[renal cell carcinoma/Wyeth/protein kinase inhibitor]
Wednesday March 6, 10:00 am Eastern Time
Press Release
SOURCE: Wyeth-Ayerst Laboratories
FDA Designates Wyeth-Ayerst's Investigational Treatment for Renal Cell Carcinoma for Fast-Track Development
MADISON, N.J., March 6 /PRNewswire-FirstCall/ -- Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation (NYSE: AHP - news), announced today that its investigational anticancer therapy, CCI-779, has been designated for the ``fast-track'' development program by the U.S. Food and Drug Administration (FDA) for the treatment of renal cell carcinoma after failure of initial therapy.
The FDA's fast-track program is designed to facilitate development and expedite review of new drugs or biologicals that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. However, fast-track designation does not guarantee approval or expedited approval of any application for the product.
CCI-779 is an mTOR (mammalian target of rapamycin) inhibitor. Its mechanism of action blocks the replication of certain cell types by targeting mTOR, a protein kinase central to cell growth. CCI-779 is currently in development for use in a variety of tumor types.
Interleukin-2 (IL-2) is the only FDA-approved therapy used to treat renal cell carcinoma in the United States. CCI-779 received fast-track designation recognizing that patients with renal cell carcinoma who fail IL-2 therapy have a median survival of approximately six months.
Renal cell carcinoma is the most common type of kidney cancer, affecting about three of 10,000 people. There are about 31,000 new cases in the United States each year, with about 12,000 deaths per year from the disorder in the United States.
``The fast-track designation from the FDA for CCI-779 is an excellent step towards a potential new treatment for patients with advanced renal cell carcinoma,'' says L. Patrick Gage, President, Wyeth-Ayerst Research. ``This compound provides a glimpse of the strength and innovation in our Wyeth Oncology pipeline, which holds the potential for exciting new treatments for a variety of cancers.''
Wyeth Oncology is dedicated to the advancement of cancer treatment with its targeted therapies and supportive care products. The oncology pipeline includes product candidates in the areas of kinase inhibition, antibody-targeted chemotherapy, and microtubule inhibition. The Wyeth Oncology pipeline also includes product candidates in development through collaborations with partner companies on the forefront of discovery research and development.
Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular disease therapies, central nervous system drugs, anti-inflammatory agents, hemophilia, oncology, and vaccines.
American Home Products is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, agricultural products, and animal health care.
SOURCE: Wyeth-Ayerst Laboratories |
