Curis Announces Dosing of First Patient in Phase I Clinical Trial of Dual PI3
Kinase and HDAC Inhibitor CUDC-907
Curis Earns $350,000 in Milestone Payments From The Leukemia & Lymphoma
LEXINGTON, Mass., Jan. 24, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS),
a drug development company seeking to develop next generation targeted small
molecule drug candidates for cancer treatment, today announced that the first
patient has been treated in a Phase I clinical study of CUDC-907 in patients
with relapsed or refractory lymphoma or multiple myeloma. CUDC-907 is an
orally-administered first-in-class small molecule drug candidate that has been
designed as a dual inhibitor of phosphatidylinositol-3-kinase (PI3K) and
histone deacetylase (HDAC). As a result of this clinical advance, Curis is
entitled to receive an additional $350,000 in milestone payments under the
terms of its agreement with The Leukemia and Lymphoma Society (LLS).
"We're very pleased to announce the initiation of the CUDC-907 Phase I
clinical study in patients with advanced hematological cancers," said Dan
Passeri, Curis' President and Chief Executive Officer. "The synergistic
effects of targeting PI3K and HDAC with CUDC-907 have shown very potent
antitumor activity in preclinical models of lymphoma and multiple myeloma. We
are hopeful that CUDC-907 will demonstrate an adequate safety profile and also
provide clinical activity in this study population. We look forward to seeking
to advance this important molecule through this Phase I dose escalation study
and further clinical trials."
"LLS is pleased that Curis has met this significant milestone," said Richard
Winneker, Ph.D, LLS senior vice president of research. "Initiating this first
human clinical trial for this drug candidate is a major advance, and we are
hopeful that this therapy could yield promising outcomes for patients with
lymphomas and multiple myeloma, who are often in critical need of new
This clinical trial is designed as a standard dose escalation study in which
CUDC-907 will be orally administered to patients with relapsed or refractory
lymphoma or multiple myeloma at up to four study centers in the United States.
The primary objectives of the study are to determine the maximum tolerated
dose and recommended oral dose of CUDC-907 for Phase II study. The secondary
objectives of this study are to assess safety and tolerability, to assess
pharmacokinetics, to evaluate biomarker activity and to assess preliminary
anti-cancer activity of CUDC-907 in this patient population.
In the absence of dose limiting toxicity, each patient will receive oral
CUDC-907 once daily for a minimum of 21 days of continuous daily dosing (1
cycle), and may continue to receive additional cycles of study treatment until
disease progression or other treatment discontinuation criteria are met.
Additional details about this study can be found on clinicaltrials.gov
CUDC-907 is a dual inhibitor of the Class I PI3K and Class I and II HDAC
subtypes, the combination of which Curis scientists believe has synergistic
interaction against cancer cells and their microenvironment. In preclinical
studies, CUDC-907 has demonstrated the ability to suppress multiple nodes of
survival and proliferation. In addition, preclinical data have shown that
CUDC-907 inhibits compensatory pathways often utilized in cancer cells during
the emergence of resistance to standard of care agents and induces apoptosis
in treated cancer cells.
CUDC-907 exhibits anti-proliferation activity against a broad range of cancer
cell types in in vitro studies, including cell lines that exhibit reduced
sensitivity to single-target PI3K inhibitors. CUDC-907's anti-proliferation
activity has been demonstrated to be much more potent than that of leading
PI3K inhibitors in development. CUDC-907 also inhibits tumor growth in
preclinical xenograft models of blood cancers as well as solid tumors with
K-RAS mutations that exhibit reduced sensitivity to known PI3K inhibitors,
indicating that this compound may have the potential for broader activity than
other leading PI3K inhibitors currently in clinical development.
About the LLS Agreement
Under the agreement between Curis and LLS, LLS has agreed to fund
approximately 50% of the direct costs of the development of CUDC-907, up to $4
million, of which Curis received $1.1 million in funding to date. As noted
above, Curis has initiated a Phase I dose escalation clinical trial in
patients with relapsed or refractory lymphomas or multiple myeloma. Provided
that the Phase I study is successful, the agreement also provides for LLS to
support Curis' subsequent Phase Ib or Phase IIa study in one or more specific
indications as well as Curis' ongoing investigation of biomarkers for CUDC-907
in these diseases.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society ® (LLS) is the world's largest voluntary
health agency dedicated to blood cancer. The LLS mission: Cure leukemia,
lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of
patients and their families. LLS funds lifesaving blood cancer research around
the world and provides free information and support services. Founded in 1949
and headquartered in White Plains, NY, LLS has chapters throughout the United
States and Canada. To learn more, visit www.LLS.org or contact the Information
Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET.
About Curis, Inc.
Curis is a drug development company seeking to develop and commercialize next
generation targeted small molecule drug candidates for cancer treatment.
Erivedge® is the first and only FDA-approved medicine for the treatment of
advanced basal cell carcinoma and is being commercialized and was developed by
Roche and Genentech, a member of the Roche Group, under a collaboration
agreement between Curis and Genentech. Curis is also leveraging its experience
in targeting signaling pathways to develop proprietary targeted cancer
programs, including CUDC-427, a small molecule IAP inhibitor, and CUDC-907, a
dual PI3K and HDAC inhibitor. For more information, visit Curis' website at
The Curis, Inc. logo is available at
Curis Cautionary Statement: This press release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act
of 1995, including without limitation statements regarding Curis' expectations
regarding the potential safety profile and clinical benefits of CUDC-907, the
Company's goals for advancing the molecule through clinical studies and the
Company's expectation that LLS will support the Company's subsequent
preclinical studies and clinical trials. Forward-looking statements used in
this press release may contain the words "believes," "expects," "anticipates,"
"plans," "seeks," "estimates," "assumes," "will," "may," "could" or similar
expressions. These forward-looking statements are not guarantees of future
performance and involve risks, uncertainties, assumptions and other important
factors that may cause actual results to be materially different from those
indicated by such forward-looking statements. For example, Curis (i) may not
be able to successfully enroll patients in its Phase I clinical trial of
CUDC-907, (ii) may experience delays, setbacks and other failures in its
planned clinical development of CUDC-907, including negative, inconsistent or
inconclusive results, and/or results that fail to achieve the primary or
secondary objectives of the trial, (iii) may encounter manufacturing delays or
difficulties and (iv) may be required by the FDA or institutional review
boards to hold, delay, suspend or terminate such trial. Moreover, Curis may
not be able to maintain its collaboration agreement with LLS on terms that are
favorable to Curis, or at all. Curis also faces other important risks relating
to its business, operations, financial condition and future prospects
generally that are discussed in its Quarterly Report on Form 10-Q for the
quarter ended September 30, 2012 and other filings that it periodically makes
with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the views of Curis only
as of today and should not be relied upon as representing Curis' views as of
any subsequent date. Curis disclaims any intention or obligation to update any
of the forward-looking statements after the date of this press release whether
as a result of new information, future events or otherwise.
CONTACT: Michael P. Gray
Chief Financial and Chief Operating Officer
Director of Public Relations
The Leukemia & Lymphoma Society
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