New data from a Phase 1 clinical trial combining TH-302 and pazopanib (Investigator Sponsored Trial 4001) in patients with advanced solid tumors will be presented in a poster session on Tuesday, October 22 (Abstract #C61). Updated data from a Phase 1/2 clinical trial combining TH-302 and sunitinib (Study 410) in patients with renal cell carcinoma, gastrointestinal tumors, or pancreatic neuroendocrine tumors will be presented in a poster session on Monday, October 21 (Abstract #B77). Emerging preclinical research suggests that anti-angiogenic therapy may increase tumor hypoxia. These two clinical trials further characterize the potential of combining TH-302 with anti-angiogenic agents.
The more interesting presentation is the pre-clinical data of TH-302 in pancreatic cancer when combined with Gem & Abraxane. Abraxane was just approved after a Phase-III trial showing a 1.8 month improvement in OS when combined with Gem vs Gem alone (OS improved from 6.7 months to 8.5 months). In the xenograft/mouse studies, Gem+Abraxane showed a complete response rate of 50%, while the Gem+Abraxane+TH-302 generated a 100% complete rate. Obviously, these xenograft study results don't translate directly to the clinic (otherwise the 50% of the patients in the Abraxane+Gem Phase III trial would have had complete responses), but if TH-302 can double the OS impact, it would still be meaningful. I assume there will be a Phase II study of TH-302+Gem+Abraxane done over the next year, so that by the time the Gem+TH-302 Phase III study is done, they will have a clinical dosing regime in place allowing doctors to add Abraxane "off label", so they don't have to choose which combo to use.