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KATHARINE RUSSELL
Russell-Welsh, Inc.
(415) 312-0700
Richmond, California, May 7, 1996 -- Neurobiological Technologies,
Inc. (Nasdaq: NTII) today announced that the company has formed
a research collaboration with Dr. Stuart A. Lipton, M.D., Ph.D.
of The Harvard Medical School Department of Neurology and Children's
Hospital of Boston, Massachusetts, to identify and develop novel
neuroprotective compounds.
Under the direction of Dr. Lipton, a team of researchers anticipate
synthesizing and testing a series of new NMDA receptor and calcium
channel antagonists and nitric oxide related compounds. If promising
compounds arise from the collaboration, they will be tested for
their potential for treatment of or protection against central
nervous system damage associated with brain surgery, traumatic
brain injury, and stroke as well as chronic conditions such as
dementia, including AIDS dementia complex, other neurodegenerative
conditions and neuropathic pain.
NTII will provide funding to Children's Hospital and receive an
exclusive license to inventions in the neuroprotection field and
options to commercialize other products invented or developed
within the collaboration. Financial terms of the two-year renewable
research agreement were not disclosed.
Dr. Stuart A. Lipton, Director of the Laboratory of Cellular and
Molecular Neuroscience at Children's Hospital, said, "Excessive
activation of the glutamate type of NMDA receptors appears to
play a role in neuronal injury and death in a variety of pathologic
conditions including chronic neurodegenerative disorders such
as AIDS dementia complex. Finding drugs which are both safe and
effective has been a challenge. We are interested in modulatory
site-directed, uncompetitive antagonists because they may not
interfere with normal physiologic activities such as cognition
and memory. They may also be able to combat the effects of elevated
concentrations of glutamate and similar substances which occur
in compromised areas of the brain in certain pathological conditions."
Jeffrey S. Price, Ph.D., president and chief executive officer
of NTII, said, "We believe the use of NMDA receptor antagonists
holds considerable promise for the treatment of neurodegenerative
conditions. By forming this alliance with Children's Hospital,
we believe Dr. Lipton's seminal research in cellular and molecular
neuroscience provides us with a platform technology for discovering
promising new agents through collaboration with a group noted
for pioneering work on the NMDA receptor and its agonists and
antagonists."
Dr. Lipton previously reported on the therapeutic potential of
Memantine as an NMDA antagonist. In 1995, NTII obtained an exclusive
license from Children's Hospital to uses of Memantine for the
prevention of NMDA receptor mediated neuronal damage and the treatment
of certain neurodegenerative diseases. The company has begun a
clinical development program for Memantine.
Memantine is a compound in a class of potential neuroprotective
agents called NMDA receptor antagonists that appear to prevent
excessive activation of the N-methyl-D-aspartate (NMDA) subtype
of glutamate receptor on nerve cells in the central nervous system.
Memantine is an open channel blocker which moves in and out of
the ion channel with a short residence time.
Memantine has been reported by independent researchers to reduce
NMDA receptor-mediated neurotoxicity in preclinical models. Animal
studies have shown that Memantine reduces tissue death in the
forebrain stroke model, retards NMDA-induced toxicity to cholinergic
neurons and inhibits neuropathic pain. Memantine also has shown
activity in human trials by independent researchers in patients
with senile dementia, and has been administered for the treatment
of Parkinson's disease and spasticity for many years in Germany.
The company is collaborating with the AIDS Clinical Trials Group
of the National Institutes of Health to plan a randomized, double-blind,
placebo-controlled trial of Memantine administered orally in patients
with AIDS-related dementia complex and painful peripheral neuropathies.
The neuronal injury caused by HIV has been reported by independent
researchers to respond to treatment by Memantine in in vitro
and animal models.
The company also may assess the potential for additional clinical
trials of Memantine in indications such as brain surgery, traumatic
brain injury, stroke, and neurodegenerative conditions such as
Alzheimer's disease. NTII may seek additional scientific collaborators
for participation in the neurodegeneration program, as well as
a development and marketing partner.
Except for the historical information contained herein, the matters
discussed in this press release are forward-looking statements
that involve risk and uncertainties, as detailed from time to
time in the company's Securities and Exchange Commission filings.
When used in this press release, the words "expects,"
"anticipates," and similar statements are intended to
identify forward-looking statements. These include, but are not
limited to, uncertainties generally present in early stage biological
research such as the possibility that safe and effective products
will not emerge from the company's research and that if any do
result, a number of years and significant investment will be required
in order to obtain sufficient data to obtain marketing approval
from regulatory authorities. Actual results may differ materially
from those projected. These forward-looking statements represent
the company's judgment as of the date of this release. The company
disclaims, however, any intent or obligation to update these forward-looking
statements.
NTII is a biopharmaceutical company focused on the development
of neuroscience-based drugs. The Company's lead product candidate,
Corticotropin-Releasing Factor (CRF), is a human peptide which
the Company believes has broad anti-inflammatory activity. CRF
is currently being developed for the reduction of edema and inflammation
in patients with brain cancer and rheumatoid arthritis. Memantine
is being developed as a potential neuroprotective agent. Dynorphin
A is being developed as an analgesic agent, initially as an adjunct
to opioid therapy. NTII is pursuing a strategy employing a network
of scientific and medical experts for early drug discovery and
selected contractors for product development and manufacturing.
NOTICE TO STOCKHOLDERS, ANALYSTS AND OTHER INTERESTED PARTIES:
There will be a conference call on this subject on Tuesday, May
7 at 8:15 a.m. Eastern time. Dr. Lipton and Dr. Price will moderate
the call. To participate, please dial (212) 376-2011 and give
the operator the access code 471-416 and the name of Dr. Jeffrey
Price, Neurobiological Technologies. People who are unable to
participate at this time may listen to an "instant replay"
of the call and the question and answer session through Thursday,
May 9, 7:00 p.m. Eastern time by calling (402) 220-5193.