More MS news articles for Dec 2001

IVAX' Talampanel Protective for Brain Trauma

Mon, Dec 10 12:15 PM EST

MIAMI (BUSINESS WIRE) - IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that researchers at the University of Miami found IVAX' talampanel neuroprotective after traumatic brain injury (TBI). As published in the November 10, 2001 issue of the Journal of Neurotrauma, in pre-clinical animal studies the total contusion area was reduced by approximately 70% when talampanel was administered 30 minutes after injury as compared to a placebo treatment.

"Each year in the United States, nearly two million people suffer from head injuries of sufficient severity to result in brain trauma. As a result, there is a substantial need for effective neuroprotective or neuroregenerative therapeutic intervention and, based on these early results, we expect to move ahead with the next phase of clinical testing as soon as practical," said Phillip Frost, M.D., chairman and CEO of IVAX Corporation.

This study demonstrated for the first time that treatment with talampanel is beneficial in reducing injured areas and helps to preserve nerve cells of the brain after experimental TBI. Treatment with talampanel, given 30 minutes after trauma, significantly reduced the area of brain damage compared to vehicle-treated rats.

Separately, IVAX is conducting other clinical studies of talampanel to treat epilepsy, multiple sclerosis and Parkinson's disease. During the fourth quarter of this year, IVAX has commenced a Phase II clinical study of talampanel for the treatment of epilepsy at 22 centers in the U.S. and three centers in Europe. This study of approximately 250 epilepsy patients with refractory partial seizures is expected to take about one year to complete. Epilepsy affects 7 million patients in the U.S. and about 50 million worldwide. The market for epilepsy drugs is growing and is predicted to exceed $5 billion in 2002. Despite the large number of medicines currently available for this condition, fewer than 40% of all epileptics are seizure-free.

This press release contains certain forward-looking statements regarding product development efforts and product performance and other non-historical facts, which are being are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that cannot be predicted or quantified and, consequentially, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, that clinical trials for talampanel may not be commenced, may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of this product for the indications being studied or other indications. In addition to the risk factors set forth above, IVAX' forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, trade buying patterns, patent positions and litigation, among other things. For further details and discussion of these and other risks and uncertainties, see IVAX' Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.

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