Biosight Announces Clinical Trial Collaboration with the European Cooperative Group, Groupe Francophone des Myélodysplasies
Initiation of Phase 2 Trial Evaluating BST-236 in Second Line Relapsed/Refractory MDS and AML Expected in Q4 2020
AIRPORT CITY, Israel, July 21, 2020 (GLOBE NEWSWIRE) -- 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.
“We are thrilled and honored to collaborate with GFM as we expand the reach of BST-236 to additional indications and territories based on the encouraging clinical data accumulated with BST-236 to date,” said Dr. Ruth Ben Yakar, Chief Executive Officer of Biosight. “The prestigious GFM cooperative working group, with its extensive network of French hematology centers including registered centers of excellence, is an ideal partner for expanding the evaluation of the potential of BST-236 to MDS and additional AML indications. We look forward to collaborating with the GFM team whose expertise in clinical trials, treatments and diagnostics have made a tremendous impact on patients and will be invaluable as we advance into this new Phase 2 trial.”
Professor Pierre Fenaux, M.D., Ph.D., Head of Hematology at Hospital Saint Louis in Paris, and founding member and Chairman of GFM, said, “There is an urgent need for new therapies for patients with relapsed or refractory MDS and AML who currently are faced with poor prognoses and no effective standard of care treatment. Based on the mechanism of action and the encouraging clinical data accumulated to date from a completed Phase 1/2a study and an ongoing Phase 2b study in AML patients medically unfit for intensive chemotherapy, including a majority of patients who progressed to AML from MDS, we believe BST-236 may have the potential as an effective treatment in these indications. Importantly, as the median age of AML and MDS diagnosis is 68 and 76, respectively, we are particularly encouraged by the safety and tolerability profile of BST-236 observed to date. We look forward to collaborating with Biosight to advance what we believe may be an important new option to provide effective and tolerable standard of care treatment for MDS and AML patients.”
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 (INN aspacytarabine), is an innovative proprietary anti-metabolite designed to enable 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. For additional information, please visit www.biosight-pharma.com.
About Groupe Francophone des Myélodysplasies
Groupe Francophone des Myélodysplasies (GFM) is a Study Group of the European Myelodysplastic Syndromes Cooperative Group (EMSCO), which was founded in 2013 upon an initiative of the European Leukemia Network (ELN), and serves as a platform to foster academic clinical research, cooperation and education in the field of myelodysplastic syndromes (MDS). GFM is a non-profit organization that includes most French hematology centers, several of them registered as centers of excellence of the International MDS Foundation. Amongst others, the group conducts and sponsors clinical trials and translational research, coordinates the online French registry of MDS since 2003 and updates diagnostic guidelines and therapeutic procedures.
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