Business Editors/Health & Medical Writers
(BW HealthWire) — IDEC Pharmaceuticals Corporation (Nasdaq:IDPH) today announced results obtained from a Phase I trial of its investigational agent, IDEC-114, a PRIMATIZED anti-B7-1 (anti-CD80) monoclonal antibody.
Analysis of the data showed a favorable safety profile with preliminary findings of clinical activity in patients with moderate to severe psoriasis. The findings were reported this week in an oral presentation delivered by Dr. Alice B. Gottlieb, M.D., Ph.D., at the 58th Annual Meeting of American Academy of Dermatology in San Francisco.
The primary objectives of the study were to assess the safety, tolerability, and pharmacokinetics of a single dose of IDEC-114. The secondary objective was to assess preliminary evidence of clinical activity.
Dr. Gottlieb reported that IDEC-114 was well tolerated in the 24 patients who each received a single dose, ranging from 0.05 to 15.0 mg/kg. “Pharmacokinetic measurements were linear, with a half-life of approximately 13 days in the higher dosage groups,” Dr. Gottlieb said. “In addition, some patients in the higher dosage groups showed preliminary findings of clinical improvement, according to standard methods of assessing psoriasis severity.”
“We are very encouraged by the results of this study, in particular its safety profile,” said Richard G. Lizambri, M.D., director, Autoimmune and Inflammatory Diseases. “IDEC-114 as a single dose demonstrated an overall favorable safety profile and there were no serious adverse events. The majority of adverse events were mild, such as short-lived flu-like symptoms, headache and chills.” Dr. Lizambri noted that based on these results IDEC initiated a multiple-center, multiple-dose phase I/II clinical trial to further assess the safety and clinical activity of IDEC-114.
Dr. Gottlieb is the W.H. Conzen Chair in Clinical Pharmacology, Director of the Clinical Research Center and Professor of Medicine at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ. Mark G. Lebwohl, M.D., Chairman and Professor of Dermatology, Mount Sinai School of Medicine, New York, NY, was co-investigator in the IDEC-114 clinical trial.
Mitsubishi-Tokyo Pharmaceuticals, Inc., has licensed the commercial rights of IDEC-114 in Asia. IDEC retains exclusive rights outside of Asia.
IDEC Pharmaceuticals focuses on the commercialization and development of targeted therapies for the treatment of cancer and autoimmune diseases.IDEC’s antibody products act chiefly through immune system mechanisms, exerting their effect by binding to specific, readily targeted immune cells in the patient’s blood or lymphatic systems.
The statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ from IDEC’s expectations. In addition to the matters described in this press release, the timing and success, and cost of product launches and clinical studies may vary from study to study. In addition to these matters, the risk factors listed from time to time in IDEC’s SEC filings, including but not limited, to its Annual Report on Form 10-K for the year ended December 31, 1998 and Form 10-Q for the quarter ended September 30, 1999, may affect the actual results achieved by IDEC. IDEC Pharmaceuticals and PRIMATIZED are registered U.S. trademarks ofthe company. The company’s headquarters is located at 11011 Torreyana Road,San Diego, CA 92121.
IDEC Pharmaceuticals’ news releases are available at no charge through Business Wire’s News on Demand Plus. For a menu of IDEC’s current news releases and quarterly reports or to retrieve a specific release, call (888) 329-2309. On the Internet check the News Center at IDEC’s website: http://idecpharm.cdmail.biz .
--30--jf/sd* js/sd CONTACT: IDEC Pharmaceuticals Corporation Vince Reardon, Director, Corporate Communications 858/431-8656 KEYWORD: CALIFORNIA INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICAL MEDICAL DEVICES PHARMACEUTICAL