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|Infinity Reports IPI-145 Phase 1 Data Showing Clinical Activity in B-Cell and T-Cell Malignancies at ASH Annual Meeting|
– Company Provides Anticipated PI3K Program Milestones –
– Company to Host Investor Reception and Webcast Monday Evening –
“Data from this Phase 1 trial of IPI-145 show good tolerability and
rapid clinical responses across a broad spectrum of difficult-to-treat
hematologic malignancies,” commented
“These results reinforce our enthusiasm for IPI-145. We believe that the
potency and activity of IPI-145 against both PI3K-delta and PI3K-gamma
contribute to its potential to become the best-in-class PI3K inhibitor
for the treatment of hematologic malignancies,” stated
IPI-145 Data Presented at ASH
The poster, “Clinical safety and activity in a Phase 1 trial of IPI-145,
a potent inhibitor of phosphoinositide-3-kinase (PI3K)-delta,gamma in
patients with advanced hematologic malignancies” (Abstract #3663),
includes 55 patients evaluable for tolerability and 41 patients
evaluable for clinical activity as of the
Tolerability and Pharmacokinetics
The Phase 1, open-label, dose-escalation trial of IPI-145 is designed to evaluate the safety, pharmacokinetics (PK) and clinical activity of IPI-145 administered orally twice daily (BID) in patients with advanced hematologic malignancies. The maximum tolerated dose has not been reached at doses up to 75 mg BID. Thus, the trial is ongoing, and patients are now being enrolled in a dose-escalation cohort evaluating IPI-145 at a dose of 100 mg BID.
Data presented today showed that IPI-145 was well tolerated to date, and there have been no dose-related trends in adverse events. The most frequent Grade 3 and Grade 4 adverse events were cytopenias and liver enzyme elevations, which were managed by dose interruption and dose reduction. Of the 55 patients evaluable for tolerability, three (5 percent of) patients discontinued treatment due to an adverse event. Sixty-seven percent of all patients remain on study, and 90 percent of patients who did not experience progressive disease after two cycles remain on study.
Data also showed that IPI-145 is rapidly absorbed and demonstrates a linear PK profile through all dose levels analyzed thus far. The PK data suggest that IPI-145 completely inhibits PI3K-delta, with increasing suppression of PI3K-gamma at doses greater than or equal to 25 mg BID.
IPI-145 showed broad activity in patients with both B-cell and T-cell malignancies, including partial responses or complete responses in patients with chronic lymphocytic leukemia, indolent non-Hodgkin’s lymphoma, mantle cell lymphoma, Hodgkin’s lymphoma and T-cell lymphoma. Onset of activity appeared to be rapid, as evidenced by the median time to response (table below). Additionally, clinical activity reported for 16 of 19 responders occurred within the first two cycles of treatment.
Clinical responses as of the
*iNHL (indolent non-Hodgkin’s lymphoma), CLL/SLL (chronic lymphocytic leukemia/small lymphocytic lymphoma), aNHL (aggressive non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma (DLBCL)), MCL (mantle cell lymphoma), MM (multiple myeloma), HL (Hodgkin’s lymphoma)
NA (not applicable)
The Phase 1 study poster is being presented in the Georgia World Congress Center, Hall B1-B2, and may also be found in the Publications Archive on Infinity’s website http://www.infi.com/product-candidates-publications.asp.
Additional Program Updates
Infinity today also provided the following updates related to its PI3K program:
Investor Reception and Webcast
Infinity will host a reception on
About Infinity’s PI3K Program
IPI-145 is a potent, oral inhibitor of Class I phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity believes IPI-145 is the only PI3K-delta and -gamma inhibitor in clinical development. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity.1 The PI3K-delta and PI3K-gamma isoforms are preferentially expressed in leukocytes, where they have distinct and non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of inflammatory diseases as well as hematologic malignancies.
In addition to its ongoing Phase 1 trial in patients with advanced hematologic malignancies, Infinity is conducting a Phase 2a, randomized, double-blind, placebo-controlled, multi-dose, cross-over study of IPI-145 in patients with asthma. The company is also planning a Phase 2 trial of IPI-145 in rheumatoid arthritis.
Infinity is an innovative drug discovery and development company seeking to discover, develop and deliver to patients best-in-class medicines for diseases with significant unmet need. 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 phosphoinositide-3-kinase and heat shock protein 90 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. Such
forward-looking statements include those regarding the therapeutic
potential of and potential clinical development plans for IPI-145,
including the expected timing of initiation and completion of, and the
expecting timing of reporting of data from, clinical trials of IPI-145.
Such statements are subject to numerous important 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 will report data in the time frames it
has estimated, 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 and, therefore, any
forward-looking statements in this press release could also be affected
by risks and uncertainties relating to a number of other factors,
including the following: 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 U.S.
1 Weinberg RA (2007) Cytoplasmic signaling circuitry programs
many of the traits of cancer. In Jeffcock E, Zayatz E, and Mickey RK
(Eds.) The biology of cancer (pp. 179-183).