Exelixis has been cleared by the FDA to begin a new trial of XL999 for non-small cell lung cancer. The clinical trial will evaluate XL999 in patients with NSCLC who have failed at least one previous therapy. Exelixis said that the results from this Phase I clinical trial could provide Exelixis with the opportunity to move directly into a late stage clinical trial if XL999 demonstrates anti-tumor activity with an acceptable side-effect profile. The FDA had put a partial hold on the development program last December after researchers reported data on adverse cardiovascular events in early and mid-stage studies.
"We have worked closely with the FDA to reinitiate the clinical development of XL999 and believe that the approved protocol will enable us to assess both safety and preliminary anti-tumor activity of the compound in patients with NSCLC," said George A. Scangos, PhD, president and chief executive officer of Exelixis. "In the previous Phase II clinical trial of XL999 in NSCLC patients, nine patients participated, of whom two had partial responses and one had prolonged stable disease."
- check out the release on the XL999 trial