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news.The National Comprehensive Cancer Network (NCCN) has awarded a grant to assess the safety and efficacy of Threshold Pharmaceuticals' novel small molecule hypoxia-targeted prodrug - TH-302.
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The award has been granted to the Duke Cancer Institute Medicine associate professor Herb Hurwitz.
The Duke Cancer Institute plans to commence a Phase 1 clinical trial of TH-302 in combination with pazopanib (marketed by GlaxoSmithKline as Votrient) in various advanced solid tumors.
Threshold is currently evaluating TH-302 in a Phase 2 controlled clinical trial in patients with advanced pancreatic cancer.
It plans to initiate a pivotal Phase 3 trial in patients with soft tissue sarcoma in 2011 under a Special Protocol Assessment agreement with the US Food and Drug Administration.
Hurwitz said the team at Threshold has shown that TH302 not only augments the anti-tumor effects of two different anti-VEGF inhibitors (sunitinib and sorafenib) in animal xenograft models, but that the added benefit was directly related to the amount of hypoxia induced by different doses of those drugs.
"Thus targeting the hypoxic compartment of the tumor may be highly complementary to targeting VEGF and may result in greater anti-tumor effects. This concept needs testing in patients," Hurwitz said.
"Our study is one of the first steps in that process; we will test whether the combination of pazopanib and TH302 is safe and whether there are suggestions of anti-tumor activity in patients with advanced cancer."