Avraham Pharmaceuticals Announces Commencement of a Phase 2 Study of Ladostigil for the Treatment of MCI
News May 18, 2012
Avraham Pharmaceuticals Ltd. has announced the commencement of a Phase 2 clinical trial to evaluate the safety and efficacy of ladostigil in patients diagnosed with mild cognitive impairment (MCI).
This 36-month, multi-centre, randomized, double-blind, placebo-controlled trial will include at least 200 patients in 16 centers in Europe and Israel.
In parallel, Avraham Pharmaceuticals has also completed the enrollment of 200 patients in a Phase 2 trial of ladostigil, a novel molecule for the treatment of mild to moderate Alzheimer's disease.
The Phase 2 study is a double-blind, closed-label, placebo-controlled trial taking place at 20 sites in five countries across Europe. In January 2012, the Company performed an interim analysis of this Phase 2 trial, which indicated that the drug is safe and well tolerated, as well as shows a positive trend toward efficacy.
Final results of the 26-week trial are expected in the fourth quarter of 2012.
The Company also announced that it has appointed Yaacov Michlin, CEO of Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., the technology transfer arm of the University, as Chairman of the Board and Yona Geffen, Ph.D., as Chief Executive Officer.
“We strongly believe in ladostigil and are confident that Yona's background and extensive experience in developing therapies for neurological disorders and neurodegenerative diseases renders her the perfect choice to lead Avraham," said Yaacov Michlin, Chairman of Avraham Pharmaceuticals and Chief Executive Officer of Yissum.
Michlin continued, "In further researches performed by Prof. Weinstock-Rosin, ladostigil has showed promise also for the treatment of MCI in addition to Alzheimer's disease. We are pleased that another Phase 2 clinical trial in patients with MCI has begun in parallel, and look forward to the final results of the Phase 2 study for the treatment of Alzheimer's disease expected at the end of this year.”
“I am delighted to lead Avraham in these exciting times for the company, as we advance ladostigil in 2 Phase 2 clinical trials simultaneously. We believe that this unique drug candidate has the potential to transform the treatment of various neurodegenerative diseases,” said Dr. Yona Geffen, Avraham Pharmaceuticals Chief Executive Officer.
Dr. Yona Geffen joined Avraham Pharmaceuticals in January 2011 as Senior Vice President of Clinical Affairs and Chief Operating Officer. Dr. Geffen has more than 12 years of experience in the field of drug development in biopharmaceutical companies.
Prior to Avraham, she was Executive Drug Development Director at BiolineRx. Before that, Dr. Geffen was a project manager at Proneuron Biotechnologies.
Dr. Geffen received her Ph.D. from Ben Gurion University in Beer Sheva, Israel. She also holds an M.Sc. in business management.
Yaacov Michlin has been CEO of Yissum since 2009. Prior to Yissum, Mr. Michlin spent over a decade in leading and assisting pharmaceutical, hi-tech and biomedical companies in various technology commercialization deals, licensing agreements, capital raising activities, partnerships, mergers and acquisitions.
Michlin holds a Bachelor of Law and Economics cum laude, and a Master of Law all from Bar-Ilan University, Ramat Gan, Israel.
In addition, he has an MBA cum laude from the Technion Israel Institute of Technology, Haifa, Israel.
A form of the hallucinogenic party drug ketamine has cleared one of the final hurdles toward clinical use as an antidepressant. During a meeting at the US Food and Drug Administration (FDA) in Silver Spring, Maryland, an independent advisory panel voted 14-2 in favor of recommending a compound known as esketamine for use in treating depression.READ MORE