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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 27, 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
Page 1 of 5
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Item 5. Other Events
Reference is made to the press release issued to the public by the
Registrant on July 27, 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 JULY 27, 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: July 27, 1998 By: /s/ SAMUEL GULKO
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Samuel Gulko
Chief Financial Officer
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EXHIBIT INDEX
EXHIBITS DESCRIPTION
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99.1 Press Release dated July 27, 1998
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EXHIBIT 99.1
CONTACT: Alex Fudukidis Carol Hess
Corporate & Investor Relations Investor Relations
Ruder Finn, Inc. NeoTherapeutics, Inc.
(212) 583-2746 (949) 788-6700
Erika Freed
Media Relations
Ruder Finn, Inc.
(212) 715-1673
FOR IMMEDIATE RELEASE
NEOTHERAPEUTICS' LEAD COMPOUND DEMONSTRATES
NERVE REGENERATION PROCESS
Production of Nerve Growth Factors Leads to Functional Improvement
in the Brain Which May Provide Therapeutic Benefit in Battle
Against Neurodegenerative Diseases
IRVINE, CA, JULY 27, 1998 -- NeoTherapeutics, Inc. (Nasdaq: NEOT, NEOTW)
announced today that tests with its lead compound, NEOTROFIN-TM- (AIT-082,
leteprinim potassium), have demonstrated that the drug enhances all the stages
required to complete the nerve regeneration process. This process starts with
stimulating genes to produce nerve growth factors and leads to functional
improvement in the brain. NEOTROFIN-TM- is currently in Phase II clinical
trials for the treatment of Alzheimer's disease.
At the XIII International Congress of Pharmacology, in Munich, Germany, Dr.
Alvin J. Glasky, NeoTherapeutics' President, CEO and Director of Research,
reported that, in animals, NEOTROFIN-TM- causes nerves to regenerate after they
have been destroyed under conditions similar to those that occur in brain injury
and stroke. New nerve sprouting was seen in nerve cells within hours in tissue
culture and after only four days of treatment with NEOTROFIN-TM- in animals
after brain damage.
It was further reported that NEOTROFIN-TM- appears to work by "turning on" or
stimulating the genes that are involved in the natural repair of the brain and
spinal cord. In animal studies, evidence of increased gene expression occurs
within 15 minutes after administration of the drug. This increase continues for
many hours after the drug has been eliminated from the body. The enhanced gene
function causes a cascade of beneficial biological effects involving increased
specific mRNA and neurotrophic factor proteins in brain cells and is followed by
nerve regeneration and improved memory function.
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NeoTherapeutics' Lead Compound Demonstrates
Nerve Regeneration Process
July 27, 1998
Page Two
Dr. Glasky stated that "Scientists at NeoTherapeutics, together with our
collaborators from the United States, Canada and Europe, have demonstrated in
different experimental tests that NEOTROFIN-TM- can turn on the production of
several specific natural growth factors, called neurotrophins, in the brain and
spinal cord of animals. The consequences of the production of these growth
factors are the protection of nerves from injury, nerve regeneration and
improved functioning. NEOTROFIN-TM- clearly has demonstrated unique properties
which should continue to validate the use of this drug in neurodegenerative
diseases."
"In our clinical testing program, we currently have a Phase II efficacy study in
progress in mild to moderately affected Alzheimer's patients. We believe that
NEOTROFIN-TM- is the first drug that has been shown to turn on specific genes in
nerve cells to produce the natural neurotrophic factors necessary to cause nerve
regeneration. These results indicate that NEOTROFIN-TM- may provide therapeutic
benefit in several different neurodegenerative diseases such as Alzheimer's
disease, spinal cord injury and stroke" concluded Dr. Glasky.
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' compounds 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 NEOTROFIN-TM-, 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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