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Pharmacyclics Initiates Phase 1 Clinical Trial of Xcytrin Plus Temodar for the Treatment of Refractory Brain Tumors


Posted on: 01/29/2004

Pharmacyclics Initiates Phase 1 Clinical Trial of Xcytrin Plus Temodar for the Treatment of Refractory Brain Tumors

Press Release Source: Pharmacyclics, Inc.
Wednesday January 28, 7:30 am ET
SUNNYVALE, Calif., Jan. 28 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC - News) today announced the initiation of a Phase 1 clinical trial evaluating the safety and efficacy of its investigational drug Xcytrin® (motexafin gadolinium) in combination with Temodar® (temozolamide) for the treatment of patients with relapsed malignant gliomas, the most common type of brain tumor. Temodar is currently approved for the treatment of relapsed malignant gliomas.

"We continue to expand our clinical development programs for Xcytrin," said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics. "This clinical trial builds on our experience with Xcytrin in other trials conducted in patients with central nervous system tumors. Temodar is the current standard of therapy for recurrent gliomas. Patients with these tumors have a very poor prognosis, especially after a relapse, and improved treatments are needed."

The Phase 1 clinical trial will evaluate Temodar plus Xcytrin as a combination therapy for the treatment of recurrent brain tumors including anaplastic astrocytoma and glioblastoma multiforme, two of the most aggressive forms of brain cancer. The study will enroll 25 patients with refractory tumors who have failed other treatment options including chemotherapy and radiation therapy. Temodar, an oral medication, and Xcytrin, which is administered intravenously, will be administered in combination for five days each month for up to one year.

The endpoints of the study are safety and tumor response, which will be evaluated by magnetic resonance imaging (MRI). The trial will employ the standard dose of Temodar with increasing doses of Xcytrin to be used in successive patient cohorts. Active enrollment has already been initiated at the Barrow Neurological Institute of St Joseph's Hospital and Medical Center, an internationally renowned medical center based in Phoenix, Arizona that offers care for people with brain and spine diseases, disorders and injuries, under the supervision of principal investigator, William R. Shapiro, M.D.

About Gliomas

Malignant gliomas are the most common type of brain cancer, representing about half of all primary brain tumors. There are several types of gliomas, of which the most common are astrocytomas. Each year approximately 20,000 people are diagnosed with gliomas of which more than half die within 18 months. Current methods of treatment include neurosurgery, chemotherapy, radiation and steroids.

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. Possessing a novel mechanism of action, Xcytrin is a tumor-targeted generator of intracellular molecules known as reactive oxygen species (ROS).

After administration, Xcytrin selectively localizes and accumulates inside cancer cells, due to their high rates of metabolism, including anaerobic glycolysis. Because Xcytrin is a paramagnetic compound, its presence is visible with MRI. Studies with MRI have confirmed the selective localization of Xcytrin in primary and metastatic tumors.

Within cancer cells, Xcytrin disrupts cellular metabolism, interferes with the flow of energy, and results in the generation of ROS. This mechanism of action of Xcytrin is believed to make cancer cells more vulnerable to the oxidative stress (i.e., specific types of damage involving oxidation-reduction reactions) caused by radiation therapy and chemotherapy. The generation of ROS within cancer cells promotes a process called 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, monoclonal antibody therapy, 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 results from preclinical studies, clinical trial results, 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; whether Xcytrin will be shown to be safe or effective in combination with Temodar in treating patients with relapsed malignant gliomas in Phase 1 or later stage clinical trials; the progress of research and development programs in this indication; 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. -------------------------------------------------------------------------------- Source: Pharmacyclics, Inc.


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