The candidate, IPI-504, currently being evaluated in two separate multi-center clinical trials in patients with gastrointestinal stromal tumors (GIST) and other soft tissue sarcomas (STS), and in patients with non-small cell lung cancer.
Julian Adams, president and CEO of Infinity, said: “The orphan drug designation granted to IPI-504 is a significant regulatory milestone for Infinity and MedImmune. We are encouraged by the growing body of clinical data on IPI-504 and are working diligently with key opinion leaders and the FDA to accelerate the development of our lead anticancer agent. We intend to move expeditiously through the regulatory process in the effort to rapidly bring IPI-504 to patients.”
At ASCO in June 2007, Infinity and MedImmune provided updated preliminary data from the open-label Phase I study of IPI-504 in patients with relapsed, refractory Gleevec-resistant gastrointestinal stromal tumors (GIST) and soft tissue sarcomas (STS).
As measured by RECIST criteria, 16 of 21 evaluated patients (76%) had a best response of stable disease. The companies also assessed positron emission tomography (PET) response on a 21-day cycle with patients treated on days one, four, eight, and 11, followed by 10 days off treatment.
PET response was measured using the European Organization for Research and Treatment of Cancer's (EORTC) criteria that entail a quantitative measurement using SUVmax (maximum standardized uptake value). As reported, 15 of 18 evaluated patients (83%) achieved partial response or stable disease by EORTC PET response criteria.
In addition, the companies have now completed the dose escalation portion of the Phase I trial in patients with GIST/STS. In this expansion phase, 20 additional patients will be evaluated to further characterize safety and biological activity of IPI-504.