Avraham Pharmaceuticals (ILSI 2012) - May 15, 2012 - Avraham announced commencement of a P2 clinical trial to evaluate the safety and efficacy of ladostigil in patients diagnosed with mild cognitive impairment (NCT01429623); Avraham has also completed enrollment of 200 patients in P2 trial of ladostigil; In January 2012, company performed an interim analysis of this P2 trial, which indicated showed a positive trend in the drug's efficacy and found no safety issues; Results are expected in Q4 2012
Anticipated P2 data • Enrollment completion • Interim analysis • P2 initiation • Alzheimer's Disease
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ILSI-BioMed, Israel 2012; May 21-23
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Dr. Yona Geffen
Company Type: BioPharma
Company Name: Avraham Pharmaceuticals
Company Description: Founded in 2010, privately held Avraham Pharmaceuticals Ltd. (“Avraham”) has raised more than $12 million to advance the development of its unique, multi-functional drug substance, ladostigil. The Company is now conducting a double-blind, placebo-controlled, Phase 2, proof-of-concept trial in patients with Alzheimer's disease at 20 sites in five countries across Europe. An interim report showed a positive trend in the drug's efficacy and found no safety issues. Results are expected in Q4 2012.In addition, the Company initiated another Phase 2, double-blind, placebo-controlled trial in patients with mild cognitive impairment (“MCI”).
Ladostigil was designed by Professors Marta Weinstock-Rosin of the Hebrew University and Moussa B.H. Youdim of the Technion.
Ladostigil is a multi-functional drug substance that contains the pharmacophores of, rasagiline (Azilect), a monoamine oxidase B (MAO-B) inhibitor, and rivastigmine (Exelon), a cholinesterase inhibitor. Ladostigil not only combines the enzyme inhibitory activities of these two drugs, but also adds the ability to inhibit monoamine oxidase A (MAO-A) in a highly brain-selective fashion, and has a neuroprotective activity.
Like other cholinesterase inhibitors currently on the market, ladostigil targets symptomatic relief for Alzheimer's patients. But also provides potential to improve the behavioural and psychological symptoms of dementia, such as depression and anxiety. Moreover, ladostigil holds the potential to slow progression of Alzheimer's disease and to modify the pathology associated with the disease.
The unique synergistic multi-functionality of ladostigil offers promising potential for an improved clinical outcome in Alzheimer's patients, MCI and other neurodegenerative diseases.
Avraham has been capitalized by Yissum ,Clal Biotechnology and Pontifax .
Related article:
Avraham Pharmaceuticals announces commencement of a phase 2 study of ladostigil for the treatment of MCI
http://www.businesswire.com/news/home/20120517005968/en/Avraham-Pharmaceuticals-Announces-Commencement-Phase-2-Study
May 17, 2012
Avraham Pharmaceuticals Ltd. announced today 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 today 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. "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 (NASDAQ: BLRX). 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.
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