Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it has initiated two Phase 1 clinical trials of IPI-145, a potent, orally available inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma. These two enzymes are implicated in hematologic cancers as well as a broad range of inflammatory conditions, which are the areas of focus within Infinity's PI3K clinical development program.
“We have started seven clinical studies in 2011, an accomplishment that we believe underscores the productivity of our R&D organization, highlights our commitment to developing therapies for underserved diseases and increases our potential for long-term growth and success.”
PI3K delta and gamma are involved in key immune cell functions, including cell proliferation, survival and cellular trafficking. Due to their critical role in the development and maintenance of certain cancers and inflammatory diseases, inhibiting the function of PI3Ks is an increasingly important focus within the medical research community. IPI-145 is currently the only PI3K delta/gamma inhibitor in clinical development. IPI-145 was licensed from Intellikine, Inc. and is part of Infinity's strategic alliance with Mundipharma International Corporation Limited.
"There have been compelling clinical data showing that PI3K delta inhibition may provide a therapeutic benefit in patients with hematologic malignancies, in addition to our own preclinical data of IPI-145 showing activity in several models of inflammatory disease," stated Pedro Santabárbara, M.D., Ph.D., chief medical officer at Infinity. "We believe the potency of IPI-145 against both PI3K delta and gamma may provide an advantage over other PI3K inhibitors currently in development. We look forward to evaluating data from these Phase 1 trials, which will guide our Phase 2 development plans for IPI-145."
The first Phase 1 trial of IPI-145 is a double-blind, randomized, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of IPI-145 in healthy adult subjects.
The second Phase 1 trial is an open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics and clinical activity of IPI-145 in patients with advanced hematologic malignancies. Following the determination of the maximum tolerated dose in the dose escalation phase, an expansion phase will follow in patients with selected hematologic malignancies.
"The initiation of these Phase 1 trials of IPI-145 marks the achievement of a key development objective for Infinity this year," stated Adelene Q. Perkins, president and chief executive officer at Infinity. "We have started seven clinical studies in 2011, an accomplishment that we believe underscores the productivity of our R&D organization, highlights our commitment to developing therapies for underserved diseases and increases our potential for long-term growth and success."
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