Crohn's pilot study - this may turn out to be another viable market:
Monday November 29, 8:39 am Eastern Time
Company Press Release
SOURCE: Celgene Corporation
Study Results Reported for Celgene's Thalomid(R) (Thalidomide) in the Treatment of Crohn's Disease
WARREN, N.J., Nov. 29 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news), -- Study results published today in the current edition of Gastroenterology, suggest that the drug THALOMID® (thalidomide) may be active in patients suffering from Crohn's disease. Seventy percent of the patients who completed at least five weeks of the twelve-week trial demonstrated a response when treated with thalidomide, with 20 percent of these patients experiencing remission.
Investigators at the Inflammatory Bowel Disease Center at Cedar's Sinai, Los Angeles, evaluated the safety, tolerance and efficacy of low-dose thalidomide (50-100 mg/day) in treating moderate-to-severe, steroid-dependant Crohn's disease, an inflammatory disease of the intestinal tract.
During the course of the pilot study, all patients completing 12 weeks of therapy (9) were able to reduce their steroid regimen by greater than or equal to 50 percent, with 44 percent of patients (4) discontinuing steroids entirely.
Patient responses were measured using the Crohn's Disease Activity Index (CDAI). The side effects reported were mild and mostly transient, including drowsiness, peripheral neuropathy, edema and dermatitis. Celgene Corporation's THALOMID® (thalidomide) was recently awarded orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of Crohn's disease. This designation affords seven years of marketing exclusivity following FDA approval of the indication.
''We are very encouraged by these findings and their publication,'' said Sol Barer, Ph.D., chief operating officer of Celgene Corporation. ''This represents another important milestone in our continuing effort to develop THALOMID as a treatment option for several serious and debilitating diseases.''
The December issue of Gastroenterology also reports similar results from a second study on thalidomide therapy for Crohn's disease, conducted by researchers at the University of Chicago, Pritzker School of Medicine and the University of Toronto.
There are approximately 200,000 people in the United States who have moderate to severe Crohn's disease, with approximately 5,000-10,000 new cases diagnosed annually. According to researchers, Crohn's disease tends to run in families, and is most common in North America, Europe and Scandanavia, with a greater incidence of the disease in urban and northern environments.
Very small numbers, and they don't say how many started the study. Here are some Remicade numbers by way of comparison (normal caveats apply, and then some, given the small numbers reported here):
Previous clinical trial results among patients with moderate-to-severeCrohn's disease that had failed to respond to standard treatment were publishedin the October 9, 1997 edition of The New England Journal of Medicine. These data showed that after a single infusion of 5 mg/kg of REMICADE, 82% of patientsachieved statistically significant improvement (p less than 0.001) in diseaseactivity (defined as a more than or equal to 70 point reduction from baseline inthe Crohn's disease activity index (CDAI) at 4 weeks) and 48% of patientsachieved disease remission (CDAI less than 150 at 4 weeks)(p less than 0.001).Following four additional infusions, given eight weeks apart, REMICADE maintained the initial treatment response and more REMICADE treated patients achieved remission.
Peter |
