BiotechTracker - ISIS-2302 for Pouchitis
May 22, 2003 Data presented at the Digestive Disease Week 2003 meeting suggest that ISIS-2302’s (alicaforsen) initial inflammatory bowel disease niche may include the management of pouchitis, a post-colectomy residual inflammatory complication. Considerable investigation is still required.  Isis’s (NASDSAQ: ISIS) open-label, uncontrolled, phase II clinical trial offers some preliminary insight into ISIS-2302’s therapeutic effects in 12 patients with pouchitis. The study subjects received nightly drug for six weeks by enema, and will be assessed over one year. Data from the first eight patients at one month of follow-up were reported. The primary endpoint is improvement in the well-validated Pouchitis Disease Activity Index, which takes into account symptom intensity, endoscopic assessment (typically colonoscopy or flexible sigmoidoscopy), and histology (microscopic assessment of tissue). The use of ISIS-2302 for these patients was associated with:  mean PDAI improvements at week 10 (p=0.008 from baseline)  mean endoscopic score improvements after 3 weeks (p=0.03 from baseline)  sustained mean endoscopic score improvements at week 10 (p=0.008 from baseline)  symptomatic improvements  a reassuring adverse event profile. ISIS-2302 is an antisense inhibitor of intercellular adhesion molecule-1 (ICAM-1), an important mediator of inflammation. ICAM-1 is one of a family of molecules, the cellular adhesion molecules (CAMs) that exist on the surface of nearly every cell in the body. It not only mediates the interaction between specific cell types but also transmits signals into the cells when activated.  ISIS-2302 has been in development for a long time. In December 1999, phase IIb trials suggested a lack of clinical utility in Crohn disease. Development was resumed in October 2000, and limited momentum has been demonstrated with meeting primary endpoints in Crohn disease indications remaining quite a challenge.  Pouchitis is postoperative inflammation arising in an ileal pouch, a small bowel remnant (post-removal of the colon and rectum) attached to anal musculature in efforts to avoid ostomy voiding
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