NY-198, A new oral chemotherapeutic drug, in urinary tract and urogenital infections

We performed basic and clinical studies on a new oral antimicrobial compound, NY-198, and obtained the following results. 1. Diffusion into human prostatic fluid (PF): drug concentrations in PF were 0.43±0.16 μg/ml (n=4) and 1.05±0.02 μ/ml (n=2) at 1 and 2 hours after 200 mg administration. The PF/serum ratio was 0.98±0.08 at 2 h after administration of 200 mg. 2. Clinical results: 38 patients with urological infection were treated with NY-198 at 200-600mg per day for 3-5 days. 1) Uncomplicated UTI: 9 patients were given NY-198 orally at 200 mg per day for 3 days. Of 7 cases evaluated by the Japanese UTI Committee's criteria, results were all excellent or moderate. 2) Complicated UTI: Of 24 cases evaluated by the UTI criteria, results were excellent in 9, moderate in 7 and poor in 8 cases, with an efficacy rate of 66.7%. Most of the cases with poor results were infected by P. aeruginosa, S. marcescens and E. faecalis and had an indwelling catheter. 3) Uro-genital infection: Of 4 patients with uro-genital infection, 2 with bacterial prostatitis in which E. coli were isolated, were excellent, and 2 with acute epididymitis were good. 4) Safety: in laboratory tests, elevated GOT, GPT and Al-P were observed in 1 case and eosinophilia in another. But these abnormal values were slight and transient. As side-effects, dizziness in 1 case, headache with slight dizziness in 1 and irregular menstruation in 1 occurred transiently. All these normalized after discontinuance of the drug. 5) Conclusion: NY-198 was found to be a useful antimicrobial with efficacy and safety comparable to other new quinolones. But further discussion and study of its in vivo activity and long half-life is necessary.