Here's the phase II release. It got sort of lost in Christmas, Ostrach, and CRF/RA. For those who wanted a bigger chunk of NTII, this series of events may be a blessing.........
Neurobiological Technologies, Inc. Starts Phase II Memantine Trial
With NIH Aids Unit
Potential Treatment For AIDS-Related Dementia and Nerve Damage
RICHMOND, Calif., December 18, 1996 -- Neurobiological Technologies, Inc.
(Nasdaq: NTII) today announced that the Adult AIDS Clinical Trials Group
(AACTG) has initiated a Phase II clinical trial of NTII's neuroprotectant
Memantine, an orally administered NMDA receptor antagonist. The trial will
evaluate Memantine's ability to reduce symptoms of dementia and neuropathic
pain in patients with AIDS. Currently there are no effective treatments
available for these conditions.
At its twenty-second meeting last week in Washington, D.C., the AACTG
kicked off the Memantine trial with a session for participating clinical
investigators. The trial is now open for enrollment. The AACTG, a clinical
research network supported by the National Institute of Allergy and Infectious
Diseases (NIAID) of the National Institutes of Health, is conducting the trial
under NTII's Investigational New Drug (IND) application. NTII will supply
Memantine and will have the right to use the data resulting from the trial for
the further commercial development of Memantine.
The Phase II trial, ACTG 301, is a placebo-controlled double-blind study,
expected to enroll 120 patients at multiple AACTG centers across the country.
Qualifying patients will have been diagnosed with AIDS dementia complex and
will have been treated with an FDA-approved anti-retroviral drug for at least
eight weeks prior to study entry. Anti-retroviral treatment will be
maintained throughout the study. Memantine or placebo will be administered
for 16 weeks, followed by 12 weeks of open-label treatment with Memantine.
Improvement in dementia symptoms will be assessed by standard tests for
neuropsychological function. Relief of neuropathic pain will also be
assessed.
Jeffrey S. Price, President and Chief Executive Officer of NTII, said,
"The start of the NIAID-sponsored Phase II trial of Memantine is a major
milestone in our neuroprotection program. We are also planning additional
Phase II clinical trials of Memantine in other chronic indications, including
neuropathic pain, which we expect to begin during 1997."
The Principal Investigator of the trial, Bradford Navia, M.D., Ph.D.,
Professor of neurology at the Tufts University School of Medicine, said, "At
the present time, there are no effective treatments available for the
cognitive impairment and peripheral nerve damage associated with HIV
infection. In sponsoring this trial of Memantine, the AACTG hopes to address
this unmet medical need. ACTG 301 will be the largest clinical trial ever
sponsored by the AACTG to evaluate a potential treatment for AIDS dementia."
HIV infection of the brain results in damage to the central nervous
system. Reportedly, over one-third of adults with AIDS develop neurological
symptoms including loss of cognition, movement and sensation, and as many as
40% of AIDS patients may experience neuropathic pain. Recent studies indicate
that HIV infection of the brain causes nerve damage through overstimulation of
NMDA receptors. Preclinical studies have shown that antagonists of the NMDA
receptor, including Memantine, can reduce the neuronal injury associated with
the AIDS virus.
Stuart A. Lipton, M.D., Ph.D., Director of the Laboratory of Cellular and
Molecular Neuroscience at Harvard Medical School in Boston, Massachusetts,
said, "Those of us in the field of AIDS neurology fear that while newer
anti-retroviral AIDS drugs may allow one to live longer with the disease, they
will not prevent the onset of cognitive impairment. The newly released AIDS
drugs, including the protease inhibitors, are increasingly effective against
the disease in general, but do not appear to penetrate into the brain
sufficiently to prevent nerve cell injury and death. That is why this trial
of Memantine as an anti-dementia drug is very important. We are very
encouraged that Memantine appeared to prevent nerve cell injury and death in
an animal model of AIDS dementia."
Memantine is a compound belonging to a class of agents called NMDA
receptor antagonists which appear to have broad potential to protect nerve
cells from injury in many diseases and conditions (e.g., AIDS, diabetic
neuropathy, stroke and traumatic brain injury). NMDA receptor antagonists
prevent overactivation of the N-methyl-D-aspartate (NMDA) subtype of glutamate
receptor imbedded in the cell membranes of neurons in the central nervous
system. Overactivation of this glutamate receptor causes excessive amounts of
calcium to enter nerve cells, contributing to cell injury and death.
Memantine's mechanism of action appears to be unique from other NMDA receptor
antagonists under development. It appears to block the flow of excessive
calcium into nerve cells for a short period of time without impairment of
normal functioning and without the profound psychotic side effects associated
with a number of other NMDA antagonists.
NTII is a biopharmaceutical company focused on the development of
neuroscience-based drugs. The company is currently developing three product
candidates. Corticotropin-Releasing Factor (CRF) is a human peptide which the
company believes has broad anti-inflammatory activity. CRF is being developed
for 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.
Except for the historical information contained herein, the matters
discussed in this press release are forward looking statements that involve
risks and uncertainties, as detailed from time to time in the company's
Securities and Exchange Commission filings. These forward looking statements
include, but are not limited to, uncertainties generally present in early
stage clinical trials such as the ability to properly and timely design,
implement, and complete planned trials, and demonstrate safety and efficacy of
drug candidates. 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.
For further information about ACTG 301 and other AIDS clinical trials call
800-TRIALS A, Monday through Friday, 9 a.m. to 7 p.m., EDT.
CONTACT: Shawn K. Johnson, Director of Finance of Neurobiological
Technologies Inc., 510-215-8000 |
