EXHIBIT 99.1
CONTACTS:
INVESTMENT COMMUNITY: MEDIA:
Carol Gruetter John Lockhart
NeoTherapeutics, Inc. Halsted Communications, Inc.
Tel: (949) 788-6700 Tel: (800) 600-7111 x.224
e-mail: cgruetter@neotherapeutics.com (213) 957-3111 x.224
e-mail: jlockhart@halsted.com
Margaret Wyrwas and Christine Seketa
Hill and Knowlton, Inc.
Tel: (212) 885-0544 or (212) 885-0350
e-mail: mwyrwas@hillandknowlton.com
cseketa@hillandknowlton.com
NEOTHERAPEUTICS ANNOUNCES RESULTS FROM FIRST U.S. CLINICAL TRIAL OF AIT-082
PRESENTED TODAY AT SOCIETY FOR NEUROSCIENCE MEETING IN LOS ANGELES
Los Angeles -- November 10, 1998--NeoTherapeutics, Inc. (Nasdaq: NEOT, NEOTW)
and the Alzheimer's Disease Cooperative Study (ADCS), a clinical research
group directed by Dr. Leon Thal and funded by the National Institute on
Aging, announced today at the 28th Annual Meeting of the Society for
Neuroscience in Los Angeles results from a Phase 1 clinical trial on
NeoTherapeutics' drug compound AIT-082 (NEOTROFIN-TM-, leteprinim potassium).
The presentation entitled "A Phase 1 Study of AIT-082 in Healthy Elderly
Volunteers" was co-authored by Dr. Michael Grundman and his colleagues at
the ADCS. The ADCS conducted a Phase 1 study of AIT-082, which represented
the first U.S. clinical trial for this drug, in eight healthy elderly
volunteers at two clinical sites. After initial treatment with a placebo, six
subjects were treated with rising doses of AIT-082 on a weekly basis. Two
volunteers received placebo throughout this double-blind trial. The study
participants tolerated the drug well without significant side effects.
Subjects tended to perform better on tests of memory and concentration when
they received AIT-082 than when they received placebo. Due to the small
number of people in this study, further testing will be required before the
effects of AIT-082 on memory can be established.
AIT-082 is a novel small molecule that, in animals, crosses the blood-brain
barrier to regenerate nerve function by increasing levels of neurotrophic
growth factors and causing nerve sprouting in the brain. Pre-clinical studies
in animals have demonstrated that AIT-082 improves memory in aged animals and
in animals with neurological deficits. Dr. Leon Thal of the University of
California, San Diego and Director of the Alzheimer's Disease Cooperative
Study commented "The unique manner in which AIT-082 acts was the basis for
the interest of the ADCS in evaluating this compound. While we are very
encouraged with the preliminary results from this limited trial, additional
larger studies are required before any
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definitive conclusion can be made regarding the efficacy of AIT-082 for the
treatment of Alzheimer's disease. The ADCS is pleased to be collaborating in
the evaluation of this drug."
Dr. Neil Buckholtz, Chief of the Dementias of Aging Branch of the National
Institute on Aging (NIA), a division of the National Institutes of Health,
said: "The NIA is very encouraged that AIT-082 proved safe in this small
group of people. We look forward to additional data from larger clinical
trials. The progress on AIT-082 reflects the accomplishments that can be
made through a productive cooperation between government and the
pharmaceutical industry."
The ADCS has recently begun its second study with AIT-082. Thirty-six
patients with mild to moderate Alzheimer's disease will participate in this
second Phase 1 study in which the participants will receive AIT-082 or a
placebo daily for seven days. The study is predominately designed to measure
safety parameters but will also look at memory improvement in the patients.
"As the first drug in human clinical trials which could promote regeneration
of nerve function in patients with Alzheimer's disease, we are very
encouraged by these positive results," said Dr. Alvin Glasky, President and
Chief Scientific Officer of NeoTherapeutics. "Based upon the clinical
results observed in this study, as well as in our other Phase 1 clinical
trials, we have accelerated the clinical development program for the use of
NEOTROFIN" (AIT-082) in Alzheimer's disease." AIT-082 is also being
evaluated in a Phase 2 clinical trial of patients with mild to moderate
Alzheimer's disease.
The Alzheimer's Disease Cooperative Study (ADCS) is a consortium of
approximately 35 academic medical centers funded by the National Institute on
Aging for the purpose of conducting clinical trials in Alzheimer's disease.
In addition to AIT-082, the ADCS has conducted clinical trials with vitamin
E, prednisone, melatonin, and estrogen. Alzheimer's disease affects
approximately four million people in the United States alone.
The National Institute on Aging has provided support to this drug through
Small Business Innovative Research grants, contracted services for drug
manufacturing (with the National Institute of Mental Health) and toxicity
testing as well as funding the ADCS clinical trials.
NeoTherapeutics' research program is focused on designing and developing
small molecules capable of promoting nerve regeneration and repair for a
range of neurological diseases and conditions such as Alzheimer's and
Parkinson's diseases, stroke and spinal cord injury. Additional compounds in
NeoTherapeutics' product pipeline address other health issues such as
migraine and depression. For additional Company information, visit the
NeoTherapeutics web site at WWW.NEOTHERAPEUTICS.COM.
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 early stage of product
development, the 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 reports filed with the Securities and Exchange Commission.
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