CeNeS and Ergomed begin Ph II CNS 5161 trial recruitment

UK-based biopharmaceutical firm CeNeS Pharmaceuticals and Germany's Ergomed has begun recruitment into a Phase II study of the candidate pain medication CNS 5161. The drug, which is being co-developed by the firms under an agreement signed last year (Marketletter July 24, 2006), is intended to treat pain associated with cancer.

Specifically, the Phase II trial is a dose-escalation assessment designed to establish the maximum-tolerated dose and analgesic efficacy of CNS 5161 in late-stage cancer patients. The program, which will be conducted at a range of specialist oncology clinics in Europe, will seek to enroll 36 patients who will receive intravenous administrations of increasing doses of the drug, at four-hour intervals, in combination with opioids.

The firms said that the trial will correlate any changes in pain levels with serum concentration of CNS 5161, and is expected to produce results in the first half of next year.