Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that a pivotal Phase II clinical study of its investigational Hedgehog Pathway Inhibitor, vismodegib (RG3616/GDC-0449), showed positive results in people with advanced basal cell carcinoma (aBCC), a particularly severe and debilitating form of skin cancer. The study met its primary endpoint (overall response rate), of 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 experience with vismodegib. A detailed safety assessment is ongoing.
“We look forward to presenting the study data in more detail and discussing the results with global health authorities.”
"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."
Data from the study will be submitted for presentation at a future medical meeting.
The Hedgehog signaling pathway plays an important role in regulating proper growth and development in the early stages of life and then becomes less active in adults. However, 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.
In order to provide people with aBCC access to vismodegib while Genentech discusses next steps with the U.S. Food and Drug Administration, the company is conducting an expanded patient access study in the United States. For more information, patients and doctors can contact the Genentech clinical trial call center at 888-662-6728 or visit http://www.clinicaltrials.gov.
Genentech is also evaluating vismodegib in a Phase II trial in people with operable forms of BCC, which opened in October 2010.
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