Tyrone Shoelaces
04-12-2005, 09:30 AM
Keep on eye on these guys....Heck, maybe some of you peeps with upcoming surgeries would want to look into enrolling in this study.
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Omeros Initiates Phase 3 Clinical Trials for First Drug Product to Improve Knee Function Following Arthroscopic Surgery
SEATTLE--(BUSINESS WIRE)--April 12, 2005--Omeros Corp., a Seattle-based biopharmaceutical company, announced that it has initiated Phase 3 clinical trials of its lead drug product, OMS103HP, for improvement in knee function following arthroscopic anterior cruciate ligament (ACL) reconstruction. OMS103HP is the first drug being developed to improve joint function following arthroscopic surgery, one of the most common procedures performed today by orthopedic surgeons.
Arthroscopy, done by inserting a miniature camera lens and surgical instruments into a joint through small skin incisions, results in an acute inflammatory response causing swelling and pain that can lead to restricted joint motion and loss of function. "Traditionally, inflammation and pain are addressed postoperatively in an attempt to resolve them after they have begun," said Gregory A. Demopulos, M.D., chairman and CEO of Omeros. "We have taken a different approach with OMS103HP by delivering targeted therapeutic agents directly to the surgical site during the arthroscopic procedure -- while the trauma is occurring -- to inhibit inflammation and pain before they can begin."
Approximately 7.3 million arthroscopic procedures were performed worldwide in 2004, a number that continues to increase by 7-8 percent per year. The ACL is the most commonly ruptured ligament in the human knee, often as the result of sports injuries or other serious knee trauma, and reconstruction by arthroscopy is the recognized standard of care for younger and more active patients.
"The primary objective of arthroscopy is to improve function, and functional recovery is directly related to the successful control of intra- and postoperative inflammation," noted William E. Garrett Jr., M.D., professor of orthopedic surgery at Duke University and former president of the American Orthopaedic Society for Sports Medicine. "Early pain relief and functional recovery are important factors for patient satisfaction and outcomes. Avoiding a very painful, swollen knee in the early postoperative period has an immediate and lasting benefit, and can prevent complications that require additional therapy, rehabilitation time and even further surgery."
The OMS103HP Phase 3 program includes three double-blind, placebo-controlled, multicenter clinical trials that will enroll approximately 900 total patients undergoing arthroscopic ACL reconstruction. The primary efficacy endpoint is improvement in knee function, with secondary endpoints including reduced pain, improved range-of-motion and earlier return-to-work.
These trials were designed based on results from the OMS103HP Phase 1/Phase 2 program. In a double-blind, placebo-controlled study conducted at Stanford University, OMS103HP provided significant improvement in knee function following arthroscopic ACL reconstruction. Also, when compared to the placebo group, OMS103HP patients had less pain, achieved better joint motion and returned to work sooner. Adverse events were no different than those commonly reported following anesthesia and surgery.
"The Phase 3 program will further define the safety and effectiveness of OMS103HP," explained Gail E. Gillenwater, Ph.D., vice president, pharmaceutical development at Omeros. "We recruited outstanding surgeons and physical therapists, we standardized the performance of the clinical and rehabilitation assessments across all sites, and we expect a successful outcome."
Demopulos explained that OMS103HP is a unique product that is added to standard irrigation solutions and perfused through the joint during arthroscopic surgery. He further indicated that it is easy to use and does not require surgeons to alter their existing surgical techniques. Initial primary market research suggests that the product will be acceptable to both surgical centers and third-party payers. "Omeros is committed to becoming a leader in the development of novel anti-inflammatory therapeutics," said Demopulos. "Initiation of Phase 3 moves us closer to achieving our goal of commercializing our proprietary pipeline of pharmaceutical and drug-delivery products."
Omeros Corp., a Seattle-based biopharmaceutical company, is developing novel products that are delivered directly to the site of tissue injury, pre-emptively inhibiting inflammation, pain and other problems associated with medical and surgical procedures. Omeros' patented products are designed to act on distinct molecular targets at the site of delivery, providing improved therapeutic benefit while minimizing the risk of side effects. The company is advancing a pipeline of products for use in orthopedics and rheumatology, urology, cardiovascular medicine, general surgery and pain management. Omeros is located at 1420 Fifth Ave., Suite 2600, Seattle, WA 98101, Phone: 206-676-5000, Fax: 206-264-7856, www.omeros.com.
