PARIS - NicOx SA reported ''encouraging'' preliminary results from a Phase IIa clinical trial of its nitro-flurbiprofen derivative HCT-1026, a nitric-oxide releasing, non-steroid anti-inflammatory (NO-NSAID).
The trial is being carried out at two centers in France on patients suffering from urinary incontinence associated with a neurogenic bladder due to a lesion of the spinal cord, and the initial results showed an "improvement in the urodynamic parameters and clinical symptoms," as well as demonstrating the product's "safety and excellent tolerability," claims the company, which is based in Sophia-Antipolis in southern France.
Another Phase II clinical trial of the drug has just started at King's College hospital in London. The randomized, double-blind, placebo-controlled, crossover trial is to be carried out on 24 patients with symptoms of urinary frequency and urgency, with or without urinary incontinence (overactive bladder).
In addition, AstraZeneca has started a Phase I clinical trial of another NO-SAID developed by NicOx, HCT-3012, triggering the payment of a $2 million milestone to NicOx. Under a licensing and development agreement signed between two companies in September 1998, AstraZeneca is to develop a series of NO-NSAIDs licensed to it by NicOx for the treatment of pain and inflammation. The agreement gives AstraZeneca an exclusive license to market the drugs in all countries except Japan.
The double-blind, placebo-controlled trial, which is being conducted in Sweden, will evaluate the safety and tolerability of HCT-3012 in 60 healthy volunteers. In earlier animal studies, the compound was found to have a more effective anti-inflammatory and analgesic profile than existing NSAIDs, as well as excellent gastric, renal and cardiovascular safety.
The CEO of NicOx, Michele Garufi, expects HCT-3012 to be the first of the company's products to complete clinical development. The company's hope is that the drug will be on the market by 2005, and that it will be followed by HCT-1026 the following year. Garufi is expecting HCT-3012 to ''generate very significant revenues for NicOx,'' given that the world pain and inflammation market is now worth almost $20 billion a year.