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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) July 29, 1997
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NEOTHERAPEUTICS, INC.
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(Exact name of registrant as specified in its charter)
Delaware 0-28782 93-0979187
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
157 Technology Drive, Irvine, California 92618
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (714) 788-6700
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Not Applicable
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(Former name or former address, if changed since last report)
Exhibit Index on Page 3
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ITEM 5. OTHER EVENTS
On July 29, 1997, NeoTherapeutics, Inc. (the "Company") issued a Press
Release which reports additional interim results of the Canadian Phase I/II
trial of the Company's AIT-082 compound in Alzheimer's disease patients. A copy
of the Press Release is filed with this Report as Exhibit 99.1.
ITEM 7. EXHIBITS
Exhibits:
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99.1 Press Release dated July 29, 1997.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
NEOTHERAPEUTICS, INC.
Date: July 29, 1997 By: /s/ SAMUEL GULKO
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Samuel Gulko
Chief Financial Officer
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EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibits Description
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<C> <S>
99.1 Press Release dated July 29, 1997.
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[NEOTHERAPEUTICS LETTERHEAD]
CONTACT:
Michelle S. Glasky, Ph.D. Douglas MacDougall
Vice President Scientific Affairs Feinstein Kean Partners
NeoTherapeutics, Inc. (617) 577-8110
(714) 788-6700
FOR IMMEDIATE RELEASE
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--NEOTHERAPEUTICS REPORTS MEMORY IMPROVEMENT OF
ALZHEIMER'S PATIENTS IN CLINICAL TRIAL
IRVINE, CA, JULY 29, 1997 -- NeoTherapeutics, Inc. (Nasdaq: NEOT; NEOTW) today
announced additional interim results on its Canadian Phase I/II trial of
AIT-082 in Alzheimer's disease patients. Results from the ten patient
single-dose, double-blind, placebo-controlled trial indicate that AIT-082 was
orally absorbed, produced no serious side effects and improved memory function.
These results were reported today at the Second International Conference on
Neurodegeneration in Princeton, New Jersey.
Memory function was measured by the Word Recall Test after oral administration
of AIT-082 at doses ranging from 500 to 4000 mg. At 180 minutes after oral drug
administration, 60% of the patients treated with 500 or 1000 mg of AIT-082
showed improvement of memory function while 80% of the placebo-treated patients
showed a decrease in memory compared to pretreatment levels. These differences
were statistically significant. Patients receiving the highest doses did not
exhibit improved memory function.
The clinical trials are being administered under the direction of Dr. David
William Molloy, an internationally recognized Alzheimer's researcher, at the
Geriatric Research Group and Memory Clinic in Hamilton, Ontario, Canada.
"We are very excited that this first limited clinical trial of AIT-082 in
Alzheimer's patients has shown improvement in memory function," said Alvin J.
Glasky, Ph.D., President and CEO of NeoTherapeutics.
"These observations are surprising in that the patients were evaluated after
receiving only a single dose of AIT-082. Since Alzheimer's disease is a chronic
degenerative process, further studies employing prolonged repeated treatment
will be necessary before the true importance of these results can be
established" continued Dr. Glasky.
The Company has initiated additional dose ranging Phase I/II studies in Canada
employing lower doses of AIT-082 to determine the minimum effective dose. In
addition, repeated dosing studies on larger numbers of patients will be needed
to determine whether any adverse reactions or clinical benefits will result
from long term administration of this drug.
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NeoTherapeutics' AIT-082 is a novel small molecule compound designed to cross
the blood-brain barrier and enhance nerve cell function by increasing levels of
neurotrophic factors in damaged or degenerating neurons. Neurotrophic factors
are naturally occurring protein molecules that promote the growth, survival and
regeneration of nerve cells within the body. Published studies have shown that
AIT-082 increased levels of mRNA for the neurotrophic factors NGF, NT-3, and
bFGF in cultured neurons, and that the oral administration of AIT-082 produces
a similar increase in neurotrophic factor production in the brains of aged
animals.
NeoTherapeutics is engaged in the discovery and development of new drugs that
act on the central nervous system to treat neurodegenerative diseases, such as
memory deficits associated with Alzheimer's disease, impairment associated with
aging and stroke, as well as spinal cord injuries.
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 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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