Branch News

IVAX Corporation Initiates Phase II Clinical Trial of Oral Drug For Brain Cancer

IVAX Corporation (AMEX: IVX) has initiated a phase II trial of talampanel for the treatment of brain cancer. Dr. Howard Fine, chief of the Neuro-Oncology Branch at the National Cancer Institute, is the principal investigator of the study.

The most common forms of brain cancer, malignant gliomas, are lethal tumors for which current treatment options are limited. Malignant gliomas cause progressive and ultimately fatal damage by proliferating, by aggressively invading unaffected areas of the brain, and by causing damage to vital brain structures.

Malignant glioma cells secrete a neurotransmitter called “glutamate” and have, on their surface, receptors that bind glutamate. Pre-clinical studies have suggested that interfering with glutamate may control glioma cell proliferation and invasion, and may limit brain injury caused by glutamate excess. Talampanel blocks the effect of glutamate by blocking the AMPA subtype of glutamate receptors.

Talampanel is administered orally and has already undergone evaluation in normal volunteers and in patients with refractory seizure disorders and Parkinson’s disease. Talampanel has been well tolerated and does not have the bone marrow suppressing and other side effects of chemotherapy. The significant clinical anti-seizure activity of talampanel having been previously reported, expanded phase II studies of its use to treat refractory epilepsy and Parkinson’s disease are in progress.

Dr. Phillip Frost, Chairman and CEO of IVAX commented: “With this clinical trial, we seek to interfere with an important biological target with a potent, orally administered, well tolerated compound. Talampanel is another example of the variety of novel compounds under development by IVAX and, in particular, reflects our commitment to develop significant new treatments of cancer.”