IntraBiotics has mixed news on IB-367 Rinse

IntraBiotics Pharmaceuticals has suffered a setback in a Phase IIIclinical trial of IB-367 Rinse, its novel Protegrin antibiotic, but does not expect to see a delay in the completion of the study. However, the statistical power of the trial has been compromised, increasing the possibility that it will be unable to reveal a significant benefit for the antibiotic over placebo.

The problem stems from an error by a subcontractor that resulted in the incorrect dispensing of a portion of clinical supplies during a trial looking at the efficacy of the product in preventing oral mucositis in patients receiving chemotherapy for cancer. In effect, some 102 patients in the 331-patient study may have been switched between active drug and placebo and so will have to be excluded from statistical analysis.

Faced with the choice between enrolling new patients into the study and taking the gamble that the lower statistical power would not affect the result, IntraBiotics chose the latter option, noting that increasing enrollment would have resulted in a delay in completion of three to four months and a significant increase in costs. The trial will be completed in the second quarter, on schedule, said chief executive Ken Kelley.