NTI Initiates Phase IIb Memantine Trial for Diabetic Neuropathy
Neurobiological Technologies, Inc. Initiates Phase IIB Trial of Memantine For Diabetic Peripheral Neuropathy
Potential Oral Analgesic for Diabetics With Pain and Sleep Disturbances
RICHMOND, Calif., Nov. 2 /PRNewswire/ -- Neurobiological Technologies, Inc. (OTC Bulletin Board: NTII) today announced the initiation of a Phase IIB human clinical trial to evaluate Memantine as a treatment for painful peripheral diabetic neuropathy. The trial will evaluate the ability of Memantine to relieve chronic pain due to peripheral neuropathy or nerve damage, particularly nocturnal pain that frequently interferes with sleep. Quintiles CNS Therapeutics, a leading contract research organization with experience in neurology, will jointly manage the trial with NTI.
This randomized, double-blind, placebo-controlled dose-ranging trial is expected to enroll 375 patients at 22 sites nationwide. subjects will receive daily oral doses of Memantine or placebo for 8 weeks. Memantine subjects will initially receive a 10 mg daily dose, escalating by 10 mg at weekly intervals to either 20 mg or 40 mg.
This and other human clinical trials of Memantine will be discussed after the company's Annual Meeting of Stockholders which will be held at 10 a.m. on Thursday, November 12 at the St. Francis Yacht Club in San Francisco. Memantine is currently being tested in a Phase II trial for the treatment of AIDS dementia syndrome, and a guest speaker will highlight this unmet medical need.
"It is exciting to participate in this important clinical trial of Memantine, an oral drug with potential analgesic activity," said Dr. Louis C. Kirby, M.D. of Medici Research, Inc., lead investigator in the trial. "Many diabetic patients with painful neuropathy do not obtain pain relief from existing treatments, such as opioids, anti-depressants and anti-convulsants. Nighttime pain is associated with sleep disturbances that can greatly affect patient quality of life."
"We have worked carefully with the Food & Drug Administration and with leaders in the field to develop this trial design," said Dr. Lisa U. Carr, director of medical affairs of Neurobiological Technologies, Inc. "It is a natural progression from the design of our completed Phase IIA clinical trial of Memantine. In that trial, we observed trends toward efficacy, particularly in the reduction of nocturnal pain."
"Thanks to our collaborative relationships, the clinical development of Memantine has entered an important new phase," said Paul E. Freiman, president and chief executive officer of NTI. "This Phase IIB trial in diabetic patients was partially funded through payments previously received from our strategic partner, Merz + Co. GmbH & Co. of Frankfurt, Germany. Merz is currently conducting Phase III human clinical trials of Memantine for senile dementia and Alzheimer's disease. Finally, in association with NTI, the AIDS Clinical Trials Group of the National Institutes of Health is conducting a Phase II trial of Memantine for the treatment of AIDS dementia syndrome, which is coming close to final patient enrollment."
"Quintiles is pleased to participate in the clinical evaluation of
Memantine in the United States," said Kevin Keim, Ph.D., president, Quintiles CNS Therapeutics, Global. "The testing of novel treatments for chronic neurological conditions requires special expertise, and we have many years experience with pivotal trials in this therapeutic area."
Painful peripheral neuropathy, or pain related to damage to the peripheral nerves, is one of the most common complications of diabetes. Diabetic patients frequently experience chronic pain in the lower legs and feet, making walking or standing difficult. As neuropathy progresses, the pain may become more intense and encompass more areas. Although many medications are currently used to manage this type of pain, patient response is highly variable. The company estimates that approximately 800,000 patients in the U.S. currently receive treatment for the symptoms of diabetic peripheral neuropathy.
Memantine is an orally-available compound that appears to restore the function of impaired neurons by modulation activity of the NMDA receptor, integral to the membranes of such cells. Such restoration of function may inhibit injured or damaged neurons from firing abnormally, a pathological process associated with many neurological conditions, including dementia, Alzheimer's disease, neuropathy and AIDS dementia. Memantine has a history of safe clinical use in Germany, where it has been marketed since 1989 with the labeling "dementia syndrome."
NTI is an emerging drug development company focused on the clinical evaluation and regulatory approval of neuroscience drugs. The company's strategy is to in-license early-stage drug candidates; oversee human clinical trials to evaluate preliminary evidence of efficacy; and seek partnerships with pharmaceutical and biotechnology companies for late-stage development and marketing. In addition to developing Memantine, NTI is developing XERECEPT(TM), an anti-edema agent, for peritumoral brain edema (swelling of the brain caused by a tumor). XERECEPT has been granted orphan drug designation by the FDA.
Quintiles CNS Therapeutics is a business unit of Quintiles Transnational Corp., the market leader in providing a full range of integrated product development and marketing services to the pharmaceutical, biotechnology and medical device industries. Quintiles is headquartered near Research Triangle Park, North Carolina.
Note: Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including NTI's ability to properly design, implement and complete planned trials, meet regulatory requirements, demonstrate safety and efficacy for its products, manage third-party contractors, and avoid infringement of third-party proprietary rights, as well as other risks detailed from time to time in the company's Securities and Exchange Commission
filings. Actual results may differ materially from those projected. These forward-looking statements represent the company's judgment as of the date of the release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
SOURCE Neurobiological Technologies, Inc.
Web Site: ntii.com
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