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 tr
Contact: Sandra Van
Cedars-Sinai Medical Center