IRVINE, Calif.-(BUSINESS WIRE)-Feb. 25, 1998
AIT-082 is the first drug in human clinical trials designed to regenerate nerves, and has been shown to reduce, delay or prevent memory deficits in animals. Subjects of the Phase I study will be administered AIT-082 once a day for seven consecutive days at doses of 100 to 2,000 mg per dose. Twenty-four healthy elderly volunteers will participate in the study.
"Our development of AIT-082 is progressing favorably," said Dr. Michelle S. Glasky, Vice President, Scientific Affairs at NeoTherapeutics. "We are encouraged by the success of our single-dose Phase I studies, which showed that the drug was extremely well tolerated. We anticipate that this trend will continue in this multiple dose study," she added. "The results from this study will allow us to initiate phase II studies later this year."
NeoTherapeutics has completed three Phase I clinical trials with AIT-082, which have shown that a single administration of AIT-082 is well tolerated and demonstrates appropriate pharmacokinetics in both Alzheimer's patients and healthy elderly volunteers. The data from these studies is currently under analysis.
AIT-082, NeoTherapeutics' lead product candidate, is the first orally active drug to enter human clinical trials that is specifically designed to address the issue of nerve regeneration. AIT-082 has been shown in laboratory and animal studies to induce the production of three neurotrophic factors, NGF, NT-3 and bFGF. These three factors have been reported to induce the multiplication and functional maturation of cholinergic-neurons, those known to die in Alzheimer's disease.
NeoTherapeutics, Inc., based in Irvine, Calif., is a publicly traded biopharmaceutical company dedicated to the discovery and development of drugs that act on the central nervous system to repair nerve cells and treat neurodegenerative diseases such as Alzheimer's disease, spinal cord injury, Parkinson's disease and stroke. NeoTherapeutics' products are orally administered and based on patented technologies.
This press release contains forward looking statements regarding future events and the future performance of NeoTherapeutics, Inc. that involve risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, the biological activity, side effect profile and efficacy of AIT-082, the early stage of product development, the potential need for additional funding, the initiation and completion of additional clinical trials and dependence on third parties for clinical testing, manufacturing and marketing. These risks are described in further detail in the Company's annual and quarterly reports filed with the Securities and Exchange Commission.
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