Roche tells Curis that Ph II data on GDC-0449 in advanced ovarian cancer needs additional investigation

US drug developer Curis says that it has received preliminary results from a Phase II clinical trial of GDC-0449 from US biotechnology major Genentech its parent company Switzerland's Roche, Curis' collaborator on the investigational compound, leading to questions about further development of the product. The news saw Curis' shares slump 17% to $ 1.45 in pre-marketing trading yesterday, though picking up some of the loss by mid-afternoon to $1.52.

GDC-0449, a first-in-class Hedgehog pathway inhibitor, was tested by Roche and Genentech as a single agent maintenance therapy for ovarian cancer patients in their second or third complete remission from the disease. Roche has informed Curis that preliminary findings from the primary analysis of the study warrant additional investigation to clarify and interpret potential clinical activity of the drug candidate observed in this trial. Accordingly, Roche and Genentech have indicated that they plan to further analyze the data, including subset analyses in the coming months. Following these analyses, they expect to make a portfolio decision regarding whether, or to what extent, they will continue development of GDC-0449 in advanced ovarian cancer.

No obvious new safety signals were observed in patients treated with GDC-0449. It is expected that data from this Phase II study will be submitted for presentation at an upcoming medical meeting.