xcytrin on fast track status for brain mets

[LindaMRG]

I was sent this info from another lung cancer listserv that I belong to:

Pharmacyclics Receives FDA Fast Track Status for Xcytrin

Sunnyvale, CA

December 2, 2003

Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that the company has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for its investigational drug Xcytrin® (motexafin gadolinium) Injection for the treatment of brain metastases (cancer that has spread to the brain from another part of the body) in patients suffering from non-small-cell lung cancer (NSCLC).

The FDA designated Xcytrin as a fast track product based upon the results of previous clinical trials with Xcytrin Injection in combination with whole brain radiation therapy (WBRT) that suggested clinical benefit for lung cancer patients with brain metastases and its potential for the treatment of brain metastases in NSCLC patients, a serious and life threatening condition. In addition, it was designated based upon the company conducting its ongoing SMART (Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy) clinical trial. The SMART trial is a randomized controlled pivotal Phase 3 study to compare the effects of WBRT alone to WBRT plus Xcytrin in lung cancer patients with brain metastases.

“We are pleased to receive FDA fast track designation for Xcytrin,” said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics. “Of cancer related complications, none is more devastating than the development of brain metastases, which occurs early and frequently in lung cancer patients, the target patient population of our pivotal Phase 3 SMART trial.”

Fast track designation means that the FDA will facilitate and expedite the development and review of the application for the approval of a new drug, if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need.

The Pivotal SMART Trial

The SMART trial is a randomized controlled study that will enroll 550 patients at leading medical centers in the United States, Canada, Europe and Australia. It is designed to compare the effects of WBRT alone to WBRT plus Xcytrin for the treatment of patients with brain metastases from lung cancer. Through the Special Protocol Assessment (SPA) process, the U.S. Food and Drug Administration has agreed to the approvability of the trial’s primary endpoint which is time to neurologic progression as determined by a blinded events review committee. Survival and neurocognitive function will also be assessed as secondary endpoints of the trial.

About Xcytrin

Xcytrin is the first of an investigational class of drugs called texaphyrins, which are rationally designed small molecules that have a unique way of working inside diseased cells. Xcytrin targets tumors in a new way. After administration, Xcytrin selectively localizes and accumulates inside cancer cells where it disrupts cellular metabolism, interferes with the flow of energy, and ultimately causes programmed cell death, or apoptosis, leading to the selective destruction of the cancer cells.

Preclinical studies have shown that Xcytrin enhances the efficacy of radiation therapy and that of several commonly used chemotherapy agents. Currently, Xcytrin is being investigated as a potential therapeutic in combination with radiation therapy and/or chemotherapy and as a single agent for various types of cancers in several clinical trials sponsored by Pharmacyclics and/or the National Cancer Institute.

About Pharmacyclics

Pharmacyclics is a pharmaceutical company developing products to improve upon current therapeutic approaches to cancer and atherosclerosis. The company’s products are rationally designed, ring-shaped small molecules called texaphyrins that selectively target and disrupt the bioenergetic processes of diseased cells, such as cancer and atherosclerotic plaque. More information about the company, its technology, and products can be found on its web site at www.pcyc.com.

NOTE: The statements made in this press release about progress and reports of clinical trial results including the potential for Xcytrin to enhance the therapeutic effect of radiation and chemotherapy drug regimens, clinical development plans, and product development activities other than statements of historical fact, are forward-looking statements. The forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements, including risks associated with the initiation, timing, design, enrollment, and cost of clinical trials; the progress of research and development programs; the regulatory approval process in the United States and other countries; and future capital requirements. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. For further information about risks that may affect the actual results achieved by Pharmacyclics, please see the company's reports as filed with the U.S. Securities and Exchange Commission from time to time, including but not limited to, its reports on Forms 10-Q and 10-K. Pharmacyclics®, the “pentadentate” logo® and Xcytrin® are registered trademarks of Pharmacyclics, Inc.