Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) reported encouraging data from
its ongoing Phase 1 study of IPI-145,
its oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and
PI3K-gamma, in patients with relapsed/refractory T-cell lymphoma, a
difficult-to-treat hematologic malignancy (blood cancer) with few
available treatment options. Preliminary data showed that IPI-145 is
clinically active in patients with T-cell lymphoma, with an overall
response rate of 38 percent, including one complete response and nine
partial responses among 26 patients evaluable for response. These
findings were reported during the 6th Annual T-Cell Lymphoma
Forum being held from January 23 – 25, 2014, in San Francisco, CA.
“The clinical data for IPI-145 in patients with T-cell lymphoma
underscore the potential of IPI-145 to treat a broad range of blood
cancers,” stated Julian Adams, Ph.D., president of R&D at Infinity.
“IPI-145 has already shown clinical activity in indolent non-Hodgkin
lymphoma and chronic lymphocytic leukemia, and Infinity is advancing
IPI-145 into late-stage development in these two hematologic
malignancies. These data in patients with T-cell lymphoma help further
our understanding of the clinical potential of IPI-145 in additional
indications and may help to guide our future development plans.”
Summary of Phase 1 Data of IPI-145 in T-Cell Lymphoma
The poster presentation, “Clinical activity of IPI-145, a potent
inhibitor of phosphoinositide-3-kinase-δ,γ, in patients with
relapsed/refractory T-cell lymphoma: Preliminary results from an ongoing
Phase 1 study,” included 30 patients in the safety population, of which
26 were evaluable for clinical activity. Patients enrolled in the study
had advanced disease, with a median of five prior systemic therapies
(range: 1 – 11) and a median of one month from last therapy to first
dose on study (range: 0.2 – 12).
Clinical Activity
Treatment with IPI-145
in patients with T-cell lymphomas led to an overall response rate of 38
percent, including one complete response and nine partial responses
among 26 patients evaluable for response. Among the 11 patients with
peripheral T-cell lymphoma (PTCL) evaluable for activity, IPI-145 led to
one complete response and five partial responses, for an overall
response rate (ORR) of 55 percent. Among the 15 patients with cutaneous
T-cell lymphoma (CTCL) evaluable for activity, IPI-145 led to four
partial responses, for an ORR of 27 percent. Stable disease was observed
in seven patients with CTCL. The onset of activity was rapid, with a
median time to response of 1.9 months (range: 1.5 – 2.7) for patients
with PTCL and 2.4 months (range: 1.7 – 3.8) for patients with CTCL. The
median number of treatment cycles for the 13 patients with PTCL was 2.2
(range: 0.5 – 8), and the median number of treatment cycles for the 17
patients with CTCL was 3.1 (range: 0.4 – 11). Four patients with PTCL
and three patients with CTCL remain on treatment.
Safety and Pharmacodynamics
IPI-145 was generally well tolerated, with the majority of patients (20
of 30) receiving IPI-145 dosed at 75 mg twice daily (BID). The most
common Grade 3 side effects were increases in ALT or AST (two liver
enzymes) (10 patients; 33 percent), rash (4 patients; 13 percent) and
fatigue (3 patients; 10 percent). One patient (3 percent) had Grade 4
ALT or AST increases.
Data also showed that treatment with IPI-145 led to decreases in serum
levels of cytokines and chemokines known to play important roles in
lymphocyte trafficking and function, further supporting the rationale
that inhibiting PI3K-delta and PI3K-gamma has the potential to provide a
therapeutic benefit for T-cell lymphoma as well as other blood cancers.
The poster is available in the Publications Archive on Infinity’s
website http://www.infi.com/product-candidates-publications.asp.
About the Development of IPI-145 for the Treatment of Blood Cancers
Infinity
is developing IPI-145, an oral inhibitor of Class I PI3K-delta,gamma.
The PI3Ks are a family of enzymes involved in multiple cellular
functions, including cell proliferation and survival, cell
differentiation, cell migration and immunity. The PI3K-delta,gamma
isoforms are preferentially expressed in leukocytes (white blood cells),
where they have distinct and mostly 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 hematologic malignancies as well as inflammatory
diseases.
Infinity has launched DUETTSTM, a worldwide investigation of
IPI-145 in blood cancers. As part of the DUETTS program, Infinity is
currently enrolling patients in DYNAMOTM, a Phase 2
monotherapy study designed to evaluate the safety and efficacy of
IPI-145 in patients with refractory indolent non-Hodgkin lymphoma (iNHL)
(ClinicalTrials.gov Identifier NCT01882803), and DUOTM, a
Phase 3 monotherapy study designed to evaluate the safety and efficacy
of IPI-145 in patients with relapsed/refractory chronic lymphocytic
leukemia (CLL) (NCT02004522).
An investigator-sponsored Phase 1b, open-label study of IPI-145 in
patients with B-cell NHL, CLL and T-cell lymphoma in combination with
rituximab (a monoclonal antibody therapy), bendamustine (a chemotherapy)
or both rituximab and bendamustine is also open for enrollment
(NCT01871675).
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative biopharmaceutical company dedicated to
discovering, developing and delivering best-in-class medicines to people
with difficult-to-treat diseases. Infinity combines proven scientific
expertise with a passion for developing novel small molecule drugs that
target emerging disease pathways. 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. Such
forward-looking statements include those regarding the Company’s
expectations about: its ability to execute on its strategic plans; the
therapeutic potential of PI3K inhibition and IPI-145; and the potential
rationale of investigating IPI-145 in additional indications and
combinations therapies. 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. FDA and other regulatory
authorities, investigational review boards at clinical trial sites and
publication review bodies; Infinity’s ability to obtain and maintain
requisite regulatory approvals and to enroll patients in its clinical
trials; unplanned cash requirements and expenditures; development of
agents by Infinity’s competitors for diseases in which Infinity is
currently developing or intends to develop its product candidates;
general economic and market conditions; and Infinity’s ability to
obtain, maintain and enforce patent and other intellectual property
protection for any product candidates it is developing. These and other
risks which may impact management’s expectations are described in
greater detail under the caption “Risk Factors” included in Infinity’s
quarterly report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on November 7, 2013, and other filings filed by
Infinity with the SEC. Any forward-looking statements contained in this
press release speak only as of the date hereof, and Infinity expressly
disclaims any obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise.
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