Original Source: FD (FAIR DISCLOSURE) WIRE
. Stanley Crooke, Isis Pharmaceuticals, Inc., Chairman & CEO . Allison Trollope, Isis Pharmaceuticals, Inc., Executive Director, IR . Mark Wadel, Isis Pharmaceuticals, Inc., Chief Medical Officer . Dr. Phil Miner, Jr., M.D., Clinical Professor of Medicine at the
University of Oklahoma
ISIS is happy to announce that it has successfully completed Phase II development of the alicaforsen enema for UC and the Co. has successfully met all of its objectives for the Phase II program. Q&A Focus: Colitis study and Phase III trial.
S1. Crohn's & Ulcerative Colitis Data (M.W.) 1. Crohn's Data: 1. ISIS conducted two Phase III clinical trials of alicaforsen in
Crohn's Disease with one study taking place in North America
and one study being conducted in Europe and Israel. 1. These studies evaluated the safety and efficacy of alicaforsen at a dose higher than that previously studied in its controlled trials.
2. Between the two randomized double masked, placebo-controlled
trials, a total of 331 patients were enrolled. 1. Primary endpoint of these trials was the achievement of clinical remission as defined by a Crohn's Disease Activity Index (CDAI) of 150 points or less by week 12. 2. The patients received 300 mg IV infusions three times a week for four weeks after which patients were followed up for at least six months. 2. Conclusions of Two Phase III Studies:
1. Alicaforsen had no discernible affect vs. placebo in patients
suffering with Crohn's disease. 2. Alicaforsen may have shown benefit in patients with prior anti-TNF alpha exposure and in patients with a current or a past history of fistulizing disease. 3. Alicaforsen was well tolerated. 4. Based on these results ISIS will not invest further in the development of alicaforsen for Crohn's disease. 3. Demographics: 1. The primary endpoint of the study was the induction of clinical remission by week 12 as defined by a CDAI of 150 or less. 1. Thus placebo rates were generously high in both studies. 2. Neither the North American nor the Israeli European study showed a statistically significant difference between the effects of alicaforsen and placebo. 2. The secondary endpoint of this study was the percent of patient to achieve the clinical response defined in this case as a decrease in their CDAI score of 100 points by week 12. 1. The alicaforsen arm of the North American study saw a 63% response rate vs. 48% for the placebo arm for the `p value` of 0.08. 2. In the European study the alicaforsen treated patients achieved a 62% response rate vs. 58% in the placebo treated patients. 1. There was no statistical significance there. 3. In a small number of patients from both studies with current or a history of fistulizing disease, the difference from placebo is not statistically significant in these relatively small numbers. 4. In patients from both studies who were previously treated for TNF alpha …