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Sustained Pain Relief Demonstrated in Phase 2 Trial of Patients With Tendonitis of the Elbow
The 45-patient study met its primary endpoint-response to ALGRX 4975 in treating pain induced by wrist dorsiflexion four weeks after patients were treated with a single injection of ALGRX 4975 or placebo. At week four, 64 percent (14 of 22) of patients treated with ALGRX 4975 were considered "responders," versus 30 percent (seven of 23) of patients treated with placebo (p=0.0256). A responder was defined as having no or slight pain upon wrist dorsiflexion (0 or 1) on a 0-4 scale. For patients treated with ALGRX 4975, a statistically significant improvement in the responder analysis was maintained eight weeks after treatment compared to placebo, and the trend for ALGRX 4975 patients to have lower pain scores was maintained from two to 12 weeks. Secondary endpoints also favored the ALGRX 4975-treated group. Additionally, ALGRX 4975 was well tolerated at all time points during the 24-week study. Complete results of this trial will be presented at the upcoming 25th Annual Scientific Meeting of the American Pain Society in May 2006.
"ALGRX 4975 is a highly-differentiated product that could fill an important unmet need for an efficacious, non-opioid, long-acting pain reliever," stated James Z. Huang, president of Corgentech. "ALGRX 4975 has demonstrated its ability to provide pain relief to patients experiencing post-surgical, neuropathic and musculoskeletal pain for weeks to months after only a single administration. We look forward to reporting clinical results next quarter from three additional Phase 2 trials of ALGRX 4975 for three diverse post-surgical indications."
The randomized, double-blind, placebo-controlled Phase 2 trial enrolled 45 patients with elbow tendonitis or "tennis elbow" across two centers. Patients received either an injection of ALGRX 4975 or placebo preceded by an injection of a local anesthetic into the site of pain. With the average duration of symptoms for tendonitis patients being six to 12 weeks, pain scores were monitored for 12 weeks following the single dose of ALGRX 4975 or placebo.
About Tendonitis -- A Condition Affecting One to Three Percent of Adults in the U.S.
Elbow tendonitis is a relatively common condition affecting one to three percent of the adult population in the United States. Although commonly called "tennis elbow," only about five percent of all cases are related to playing tennis. The majority of cases are occupation-related and the condition can lead to a loss of work and productivity, with an estimated seven percent of industrial workers affected at some point in their working career. In addition to immobilization, a variety of treatments exist including non-steroidal anti-inflammatory drugs, local corticosteroid injections, and more recently, shock wave therapy. However, nothing has been convincingly proven to provide long-lasting pain relief for patients with this painful condition. The average duration of symptoms is six to 12 weeks, but occasionally patients may have persistent symptoms lasting many months. Surgery is sometimes required for patients having severe symptoms lasting greater than six months.
How ALGRX 4975 May Address Need for Fast-Acting, Long-Duration Pain Relief
ALGRX 4975 is a novel, non-opioid, drug candidate being developed in multiple mid-stage clinical trials for site-specific, moderate to severe pain. It is long-acting and provides pain relief to patients for weeks or months after just a single treatment. ALGRX 4975, a VR1 agonist, is based on capsaicin and acts as a C-neuron anesthetic. The product is administered locally at the site of pain and reduces pain by selectively acting on nerve endings expressing VR1 receptors, but does not affect other nerve fibers important for other sensory or motor sensations.
ALGRX 4975 is being evaluated in multiple Phase 2 trials for a variety of pain management indications. Corgentech recently completed enrollment for three Phase 2 trials of ALGRX 4975 for the reduction of post-surgical pain following hernia repair, total knee replacement and cholecystectomy for which data are expected in the second quarter of 2006. ALGRX 4975 demonstrated pain relief in a Phase 2 trial for post-surgical pain in patients undergoing bunionectomy, and in a Phase 2 trial for the neuropathic foot condition Morton's neuroma, a statistically significant decrease in foot pain was measured following a single administration of ALGRX 4975.
Opioid drugs, such as morphine, are commonly used agents to relieve pain in post-surgical and musculoskeletal pain conditions but are associated with significant side effects including respiratory depression, euphoria, and nausea and vomiting during acute use, and constipation and physical dependence during chronic use. In clinical studies to date, ALGRX 4975 has not demonstrated similar side effects and has been shown to be well tolerated. Additionally, it has been shown that pain in the hospital is associated with increased length of stay, longer recovery times and poorer patient outcomes. By safely decreasing a patient's level of pain with fewer side effects and associated complications, ALGRX 4975 may have the potential to reduce length of hospital stay and the need for opioids.
Source: Corgentech Inc.