>>Infinity and MedImmune Receive Orphan Drug Designation for IPI-504 for Treatment of Gastroinstestinal Stromal Tumors
Monday September 17, 9:00 am ET
CAMBRIDGE, Mass. and GAITHERSBURG, Md., Sept. 17, 2007 (PRIME NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (NasdaqGM:INFI - News) and MedImmune today announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development has granted IPI-504 orphan drug designation for the treatment of gastrointestinal stromal tumors (GIST). IPI-504, the companies' heat shock protein 90 (Hsp90) inhibitor, is currently being evaluated in two separate multi-center clinical trials in patients with GIST and other soft tissue sarcomas (STS), and in patients with non-small cell lung cancer.
``The orphan drug designation granted to IPI-504 is a significant regulatory milestone for Infinity and MedImmune,'' said Julian Adams, Ph.D., President and Chief Scientific Officer of Infinity. ``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 anti-cancer 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(r)-resistant GIST and STS. As measured by RECIST criteria, 16 of 21 evaluated patients (76 percent) 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 1, 4, 8, and 11, followed by 10 days off treatment (Schedule A). 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 percent) 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, and have initiated the expansion phase of the trial at 400 mg/m2 on Schedule A. In this expansion phase, 20 additional patients will be evaluated to further characterize safety and biological activity of IPI-504.
About Orphan Drug Designation
Orphan drug designation is granted by the FDA to products that are used to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. The designation allows Infinity and MedImmune FDA protocol assistance to optimize drug development; reduced fees associated with applying for market approval; and the right to seven years of market exclusivity after market approval for the use of IPI-504 in the treatment of GIST.
About IPI-504
IPI-504 is a small molecule drug candidate being developed jointly by Infinity and MedImmune. IPI-504 has been well-tolerated in its ongoing Phase I studies and has shown promising biological activity in a Phase I clinical trial in patients with relapsed, refractory Gleevec(r)-resistant GIST. IPI-504 is also being evaluated in a Phase I/II clinical trial in patients with advanced non-small cell lung cancer. In preclinical studies, IPI-504 has been shown to inhibit Hsp90 potently and selectively, thereby killing cancer cells. IPI-504 has also demonstrated, in preclinical studies, broad potential to treat certain cancers as both a single agent as well as in combination with existing anti-cancer drugs. The water-based formulation of IPI-504 is delivered as an intravenous infusion. Infinity and MedImmune are currently developing and evaluating two oral Hsp90 inhibitors, which have both demonstrated potent and selective inhibition of Hsp90 in preclinical models.
About Gastrointestinal Stromal Tumors (GIST) and Hsp90
The American Cancer Society (ACS) reports that GIST is the most frequent form of gastrointestinal sarcoma, a life-threatening disease highly resistant to traditional cytotoxic chemotherapy or radiation treatment. The ACS estimates that between 4,500 and 6,000 Americans develop GIST each year. In the majority of GIST cases, specific mutations in cellular signaling enzymes (``kinases'') called KIT or PDGFRA cause the growth and survival signal of the cell to become permanently active, leading to cancer. Both KIT and PDGFRA are client proteins of Hsp90, suggesting that inhibition of Hsp90 in GIST is an attractive area for clinical study.
About Infinity - MedImmune Collaboration
In August 2006, Infinity and MedImmune entered into an agreement to jointly develop and commercialize novel small molecule cancer drugs targeting Hsp90, including IPI-504 and IPI-493, as well as those targeting the Hedgehog cell signaling pathway, including IPI-926.<<
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For some reason, this has just tanked the stock, after it was up during the morning. I've been buying some on the recent weakness. All times lows just now, I think.
Cheers, Tuck |
