SOUTH SAN FRANCISCO, Calif., March 24 /PRNewswire-FirstCall/ -- Corgentech Inc. today reported clinical results from a Phase 2 trial of 4975, the company’s novel, long-acting, non-opioid drug candidate being developed in multiple mid-stage clinical trials for site-specific, moderate to severe pain.
The 41-patient, randomized, double-blind, parallel-group, placebo- controlled European study was designed to measure the effectiveness of 4975 in treating pain induced by surgical repair of an inguinal (groin) hernia as measured one and four weeks after surgery. Patients were given either a single dose of 4975 or placebo, which was instilled (dripped by syringe) into the wound over approximately one minute prior to wound closure. All patients in both the treatment and placebo arms received paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs: ibuprofen) for one week following surgery, a mandated standard of care in Denmark where the trial was conducted. While 4975 was well tolerated at all time points during the study, there was no significant difference in pain score in the drug versus control arm.
“We believe that concomitant administration of pain killing drugs may have confounded the results of this trial since the results are inconsistent with data obtained from multiple previous Phase 2 trials of 4975 that demonstrated significant, sustained pain reduction versus placebo in other indications,” stated Daniel J. Gennevois, M.D., vice president of medical affairs at Corgentech. “Several aspects of this study’s design were different from other studies we have conducted. Mainly, paracetamol and NSAIDs were systematically administered to both the treatment and placebo arms for a week. Therefore, the pain score for the placebo arm during the first week after surgery was quite low, making it difficult to show a drug effect of 4975 during the first week when the pain should be the most intense. The pain scores were sufficiently low on the visual analog scale (VAS) of one to 100 (4975 group = 14.4, placebo group = 17.5) that most clinicians would deem there to be clinically insignificant pain or no pain at all.”
This small pilot Phase 2 study is one of multiple Phase 2 studies of 4975 either ongoing or completed that are evaluating the use of this long-acting, non-opioid for pain management in several different indications, of which five already have demonstrated significant pain reduction and a favorable safety profile. The indications include tendonitis of the elbow, post-surgical pain in patients undergoing bunionectomy and neuropathic foot condition Morton’s neuroma. Phase 2 studies of 4975 for total knee replacement and cholecystectomy have completed enrollment, and data are expected in the second quarter of 2006.
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.
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, 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, 4975 may have the potential to reduce length of hospital stay and the need for opioids.
About Inguinal Hernia Repair
A hernia develops when the outer layers of the abdominal wall weaken, bulge, or actually rip. The hole in this outer layer allows the inner lining of the cavity to protrude and to form a sac. Most hernias in adults result from strain on the abdominal muscles, which have been weakened by age or by congenital factors. Inguinal (groin) hernias account for 80 percent of all hernias and are more common in men than women-about 25 percent of men and two percent of women develop an inguinal hernia in their lifetime. In surgical repair, an incision is made over the hernia and the bulging tissue or organ is replaced inside the muscle wall, and a mesh is applied over the weakness and sewn in place. Over half a million operations to repair hernias were done in the U.S. last year, the vast majority of which were done under local anesthesia.
About Corgentech
Corgentech is a late-stage biopharmaceutical company focused on the development and commercialization of novel therapeutic treatments for pain management and inflammation. The company has drug candidates in mid- to late-stage clinical trials for multiple potential indications, the most advanced of which has completed Phase 3 clinical trials and is expected to be submitted for FDA approval in mid-2006. Corgentech is based in South San Francisco, CA. For more information on the company, please visit www.corgentech.com.
Forward Looking Statements
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Corgentech Inc.
CONTACT: Jennifer Cook Williams of Corgentech Inc., +1-650-624-9600, orinvestors@corgentech.com; or Daryl Messinger of WeissComm Partners,+1-415-999-2361, or daryl@weisscommpartners.com, for Corgentech Inc.
Web site: http://www.corgentech.com/