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Omeros Initiates Phase 3 Clinical Trials for First Drug Product to Improve Knee Function Following Arthroscopic Surgery
SEATTLE--(BUSINESS WIRE)--April 12, 2005--Omeros Corp., a Seattle-based biopharmaceutical company, announced that it has initiated Phase 3 clinical trials of its lead drug product, OMS103HP, for improvement in knee function following arthroscopic anterior cruciate ligament (ACL) reconstruction. OMS103HP is the first drug being developed to improve joint function following arthroscopic surgery, one of the most common procedures performed today by orthopedic surgeons.
Arthroscopy, done by inserting a miniature camera lens and surgical instruments into a joint through small skin incisions, results in an acute inflammatory response causing swelling and pain that can lead to restricted joint motion and loss of function. "Traditionally, inflammation and pain are addressed postoperatively in an attempt to resolve them after they have begun," said Gregory A. Demopulos, M.D., chairman and CEO of Omeros. "We have taken a different approach with OMS103HP by delivering targeted therapeutic agents directly to the surgical site during the arthroscopic procedure -- while the trauma is occurring -- to inhibit inflammation and pain before they can begin."
Approximately 7.3 million arthroscopic procedures were performed worldwide in 2004, a number that continues to increase by 7-8 percent per year. The ACL is the most commonly ruptured ligament in the human knee, often as the result of sports injuries or other serious knee trauma, and reconstruction by arthroscopy is the recognized standard of care for younger and more active patients.
"The primary objective of arthroscopy is to improve function, and functional recovery is directly related to the successful control of intra- and postoperative inflammation," noted William E. Garrett Jr., M.D., professor of orthopedic surgery at Duke University and former president of the American Orthopaedic Society for Sports Medicine. "Early pain relief and functional recovery are important factors for patient satisfaction and outcomes. Avoiding a very painful, swollen knee in the early postoperative period has an immediate and lasting benefit, and can prevent complications that require additional therapy, rehabilitation time and even further surgery."
The OMS103HP Phase 3 program includes three double-blind, placebo-controlled, multicenter clinical trials that will enroll approximately 900 total patients undergoing arthroscopic ACL reconstruction. The primary efficacy endpoint is improvement in knee function, with secondary endpoints including reduced pain, improved range-of-motion and earlier return-to-work.
These trials were designed based on results from the OMS103HP Phase 1/Phase 2 program. In a double-blind, placebo-controlled study conducted at Stanford University, OMS103HP provided significant improvement in knee function following arthroscopic ACL reconstruction. Also, when compared to the placebo group, OMS103HP patients had less pain, achieved better joint motion and returned to work sooner. Adverse events were no different than those commonly reported following anesthesia and surgery.
"The Phase 3 program will further define the safety and effectiveness of OMS103HP," explained Gail E. Gillenwater, Ph.D., vice president, pharmaceutical development at Omeros. "We recruited outstanding surgeons and physical therapists, we standardized the performance of the clinical and rehabilitation assessments across all sites, and we expect a successful outcome."
Demopulos explained that OMS103HP is a unique product that is added to standard irrigation solutions and perfused through the joint during arthroscopic surgery. He further indicated that it is easy to use and does not require surgeons to alter their existing surgical techniques. Initial primary market research suggests that the product will be acceptable to both surgical centers and third-party payers. "Omeros is committed to becoming a leader in the development of novel anti-inflammatory therapeutics," said Demopulos. "Initiation of Phase 3 moves us closer to achieving our goal of commercializing our proprietary pipeline of pharmaceutical and drug-delivery products."
Omeros Corp., a Seattle-based biopharmaceutical company, is developing novel products that are delivered directly to the site of tissue injury, pre-emptively inhibiting inflammation, pain and other problems associated with medical and surgical procedures. Omeros' patented products are designed to act on distinct molecular targets at the site of delivery, providing improved therapeutic benefit while minimizing the risk of side effects. The company is advancing a pipeline of products for use in orthopedics and rheumatology, urology, cardiovascular medicine, general surgery and pain management. Omeros is located at 1420 Fifth Ave., Suite 2600, Seattle, WA 98101, Phone: 206-676-5000, Fax: 206-264-7856, www.omeros.com.