BioWorld International Correspondent

PARIS - NicOx SA initiated two large-scale clinical trials in the U.S. to assess the blood pressure profile of naproxcinod in comparison to ibuprofen and naproxen, utilizing the ambulatory blood pressure monitoring technique.

The separate studies, which will last 12 weeks and 16 weeks, respectively, will involve a total of about 420 osteoarthritis patients with controlled hypertension, and the results are due in the fourth quarter.

Naproxcinod is the leading COX-inhibiting nitric oxide-donating anti-inflammatory agent being developed by NicOx, of Sophia-Antipolis, France, and is currently in Phase III clinical development for the treatment of the signs and symptoms of osteoarthritis.

The results of the last two Phase III trials are due in the second half of this year.

Osteoarthritis sufferers currently use nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, to control their chronic pain, inflammation and stiffness.

But while those products bring a significant improvement in patients' quality of life, they tend to raise blood pressure to an extent that increases the risk of adverse cardiovascular events.

"Our development program for naproxcinod aims to address the safety concerns surrounding anti-inflammatory agents and blood pressure, which represent a serious medical issue," explained Pascal Pfister, NicOx' chief scientific officer and head of research and development.

"Previous studies . . . have suggested that naproxcinod may have an improved blood pressure profile compared to existing anti-inflammatory drugs," he noted.

According to Staffan Strömberg, NicOx' vice president of drug development, naproxen was chosen as the comparator because of its well-established anti-inflammatory efficacy and its perception as the least risky of existing NSAIDs, in terms of blood pressure and cardiovascular safety.

NicOx also has reported an increased net loss of €32.1 million (US$48.8 million) for 2007, up from €24.7 million in 2006, despite the fact that revenues more than doubled from €9.6 million to €20.6 million from one year to the next.

That was due essentially to the receipt of two €5 million milestone payments from Merck & Co. Inc., of Whitehouse Station, N.J., under the collaboration agreement the two companies signed in March 2006 for the development of new antihypertensive drugs using NicOx' nitric oxide-donating technology.

Operating costs increased to €57.8 million last year from €36.3 million in 2006 due to the intensification of the company's clinical development program, especially for naproxcinod.

Its research and development outlays in particular rose by 62.6 percent, from €28.6 million in 2006 to €46.5 million in 2007.

As a result, the company's net burn rate rose to €29.5 million last year from €17.8 million the year before.

Thanks to the €120.7 million capital increase completed in February 2007, the company had cash and cash equivalents of €143.4 million at the end of 2007, up from €54.1 million a year earlier.