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|Infinity and Mundipharma Extend Global Strategic Alliance|
– Mundipharma Commits to Providing Over
“Mundipharma’s substantial financial commitment to our PI3K and discovery programs through at least 2013 demonstrates our shared belief that, with key clinical events anticipated in 2012, we are building one of the broadest, deepest and most exciting pipelines of any clinical-stage company in oncology and inflammation,” stated Adelene Q. Perkins, president and chief executive officer of Infinity. “Mundipharma has been a wonderful partner, and we are pleased to continue our relationship as we work to bring important new medicines to patients.”
“Since our alliance began in 2008, Infinity has advanced and expanded
its portfolio of innovative product candidates,” said
IPI-145 targets PI3K-delta and gamma, two enzymes that are implicated in hematologic cancers as well as a broad range of inflammatory and autoimmune diseases. As the only PI3K delta/gamma inhibitor currently in clinical development, IPI-145 is distinct from other investigational drugs targeting PI3K and has significant potential in both hematologic cancers and inflammatory diseases.
“The unique profile of IPI-145 provides us potential first-in-class or
best-in-class product opportunities in multiple indications. The potent
activity of IPI-145 against both PI3K-delta and gamma could enable us to
see clinical activity against a broad range of hematologic malignancies,
including those that may not be suitable for a delta-specific PI3K
Infinity is currently conducting two Phase 1 clinical trials of IPI-145. The first trial, which is intended to facilitate Phase 2 clinical development of IPI-145 in inflammation, 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 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. Data from both of these studies are expected in 2012.
Beyond IPI-145, Infinity is advancing a broad research program to identify additional novel, differentiated inhibitors of PI3K-delta and/or gamma for future development. In addition, Infinity maintains a robust discovery effort to fuel its future pipeline in emerging areas such as cancer metabolism, apoptosis, protein homeostasis and inflammation. Mundipharma has non-U.S. commercial rights to all existing discovery programs and any new discovery programs added to Infinity’s portfolio before the end of 2013, subject to an obligation to fund Infinity’s research and development costs for these programs up to the start of Phase 3 clinical development.
As part of its strategic alliance with Mundipharma and its independent
Mundipharma is obligated to fund all research and development costs for
each of these programs up to the commencement of Phase 3 clinical
development or, if later, through the end of 2013, subject to annual
funding caps. The funding cap for calendar year 2012 is
As announced today, Mundipharma is now committed to funding over
In addition, in
Infinity is an innovative drug discovery and development company seeking to discover, develop and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity's programs in the inhibition of the Hedgehog pathway, the Hsp90 chaperone system, phosphoinositide-3-kinase and fatty acid amide hydrolase are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company's website at www.infi.com.
Forward Looking Statements
This press release contains forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995. These
statements involve risks and uncertainties that could cause actual
results to be materially different from historical results or from any
future results expressed or implied by such forward-looking statements.
Such forward-looking statements include those regarding the therapeutic
potential of inhibition of PI3K-delta and gamma, including the ability
of IPI-145 to be first- and best-in-class, the timing for receipt of
data from Infinity’s ongoing clinical studies, the expectation of an
expansion phase in the clinical trial of IPI-145 in patients with
advanced hematologic malignancies, and the ability of Infinity to
generate new development candidates out of its discovery programs. Such
statements are subject to numerous factors, risks and uncertainties that
may cause actual events or results to differ materially from the
company's current expectations. For example, there can be no guarantee
that IPI-145 will successfully complete necessary preclinical and
clinical development phases or that Infinity's strategic alliance with