PR Newswire, Wednesday, 18 December 1996.

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/ 08:01 EST

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