ORLANDO, FL, May 19, 1999 -- Researchers investigating the use of THALOMIDR (thalidomide) to treat Crohn's disease today announced preliminary findings from a pilot study at the annual Digestive Disease WeekR meeting in Orlando, FL.
Lead investigator, Eric A. Vasiliauskas, M.D., associate clinical director of the Inflammatory Bowel Disease Center at Cedar's Sinai, Los Angeles reported findings from a pilot study of 12 patients at the Center. All patients had chronic, steroid-dependent or unresponsive Crohn's disease, an inflammatory disease of the intestinal tract.
According to Dr. Vasiliauskas, while all study participants felt better on the drug, two-thirds of the patients treated with THALOMID experienced a "significant improvement in their condition," as measured by the Crohn's Disease Activity Index (CDAI). The most common side effects reported were drowsiness and transient peripheral neuropathy. Celgene (NASDAQ: CELG) Corporation's THALOMID (thalidomide) was recently awarded orphan drug designation by the U.S. Food and Drug Administration (FDA).
"Although this was a pilot study, we did observe improvements in CDAI in these patients with Crohn's disease, which had been refractory to standard therapies," says Dr. Vasiliauskas. "In addition, these scores were maintained in most patients, even after steroids were tapered. Decreased fistula drainage and fistula closure was also observed in some patients. The data suggest that a Phase III study using thalidomide to treat Crohn's disease, should be conducted."
Dr. Vasiliauskas reported on the pilot study findings of 12 patients treated during a 12-week study with low-dose (50-100 mg per day) THALOMID (thalidomide). The Cedar's Sinai investigative team for this study also included Stephen R. Targan, M.D., director of the Inflammatory Bowel Disease Center.
In addition to this pilot study, other groups of researchers, including European and American investigative teams, are conducting trials using thalidomide to treat Crohn's disease. These groups reported results that are consistent with the Cedars-Sinai, Celgene-supported study during this meeting. There are approximately 200,000 people in the United States who have Crohn's disease, and approximately 5,000-10,000 new cases are diagnosed annually. Researchers have observed that Crohn's disease tends to run in families, and that the disease is most common in North America, Europe and Scandanavia, with a greater incidence of the disease in urban and northern environments.
Celgene Corporation provided the THALOMID (thalidomide) used in the Cedar's-Sinai study. The company received U.S. Food and Drug Administration (FDA) clearance to market and sell THALOMID (thalidomide) for the treatment of the cutaneous manifestations of moderate to severe 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. Recently, THALOMIDR received orphan drug designation for multiple myeloma and Crohn's disease.
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 THALOMIDR (thalidomide). Celgene Corporation, headquartered in Warren, N.J., is engaged in the development of pharmaceuticals and agrochemicals.
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