NeoTherapeutics to Initiate Pivotal Trial in Alzheimer's Disease For Neotrofin(TM)
New higher dose clinical trial to begin in April 2001
Mounting pre-clinical data on drugs action and clinical data gained from dosing studies completed in 2000 lead to enhanced protocol
NeoTherapeutics will hold a telephone conference call today (2/5/00) starting at 11:00 A.M. (EST). Alvin J. Glasky, Ph.D., Chairman and Chief Executive Officer; Rajesh Shrotriya, M.D., President; and, Sam Gulko, Senior Vice President Finance and Chief Financial Officer, will discuss issues and answer questions relating to this news release and discuss goals and objectives for 2001. Those wishing to participate should call 888-552-7850 at approximately 10:50 A.M. (EST) . A replay of today's conference call will be available for approximately seven days following the call and can be accessed by dialing 800-642-1687 (reservation # 300784).
IRVINE, Calif., Feb. 5 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT; NEOTW) announced today that it will initiate a higher dose 12- week study of Neotrofin in Alzheimer's disease. The new study, designed to be ``pivotal'' for registration, will evaluate the effectiveness of higher doses in treating symptoms of Alzheimer's disease. Results from previous studies indicate that daily doses in the higher range were well tolerated, and NeoTherapeutics believes that there is sufficient evidence to expect that the doses to be used will provide enhanced clinical effects. The study is expected to begin in April 2001, and will incorporate 12 weeks of treatment for the primary analysis, followed by 12 weeks of treatment in order to allow patients initially given placebo to receive Neotrofin. Assuming no enrollment delays, this clinical trial should be completed by the end of this year. A second and longer-term pivotal study is planned to commence in the second half of 2001, in which disease course modification will be measured over one year of treatment, while effects on symptom improvement will be measured after 12 weeks of treatment.
``This logical next step for our Neotrofin Alzheimer s clinical program has been based upon a thorough review of all pre-clinical research and clinical data in over 1,100 patients who received this drug in previous clinical trials, particularly the rate and extent of drug absorption in humans as compared to our animal studies,'' stated Rajesh Shrotriya, M.D., President of NeoTherapeutics. ``We have also incorporated the recommendations of our expanded Alzheimer's Clinical Advisory Board and several new consultants, including former high-ranking members of regulatory authorities. The Company s expanded internal medical and scientific staff, including two board- certified neurologists, have developed new clinical protocols to measure and evaluate Neotrofin's efficacy at higher dosage levels in patients with Alzheimer s disease.''
``A great deal of in-depth analysis, as well as consultation with experts in the field of Alzheimer s disease, has gone into the development of our protocol for the new trial in Alzheimer's disease,'' stated Jacob Huff, M.D., Vice President, Medical Affairs of NeoTherapeutics. ``Neotrofin holds great promise for patients with Alzheimer's disease, both as a symptomatic treatment and as a potential disease course-modifying agent. Our first focus is to get the NDA filed for symptomatic treatment in the shortest timeframe possible. At a later date, if positive results are seen in the second longer-term study designed to show the drug's effectiveness in producing disease-course modification, we plan to ask for extension of the approved treatment indication to include the effect on disease course.''
In a phase 2 clinical study conducted by Steven Potkin, M.D., professor of psychiatry and director of the Brain Imaging Center at the University of California, Irvine, patients treated with 500 and 1000 mg doses of Neotrofin experienced statistically significant improvement in memory, attention and judgement. These behavioral improvements at the higher doses were consistent with changes in brain metabolism seen using Positron Emission Tomography scanning and changes in brain waves measured by electroencephalography. The data from this study were presented in December 2000 at the American College of Neuropsychopharmacology.
On January 31, 2001, NeoTherapeutics announced that Neotrofin has significant effects producing increased proliferation of stem cells in the brains of adult mice. A single dose of Neotrofin led to a significant increase in progenitor cells within 24 hours. Regeneration of the nervous system after disease or injury would require re-population by new neurons, and stimulation of brain stem cells may be involved. These data were presented at a recent conference in London.
NeoTherapeutics is a biopharmaceutical company focused on the development of small molecule drugs for unmet medical needs for the treatment of important diseases. The Company's most advanced drug, Neotrofin, is currently being developed for Alzheimer's disease and other neurodegenerative diseases, such as Parkinson's disease and spinal cord injury. In animal models of cognitive decline, aging and spinal cord injury, Neotrofin(TM) has been shown to restore neurological function. NeoGene Technologies, Inc., a subsidiary of NeoTherapeutics, is engaged in functional genomics research. NeoOncoRx, Inc., a subsidiary of NeoTherapeutics, is engaged in the development of anticancer drugs. For additional Company information, visit NeoTherapeutics' web site at www.neotherapeutics.com.
This press release may contain forward-looking statements regarding future events and the future performance of NeoTherapeutics that involve risks and uncertainties that could cause actual results to differ materially. These risks are described in further detail in the Company's reports filed with the Securities and Exchange Commission. |
