September 2007
Phase IIb Clinical Study of CRx-102 Launched
Posted 9/27/07
The first patient received treatment with CRx-102 in a Phase IIb trial in knee osteoarthritis. According to the drug developer, “CRx-102 is an oral synergistic combination drug candidate containing the cardiovascular agent dipyridamole and an unconventionally low dose (3mg) of the steroid prednisolone. CRx-102 works through a novel mechanism of action in which dipyridamole selectively amplifies prednisolone’s anti-inflammatory and immunomodulatory activities without replicating its side effects.”
The drug demonstrated clinical efficacy in three Phase IIa clinical studies, including ones in hand osteoarthritis and rheumatoid arthritis. The current study will evaluate the efficacy of CRx-102 compared with placebo in subjects with symptomatic knee osteoarthritis.
Long-Acting Arthritis Pain Reliever in the Works
Posted 9/17/07
A new Phase II study of Adlea (formerly called drug #4975) has begun for the relief of postoperative pain in people undergoing total knee replacement surgery. Adlea is a long-acting, nonopiate analgesic drug designed to provide pain relief for weeks to months after a single local administration during the surgical procedure.
The drug previously was studied at a 5-mg dose in patients who had total knee replacement. The new trial will evaluate a 15-mg dose versus a 5-mg dose and placebo in a double-blind, multicenter study of approximately 80 patients.
The company developing the drug, Anesiva, hopes to initiate other clinical trials of Adlea for two indications in the coming months — management of acute postoperative pain associated with orthopedic surgeries and management of osteoarthritis pain in the knee. These planned studies include a Phase II trial in total hip replacement, a Phase II trial in arthroscopic shoulder surgery, a Phase II/III trial in osteoarthritis of the knee and a Phase III trial in total knee replacement.
How Adlea May Provide Pain Relief
Adlea is long-acting, with the potential to provide pain relief for weeks or months after a single localized treatment. It is a nonopiate medication that selectively acts on pain-sensing nerve endings, blocking the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. It does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure. In clinical studies to date, the prolonged analgesic effect of Adlea does not seem to be associated with the systemic side effects commonly associated with NSAIDs (gastrointestinal and renal toxicities, and impaired blood clotting), COX-2 inhibitors (cardiovascular risks and renal toxicity), or opiates (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence, and the risk of addiction), says the pharmaceutical company.
CellCept for Lupus Nephritis
Posted 9/12/07
Developers decided not to proceed with a regulatory submission for CellCept as induction therapy for lupus nephritis. Preliminary results from the induction stage of the Phase III clinical trial comparing CellCept (oral mycophenolate mofetil) with intravenous cyclophosphamide were released in June. These initial results showed that, although response rates were similar in both arms of the study, the induction stage of the trial did not meet its primary objective of demonstrating that CellCept was superior to intravenous cyclophosphamide in inducing treatment response.
The patients who successfully completed the induction phase of the lupus nephritis study were rerandomized into the maintenance phase, a blinded study comparing CellCept with azathioprine in maintaining remission and renal function in subjects with lupus nephritis.
Preliminary Results of TRU-015 for RA
Posted 9/12/07
Results were announced from a Phase IIb randomized, double-blind, placebo-controlled, multicenter clinical trial of its TRU-015 for the treatment of rheumatoid arthritis. TRU-015 is designed to target and deplete B cells. The trial included 276 patients with RA who also were receiving methotrexate as background therapy. Patients in the study were randomized into five groups that received 200, 400, 800 or 1,600 mg of TRU-015 or placebo.
TRU-015 administered as a single dose was generally well tolerated, and only one subject in the 400-mg group experienced a grade 3 adverse event on the day of infusion. The results indicated that TRU-015 provided statistically significant improvements in rheumatoid arthritis signs and symptoms compared with placebo at 24 weeks.
