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Pharmacyclics Announces Six Xcytrin Abstracts to Be Presented at ASCO Annual Meeting Next Week


Posted on: 05/16/2002

Thursday May 16, 7:30 am Eastern Time
Press Release
SOURCE: Pharmacyclics, Inc.

Pharmacyclics Announces Six Xcytrin Abstracts to Be Presented at ASCO Annual Meeting Next Week Company Will Hold Clinical and Corporate Update Conference Call on June 5

SUNNYVALE, Calif., May 16 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC - News) announced today that six abstracts related to its lead investigational product candidate, Xcytrin® (motexafin gadolinium) Injection, are being presented next week at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO) at the Orange County Convention Center in Orlando, Fla., May 18 - 21. The Company also announced that it will hold a clinical and corporate update conference call on Wed., June 5, 2002 (specific details to follow later).

Among the highlights at ASCO is an oral presentation on Sun., May 19, that will review results of a Phase III clinical trial of Xcytrin for the potential treatment of brain metastases. This updated analysis of the data indicate that there was significant improvement in time to neurologic progression overall in patients receiving Xcytrin in the 401-patient intent-to-treat population evaluated by clinical investigator assessment, the most commonly used method to measure neurologic function. These findings were most apparent in lung cancer patients where improvement in time to neurologic progression was found using both investigator assessment as well as that of an independent Events Review Committee. These findings form the basis of a pivotal Phase III trial that will begin later this year to evaluate Xcytrin's safety and efficacy in patients with lung cancer whose cancer has metastasized (i.e., spread) to the brain.

In addition, a poster presentation on Tues., May 21, highlights the potential of Xcytrin for use in combination with a number of chemotherapy drugs based on tumor responses in a common lung cancer animal model.

"We are pleased with our presence at ASCO this year, and the range of presentations covering use of Xcytrin with radiation therapy and chemotherapy," said Richard A. Miller, M.D., Pharmacyclics' president and chief executive officer. "We expect our activities to increase next year as many of the ongoing studies with Xcytrin in other tumor types are advancing in the second half of this year and early next year. We also look forward to updating investors on a regular basis regarding our progress with our multiple pre-clinical and clinical development programs for Xcytrin and Antrin."

The six abstracts, which are available upon request or in the ASCO abstract program book, are:

1. Abstract #286: Results from the Phase III Trial of Motexafin Gadolinium (MGd) in Brain Metastases (Oral Presentation by Dr. Minesh Mehta, University of Wisconsin-Madison Medical School, Sun., May 19 at 2:45 - 5:45 p.m. EDT, Room 414C);

2. Abstract #292: Impaired Neurocognitive Function (NCF) in Brain Metastasis (BM) Patients (Pts) is Strongly Correlated with MRI Tumor Volume and Tumor Histology: Baseline Results from the Phase III Trial of Motexafin Gadolinium (MGd) (Poster Display by Dr. Patrick Rodrigus, Bernard Verbeeten Instituut, Tilburg, Netherlands, Tues., May 21, 8:00 a.m. - 12:00 p.m. EDT, Room 308A and Discussion by Dr. Christina Meyers, University of Texas MD Anderson Cancer Center, Tues., May 21, 11:00 a.m. EDT, Room 311A);

3. Abstract #290: Quality of Life (QOL) in Patients (Pts) with Brain Metastases (BM) is Strongly Related to MRI Tumor Volume and Neurocognitive Function (NCF): Baseline Results from the Phase III Trial of Motexafin Gadolinium (MGd) (Poster Display by Dr. C. Terhaard, Academic Medical Center, Utrecht, Netherlands, Tues., May 21, 8:00 a.m. - 12:00 p.m. EDT, Room 311A and Discussion by Dr. Christina Meyers, University of Texas MD Anderson Cancer Center, Tues., May 21, 11:00 a.m. EDT, Room 311A);

4. Abstract #466: Motexafin Gadolinium (MGd) Increases Tumor Response to Chemotherapy in Lewis Lung Cancer (LLC) Animal Model (Poster Presentation by Dr. Richard A. Miller of Pharmacyclics, Tues., May 21, 8:00 - 11:00 a.m. EDT, Level 2, Hall C);

5. Abstract #474: An Evaluation of Gender, Alkaline Phosphatase, and Cytochrome P450 on Motexafin Gadolinium Pharmacokinetics in Patients with Brain Tumors Using a Population Pharmacokinetic Analysis (Poster Presentation by Dr. Dale Miles of Pharmacyclics, Tues., May 21, 8:00 - 11:00 a.m. EDT, Level 2, Hall C);

6. Abstract #1768: The Redox Cycling Agent Motexafin Gadolinium (MGd) Inhibits Potentially Lethal Damage Repair (PLDR) in Cancer Cells Following Exposure to Ionizing Radiation (Poster presentation by Dr. Darren Magda of Pharmacyclics, on Tues., May 21, 12:00 - 3:00 p.m. EDT, Level 2, Hall C).

About Xcytrin

Xcytrin, the first of a new class of drugs called texaphyrins, selectively accumulates in cancer cells and disrupts cellular metabolism by a unique mechanism of action. By interfering with the flow of energy in cancer cells, Xcytrin makes the tumor potentially more responsive to the effects of radiation and chemotherapy without increasing damage to normal tissue.

About Brain Metastases

Brain metastases is one of the most common conditions treated with radiation therapy. There are about 140,000 to 170,000 cases per year and the incidence is increasing. The most common cause of brain metastases is lung cancer, affecting up to 90,000 patients. Brain metastases occur when cancer cells spread to the brain and grow, causing major neurologic complications and, in most cases, death.

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. Most patients with brain metastases have multiple lesions and are not candidates for surgical resection or radiosurgery. The goal of whole brain radiation therapy is to reverse or prevent neurological deterioration and prevent death due to tumor progression in the brain.

Pharmacyclics is a pharmaceutical company developing products to improve upon current therapeutic approaches to cancer, atherosclerosis and retinal disease. The company's products are rationally designed, ring-shaped small molecules called texaphyrins that disrupt the bioenergetic processes of diseased cells, such as cancer and atherosclerotic plaque. When activated by various forms of energy, including X-ray and light, these texaphyrins can help to reduce or eliminate the diseased tissue. 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 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, and results of clinical trials, the progress of research and development programs, the regulatory approval process in the U.S. and other countries, and future capital requirements. 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 Form 10-Q and 10-K. Pharmacyclics®, Xcytrin®, Antrin® and the "pentadentate" logo are registered trademarks of Pharmacyclics, Inc.

SOURCE: Pharmacyclics, Inc.
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