From 10Q:
New is 6 months (3 + 3) extension for second PIII A trial, and safety of the fix 100 mg IL-1 Trap dose in pilot study.
During the second quarter of 2002, we initiated three additional studies in the AXOKINE Phase III program. Two of the studies were fully enrolled in July 2002 and are running concurrently. Each of these randomized, double-blind short-term treatment studies will assess the safety and efficacy of AXOKINE compared with placebo in approximately 300 subjects over defined dosing periods. Participants in the first study are being given AXOKINE or placebo for 6 months and will then be observed for another 6 months off-treatment. The companion study is treating subjects with AXOKINE or placebo for 3 months and will observe them for an additional 9 months off-treatment. The primary end-point of these studies is weight loss at the end of 12 months. At the end of the initial 12-month treatment and observation periods of the two studies, participants will receive an additional 6 months of treatment of which 3 months is on AXOKINE and 3 months on placebo. A follow-up evaluation will assess the safety and weight-loss effects of re-treatment with AXOKINE.
The third study, initiated in June 2002, will assess the safety and efficacy of AXOKINE in overweight and obese individuals with type 2 diabetes mellitus. In this double-blind, placebo-controlled study, participants are randomized into three treatment groups and given placebo or one of two AXOKINE doses (0.5 or 1.0 mcg/kg/day) for 12 weeks. At the end of the initial phase, all participants will receive AXOKINE for a 12-week extension period in two separate dose groups. This study involves approximately 160 overweight and obese subjects with type 2 diabetes and is being conducted at 24 sites within the United States. The trial will measure weight loss and explore the short-term effects of weight loss with AXOKINE on blood levels of insulin, glucose, and other glycemic parameters.
As part of the overall Phase III program, Regeneron plans to conduct additional confirmatory and ancillary studies of AXOKINE in obese and obese diabetic subjects. These studies, which are expected to begin in 2003, will vary in duration and size and are planned to be completed in 2004. The Phase III program is expected to enroll over 4,000 subjects in total.
In December 2000, we initiated a Phase I study of the IL-1 Trap to assess its safety and tolerability in subjects with rheumatoid arthritis. The placebo-controlled, double-blind, dose-escalation study was conducted at several centers in the United States and included a single dose phase and a multiple dose phase. In January 2002, we reported positive preliminary results from the trial. The preliminary results indicated that subjects treated with the IL-1 Trap experienced dose dependent improvements in tender and swollen joints and CRP levels as well as the composite ACR measure of disease activity. We also conducted a small pilot safety study of the IL-1 Trap at a single, fixed high dose of 100 mg compared with placebo. This study involved 14 subjects with active rheumatoid arthritis who received IL-1 Trap by weekly subcutaneous injections at the study sites over 6 weeks. The trial was not designed to measure disease activity. Preliminary results indicated that the IL-1 Trap was generally well tolerated with similar adverse events in the drug-treated and placebo-treated subjects. There were no drug-related serious adverse events.
In July 2002, we announced the initiation of a dose-ranging Phase II trial to study the safety and efficacy of the IL-1 Trap in subjects with rheumatoid arthritis. The trial is a randomized, placebo-controlled, double-blind study in subjects who have had an inadequate response to at least one disease-modifying anti-rheumatic medicine. The study will involve approximately 200 participants, who will be randomized equally into placebo or one of three fixed-dose groups (25, 50, or 100 milligrams) to receive self-administered, weekly subcutaneous injections. The double-blind treatment period is 12 weeks, and participants will also be evaluated for 10 weeks following treatment. The ACR20 criteria for improvement in rheumatoid arthritis as a function of IL-1 Trap dose is the primary end-point. |
