>>TARRYTOWN, N.Y.--(BW HealthWire)--Nov. 14, 2001-- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN - news) announced today promising preliminary results from its Phase I trial for the Company's Interleukin-1 (IL-1) Cytokine Trap. The study is assessing the safety and tolerability of IL-1 Trap in patients with rheumatoid arthritis. Based on these results, the Company plans to proceed into Phase II studies with the IL-1 Trap and to begin clinical trials of two additional product candidates from its custom-designed Trap platform.
The results, discussed in a poster at the American College of Rheumatology conference in San Francisco indicate that the IL-1 Trap has achieved its Phase I goals. The IL-1 Trap was generally well tolerated and displayed a favorable safety profile. In the Phase I trial, investigators reported no drug-related serious adverse events.
The IL-1 Trap also displayed positive pharmacological properties. The IL-1 Trap had an elimination half-life of 5-9 days in patients, so that a once per week treatment regimen will be tested in Phase II studies. This would fit well with the desire of the medical community for simpler regimens for medicines that treat rheumatoid arthritis. There was also no evidence of immunogenicity in the trial. After six weeks of treatment and four weeks of follow-up, no antibodies were detected in reaction to the IL-1 Trap.
``We're delighted with the results we have seen so far with the IL-1 Trap,'' commented Dr. Hans-Peter Guler, Regeneron's Vice President, Clinical Sciences. ``These findings are completely consistent with the results predicted in preclinical studies. Based on these preliminary results, we're eager to move as rapidly as we can into Phase II studies.''
``The positive data we have observed thus far is important not only for our IL-1 Trap program but for our entire platform of custom-designed Traps,'' noted Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. ``We plan to start human clinical trials in the near future with our Vascular Endothelial Growth Factor Trap (VEGF Trap) as well as our Interleukin 4/13 Dual Trap.''
Rheumatoid Arthritis, IL-1, and Regeneron's IL-1 Cytokine Trap
Rheumatoid arthritis is a chronic disease in which the immune system attacks the tissue that lines and cushions joints. Over time, the cartilage, bone, and ligaments of the joint erode, leading to progressive joint deformity and joint destruction, generally in the hand, wrist, knee, and foot. Joints become painful and swollen and motion is limited. Over two million people, 1% of the U.S. population, are estimated to have rheumatoid arthritis, and 10% eventually become disabled. Women account for two-thirds of patients with rheumatoid arthritis.
Rheumatoid arthritis involves an excess of certain cytokines, including IL-1 and tumor necrosis factor (TNF). Medicines that block TNF have already been approved for the treatment of rheumatoid arthritis, while animal and human studies indicate that IL-1 is also an attractive target for therapeutic development in this disease. Preclinical studies predict that Regeneron's IL-1 Trap should be a potent blocker of IL-1 activity, have a long half-life in the blood, and penetrate into the inflamed joint. In animal studies, the IL-1 Trap blocked cartilage erosion.
While both TNF and IL-1 can induce arthritis, IL-1 more potently induces cartilage destruction in animal models. In addition, the arthritis caused by TNF in some animals can be prevented by blocking the action of IL-1, indicating that the arthritogenic action of TNF may be mediated in part through IL-1. Perhaps even stronger evidence for the role of IL-1 in this condition is the arthritis that occurs spontaneously in mice that are deficient in the interleukin-1 receptor antagonist (IL-1ra), a naturally occurring blocker of IL-1 action. The validation of IL-1 blockade as a target for drugs to treat rheumatoid arthritis also appears to have been demonstrated by the positive results reported by another company with administration of IL-1ra in clinical trials in patients with rheumatoid arthritis.
Regeneron's Custom-Designed Trap Program
Cytokines are soluble proteins secreted by the cells of the body. In many cases, cytokines act as messengers to help regulate immune and inflammatory responses. In excess, cytokines can be harmful and have been linked to a variety of diseases. Blocking cytokines and growth factors is a proven therapeutic approach with a number of drugs already approved or in clinical development.
In 1994, Regeneron scientists made a breakthrough in understanding how receptors work for an entire class of interleukins in the human body. Based on this finding, Regeneron developed a family of antagonists, referred to as ``Cytokine Traps.'' This family includes Cytokine Traps for IL-1, IL-4, and IL-6, and a single Trap which blocks both IL-4 and IL-13. Because these Traps mimic the body's natural receptors, they are effective at catching and holding the cytokines. With cytokines trapped, the immune system responds as if the perceived threat is under control.
In preclinical studies, these Cytokine Traps are more potent than other antagonists, potentially allowing lower levels of the drug to be used. Moreover, because these Cytokine Traps are comprised entirely of natural human-derived protein sequences they may be less likely to induce an immune reaction in humans. Because pathological levels of IL-1, IL-4, IL-6 and IL-13 seem to contribute to a variety of disease states, these Cytokine Traps have the potential to be important therapeutic agents. The IL-1 Trap is in clinical studies. The IL-4/13 Trap is in preclinical development.
Regeneron also has a highly potent VEGF antagonist, termed the VEGF Trap, in preclinical development as an anti-angiogenic agent for cancer. The Company expects to begin a clinical trial of the VEGF Trap as a potential treatment for harmful angiogenesis or vascular leak in settings of cancer and/or other conditions in the near future.<<
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