NicOx says first phase 3 trial of HCT 3012 for osteoarthritis of knee underway

By E. Janene Geiss

Philadelphia, Dec. 20 - NicOx SA announced Tuesday the start of the first phase 3 trial for HCT 3012 in patients with osteoarthritis of the knee.

Patient screening has begun at the first set of clinical centers and the majority of sites are expected to be initiated by the end of January, according to a company news release.

The trial will involve about 120 clinical study sites and 820 patients in the United States. Results are anticipated in the fourth quarter of 2006, officials said.

This represents the first study in the planned phase 3 program for HCT 3012, a novel, proprietary, nitric oxide-donating derivative of naproxen, which NicOx aims to develop as the drug of choice for osteoarthritis patients, particularly those with coexisting hypertension (high blood pressure).

The trial is designed to demonstrate that HCT 3012 is superior to placebo and as effective as naproxen in relieving the signs and symptoms of osteoarthritis, in addition to showing that HCT 3012 has no detrimental effect on blood pressure, officials said.

An estimated 43 million people suffer from arthritis in the United States and that number is expected to rise to 59 million by 2020, officials said. Arthritic conditions account for the majority of the prescriptions for non-steroidal anti- inflammatory drugs (NSAIDs) and COX-2 inhibitors. These agents recently have been linked to an increased risk of cardiovascular adverse events, which may be partially due to their propensity to increase blood pressure and interfere with antihypertensive medication, officials said

An additional trial is expected to start during the first half of 2006, which will employ ambulatory blood pressure monitoring to provide a description of the blood pressure profile of HCT 3012 and naproxen over a 24-hour period in hypertensive subjects.

"We believe HCT 3012 has the potential to play a major role in the anti-inflammatory market. Our view is that HCT 3012 could become the reference drug for millions of osteoarthritis patients with hypertension if this phase 3 program is successful in confirming its lack of interference with blood pressure," Michele Garufi, chairman and chief executive officer, said in the release.

NicOx is a Sophia Antipolis, France, biopharmaceutical company focused on the development of nitric oxide- donating drugs to meet unmet medical needs.

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