Looming Competition for ENBREL ?
Alexion Completes Enrollment in Phase II Efficacy Study of C5 Complement Inhibitor in Rheumatoid Arthritis Patients
- Alexion Also Commences Open Label Extension Study in Arthritis -
NEW HAVEN, Conn., Aug. 24 /PRNewswire/ -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that it has completed patient enrollment with 5G1.1, its anti-inflammatory complement inhibitor drug candidate, in a Phase II efficacy trial in rheumatoid arthritis patients. 5G1.1 is a fully humanized monoclonal antibody that has been shown to potently block the inflammatory effects of the complement system. The Phase II multi-center, double-blinded, randomized, placebo-controlled study is designed to examine the safety and clinical efficacy of repeated dosing of 5G1.1 during a three month period in approximately 200 rheumatoid arthritis patients in the United States. This efficacy study follows clinical results announced in 1999 in which a single administration of 5G1.1 in this patient population was associated with short-term reductions in a validated, objective measurement of clinical disease activity and in disease symptoms. Alexion also announced that, as a part of its comprehensive development plan for 5G1.1, it has already commenced dosing in a follow-on open label extension study of 5G1.1 in these patients, designed to examine long-term safety and tolerability.
"Following up on our positive results in initial clinical studies with 5G1.1 in arthritis last year, we are encouraged that we have met an additional important milestone with the completion of enrollment in this large rheumatoid arthritis efficacy trial with this promising compound," said Dr. Leonard Bell, President and Chief Executive Officer of Alexion. "After completion of the treatment period and analysis of the results in these patients, we expect to report the results from this trial. Additionally, we are pleased to have already commenced the long-term extension safety study with 5G1.1 in our arthritis trial patients, as we expect this will represent an important component of our clinical package."
The company presented data from the earlier 42 patient Phase I/II trial of 5G1.1 in arthritis patients at the 63rd annual American College of Rheumatology (ACR) meeting in November, 1999 demonstrating that 50% of the patients (n=6) who received a single 8 mg/kg dose achieved an ACR20 score, as compared to 10% of the patients (n=10) treated with placebo (P=.07). ACR20 score means that a patient had a 20% improvement in tender and swollen joint count plus 20% improvement in at least 3 of 5 of the following criteria: patient pain assessment, physician global assessment, patient global assessment, patient self-assessed disability and acute phase reactant. It was previously reported in April 1999 that the single 8 mg/kg dose resulted in a 30% decrease (P<.05) in the levels of the acute phase reactant C-reactive protein, an objective measure of disease activity.
"The need for therapeutic alternatives with distinct mechanisms of action from all current therapies in rheumatoid arthritis remains great, since, for many patients, the observed benefits of most existing treatments are often incomplete and may be offset by potentially serious side effects," commented Dr. Christopher Mojcik, a clinical rheumatologist and Senior Director of Clinical Development at Alexion. "The current trial is designed to employ multiple dosing regimens of 5G1.1 in rheumatoid arthritis patients with the primary efficacy endpoint as the ACR20 score."
It is estimated that more than two million Americans are affected by rheumatoid arthritis, a disease in which the immune system attacks multiple joints as well as the whole body. This chronic immune attack frequently involves multiple organs in the body leading to the onset of fatigue, severe joint destruction, pain and disfigurement.
Alexion's C5 complement inhibitors are designed to selectively block the production of inflammation-causing proteins in a process of the human immune system known as the complement cascade. Alexion believes that selective suppression of this immune response will provide a significant therapeutic advantage relative to existing therapies. Because of the generally beneficial effects of the components of the complement cascade prior to C5 and the greater inflammatory disease-promoting effects of the cleavage products of C5, the Company has identified C5 as a potentially effective anti-inflammatory drug target. The first two C5 Inhibitors, 5G1.1 and 5G1.1-SC, specifically and tightly bind to C5 blocking its cleavage into harmful byproducts and are designed to inhibit subsequent damage from the inflammatory process.
Alexion is engaged in the development of products for the treatment of cardiovascular, autoimmune and neurologic diseases caused by undesired effects of the human immune system. Alexion's two lead product candidates are currently in eight clinical development programs. 5G1.1-SC, in collaboration with Procter & Gamble, is in a Phase IIb cardiopulmonary bypass efficacy trial and in two Phase II myocardial infarction efficacy trials. In addition to the above-mentioned Phase II efficacy trial for the chronic treatment of rheumatoid arthritis, 5G1.1 is in a Phase II efficacy trial for the treatment of membranous nephritis and in Phase Ib pilot studies for treatment of psoriasis, dermatomyositis, and pemphigoid. This press release and further information about Alexion Pharmaceuticals, Inc. can be found on the World Wide Web at: alexionpharm.com.
This news release contains forward-looking statements. Such statements are subject to certain factors which may cause Alexion's plans to differ or results to vary from those expected including unexpected pre-clinical or clinical results, the need for additional research and testing, delays in manufacturing, access to capital and funding, delays and adverse changes in development of commercial relationships and a variety of risks set forth from time to time in Alexion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Annual Report on Form 10-K/A for the year ended July 31, 1999. Alexion undertakes no obligation to publicly release results of any of these forward-looking statements which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
SOURCE Alexion Pharmaceuticals, Inc.
CONTACT: Leonard Bell, M.D., President & CEO of Alexion Pharmaceuticals, 203-776 1790; or Media - Ernie Knewitz of Noonan/Russo Communications, Inc., 212-696-4455, ext. 204; or Investor - Rhonda Chiger of Thomson Financial, 212-510-9280
Web site: alexionpharm.com (ALXN) |
