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Infinity to Present IPI-145 Phase 1 Clinical Data at ASH



  Infinity to Present IPI-145 Phase 1 Clinical Data at ASH

      – Company to Host Investor Reception at ASH on December 10, 2012 –

Business Wire

CAMBRIDGE, Mass. -- November 05, 2012

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that data from
its ongoing Phase 1 trial of IPI-145, the company’s potent, oral inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma will be presented at the
54^th American Society of Hematology (ASH) Annual Meeting and Exhibition. The
Phase 1 trial of IPI-145 is an open-label, dose-escalation study evaluating
IPI-145 in patients with advanced hematologic malignancies. The presentation
will include data describing the safety, pharmacokinetics and clinical
activity of IPI-145. The ASH meeting is being held in Atlanta, Georgia, from
December 8 – 11, 2012.

“In this ongoing Phase 1 trial, we are very encouraged by the activity
observed at the three lowest dose levels of IPI-145 evaluable for response,
including responses in patients with chronic lymphocytic leukemia, indolent
non-Hodgkin’s lymphoma and mantle cell lymphoma. We have continued to make
progress in this study since submitting our abstract in July. Specifically,
dose escalation is still ongoing, and we expect to soon complete patient
enrollment in our first expansion cohort evaluating IPI-145 at a dose of 25 mg
twice daily in the same indications for which we have seen responses,” stated
Julian Adams, Ph.D., president of R&D at Infinity. “We look forward to
presenting updated data from this study, which will include additional safety
and efficacy data from the first expansion cohort as well as the ongoing dose
escalation in patients with both B-cell and T-cell malignancies.”

“IPI-145 has a number of distinct features, including high potency against
PI3K-delta, the ability to inhibit PI3K-gamma and dose proportional
pharmacokinetics. We believe that these properties have the potential to
translate into benefits for patients and establish IPI-145 as the
best-in-class PI3K inhibitor in hematologic malignancies as well as
inflammation,” Dr. Adams continued.

Infinity will also host a reception on Monday, December 10, 2012, from 8:00
p.m. to 10:00 p.m. ET to discuss IPI-145 and to review the data presented at
ASH. The reception will be webcast beginning at 8:45 p.m. ET and can be
accessed in the “investors/media” section of Infinity’s website, www.infi.com.
A replay of the event will also be available.

Poster Presentation Details

  * Title: 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)
  * Time: 10:00 a.m. – 8:00 p.m. ET (viewing) and 6:00 p.m. – 8:00 p.m.
    (presentation)
  * Presenter: Ian W. Flinn, M.D., Ph.D., Director, Hematologic Malignancies
    Research Program, Sarah Cannon Research Institute
  * Location: Georgia World Congress Center, Hall B1-B2.

Abstract Highlights

The abstract accepted for presentation at ASH includes an evaluation of the
safety, activity and pharmacokinetics of IPI-145 as of July 16, 2012. At the
time of the data cutoff, 20 patients were evaluable for safety and 11 patients
were evaluable for efficacy. Twice daily (BID) doses of IPI-145 evaluated
included 8 mg, 15 mg, 25 mg, 35 mg and 50 mg, which were generally well
tolerated. A single dose-limiting toxicity was observed at the 15 mg BID dose
level. Treatment-related adverse events occurred in 11 of 20 evaluable
patients, with Grade 3 and 4 events occurring in five patients. Based on the
tolerability observed to date, dose escalation remains ongoing and a maximum
tolerated dose has not been reached.

Responses were observed at each of the lowest dose levels of IPI-145
evaluated, including 8 mg BID, 15 mg BID and 25 mg BID, in patients with
chronic lymphocytic leukemia (2 partial responses in 3 patients), indolent
non-Hodgkin’s lymphoma (1 complete response in 2 patients) and mantle cell
lymphoma (1 partial response in 1 patient), for a total of 4 responses among 6
evaluable patients with either chronic lymphocytic leukemia, indolent
non-Hodgkin’s lymphoma or mantle cell lymphoma. Responses were not observed
among five evaluable patients with aggressive non-Hodgkin’s lymphoma or
multiple myeloma.

The Phase 1 trial is evaluating patients with B-cell and T-cell malignancies
in the ongoing dose escalation.

About Infinity Pharmaceuticals, Inc.

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.

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 expected timing for reporting data
regarding IPI-145, the therapeutic potential of IPI-145 and the potential for
IPI-145 to be the best-in-class PI3K inhibitor in hematologic malignancies and
inflammation. 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 timeframes 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 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 U.S. FDA and other regulatory
authorities, investigational review boards at clinical trial sites and
publication review bodies; Infinity’s ability 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 Annual Report on Form 10-K for the year
ended December 31, 2011 and subsequent filings filed by Infinity with the
Securities and Exchange Commission. 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.

Contact:

Infinity Pharmaceuticals, Inc.
Jaren Irene Madden, 617-453-1336
Jaren.Madden@infi.com
http://www.infi.com
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