Icagen: Extension study of sickle cell drug ICA-17043 shows long-term safety data

By E. Janene Geiss

Philadelphia, Oct. 19 - Icagen, Inc. reported that the open label extension study to its phase II study of ICA-17043 for the treatment of sickle cell anemia showed the drug's long-term safety.

According to a company press release, officials said that because the study did not include a placebo control arm, it was difficult to detect improvements in crisis rate in the 44 patients that participated.

The study also showed a consistent pattern of improvement in hematologic parameters observed during the phase II study.

"This study provides important long-term safety data, which further supports the favorable safety and tolerability profile of ICA-17043 that we have observed to date," P. Kay Wagoner, president and chief executive officer, said in the release.

The open label extension study provided a daily dose of 10 mg of ICA-17043 for up to 48 weeks beyond completion of the initial 12-week phase II trial. Forty-four patients of 56 eligible enrolled with 32 patients completing the study. Without a placebo, the study was conducted primarily to evaluate further the long-term safety and evaluate descriptive evidence of efficacy. No formal statistical tests were performed, officials said.

Only two patients discontinued participation as a result of adverse events that were considered possibly related to the medication, officials said.

Icagen, a biopharmaceutical company based in Research Triangle Park, N.C., is focused on the discovery, development and commercialization of novel orally-administered small molecule drugs.

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