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Positive Phase II Clinical Results Validate Potential of New Arthroscopy Drug From Omeros; Stanford Study Indicates Significant Pain Reduction and Improved Postoperative Function.

Business Editors & Health/Medical Writers

SEATTLE--(BW HealthWire)--Feb. 27, 2002

Omeros Medical Systems Inc. today announced that its lead drug product, OMS-103HP, developed to inhibit inflammation and pain associated with arthroscopy, provided statistically significant improvement in postoperative pain reduction, joint motion and recovery of function.

With more than 6 million arthroscopic procedures performed worldwide in 2001, a number that continues to increase by approximately 8% per year, the drug is expected to achieve global market use.

"One of the major challenges facing orthopedic surgeons is controlling the inflammatory response to surgical trauma," explained Gregory A. Demopulos, M.D., chairman and CEO of Omeros, a Seattle-based biotechnology company that develops novel therapeutics to pre-emptively inhibit inflammation, pain and other problems associated with surgical and medical procedures.

"The speed and effectiveness of pain relief and functional recovery following arthroscopic surgery are directly related to the amount of inflammation in the joint. OMS-103HP was designed to decrease that inflammation. The study results confirmed that the drug relieved pain and enhanced return of muscle function, accelerating recovery of normal joint activity."

Demopulos added that, in addition to the drug's direct benefits to patients undergoing arthroscopic surgery, the use of OMS-103HP is expected to result in overall cost savings in the management of those patients.

Results of the double-blind, placebo-controlled study conducted at Stanford University consistently demonstrated that OMS-103HP provided better postoperative pain relief, improved joint motion and accelerated recovery of knee function. These consistent trends were statistically significant on important pain, motion and functional recovery endpoints.

The study evaluated patients who underwent arthroscopic anterior cruciate ligament (ACL) reconstruction of the knee. Pain and function were assessed immediately after knee surgery and for an additional 30 days at clinic visits and rehabilitation therapy sessions.

During the first week following surgery, when compared with the control group, more than three times as many OMS-103HP-treated patients met criteria for successful pain relief while requiring a lower total daily dose of pain medication. Joint motion was improved with 31% more OMS-103HP-treated patients able to obtain at least 90 degrees of flexion without pain at repeated clinic visits.

In addition, patients in the OMS-103HP group were able to stop using continuous passive motion (CPM) machines, devices prescribed to increase postoperative joint motion, 37% faster.

The drug also enhanced recovery of knee function and muscle activity, with 31% more OMS-103HP-treated patients showing no difficulty in performing the straight leg raise test and more than twice as many OMS-103HP-treated patients than the control group able to perform the highest level of single-leg stance.

These functional tests commonly are used by rehabilitation therapists following knee arthroscopy to assess knee and muscle recovery and to determine the progression of a patient's rehabilitation program.

Gary S. Fanton, M.D., team physician for the San Francisco Giants, orthopedic surgery consultant for the San Francisco 49ers and clinical assistant professor at Stanford University School of Medicine, was the principal investigator for the study.

"This is the first drug I've seen that targets functional recovery of the joint following arthroscopic surgery," said Fanton. "Enhanced recovery of function, together with better pain relief, should make OMS-103HP well received by orthopedic surgeons and patients. It's simple to use and does not require surgeons to alter their existing surgical techniques."

"When using OMS-103HP during arthroscopy, the drug is delivered during the operation directly to the joint, at the actual site of injury, and works at the molecular level to inhibit the mediators of inflammation and pain before surgical trauma occurs," explained Gail E. Gillenwater, Ph.D., vice president, pharmaceutical development at Omeros.

"The drug pre-emptively blocks inflammation and pain throughout the arthroscopic procedure. Although the therapeutic approach is new, the scientific concept is straightforward and the clinical data show that benefits to patients are substantial." Gillenwater noted that the positive clinical data are consistent with preclinical work performed by Omeros.

Based upon the strength of the Phase II clinical results, Omeros has begun preparations for the drug's Phase III clinical program, which is the final phase of testing before submitting the drug for FDA approval. Phase III trials are expected to start later this year.

"These Phase II clinical results further validate the strength of the company's broad-based pharmaceutical technology," said Demopulos. "This drug is proving to deliver the benefits we anticipated for patients, physicians and third-party payers. We are making tremendous progress toward commercializing our proprietary pipeline of pharmaceutical and drug delivery products."

Omeros Medical Systems, a venture-funded biotechnology company, is developing novel therapeutics that target receptors and enzymes to inhibit inflammation, pain and other problems associated with medical and surgical procedures.

Omeros is advancing a pipeline of pharmaceutical and drug delivery products for use in orthopedics, urology, cardiovascular medicine and general surgery that provide preventive and restorative treatments directly to the site of tissue injury.

With its proprietary platform technologies and streamlined approach to product development, Omeros is positioned to rapidly provide its innovative and clinically valuable products to health-care professionals and patients around the world.

Omeros is located at 1420 Fifth Ave., Suite 2675, Seattle, Wash. 98101, Phone: 206/623-4688, Fax: 206/264-7856, Web site: www.omeros.com.
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Publication:Business Wire
Geographic Code:1USA
Date:Feb 27, 2002
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