Osiris Therapeutics, Inc. announced positive 1-year interim results in the evaluation of Chondrogen. Chondrogen is a preparation of mesenchymal stem cells specifically formulated for direct injection into the knee. The stem cells are obtained from the bone marrow of healthy adult donors. The 1-year data showed improvement in joint condition that correlated with a clinically and statistically significant improvement in pain in patients with osteoarthritis (OA) who received Chondrogen as compared to those treated with the control, hyaluronic acid (HA).
“These results are very promising given that a single injection of Chondrogen resulted in a clinically significant reduction in pain that was about double what we typically achieve with products currently available for OA,” said C. Thomas Vangsness Jr., M.D., Professor of Orthopedic Surgery and Chief of Sports Medicine with the Keck School of Medicine at the University of Southern California. “These data have added significance given that superiority was observed over the control arm in this trial, HA, which is routinely used today for the treatment of osteoarthritis.”
Chondrogen is currently being evaluated in a double-blind, controlled Phase I/II study for the treatment of arthritis of the knee. The study of 55 patients is evaluating the safety and exploratory effectiveness of Chondrogen in patients undergoing surgery to remove a torn meniscus. In patients with OA at the time of surgery, a statistically significant 20 mm reduction in pain, as measured by the visual analog scale (VAS), was observed in patients receiving a single injection of Chondrogen over patients receiving an injection of the control, HA, at 1 year (Chondrogen 48 mm vs. Control 28 mm, p=0.05). The reduction in pain increased even further to 37 mm with more severe osteoarthritic changes in the patient’s joint (p=0.004, Chondrogen 56 mm vs. Control 19 mm). For comparison, currently available treatments for OA, such as HA which requires multiple injections, were approved by the Food and Drug Administration (FDA) based upon improvements of 9-23 mm over placebo.
“We are excited about the dramatic improvements seen in this trial, which offer hope to the 21 million Americans who suffer every day from the debilitating effects of osteoarthritis. Additionally, the durability of the effect may have a profound impact on cost of treating arthritis,” said C. Randal Mills, Ph.D., President and CEO of Osiris Therapeutics. “These data allow us to advance our development efforts with confidence. With both clinically and statistically significant results in an approvable endpoint, we have started preparing for the appropriate registration trials. I would like to thank the investigators and patients for their continued support with this landmark study.”
The beneficial effects of Chondrogen were also seen in physical measures of joint condition. Bony changes associated with osteoarthritis, such as subchrondral sclerosis and osteophyte formation, were reported in 21% of patients receiving the control, but only 6% of Chondrogen-treated patients. Joint condition was determined from MRI analysis using centralized, independent, blinded orthopedic radiologists.
“A major problem with OA is that our current treatments only provide patients with short-term relief. Chondrogen is the first product evaluated in humans with the ability to modify the biological processes associated with arthritis and therefore hold the promise of a lasting effect,” said Joel Boyd, M.D., an orthopedic surgeon at TRIA Orthopaedic Research Institute in Minneapolis, Minnesota, and a United States Olympic team physician. “The difference in improvement observed between patients receiving Chondrogen and HA continued to widen from 6 months to 1 year without the need for additional treatment. These results are consistent with the progressive nature of arthritis and support the preclinical data demonstrating Chondrogen can have a fundamental impact on the biological course of arthritis.”
In addition to the benefits observed in OA, Chondrogen continued to demonstrate a strong safety profile. Through one year there were no serious adverse events attributed to Chondrogen, and there was no evidence of abnormal tissue formation. One of the goals of the study was to assess the ability of MRI to detect the volume of meniscus regeneration following meniscectomy. The MRI volume analysis method was deemed unsuitable for computational analysis because of the high level of variability seen between readings. As a result, no meaningful evaluation of meniscus regeneration can be made.
Illustration: Microsoft Clipart.
Osiris Press Release (11/27/07)
Business Wire (11/27/07)
Genetic Engineering & Biotechnology News (11/27/07)
Baltimore Business Journal (11/28/07)
Trading Markets (11/28/07)
Medical News Today (11/28/07)
Osiris Product: Chondrogen