March 14, 2006
Taisho Pharmaceutical Co., Ltd. [Headquarter: Toshima-ku, Tokyo, President: Akira Uehara] (hereinafter, Taisho) and Nissan Chemical Industries, Ltd. [Headquarter: Chiyoda-ku, Tokyo, President: Nobuichiro Fujimoto] (hereinafter, Nissan Chemical) announced that the Phase IIb clinical study of NM-702 (development code in Japan: NT-702), which was conducted in the USA, yielded positive results. Taisho and Nissan Chemical have been jointly developing NM-702, a drug for the treatment of arteriosclerosis obliterans.
The Phase IIb study of NM-702 for the treatment of intermittent claudication was conducted in the USA, and the results support drug efficacy. The study enrolled 391 patients, and the patients were assessed after six months of therapy. Compared to the placebo, NM-702 demonstrated a statistically significant increase in patients' Peak Walking Time, the study's primary endpoint. Results of secondary endpoints were also supportive of NM-702 efficacy.
NM-702 (NT-702), which Taisho and Nissan Chemical are developing in Japan and the USA, is an orally active inhibitor of phosphodiesterase and thromboxane synthetase. In Japan, three Phase II studies are being conducted for intermittent claudication caused by arteriosclerosis obliterans, intermittent claudication caused by stenosis of the lumbar spinal canal, and bronchial asthma. The companies are seeking development and marketing partners for NM-702 for regions outside Japan.
Intermittent claudication is a major symptom of arteriosclerosis obliterans. It is caused by insufficient oxygen supply to exercising muscles in the lower extremities due to decreased blood flow. It is estimated that 5.6 million people suffer from intermittent claudication in the USA, with only 10% of these people currently receiving treatment. Furthermore, there are only a few effective drugs in this field, and Taisho and Nissan Chemical believe NM-702 will greatly contribute to the treatment of intermittent claudication.