Details:
Durable Remissions and Increased Overall Survival in AML Patients Deemed Unfit for Standard Intensive Chemotherapy Achieved with High-Dose BST-236 (Aspacytarabine) Induction and Consolidation 

Poster Presentation
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II 
Date: Sunday, December 6, 2020, 7:00 a.m. - 3:30 p.m. (Pacific Time) 

 

Virtual Poster Walk
Date: Thursday, December 10, 2020 at 7:00 AM Pacific Time.

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August 4, 2020, Airport City, Israel

Biosight Granted U.S. FDA Fast Track Designation for BST-236 for the Treatment of Acute Myeloid Leukemia

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,

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July 21, 2020, Airport City, Israel

Biosight Announces Clinical Trial Collaboration with the European Cooperative Group, Groupe Francophone des Myélodysplasies

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.

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May 26, 2020, Airport City, Israel

Biosight to Present at the Jefferies 2020 Virtual Healthcare Conference

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.

Presentation Details:

Date: Wednesday, June 3

Time: 10 am EDT

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May 18, 2020, Airport City, Israel

Biosight Strengthens Board of Directors with Appointment of Industry Executive Gary Gordon, M.D, Ph.D.

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.

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March 11, 2020, Airport City, Israel

Biosight Raises $19M in Series C Funding to Support Clinical Stage Oncology Programs 

 

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).

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November 6, 2019, Airport City, Israel

Biosight Announces Data to be Presented at ASH 2019 Annual Meeting 

 

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 Receives Orphan Drug Designation From the FDA for BST-236 for the Treatment of Acute Myeloid Leukemia 

 

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.

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July 11, 2018, Airport City, Israel

 

Biosight Launches a Phase 2b Clinical Trial of BST-236 as a First-Line Treatment of Acute Myeloid Leukemia 

 

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.

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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.

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Aug 09, 2017, Airport City, Israel

 

Biosight Completed Patient Enrollment and Treatment in its Extended Acute Leukemia Phase I/II Clinical Trial with BST-236, a Novel Cytarabine Pro-Drug

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.

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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.

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May 16, 2016, Karmiel, Israel

 

Arkin Holdings and Primera Capital Lead an Investment of $13M in Biosight for an Innovative Treatment of Acute Leukemia

 

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). 

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Dec 7, 2015, Orlando, FL

 

BST-236 (Formerly Astarabine), a Pro-Drug of Cytarabine, Is Safe for Patients with Advanced Acute Leukemia. A Phase I/IIa Single Center Study in Relapsed/Refractory or Medically Unfit Patients

 

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.

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October 26, 2015, Tel Aviv, Israel

 

Biosight Will Present Interim Results From a Phase 1/2 Clinical Trial of BST-236 (Formerly Astarabine)for Treating Acute Leukemia at the ASH Annual Meeting 2015

 

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.

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