Kalypsys Inc. announced the initiation of a Phase IIa clinical trial of KD7040, an inducible nitric oxide synthase (iNOS) inhibitor formulated as a topical gel, for the treatment of postherpetic neuralgia (PHN).

Kalypsys will conduct a double-blind, placebo-controlled trial, which will enroll approximately 50 patients at 12-15 centers in the United States, to demonstrate proof-of-concept for KD7040 as a treatment for neuropathic pain. Trial participants, who have had PHN-related pain of moderate-to-severe intensity for at least three months, will receive KD7040 or placebo for a period of 14 days. The endpoints of the trial include assessment of changes in worst and average daily pain scores, as well as impact on sleep, mood and function.

"KD7040 topical gel is our most advanced compound from a broad portfolio that we are building to create long-term value through the discovery and development of treatments for pain and inflammation," noted Paul Grint, M.D., chief medical officer for Kalypsys. "Over the course of 2007 this project has moved in rapid progression from first-in-human studies to the initiation of the Phase II study. This progress demonstrates the quality and speed with which Kalypsys is bringing novel therapeutic candidates forward for the treatment of chronic pain conditions."

August Watanabe, M.D., vice chairman of Kalypsys, added, "While our initial focus is on the investigation of the therapeutic effects of the topical gel on PHN, we believe that KD7040 has potential in other indications. Therefore, KD7040 has a profile that fits nicely into a franchise focused on underserved chronic pain markets."

About KD7040

KD7040 topical gel is an internally discovered, proprietary, potent and selective iNOS dimerization inhibitor. It has been optimized to deliver efficacious doses of drug into the skin with minimal systemic exposure.

About PHN

PHN is a chronic pain condition that may complicate an outbreak of herpes zoster (shingles). It afflicts more than 500,000 people in the United States. Patients with shingles generally develop a blistering rash that clears up over several weeks. PHN occurs when nerve fibers in the skin are damaged during a shingles episode, resulting in a localized, painful condition in the absence of apparent skin damage. Pain may be intense and interfere with daily activities and sleep. This complication particularly afflicts older adults, who are at greater risk of both developing shingles and subsequent PHN. Currently available treatments for PHN include topical medications, tricyclic antidepressants and antiseizure medications.

About Kalypsys

Kalypsys is a San Diego-based pharmaceutical company that is changing the way drugs are discovered and developed. Kalypsys seamlessly integrates its scientific expertise and technologies to develop small molecule drugs in a fast, efficient and effective manner. The company's discovery and clinical pipeline consists of drugs that target pain/inflammation and cardiovascular/metabolic diseases. In addition to focusing on its own products, Kalypsys partners with top-tier pharmaceutical companies to rapidly advance the identification, development and commercialization of new therapeutics.