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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) May 11, 1998
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NEOTHERAPEUTICS, INC.
(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: (949) 788-6700
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Not Applicable
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(Former name or former address, if changed since last report)
(Telephone area code changed from (714) to (949)
Exhibit Index on Page 3
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ITEM 5. OTHER EVENTS
Reference is made to the press release issued to the public by the
Registrant on May 11, 1998, the text of which is attached hereto as Exhibit
99.1, for a description of the events reported pursuant to this Form 8-K.
ITEM 7. EXHIBITS
EXHIBIT:
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99.1 PRESS RELEASE DATED MAY 11, 1998.
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: May 11, 1998 By: /s/ Samuel Gulko
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Samuel Gulko
Chief Financial Officer
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EXHIBIT INDEX
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EXHIBITS DESCRIPTION
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99.1 Press Release dated May 11, 1998
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EXHIBIT 99.1
CONTACT: Esra Ozer
Ruder Finn, Inc.
(212) 715-1673
[email protected]
Carol Hess
NeoTherapeutics, Inc.
(949) 788-6700
[email protected]
FOR IMMEDIATE RELEASE
NEOTHERAPEUTICS INITIATES PHASE II CLINICAL TRIALS
ON ALZHEIMER'S DRUG
- -- COMPANY BELIEVES AIT-082 IS FIRST TO PROMOTE NERVE REGENERATION --
IRVINE, Calif., May 11, 1998 -- 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.
-- more --
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PHASE II CLINICAL TRIALS - PAGE 2
"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
-- more --
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PHASE II CLINICAL TRIALS - PAGE 3
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.
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.
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