Industry veteran brings successful track record of clinical development and marketing authorizations of several cancer and leukemia drug products Appointment establishes US presence of senior Biosight leadership
Industry veteran brings successful track record of clinical development and marketing authorizations of several cancer and leukemia drug products
Appointment establishes US presence of senior Biosight leadership
AIRPORT CITY, Israel, May 18, 2021 (GLOBE NEWSWIRE) -- BioSight Ltd. , a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced the appointment of Darrel Cohen, M.D., Ph.D. as Chief Medical Officer where he will oversee global clinical development and regulatory submissions for aspacytarabine.
“We are thrilled to welcome Darrel as Chief Medical Officer, strengthening our management team as we prepare for significant milestones in the development of aspacytarabine in the coming months,” said Dr. Ruth Ben Yakar, Chief Executive Officer of Biosight. “Darrel has deep expertise and a successful industry track record in the clinical development and regulatory approvals of several cancer and leukemia drugs, which will be invaluable as we advance aspacytarabine to provide a new standard-of-care treatment option for acute myeloid leukemia (AML) patients with high unmet medical needs. In addition to providing important leadership for our expanding aspacytarabine clinical development program, Darrel will also play a central role in establishing our US presence. This important addition to our management team builds our momentum as we prepare for new data readouts and clinical trials after the recent completion of enrollment into our Phase 2b trial of aspacytarabine in AML patients who are unfit to receive intensive chemotherapy.”
Dr. Cohen said, “The clinical aspacytarabine data generated to date are compelling, with single-agent efficacy demonstrated across key measures, including complete remission with negative minimal residual disease rates, duration of response, and overall survival in front-line therapy of AML patients unfit for standard intensive chemotherapy. I am excited to work with the Biosight management team to continue the advancement of this innovative new therapy for AML patients with the greatest medical need and limited treatment options, including those unfit for intensive chemotherapy and patients with poor-prognosis baseline characteristics.”
Dr. Cohen brings over 20 years of industry hematology/oncology drug development experience to Biosight, most recently serving as Head of Clinical Development at EUSA Pharma. Prior to that, he was Vice President, Late-Phase Clinical Development at Pfizer Oncology. During his time at Pfizer, Dr. Cohen either led or contributed to the clinical development strategies and successful regulatory submissions of several cancer and leukemia drugs, including Mylotarg, Daurismo, and Besponsa. Prior to Pfizer, he was a Director and Associate Director of Oncology Clinical Development at Sanofi-Aventis and Pharmacia, respectively. Dr. Cohen received his M.D. and Ph.D. degrees in Medicine and Microbiology from Boston University School of Medicine, trained as a resident in Internal Medicine at Georgetown University Medical Center, and completed a fellowship in Hematology/Oncology at Duke University Medical Center.
About Aspacytarabine (BST-236)
Aspacytarabine is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a prodrug of cytarabine. Cytarabine serves as the backbone of AML therapy for over 45 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 pharmacokinetics and metabolism, aspacytarabine enables high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, aspacytarabine may serve as a superior therapy for AML and other hematological malignancies and disorders, including for older adults who are unfit to receive intensive chemotherapy.
Aspacytarabine was granted FDA Fast Track Designation for first-line treatment of AML patients unfit for standard chemotherapy, and Orphan Drug Designation, which entitles Biosight to 7 years of market exclusivity upon aspacytarabine marketing approval for the treatment of AML.
Interim results from an ongoing Phase 2b study evaluating single-agent aspacytarabine as a first-line AML therapy demonstrated strong activity with a favorable safety profile, and additional studies are being launched to investigate aspacytarabine as a second-line treatment for patients with relapsed or refractory AML or myelodysplastic syndrome (MDS). 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, aspacytarabine (BST-236), is an innovative proprietary anti-metabolite which addresses unmet medical needs by enabling high-dose chemotherapy with reduced systemic toxicity. Aspacytarabine is currently being investigated as a single agent in a Phase 2b clinical trial for the first-line treatment of patients with AML, following completion of a Phase 1/2a study which demonstrated tolerability with promising efficacy in the challenging population of AML patients unfit for intensive standard-of-care chemotherapy. Additional Phase 2 studies are being launched in patients with relapsed or refractory AML or MDS, including a study in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM). For additional information, please visit www.biosight-pharma.com.
Contact:
Chuck Padala
646-627-8390
LifeSci Advisors, LLC
