Thrombotech Ltd., a biotechnology company based on cutting-edge stroke research at the Hadassah University Medical Center, has received approval from the United States' Food and Drug Administration (FDA) to expand clinical trials to the US for its lead product, THR-18. This medicine is designed to improve the safety and efficacy of tPA, the currently available treatment for ischemic stroke.
THR-18 is designed to allow tPA to dissolve blood clots easily, extending its short therapeutic time window and diminishing life-threatening side effects. It is currently undergoing Phase IIA clinical trials at several hospitals in Israel, including Hadassah, and is awaiting regulatory approvals in Europe and India.
"This important regulatory approval serves as external validation for our development program and the quality of the science and management behind the company," says Thrombotech Chief Executive Officer Dr. Ruth Ben Yakar. "It will enable us to recruit more patients in some of the leading medical centers specializing in stroke in the US and move towards commercialization of the therapy for this serious medical condition."
Hadasit, Hadassah's technology transfer company, holds a 24% stake in Thrombotech. Commenting on the approval, Ophir Shahaf, Chief Executive Officer of Hadasit Bio-Holdings, Hadasit's publicly traded subsidiary, stated: "We are proud to expand the clinical trial to medical centers in the US, a world leader in Central Nervous System therapeutics and stroke treatment in particular." Date: 3/28/2012