Roche preps vismodegib app with "profound" efficacy data

Armed with positive data from a pivotal Phase II trial, Lexington, MA-based Curis is waiting for its partner Roche to begin its long-awaited pitch to gain FDA approval for a new treatment for advanced basal cell carcinoma. Curis has been on a lengthy clinical journey with vismodegib, as Xconomy's Arlene Weintraub outlines in her in-depth article.

Focused on the hedgehog signaling pathway, investigators reported recently 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. The drug works by inhibiting hedgehog, and Roche's Genentech has been working with the National Cancer Institute to see if the same approach has applications in other cancers as well.

"The data was very profound in terms of the drug being able to hold this cancer at bay," Curis CEO Daniel Passeri tells Xconomy. And now Passeri says that the two companies have solid reasons to believe they can gain an approval in 2012. For its next development act Curis plans a combo approach to attack cancer from three different angles, an increasingly popular strategy in the cancer field.

- here's the article from Xconomy

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