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|Infinity Reports Update from Phase 2 Study of Saridegib Plus Gemcitabine in Patients with Metastatic Pancreatic Cancer|
– Infinity Stops Phase 2 Study Following Preliminary Analysis Showing Trial Would Not Meet Primary Endpoint of Overall Survival –
– No Unexpected Adverse Events Observed in Study –
– Phase 2 Trials Exploring Distinct Biological Hypotheses in Myelofibrosis and Chondrosarcoma Continuing –
– Company to Host Conference Call Today at
While the final analysis is not complete, a preliminary analysis of data from the study that was completed yesterday showed a difference in survival favoring the placebo plus gemcitabine arm due to a higher rate of progressive disease in the saridegib plus gemcitabine arm. The median survival for patients receiving saridegib plus gemcitabine was less than the historical median survival for single-agent gemcitabine of approximately six months1,2, as compared to a median survival for the placebo plus gemcitabine arm of greater than six months. The adverse events observed in both arms were consistent with the known safety profile of each agent, with no unexpected toxicities. Based on this interim analysis, Infinity is voluntarily stopping the trial. The company expects to present the final data after the analyses are complete.
“While the outcome of this study is disappointing, we continue to
believe in the therapeutic potential of Hedgehog pathway inhibition. As
the Hedgehog pathway plays distinctly different biological roles in
myelofibrosis and chondrosarcoma, our Phase 2 trials in these disease
settings are ongoing,” stated
Infinity is conducting Phase 2 trials of saridegib as a single agent in myelofibrosis, an incurable malignancy of the bone marrow, and in chondrosarcoma, a rare and life-threatening cancer of the cartilage. Infinity expects to report data from its single-arm, exploratory Phase 2 trial of saridegib in up to 45 patients with myelofibrosis in the second half of 2012. The company expects to complete enrollment in its double-blind, randomized, placebo-controlled trial of saridegib in approximately 140 patients with metastatic or locally advanced, unresectable chondrosarcoma in the second half of 2012 and to report data from this trial in the first half of 2013.
Infinity has underway six clinical trials across three development programs, including saridegib, retaspimycin HCl (also known as IPI-504), a novel heat shock protein 90 inhibitor, and IPI-145, a potent, oral inhibitor of phosphoinositide-3-kinase delta and gamma. Infinity expects to report data from each of its three development programs in the second half of 2012.
“Despite the disappointment that this news represents, our financial
foundation combined with the strength of our pipeline and team enable us
to continue to invest in our pipeline of innovative product candidates,”
Infinity expects to provide updated financial guidance during its fourth quarter earnings call to be scheduled for later this quarter.
Saridegib Update on
Infinity’s planned review of the saridegib program on
Conference Call Information
Infinity will host a conference call on
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 focused on the inhibition of the Hedgehog pathway, heat shock protein 90 and phosphoinositide-3-kinase 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.
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 the expectation that Infinity
will report final data from the Phase 2 trial of saridegib; will report
data from each of its development programs in the second half of 2012,
including the ongoing Phase 2 trial of saridegib in patients with
myelofibrosis; will complete enrollment in the ongoing Phase 2 trial of
saridegib in patients with chondrosarcoma in the second half of 2012 and
report data from this trial in the first half of 2013; and will provide
updated financial guidance during its fourth quarter earnings call later
this quarter. 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 Infinity’s strategic alliance with Mundipharma
will continue for its expected term or that it will fund Infinity’s
programs as agreed, that any product candidate Infinity is developing
will successfully complete necessary preclinical and clinical
development phases, or that development of any of Infinity’s product
candidates will continue. Further, there can be no guarantee that any
positive developments in Infinity’s product portfolio will result in
stock price appreciation. Management’s expectations could also be
affected by risks and uncertainties relating to: Infinity’s results of
clinical trials and preclinical studies, including subsequent analysis
of existing data and new data received from ongoing and future studies;
the content and timing of decisions made by the
1 Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger
S, et al. Erlotinib plus gemcitabine compared with gemcitabine alone in
patients with advanced pancreatic cancer: a phase III trial of the
2 Seitz JF, Dahan L, Ries P. Pemetrexed in pancreatic cancer. Oncology 2004; 18(13 Suppl 8):43-7.