Biosight Granted U.S. FDA Fast Track Designation for BST-236 for the Treatment of Acute Myeloid Leukemia
AIRPORT CITY, Israel, Aug. 04, 2020 (GLOBE NEWSWIRE) -- 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, and recently announced a collaboration with the European cooperative group, GFM, for the initiation of a phase 2 trial of BST-236 in relapsed/refractory myelodysplastic syndrome (MDS) and AML patients, to begin in the fourth quarter of 2020.
“Receiving Fast Track designation from the FDA is an important recognition of the potential of BST-236 to address the significant unmet need in the population of AML patients who are medically unfit to receive intensive chemotherapy, and to improve the outcomes for these patients” said Dr. Ruth Ben Yakar, Chief Executive Officer of Biosight. “The compelling safety and efficacy data from both a completed Phase 1/2a and ongoing Phase 2b studies of BST-236, may establish it as a new intensive therapy backbone of AML and may, for the first time, allow older adults deemed unfit for standard chemotherapy, to benefit from an intensive treatment.”
The FDA Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions to fulfill an unmet medical need, ultimately enabling drugs to reach patients more rapidly. A drug or treatment regimen that receives Fast Track designation may be eligible for more frequent interactions and communications with the FDA on matters related to the drug’s clinical development plan as well as eligibility for accelerated approval and priority review.
About BST-236 (Aspacytarabine)
BST-236 (aspacytarabine) is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine serves as the backbone of AML therapy for over 40 years due to its superior efficacy, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities, which significantly limit its use, especially in older and medically compromised patients. Due to its unique kinetics and metabolism, BST-236 is designed to enable high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, BST-236 may serve as a superior therapy for AML and other hematological malignancies and disorders, including for older adults who are unfit for intensive therapy.
BST-236 was granted Orphan Drug Designation from the FDA, which entitles Biosight to seven years of market exclusivity upon BST-236 marketing approval for the treatment of AML.
A Phase 2b study is ongoing to confirm the promising results obtained in a Phase 1/2a study of BST-236 as a single-agent first-line AML therapy. For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov.
About Biosight Ltd.
Biosight is a private Phase 2 clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders. Biosight’s lead product, BST-236 (aspacytarabine), is an innovative proprietary anti-metabolite which addresses unmet medical needs by enabling high-dose chemotherapy with reduced systemic toxicity. BST-236 is currently being investigated as a single agent in a Phase 2b for first-line treatment of acute myeloid leukemia (AML), following completion of a Phase 1/2a study which demonstrated tolerability with promising efficacy in the challenging population of AML patients unfit for standard of care chemotherapy. A Phase 2 study in relapsed/refractory AML and myelodysplastic syndrome (MDS) will be launched in 2020 under a collaboration agreement recently signed with the European cooperative group, GFM. For additional information, please visit www.biosight-pharma.com.
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