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NTII Initiates Neuroprotection Research Program with Children's Hospital in Boston; Partners to Develop CNS Disease Therapies.


RICHMOND, Calif.--(BUSINESS WIRE)--May 6, 1996--Neurobiological Technologies, Inc. (Nasdaq:NTII NTII Neurobiological Technologies, Inc. ) today announced that the company has formed a research collaboration with Dr. Stuart A. Lipton, M.D., Ph.D. of The Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts.  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 Traumatic brain injury (TBI), traumatic injuries to the brain, also called intracranial injury, or simply head injury, occurs when a sudden trauma causes brain damage. TBI can result from a closed head injury or a penetrating head injury and is one of two subsets of acquired brain , and stroke as well as chronic conditions such as dementia, including AIDS dementia complex AIDS dementia complex
n.
The neurological disease complex that is sometimes experienced by AIDS patients, caused by neuron injury and death and characterized by cognitive impairment.
, 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, uncompetitve antagonists because they may not interfere with normal physiologic activities such as cognition and memory. They may also be ale 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 NMDA

N-methyl-D-asparate
) 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 neurotoxicity /neu·ro·tox·ic·i·ty/ (noor?o-tok-sis´it-e) the quality of exerting a destructive or poisonous effect upon nerve tissue.  in preclinical models. Animal studies have shown that Memantine reduces tissue death in the forebrain forebrain: see brain.  stroke model, retards NMDA-induced toxicity to cholingeric 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 spasticity /spas·tic·i·ty/ (spas-tis´i-te) the state of being spastic; see spastic (2).

spas·tic·i·ty
n.
1. A spastic state or condition.

2. Spastic paralysis.
 for many years in Germany This is a list of years in Germany. See also the timeline of German history. For only articles about years in Germany that have been written, see .
  • 1870s: 1870 - 1871 - 1872 - 1873 - 1874 - 1875 - 1876 - 1877 - 1878 - 1879
.

The company is collaborating with the AIDS Clinical Trials Group The AIDS Clinical Trials Group (ACTG) is the largest HIV clinical trials organization in the world, playing a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV and AIDS in the United States and the developed world.  of the National Institutes of Health to plan a randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  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 CRF
abbr.
chronic renal failure


CRF Chronic renal failure
), is a human peptide which the company believes has broad anti-inflammatory activity. CRF is currently being developed for the reduction of edema edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts.  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 analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs  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. EDT EDT
abbr.
Eastern Daylight Time


EDT Eastern Daylight Time

EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York

EDT 
. 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 neu·ro·bi·ol·o·gy  
n.
The biological study of the nervous system or any part of it.



neuro·bi
 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 p.m. EDT by calling 402/220-5193.

CONTACT: Neurobiological Technologies, Inc.

Michael Ostrach, 510/215-8000

or

Russell-Welsh, Inc.

Katharine Russell, 415/312-0700
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:May 6, 1996
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