2003 - [What they plan to work on in 2003]
Recent Developments and Outlook for 2003
Earlier this year we welcomed the following new members to our Board of Directors: Dr. Steven H. Ferris, Dr. Gerard J. Vlak, and Mr. Louis G. Cornacchia. These individuals bring a wealth of expertise to Axonyx in the areas of clinical drug research, accounting economics, fund-raising and banking.
In January we announced our decision to launch two European-based clinical trials with the objective of generating additional data in support of the safety and efficacy of Phenserine for regulatory approval for marketing in AD.
The first study, now scheduled to commence in the second quarter, is a Phase IIB trial that will evaluate Phenserine's effects on the levels of beta-amyloid precursor protein and beta-amyloid in the plasma and cerebrospinal fluid of 75 mild to moderate Alzheimer's disease patients.
This trial may substantiate, in patients, Phenserine's unique dual treatment action:
the ability to improve memory and cognition by suppressing the activity of the enzyme acetylcholinesterase,
and to reduce toxic amyloid beta levels, through messenger RNA activity, thus potentially slowing the progression of the disease.
The second clinical trial is a potentially pivotal Phase III trial that will examine the safety and treatment efficacy of Phenserine in up to 375 patients with mild to moderate Alzheimer's disease at multiple centers throughout Europe.
This trial, if successful, would be a significant step in our preparation for an NDA submission in the United States and its equivalent in Europe.
We now anticipate starting this trial, as well, in the second quarter of this year. The 75 patients in the Phase IIB study, with respect to cognition/memory clinical data, will become a component of this Phase III pivotal trial.
The strategy of our company is to focus our resources on the clinical development of Phenserine for AD.
In this regard, we have decided not to exercise our exclusive option from Thomas Jefferson University to acquire the patent rights to Gilatide, a potential pharmaceutical compound designed to enhance memory and cognition.
"2003 is the beginning of a second "era" for Axonyx with the initiation of the pivotal trial for Phenserine. We are a small bio-pharmaceutical company with the potential to successfully develop a unique drug for AD and bring relief to those devastated by this illness," stated Marvin S. Hausman, M.D., President and Chief Executive Officer of Axonyx.
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