SAN ANTONIO and SOUTH SAN FRANCISCO, Calif., May 4 /PRNewswire-FirstCall/ -- Corgentech Inc. today announced the presentation of promising primary and secondary data from two Phase 2 clinical trials of 4975, Corgentech's novel, long-acting, non-opioid drug candidate, in patients with elbow tendonitis (acute lateral epicondylitis) and Morton's neuroma (intermetatarsal neuroma), a painful foot condition, at the 25th Annual Scientific Meeting of the American Pain Society. New, secondary data from the tendonitis trial demonstrated that patients treated with a single, local injection of 4975 exhibited sustained, significant reductions at all pain endpoints and a significant improvement in function, compared to the placebo group at the 4-week observation period. The meeting is being held in San Antonio, TX.
"Tendonitis is a debilitating condition with very painful symptoms that can last for months and current treatment options have inconsistent efficacy. This study shows that treatment with 4975 not only effectively manages pain, but improves function by more than 50 percent at four weeks," stated Daniel J. Gennevois, M.D., vice president of Medical Affairs at Corgentech.
4975 Reduces Pain of Acute Lateral Epicondylitis: Preliminary Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 2, Multicenter Clinical Trial
In this Phase 2 trial, patients with acute elbow tendonitis received a single, local injection of 100 micrograms of 4975 or placebo at the site of pain, preceded by an injection of a local anesthetic. At 4 weeks, 64 percent (14/22) of patients treated with 4975 experienced decreased pain during resisted wrist movement, compared to 30 percent (7/23) of patients treated with placebo (p = 0.026). Treatment with 4975 also resulted in an approximately 60 percent improvement from baseline in grip strength at 4 weeks, compared to an approximate 14 percent improvement in the placebo group (p = 0.009). Importantly, treatment with 4975 produced a significant improvement on patients' global impression of change in pain at all post treatment time points compared to placebo. At week 4, 64 percent (14/22) of the 4975 patients categorized themselves as "very much improved" or "improved" since elbow injection versus 22 percent (5/23) of patients in the placebo group.
With the exception of pain on injection (which was managed with icepacks), 4975 was well tolerated, causing no other treatment-related adverse events, no decreases in sensory function, and no significant local reactions of the skin.
4975 Reduces Pain of Intermetatarsal Neuroma: Preliminary Results from a Randomized, Double-Blind, Placebo-Controlled, Phase 2, Multicenter Clinical Trial
In the Phase 2 Morton's neuroma trial, patients who had failed conservative treatments including analgesics and steroid injections received a single local injection of 100 micrograms of 4975 or placebo at the site of pain, preceded by an injection of a local anesthetic. Patients treated with 4975 experienced greater pain relief compared to placebo as measured by change from baseline in average weekly foot pain, sum of average foot pain intensity, change from baseline in pain-related interference items of the Brief Pain Inventory, and patients' use of supplemental analgesic medication. Importantly, significantly superior pain reduction occurred early, at 1 week after start of treatment, and was sustained at the 4-week observation period (p<0.05).
How 4975 May Address Need for Fast-Acting, Long-Duration Pain Relief
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. 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.
Five clinical trials already have demonstrated significant pain reduction and a favorable safety profile of 4975. The other indications showing promising clinical trial results include end-stage osteoarthritis of the knee and post-surgical pain in patients undergoing bunionectomy. Phase 2 studies of 4975 for the post-surgical pain of total knee replacement and open cholecystectomy have completed enrollment, and data are expected in the second quarter of 2006. Current treatments for post-surgical pain of total knee replacement and cholecystectomy include opioid drugs, such as morphine, which 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, 4975 has not exhibited 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, 4975 may have the potential to reduce length of hospital stay and the need for opioids.
About Tendonitis, a Common Condition Causing Pain and Reduced Function
Acute lateral epicondylitis or 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. 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. The average duration of symptoms is 6 to 12 weeks, but occasionally patients may have persistent symptoms lasting many months. 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, there is no consensus around current treatment options due to conflicting accounts of efficacy. Surgery is sometimes required for patients having severe symptoms lasting greater than six months.
About Morton's Neuroma
Morton's neuroma is a painful foot condition that typically occurs as a result of wearing high narrow shoes, running, or spending considerable time standing each day. The thickening of the nerve tissue (neuroma) seems to occur in response to pressure or injury to one of the nerves that lead to the toes, resulting in pain and numbness that can make walking unbearable. Morton's neuroma is difficult to treat, so patients are often referred to foot specialists (podiatrists). In many patients, orthotics, analgesics and injectable corticosteroids have limited effectiveness. More aggressive treatments, including surgical intervention to remove the nerve, are sometimes employed, but may not prevent recurrence of the pain, or may leave patients with permanent numbness in the foot.
Corgentech is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has four drug candidates in clinical development for multiple potential indications, the most advanced of which, 3268, has completed Phase 3 clinical trials. Corgentech is based in South San Francisco, CA.
Forward Looking Statements
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