Pressing into Phase III
Three small companies last week moved products into Phase III testing: Aeterna Laboratories Inc.'s Neovastat (AE-941) angiogenesis inhibitor to treat renal cell carcinoma, Cellegy Pharmaceuticals Inc.'s Anogesic nitroglycerin to treat chronic anal fissures and Genta Inc.'s G3139 antisense agent against Bcl-2 to treat malignant melanoma. However, based on experience to date with the compounds, it is not clear how much risk has been taken out prior to Phase III.
In CLGY's previous 304-patient Phase III trial, Anogesic failed to meet its primary end point of complete fissure healing, as 44 percent of treated patients had a complete cure at the most effective dose while a similar percentage of placebo patients also were cured (see BioCentury, Dec. 6, 1999). In that trial, Anogesic did show a significantly greater rate of decrease in pain versus placebo (p<0.0002), a secondary end point...