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Biotech / Medical : EntreMed (ENMD) -- Ignore unavailable to you. Want to Upgrade?

To: Don Dorsey who wrote (1969)	8/5/1999 3:07:00 PM
From: Don Dorsey	Respond to of 2135

Celgene and National Cancer Institute to Collaborate on Colorectal Cancer Trial Using THALOMID(R) THALOMID(R) to be Tested as Adjuvant Agent Following Surgery for Colorectal Cancer WARREN, N.J., Aug. 5 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG) today announced the initiation of a randomized, placebo controlled, phase II trial by the intramural Division of Clinical Sciences at the National Cancer Institute (NCI) to administer THALOMID(R) (thalidomide) or placebo to 94 patients following surgical resection of metastases from colon and rectal carcinoma. The THALOMID study group will be treated for 24 months to determine if thalidomide improves disease-free survival rates. Colorectal cancer is the second leading cause of cancer death in the U.S. The recurrence rate following surgical removal of colorectal metastases can run as high as 70-95 percent, according to Steven K. Libutti, M.D., principal investigator for the NCI study, which will take place at the Warren G. Magnuson Clinical Center at the National Institutes of Health. Dr. Libutti says this study is intended to evaluate whether THALOMID can inhibit recurrences of colorectal metastases following surgery. The study is being conducted under an investigator IND with THALOMID provided by Celgene. Patients interested in participating in this trial are urged to call the National Institutes of Health toll free at 888-NCI-1937. There are approximately 130,000 new cases of colorectal cancer diagnosed each year in the United States with nearly 57,000 deaths expected during 1999, according to the American Cancer Society. The five-year, relative survival rate for patients with colorectal cancer that is identified and treated in an early stage, before spreading, is 91 percent. Once the cancer has spread to neighboring lymph nodes, the five-year survival rate drops to 66 percent, with that rate falling to nine percent once the cancer has reached other parts of the body such as the liver and lungs. A primary objective of this trial is to determine the time to recurrence for patients receiving surgical resection plus THALOMID treatment for metastatic colorectal disease, compared to patients receiving resection plus placebo. The study is also intended to measure the antiangiogenic activity in the patients receiving THALOMID. "Antiangiogenic agents are thought to inhibit the growth of blood vessels to tumors and starve them," said Jerome B. Zeldis, M.D., Ph.D., vice president of medical affairs for Celgene Corporation. "We are excited to have initiated this clinical trial of THALOMID as adjuvant therapy in colorectal cancer patients who have few options available today." Celgene Corporation is providing the THALOMID (thalidomide) being used in this study under an agreement with the Division of Clinical Sciences at the NCI. The company received U.S. Food and Drug Administration (FDA) clearance to market and sell THALOMID (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 (thalidomide). Celgene Corporation, headquartered in Warren, N.J., is an independent, biopharmaceutical company engaged in the discovery, development and commercialization of small molecule drugs for cancer and immunological diseases.