Avraham Pharmaceuticals Ltd. announced today successful interim results
in a Phase 2b clinical trial for the evaluation of the safety and
efficacy of ladostigil in patients diagnosed with mild cognitive
The on-going Phase 2b trial is a 3 years, multi-center, randomized,
double-blind, placebo-controlled trial and includes approximately 200
patients in 16 centers in Europe and Israel. An independent expert
committee evaluated the safety data on all patients participating in the
trial and that have completed at least 1 year of treatment. The expert
committee concluded that there are no safety issues preventing
continuation of the trial. There were no serious or unexpected adverse
events related to the drug.
In addition, the interim results point to a positive trend as to the
efficacy of the drug, as evident by various clinical parameters and
relevant biomarkers. This includes reduced loss of brain volume as
determined by MRI, improved immune system parameters and trends in
improvement of cognitive parameters.
Yaacov Michlin, Chairman of Avraham Pharmaceuticals and Chief
Executive Officer of Yissum, said, "MCI often progresses to
dementia, and in particular to Alzheimer's disease. It is, therefore, a
high medical and human interest to be able to delay this progression.
This Phase 2 trial is intended to assess the ability of ladostigil, a
drug with neuroprotective activity, to slow the cognitive deterioration
of people with MCI. We are thus very pleased with the favorable interim
results, and look forward to the next interim results, expected at Q3
2015 and the final results at 3 2016."
Yona Geffen, Ph.D., Chief Executive Officer of Avraham
Pharmaceuticals, said, "Currently there is no treatment for MCI, and
we are very encouraged from the positive interim results of the Phase 2b
study and previous clinical and pre-clinical data, and believe that
ladostigil might be a disease modifying drug that will alleviate MCI
symptoms and will prevent progression to Alzheimer's disease."
About LadostigilLadostigil was designed by Professor Marta
Weinstock-Rosin of the Hebrew University of Jerusalem, inventor of
Exelon® and Professor Moussa B.H. Youdim of the Technion Israel
Institute of Technology, inventor of Azilect®. The drug substance was
first synthesized by Professor Michael Chorev of the Hebrew University,
who is now based at Harvard University. All three distinguished
scientists act as scientific advisors to Avraham Pharmaceuticals.
Ladostigil was originally designed as a cholinesterase and
brain-selective monoamine oxides inhibitor. However, in low doses that
do not inhibit the enzymes, ladostigil has neuroprotective activity, by
reducing oxidative stress, reducing microglial activation and inhibiting
proinflamtory cytokines. Therefore, ladostigil provides a drug candidate
that may have the potential to slow progression to Alzheimer's disease
in patients diagnosed with MCI. This potential has been amply
demonstrated in animal models, especially in studies of aging rats. The
drug, which was exclusively licensed to Avraham Pharmaceuticals by
Yissum Research Development Company Ltd., and by the Technion Research
and Development Foundation Ltd. (TRDF), has proven to be safe and well
tolerated in Phase I and Phase II clinical trials.
About Mild Cognitive ImpairmentMild cognitive impairment
(MCI) is a syndrome defined as an intermediate stage between the
expected cognitive decline of normal aging and the more pronounced
decline of dementia. It involves problems with memory, language,
thinking and judgment that are greater than typical age-related changes.
Although MCI can present with a variety of symptoms, when memory loss is
the predominant symptom it is termed "amnestic MCI" and is frequently
seen as a prodromal stage of Alzheimer's
disease. Prevalence in population-based epidemiological studies
ranges from 15% in adults older than 65 years. There is no proven
treatment or therapy for MCI.
About Avraham PharmaceuticalFounded in 2010, Avraham
Pharmaceuticals develops ladostigil, a unique, multi-functional drug
substance for the treatment of mild cognitive impairment, currently
undergoing a Phase IIb clinical trial. Investors in the Company include
Yissum Research Development Company Ltd., the technology transfer arm of
the Hebrew University Clal Biotechnology Industries Ltd., the Pontifax
Fund, Integra Holdings and the Technion Research and Development
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