Melacine: Phase III data; marketed in Canada

CRXA said that its Phase III trial of 253 patients with Stage IV metastatic melanoma showed no overall survival advantage for the combination of Melacine plus Schering-Plough Corp.'s Intron A interferon alfa-2b compared to Intron A alone. Response rates, including both complete and partial responses, were 8-10 percent in both groups. However, CRXA said women receiving the combination treatment survived longer than women treated with Intron A alone (353 days versus 187 days, p=0.018), and of the women who responded, the median duration of response was 668 days in the combination group versus 157 days in the Intron A monotherapy group. CRXA said it will discuss the Phase III data with the FDA in September and following that meeting may proceed with a BLA submission for the product.

Separately, additional data from CRXA's Phase III trial of 689 patients with Stage II melanoma who received Melacine or observation alone following surgical removal of their tumors showed that median duration of disease free survival improved with Melacine treatment in patients whose tumors were ?3 mm thick at baseline (p=0.018) (see BioCentury, Feb. 22). ...