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Genentech aBCC Drug Meets Phase II Endpoint

Genentech’s Phase II study of its investigational Hedgehog Pathway Inhibitor, vismodegib (RG3616/GDC-0449), showed positive results in people with advanced basal cell carcinoma (aBCC), a severe form of skin cancer.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Genentech’s Phase II study of its investigational Hedgehog Pathway Inhibitor, vismodegib (RG3616/GDC-0449), showed positive results in people with advanced basal cell carcinoma (aBCC), a severe form of skin cancer. The study met its primary endpoint, showing vismodegib shrank tumors in a pre-defined percentage of people in the study. A preliminary safety assessment showed the most common adverse events were consistent with previous vismodegib studies.

“These results are important because people with this disfiguring and potentially life-threatening advanced form of skin cancer currently have no approved treatment options,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We look forward to presenting the study data in more detail and discussing the results with global health authorities.”

The Hedgehog signaling pathway plays an important role in regulating proper growth and development. Mutations in the pathway that reactivate Hedgehog signaling are seen in several different types of cancer. Abnormal signaling in the Hedgehog pathway is implicated in the majority of BCC cases.

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