Roche preps vismodegib app after Ph2 skin cancer success

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Roche and Genentech have posted a fresh set of promising mid-stage data on vismodegib, a cancer drug it's collaborating on with Lexington, MA-based Curis. In what investigators describe as a pivotal Phase II study, there was an overall response rate of 55 percent among the advanced basal cell carcinoma patients taking the drug. And Roche says the data is good enough to take to the FDA latest this year in search of an approval.

Researchers said that vismodegib (GDC-0449) "substantially shrank tumors or healed visible lesions, with observed response rates of 43 percent of patients" in one cohort comprised of locally advanced BCC and 30 percent of patients in metastatic cohort. Vismodegib is designed to selectively inhibit signaling in the Hedgehog pathway by targeting a protein called Smoothened.

"We believe that the strength of the data generated in this clinical study, including the overall response rates observed, demonstrate the potential for vismodegib to have a compelling clinical benefit in treating advanced BCC patients," said Curis CEO Dan Passeri. "Vismodegib has the potential to be an important new treatment for cancer patients with this debilitating condition and we are pleased to see the molecule reach this critical stage of development."

Genentech says it discovered vismodegib, which was then jointly validated by Genentech and Curis through a series of preclinical studies. Genentech is developing vismodegib under a collaboration agreement with Curis. Curis is eligible to receive payments upon the certain milestones and royalties upon potential commercialization of vismodegib.

The data builds on Genentech's Phase II study of the drug in inoperable BCC patients. Investigators reported last March that vismodegib met its primary goal of shrinking tumors of a certain percentage of patients. This was good news after the drug flunked in mid-stage studies Genentech conducted in patients with ovarian and colorectal cancers last year. Curis, which does not yet have a drug on the market, is eligible for up to $115 million in milestone payments through this program with Roche/Genentech as well as single-digit royalties on potential sales. But Roche has tried for an approval on Phase II data before without success. The FDA handed back its application on T-DM1 after regulators said they needed to see more data.

- read the Curis release
- here's the Reuters story 

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