We know where this is going, and with the news out today it looks like it will get there faster(The hope it must be giving the people in the studies). Whether the stock price will respond upward faster is beyond me.
Matrix Initiates Phase II Trial of New Anticancer Agent in Colorectal Cancer; Phase II Trial in Non Small Cell Lung Cancer Ahead of Schedule
FREMONT, Calif.--(BW HealthWire)--May 26, 1999--Matrix Pharmaceutical Inc. (Nasdaq/NMS:MATX) Tuesday announced that it has expanded the Phase II clinical trial program for its anticancer agent FMdC by initiating a Phase II study in advanced or recurrent cancer of the colon or rectum.
The study will assess the efficacy and safety of FMdC in this patient population as well as the impact on quality of life and disease symptom relief. It will be conducted at several medical centers in the United States and will enroll up to 30 patients.
Donald Brooks, M.D., a medical oncologist with Arizona Oncology Associates (Tucson), who treated the first patient, said, "Prior clinical and preclinical studies suggest that FMdC may be a useful agent for colorectal and other solid tumors. The novelty of FMdC is that it inhibits cell division through multiple pathways and is resistant to an enzyme that breaks down other compounds of its class." Dr. Brooks is also affiliated with the Arizona Cancer Research Center.
"Physician interest in FMdC has been high due to the novelty of the compound and the clear need for better therapies for lung cancer and colorectal cancer," said Richard D. Leavitt, M.D., senior vice president of Matrix.
Since February 1999, FMdC has also been studied in a Phase II trial in patients with non-small cell lung cancer. This trial of up to 30 patients is now expected to be completed this year due to faster than anticipated enrollment.
The trial in colorectal cancer is open to qualified patients with Stage III or IV disease. Patients may have received one prior course of chemotherapy as well as previous surgery or radiation. Patients will receive an intravenous infusion of FMdC once every 15 days during a two month period. Patients who respond after two months of treatment will continue treatment for at least two more months.
Study endpoints include objective tumor responses, duration of response, time to progressive disease, survival and safety.
FMdC is a new chemical entity in a class of compounds known as nucleoside analogs that interfere with cell division. FMdC is believed to inhibit DNA synthesis directly by incorporation into DNA strands and indirectly by blocking the action of an enzyme, ribonucleotide reductase, that is important to the formation of nucleotides, the building blocks of DNA.
FMdC has been effective in reversing tumor growth in laboratory animals and has been active and generally well tolerated in four Phase I human trials that included 70 patients.
Cancer of the colon or rectum is one of the most common and difficult-to-treat cancers. According to The American Cancer Society, each year 131,000 Americans are diagnosed with colorectal cancer and 56,500 die from the disease.
In Western Europe, the International Agency for Research on Cancer, an agency of the World Health Organization, estimates there are more than 188,000 new cases of colorectal cancer per year and more than 100,000 deaths per year from the disease.
Early stage cancers of the colon and rectum are often treated with surgery or radiation. Single agent chemotherapy and combination chemotherapy have shown variable results in the treatment of advanced and recurrent colorectal cancer. Chemotherapy is often also used as an adjunct to early surgery and radiation.
Located in Fremont, Matrix Pharmaceutical is developing novel local and systemic treatments for cancer. In addition to FMdC, IntraDose (TM) (cisplatin/epinephrine) Injectable Gel, the company's lead cancer product, is in pivotal Phase III clinical studies for the treatment of head and neck cancer.
IntraDose is also being evaluated in Phase II studies in primary and metastatic liver cancer. Radiopotentiator MPI 5020, a locally injected gel designed to enhance the cytotoxic effects of radiation therapy, is in a Phase I/II trial in recurrent and metastatic breast cancer.
This news release contains, in addition to historical statements, certain forward-looking statements relating to the company's clinical development plans for FMdC. Such statements are based on management's current expectations and are subject to a number of factors and uncertainties, including the risk that FMdC may not be effective in the indicated trials. Additional factors and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended December 31, 1998.
Matrix news releases are available on the Matrix Web site at www.matx.com.
CONTACT:
Matrix Pharmaceutical Inc.
Peter Dworkin, 510/494-7750 |
