| [May 15, 2013] |
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Infinity Announces Clinical Data to Be Presented at ASCO and ICML
CAMBRIDGE, Mass. --(Business Wire)--
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that Phase
1 clinical data for IPI-145, its potent, oral inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, will be presented
at the 49th Annual Meeting of the American Society of
Clinical Oncology (ASCO), which is being held from May 31 through June 4
in Chicago, Ill., and the 12th International Conference on
Malignant Lymphoma (ICML), which is being held from June 19 through June
22 in Lugano, Switzerland. Key clinical results to be presented during
both meetings include updated data from Infinity's Phase 1 study
evaluating the safety, clinical activity and pharmacokinetics of IPI-145
in people with advanced hematologic malignancies (blood cancers).
In addition, Infinity will host a reception on Monday, June 3, 2013,
from 8:00 p.m. to 9:30 p.m. CT (9:00 p.m. to 10:30 p.m. ET) in Chicago,
Ill., to review its PI3K program in hematologic malignancies and discuss
IPI-145 data being presented at the ASCO 2013 Annual Meeting. The
reception will be webcast beginning at 8:30 p.m. CT (9:30 p.m. ET) and
can be accessed in the Investors/Media section of Infinity's website at www.infi.com.
An archived version of the webcast will be available on Infinity's
website for 30 days.
Presentations at ASCO 2013 include the following: Sunday,
June 2, 2013, 8:00 a.m. - 11:45 a.m. CT (poster presentation) Title:
Preliminary safety and efficacy of IPI-145, a potent inhibitor of
phosphoinositide-3-kinase-d,?, in patients with relapsed/refractory CLL
(Abstract #7070) Presenter: Manish R. Patel, M.D., Florida
Cancer Specialists & Research Institute, Sarasota, FL and Sarah Cannon
Research Institute, Nashville, TN Location: S Hall A2
Monday, June 3, 2013, 11:30 a.m. - 11:45 a.m. CT (oral presentation) Title:
Preliminary safety and efficacy of IPI-145, a potent inhibitor of
phosphoinositide-3-kinase-d,?, in patients with relapsed/refractory
lymphoma (Abstract #8518) Presenter: Steven M. Horwitz,
M.D., Memorial Sloan-Kettering Cancer Center, New York, NY Location:
E354a
Presentations at ICML 2013 include the following: Wednesday,
June 19, 2013, 12:00 p.m. - 6:30 p.m. Central European Time (CET)
(poster presentation) Title: Preliminary safety and
efficacy of IPI-145, a potent inhibitor of
phosphoinositide-3-kinase-d,?, in patients with relapsed/refractory
T-cell lymphoma (Abstract #294) Presenter: Steven M.
Horwitz, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY
Thursday, June 20, 2013, 4:05 p.m. - 4:20 p.m. CET (oral presentation) Title:
Preliminary safety and efficacy of IPI-145, a potent inhibitor of
phosphoinositide-3-kinase-d,?, in patients wih relapsed/refractory
B-cell lymphoma (Abstract #66)
Presenter: Brad Kahl,
M.D., University of Wisconsin School of Medicine and Public Health,
Madison, WI
Saturday, June 22, 2013, 8:30 a.m. - 8:40 a.m. CET (oral presentation) Title:
Preliminary safety and efficacy of IPI-145, a potent inhibitor of
phosphoinositide-3-kinase-d,?, in patients with relapsed/refractory
CLL/SLL (Abstract #145) Presenter: Ian W. Flinn, M.D, Ph.D.,
Sarah Cannon Research Institute, Nashville, TN
About Infinity's PI3K Program in Blood Cancer Infinity is
developing IPI-145 and IPI-443, potent, oral inhibitors of Class I
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. 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 (white blood cells), 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
hematologic malignancies and inflammatory diseases.
IPI-145, Infinity's lead product candidate, is currently progressing in
a Phase 1 study in people with advanced hematologic malignancies.
Preliminary data from this trial suggest that IPI-145 is well tolerated
to date and clinically active in patients with both B-cell and T-cell
malignancies, including chronic lymphocytic leukemia, indolent
non-Hodgkin lymphoma, mantle cell lymphoma, Hodgkin lymphoma and T-cell
lymphoma.2 Also, Infinity recently announced that an
investigator-sponsored Phase 1b, open-label, dose-escalation study of
IPI-145 in people with B-cell NHL, CLL and T-cell lymphoma in
combination with rituxan (a monoclonal antibody therapy), bendamustine
(a chemotherapy) or both rituxan and bendamustine is open for enrollment.
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. 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.
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: the timing and type of
data reports from clinical trials of IPI-145; and the therapeutic
potential of its PI3K inhibitors. 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 its product candidates; 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 (News - Alert)) on May 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.
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). New York, NY: Garland
Science, Taylor & Francis Group. 2 Flinn, I.W.,
Horwitz, S.M., Patel, M., Younes, A., Porter, J., Sweeney, J., Allen,
K., Kelly, P., Kahl, B. Clinical Safety and Activity in a Phase 1 Trial
of IPI-145, a Potent Inhibitor of Phosphoinositide-3-Kinase-(d,?) in
Patients with Advanced Hematologic Malignancies. Poster presented at the
54th Annual Meeting of the American Society for Hematology (ASH),
Atlanta, GA, 2012.

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