Celgene and National Cancer Institute to Collaborate on Head
and Neck Cancer Trial THALOMID(TM) to be tested in Head and Neck Cancer at M. D.
Anderson Cancer Center
WARREN, N.J., March 30 /PRNewswire/ via NewsEdge Corporation -- Celgene Corporation (Nasdaq: CELG) today announced the initiation of a Phase II pilot trial by the National Cancer Institute (NCI) to administer THALOMID(TM) (thalidomide) to patients with recurrent and metastatic squamous cell carcinoma of the head and neck.
The trial is sponsored by the NCI's Cancer Therapy Evaluation Program (CTEP), and will be conducted at The University of Texas M. D. Anderson Cancer Center, in Houston, TX, under a Clinical Trials Agreement (CTA) between the NCI and Celgene. Researchers will collect primary data on evidence of disease stabilization and/or response in approximately 35 patients.
According to Jerome B. Zeldis, M.D., Ph.D., Vice President of Medical Affairs for Celgene Corporation, "This trial will provide an important initial indication as to the potential effectiveness of thalidomide's antiangiogenesis properties in treating these extremely vascular head and neck cancers."
According to the American Cancer Society, head and neck cancer refers to a variety of malignant tumors that may occur in this region of the body, particularly the throat, sinuses and nasal cavity, the larynx, thyroid and salivary glands, as well as cancerous lesions of skin on the face, neck and cervical lymph nodes. There are approximately 40,000 new cases of head and neck cancer diagnosed each year.
Celgene Corporation is providing the THALOMID(TM) (thalidomide) to be used in the studies sponsored by the NCI under the CTA. The company received U.S. Food and Drug Administration (FDA) clearance to market and sell THALOMID(TM) (thalidomide) for the treatment of erythema nodosum leprosum (ENL) in leprosy, on July 16, 1998. The drug has been commercially available since October 1, 1998. In December 1998, Celgene licensed from EntreMed, Inc. (Nasdaq: ENMD) the rights to thalidomide as an antiangiogenic agent.
Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by a pregnant woman can cause severe birth defects or death to an unborn baby. The major adverse drug reactions known to be associated with thalidomide treatment include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with THALOMID(TM) (thalidomide). Celgene Corporation, headquartered in Warren, N.J., is engaged in the development of pharmaceuticals and agrochemicals.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
/CONTACT: Sol Barer, Ph.D., President & COO of Celgene Corporation, 732-271-4153; or Media - Dina Van Pelt of Makovsky & Co., 212-508-9676, or Investors - Susan A. Noonan of Noonan-Russo Comm., 212-696-4455, ext. 203, both for Celgene Corporation/ (CELG ENMD)