Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced the
promotion of David A. Roth, M.D., to chief medical officer. In this
role, Dr. Roth will provide strategic leadership for Infinity’s clinical
development activities, including responsibility for the company’s
medical affairs and clinical operations functions to support successful
product approvals and launches. Dr. Roth, who joined Infinity in 2013 as
senior vice president, clinical development and medical affairs, will
continue to serve as a member of Infinity’s executive leadership team
and will report to Julian Adams, Ph.D., Infinity’s president of research
and development. In accordance with the company’s management succession
plan, Dr. Roth succeeds Pedro Santabarbara, M.D., Ph.D., who previously
served as Infinity’s chief medical officer.
“David is the ideal person to lead us through the next stage of clinical
development as we focus more intensely on developing IPI-145, our
PI3K-delta,gamma inhibitor, for the treatment of hematologic
malignancies,” said Dr. Adams. “We are currently conducting DYNAMO, a
Phase 2 study in patients with indolent non-Hodgkin lymphoma and DUO, a
Phase 3 study in patients with chronic lymphocytic leukemia, each
designed to enable registration in our lead indications. We believe
IPI-145 has best-in-class potential and anticipate initiating three
additional studies in hematologic malignancies this year.”
“Pedro Santabarbara, Infinity’s first chief medical officer, was
instrumental in moving IPI-145 through the early stages of development
and in building the foundation of our clinical organization, including
the development of a succession plan and the recruitment of David Roth.
We are tremendously appreciative of the role Pedro has played in
advancing Infinity and our pipeline,” Dr. Adams continued.
“Since joining Infinity, David’s depth and breadth of hematology and
oncology expertise have proven to be a tremendous asset. His experience
enables my succession and a smooth transition as Infinity rapidly
advances IPI-145 into late-stage development and potential
registration,” stated Dr. Santabarbara. “IPI-145 has the potential to
help transform the treatment landscape for patients with hematologic
malignancies, and I am confident in David’s ability to lead the clinical
and medical affairs teams as Infinity advances its vision of bringing
IPI-145 to patients.”
Dr. Roth joined Infinity in 2013 following more than ten years with
Pfizer Inc. and Wyeth Pharmaceuticals. At Pfizer, he most recently
served as a vice president in Pfizer’s oncology business unit. Dr. Roth
joined Pfizer from Wyeth, where he held the role of assistant vice
president, clinical research & development and global therapeutic area
director of hematology. While at Pfizer and Wyeth, Dr. Roth contributed
to the successful regulatory approval of several products, including
Bosulif® (bosutinib), a dual Src/Abl tyrosine kinase
inhibitor for the treatment of chronic myelogenous leukemia, Xyntha®
and ReFacto AF® for the treatment of hemophilia A, and
BeneFIX® for the treatment of hemophilia B. Dr. Roth also led the early
development of palbociclib, a CDK 4/6 inhibitor, to Phase 3 evaluation
in women with ER positive advanced breast cancer. During his tenure at
Pfizer and Wyeth, Dr. Roth co-chaired Pfizer’s oncology research and
development board and served on several oncology and hematology R&D
leadership teams and governance committees.
In addition to his extensive industry experience, Dr. Roth is an
accomplished academic researcher and clinical practitioner. He received
his B.S. from the Massachusetts Institute of Technology and his M.D.
from Harvard Medical School in the Harvard-M.I.T. Division of Health
Sciences and Technology where he remains on the Affiliated Faculty.
About Infinity’s PI3K Program
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 hematologic malignancies, or blood cancers. As part of the
DUETTS program, Infinity is conducting 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).
Within inflammatory diseases, Infinity is conducting ASPIRA, a Phase 2
study of IPI-145 in patients with moderate-to-severe rheumatoid
arthritis (RA) (NCT01851707) as well as a Phase 2a exploratory study of
IPI-145 in patients with mild, allergic asthma (NCT01653756).
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; initiating
additional studies of IPI-145 in 2014; 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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