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Xcytrin

Generic name: motexafin gadolinium
Treatment for: Lung Cancer Brain Metastases

Pharmacyclics Receives Refuse to File Letter for Xcytrin

SUNNYVALE, Calif., February 21, 2007 -- Pharmacyclics, Inc. today announced that it has received a refuse to file letter from the U.S. Food and Drug Administration (FDA) for the company's new drug application (NDA) for Xcytrin (motexafin gadolinium) Injection for the treatment of non-small cell lung cancer patients with brain metastases.

In the letter, the FDA stated that the company's application is not sufficiently complete to permit a substantive review based on clinical studies that failed to demonstrate statistically significant differences between treatment arms in the primary endpoints.

"We will be evaluating our options with Xcytrin for the brain metastases indication and determine the best path forward," said Richard A. Miller, M.D., president and CEO of Pharmacyclics. "Beyond this indication, the clinical development program with Xcytrin continues on multiple fronts. Several ongoing trials are evaluating Xcytrin in non-small cell lung cancer and other cancers. We are also moving forward with several other novel compounds, which are in clinical and preclinical development."

About Lung Cancer and Brain Metastases

According to the National Cancer Institute, over 170,000 patients will be diagnosed with lung cancer this year in the U.S. Lung cancer is the most common cause of brain metastases, which are estimated to occur in up to 50% of lung cancer patients. Spread of lung cancer to the brain may occur early in the course of disease or may be a later complication of this illness.

Brain metastases occur when cancer cells spread to the brain and grow, causing major neurologic complications. Patients with brain metastases usually suffer serious deterioration of neurologic and neurocognitive function such as loss of short-term memory, compromised verbal skills and fine motor coordination, and reduction in cognitive performance. Standard therapy for patients with brain metastases from lung cancer involves the prompt use of cranial radiation, which is used to prevent neurological deterioration and improve neurologic outcomes.

About Xcytrin

Pharmacyclics is developing Xcytrin as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce apoptosis (programmed cell death). Xcytrin is a redox-active drug that has been shown to disrupt redox-dependent pathways in cells and inhibit oxidative stress related proteins. Its multifunctional mode of action provides the opportunity for Xcytrin to be used in a broad range of cancers.

Source: Pharmacyclics, Inc.

Posted: February 2007

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