To: scaram(o)uche who wrote (244 ) 1/31/1999 1:58:00 AM From: Miljenko Zuanic Read Replies (1) | Respond to of 804
For those who missed it: www.drugtopics.com << Cover article is on IBD (Crohns and Colitis)>> CELG thalidomide results are from small open label PII trial (12 pts, also my understanding is that large T PII Crohn's trial is ongoing), still results after only four weeks and low T dose (50 and 100 mg) show significant drug benefit and very promising results in future. Miljenko << Another type of new drug to treat CD is the selective cytokine-inhibiting drug (SelCID) CDC 801, now being developed by Celgene Corp. of Warren, N.J. The company anticipates that it will begin phase II clinical trials of CDC 801 at the Cedars-Sinai Medical Center in early 1999. Results of earlier CD trials inhibiting TNF yielded highly promising results, even in patients with severe disease. This experience afforded an excellent foundation for pursuing drugs such as CDC 801, said Targan, chief investigator of the study. Extensive preclinical trials determined that SelCIDs are selective, potent inhibitors of the overproduction of TNF. A powerful cytokine, TNF causes a destructive immune response implicated in the pathology of several prevalent inflammatory disorders, including CD. According to Jerry Zeldis, M.D., Ph.D., chief medical officer at Celgene Corp., two additional successor compounds to SelCID are about to enter phase I clinical trials. These agents are inflammation modulator imidazoles, or IMIDs. They have a more thalidomide-like mechanism of action but have proven nonteratogenic in animal models as compared with thalidomide. Celgene also has started a phase II pilot study of thalidomide, also a very potent inhibitor of TNF-a, for treatment of IBD. This trial is also led by Targan at Cedars-Sinai. "The results we have seen in the first nine patients of the 12-patient study, set for completion by the end of January, are very good. We use an open-label design of patients taking 50 mg or 100 mg of thalidomide at night," said Zeldis. Very ill CD patients can have a Crohn's disease activity affect of 250-400, which is moderate-to- severe disease. Within seven days of starting the trial, all nine patients spontaneously reported to the investigators that they felt much better than they had in a long time, noted Zeldis. All nine patients were taking steroids and could not discontinue the drugs. By the end of the four weeks on thalidomide, nearly all the CD patients who were cortiscosteroid-dependent had discontinued steroids. Most of the patients on thalidomide had a decline of greater than 100 points in their Crohn's disease activity affect. Many patients developed inactive disease at the end of four weeks.>>