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Lupus Clinical Trials

New Medical Therapies™

Knee Surgery

August 1, 2011

Histogenics released results from a phase II trial of their NeoCart Autologous Cartilage Tissue Implant (ACTI). This randomized, controlled study enrolled 30 subjects with knee cartilage injury who received the NeoCart implant or underwent microfracture (MF) repair surgery. The results showed ACTI treatment using NeoCart led to statistically significant improvements in knee and general health outcomes scores by six months, at the primary endpoint of twelve months, and were then sustained for at least two years. NeoCart had a higher proportion of therapeutic responders in comparison to MF at one and two years.

March 15, 2010

Bristol Myers Squibb and Pfizer reported positive results from a phase III trial of apixaban for the prevention and treatment of venous thromboembolism. This head-to-head, randomized, double-blind, safety and efficacy study, dubbed ADVANCE-2, enrolled 3,221 subjects undergoing elective knee replacement surgery. The subjects received 2.5 mg of apixaban orally twice daily or subcutaneous enoxaparin 40 mg once daily, over a 10-to-14 day treatment period. The primary efficacy endpoint was the composite of asymptomatic and symptomatic deep vein thrombosis, non-fatal pulmonary embolism, and death from any cause during study treatment. The primary efficacy endpoint occurred in 15.1% of the apixaban group and 24.4% of the enoxaparin group, resulting in a statistically significant relative risk reduction for apixaban of 38% (p<0.0001). The secondary efficacy endpoint, major venous thromboembolism, occurred in 1.1% of the apixaban group compared with 2.2% of the enoxaparin group (one-sided p≡0.02). The incidences of major bleeding and clinically relevant non-major bleeding were similar between the treatment arms. All other safety parameters were comparable.

December 3, 2007

Osiris released positive results from a phase I/II trial of Chondrogen for the regeneration of meniscus in the knee following knee surgery. This double blind trial enrolled fifty-five subjects. One week following surgery subjects received a single injection of either placebo, a low dose (50 million cells) of Chondrogen or high dose (150 million cells) of Chondrogen. Results after one year showed a statistically significant 20 mm reduction in pain, as measured by the visual analog scale (VAS), in subjects Chondrogen over those receiving placebo (Chondrogen 48 mm versus placebo 28 mm, p=0.05). The reduction in pain increased to 37 mm with more severe osteoarthritic changes in the patient's joint (Chondrogen 56 mm versus placebo 19 mm, p=0.004). There was also a positive dose-response effect. At one year, the improvement in pain relative to baseline (prior to surgery) was 56 mm for high dose Chondrogen, 26 mm for low dose Chondrogen, and 19 mm for placebo. In addition, bony changes associated with osteoarthritis, including subchrondral sclerosis and osteophyte formation, were reported in 21% of the placebo arm compared to 6% of the Chondrogen-treated arms. Based on the results, Osiris plans to move forward with the development of Chondrogen.

February 19, 2007

Osiris released mixed interim results from a phase I/II trial of Chondrogen for the regeneration of meniscus in the knee following knee surgery. This double blind trial enrolled 55 subjects who, one week following surgery, received a single injection of either placebo, or a low dose (50 million cells) or high dose (150 million cells) of Chondrogen. Treatment was well tolerated with no serious adverse events, including no hematological events, and it did not result in the formation of any unwanted or ectopic tissue. Of the subjects treated with Chondrogen, 30% demonstrated an improvement in their baseline cartilage or joint condition versus placebo. However, there was no significant change in the volume of meniscus on MRI at 6 months in subjects that received Chondrogen compared to those receiving placebo. The company plans to further review these results and wait for data from the one year time point before making any decisions regarding the future development of Chondrogen for this indication.

March 5, 2002

Phase II trial results indicate that OMS-103HP, developed for use with arthroscopy, significantly reduces postoperative pain and improves joint motion and recovery of function. The double-blind, placebo-controlled trial evaluated subjects who underwent arthroscopic anterior cruciate ligament reconstruction of the knee. In the first week following surgery, over three times as many OMS-103HP-treated subjects (compared to the control) met criteria for successful pain relief while requiring a lower total daily dose of pain medication. In terms of joint motion, 31% more OMS-103HP-treated subjects obtained at least 90 degrees of flexion without pain at repeated clinic visits. OMS-103HP is being developed by Omeros Medical Systems.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.