Investigators at Roche and Genentech are preparing an in-depth analysis of a fresh crop of mid-stage data on Curis's GDC-0449, with an eye to determine whether the therapy should make the cut for ovarian cancer--less than two months after the same therapy flunked its mid-stage trial for colon cancer.
"Following these analyses," wrote Curis (CRIS) in a clinical update, "they (Roche and Genentech) expect to make a portfolio decision regarding whether, or to what extent, they will continue development of GDC-0449 in advanced ovarian cancer." That's not exactly what Curis investors wanted to hear, and the news helped drag the battered stock down by 17 percent in premarket trading.
Two months ago the closely-watched drug-which blocks the Hedgehog signaling pathway--failed a mid-stage trial for colorectal cancer. That was one of several studies mounted for Curis's lead drug. And the developer once again tried to keep its focus on the positive.
"While we await the final analysis of the data from this advanced ovarian cancer study, we remain optimistic about the continued evaluation of GDC-0449 in tumors such as basal cell carcinoma," said Curis CEO Dan Passeri. "Genentech and Roche have completed enrollment in a pivotal Phase II trial in advanced basal cell carcinoma, a use for which proof of concept has already been demonstrated in a Phase I clinical study. In addition, Roche has indicated that it expects to initiate a Phase II clinical trial in operable basal cell carcinoma patients during the second half of 2010 which we believe, assuming positive data, could expand the commercial opportunity of GDC-0449 in basal cell carcinoma."
- see the Curis release
- read the Reuters story