Scott & White,  A World of Healing
Scott & White News Release

March 2, 2006
FOR IMMEDIATE RELEASE

Cancer Research Institute starts first Phase I clinical trial
- New drug targets prostate cancer cells -

For information on how to participate in the trial:

Nancy Bowman, R.N.
Clinical Research Coordinator
1-800-882-4366
254-724-0040
254-762-0076 (Pager)
nbowman@swmail.sw.org

View Trial Criteria

Updates:

Protox Information Video (KCEN-TV)
Protox Successfully Doses First Patient in Prostate Cancer Trial Using PRX302

TEMPLE, Texas – Scott & White has been named as the site for the first Phase I clinical trial of a novel investigational cancer drug aimed at recurrent prostate cancer. Protox Therapeutics, Inc., a Canadian company, developed the drug in Temple and has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with testing. It will be the first clinical trial to be conducted at the new Cancer Research Institute at Scott & White.

“This is a very important, and exciting, next step in the growth of the Cancer Research Institute here at Scott & White, and the development of this new class of drug therapy for cancer,” said Dr. Art Frankel, physician/scientist and director of the institute. “As we begin this Phase I clinical trial, we will be taking a giant step towards establishing Scott & White as a destination for medical research and development.”

According to Protox, this trial will study the drug PRX302, which is the first of a class of drugs, referred to as targeted prodrugs, based on engineered protein toxins. The PORxin™ drug is an inactive pro-drug that is injected into the prostate where it turns into a potent cell killing toxin when it comes in contact with (prostate specific antigen) PSA-producing cells.

The study is expected to enroll approximately 36 subjects who have been diagnosed with locally recurrent prostate cancer. Protox has announced that the trial will be conducted in at least one other site in the U.S., in addition to Scott & White.

The Cancer Research Institute at Scott & White was established as a way to bring new cancer-fighting therapeutics from molecular design to patients’ bedsides in shorter periods of time than has been the case in traditional development processes.

According to the American Cancer Society data, prostate cancer strikes over 230,000 men in the U.S. each year, resulting in approximately 30,000 deaths.

In a Phase I clinical trial, a novel drug is tested in a small group of people for the first time. Researchers use the trial to evaluate the drug’s safety, determine what is the range of safe dosage, and to identify side effects. When approved by regulators, additional clinical trials may be conducted on larger sized groups for further evaluation and to gather more information, to help determine safe use of the drug, and if it will eventually be approved for general use.

About Dr. Frankel:
Arthur E. Frankel, M. D.
Scott & White Division Director of Hematology/Oncology

Dr. Frankel joined Scott & White after spending the past seven years as Professor of Medicine and Cancer Biology at the Wake Forest University School of Medicine (1998-2005). Dr. Frankel began his medical education at Harvard (1965-1973) and also worked as an intern at Yale University (1973-1974). He was a research scientist with the National Institutes of Health (1974-1978) and performed two residencies at Stanford University (1978-1982).

Dr. Frankel is board certified in Internal Medicine, Medical Oncology and Hematology.

For more information about this release, contact:
Scott Clark
sdclark@swmail.sw.org
Media and Public Relations
254-724-9724 or 254-724-3047


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