Neotherapeutics Initiates Phase II Clinical Trials on Alzheimer's Drug
LA Times
11-MAY-98
IRVINE, Calif.--(BUSINESS WIRE)--May 11, 1998-- Company Believes AIT-082 is
First to Promote Nerve Regeneration NeoTherapeutics Inc. (Nasdaq: NEOT; NEOTW)
announced today that it has initiated a Phase II trial of the company's lead
compound, AIT-082 (NEOTROFIN (TM)) in patients with mild to moderate
Alzheimer's disease.
This study represents NeoTherapeutics' first Phase II study with AIT-082, and
the company indicated it is pleased to have started the trial sooner than
anticipated.
More than 60 volunteers will be enrolled in the study, which is the first
trial conducted on AIT-082 designed specifically to measure the biologic
activity of the drug in addition to dose ranging and safety parameters. Since
AIT-082 is believed to exert its effects through a mechanism different than
other Alzheimer's disease drugs currently under evaluation, the efficacy
parameters being used on AIT-082 were selected on their ability to detect
different types of cognitive and behavioral changes which may occur in the
patients.
"We believe AIT-082 represents the first drug to enter Phase II human clinical
trials designed to promote nerve regeneration," said Alvin J. Glasky, Ph.D.,
president and CEO of NeoTherapeutics. "Until now, treatment of
neurodegenerative diseases has been limited to management of symptoms.
Beginning Phase II human clinical trials represents a significant milestone
for our company," he added.
NeoTherapeutics' compound, AIT-082, is a member of a new class of drugs for
the treatment of Alzheimer's disease. Pre-clinical studies have demonstrated
that AIT-082 enhances cognitive function and memory in animals with
neurological deficits. It is a novel small molecule designed to cross the
blood-brain barrier and enhance nerve cell function by increasing levels of
neurotrophic factors. In pre-clinical laboratory studies, AIT-082 has shown
unique properties in that it is able to stimulate the production of
neurotrophins, natural proteins which promote the growth, survival and
regeneration of nerve cells.
Phase I clinical trials results in humans show that AIT-082 is orally
absorbed, produces no serious side effects over a wide dosage range, remains
in the blood sufficiently long enough for possible once a day dosing, and
demonstrates a trend for memory improvement.
NeoTherapeutics is engaged in 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 as well as other neurological conditions such
as migraine. NeoTherapeutics' products are orally administered and based upon
patented technologies. AIT-082 (NEOTROFIN(TM)) is currently in human clinical
trials for the treatment of Alzheimer's disease. For additional Company
information, visit the NeoTherapeutics website at www.neotherapeutics.com
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--This press release contains 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 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 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.