CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 25, 2009--
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today announced the
presentation of final data from a clinical trial evaluating IMO-2055, an
agonist of Toll-like Receptor (TLR) 9, as monotherapy in patients with
Renal Cell Carcinoma (RCC). The data are being presented during the
Eighth International Kidney Cancer Symposium being held in Chicago,
September 25-26, 2009.
In this phase 2 open-label, non-controlled clinical trial,
treatment-naïve and second-line patients with RCC were randomly assigned
to receive IMO-2055 subcutaneously at 0.16 mg/kg/week or 0.64
mg/kg/week. 89 patients were evaluable for efficacy (intent-to-treat
population).
“This clinical trial of IMO-2055 monotherapy in RCC has provided us data
that have been helpful in developing the strategy for clinical studies
of IMO-2055 in combination with approved anti-cancer agents. Currently
IMO-2055 is being evaluated in combination with Tarceva® and
Avastin® in non-small cell lung cancer and in combination
with Erbitux® and a Camptosar®-containing regimen
in colorectal cancer,” said Alice Bexon, MBChB, Vice President of
Clinical Development. “As previously announced, the primary objective
based on RECIST was not achieved in this trial; however, we are
encouraged by the progression-free survival compared to published
reports with interferon alpha treatment. We have seen prolonged
treatment durations in several patients.”
Based on the final data analysis:
-
Progression-free survival (PFS) medians for treatment-naïve patients
were 4.5 months at 0.16 mg/kg/week and 1.9 months at 0.64 mg/kg/week
-
PFS medians for second-line patients were 3.4 months at 0.16
mg/kg/week and 4.3 months at 0.64 mg/kg/week
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Median overall survival was 23.5 months overall, although medians were
not estimable in 2 of the 4 treatment groups
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7 patients received weekly IMO-2055 treatment for at least 1 year
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2 patients (1 second-line and 1 treatment-naïve), each receiving 0.64
mg/kg/week, had confirmed partial responses
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52 patients (58%) across all groups had stable disease
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IMO-2055 treatment was generally well-tolerated: neither dosage was
associated with any dose-limiting toxicity, although the relative dose
intensity was higher with the 0.16 mg/kg dosage
-
The most common treatment-related adverse events (any grade across
groups) were fatigue (51%), nausea (46%), chills (45%), headache
(37%), and pyrexia (33%), consistent with IMO-2055-related immune
stimulation
The oral and poster presentations, entitled “A phase 2 multicenter,
randomized, open-label study of two dose levels of IMO-2055 in patients
with metastatic or recurrent renal cell carcinoma”, are being made by
Timothy Kuzel, M.D. Dr. Kuzel is the Director of the Clinical Research
Office for the Robert H. Lurie Comprehensive Cancer Center of
Northwestern University and Professor of Medicine within the Division of
Hematology/Oncology of the Department of Medicine at Northwestern
University’s Feinberg School of Medicine in Chicago, IL.
About the Trial
The trial was conducted at centers in the U.S. and followed a Simon
two-stage statistical design based on historical performance of
interferon-alpha and IL-2 in this patient population. The enrollment
target was 92, with 23 patients in each of four arms. Treatment-naïve
and second-line patients were randomly assigned to receive IMO-2055
subcutaneously at either 0.16 mg/kg/week or 0.64 mg/kg/week. 89 patients
were evaluable for efficacy endpoints. Patients continued to receive
treatment until disease progression or another protocol-specified
stopping criterion was met. The primary objective was tumor response
according to RECIST (Response Evaluation Criteria In Solid Tumors).
Secondary objectives included time to progression, survival and safety.
Progression-free survival also was analyzed, as the Company believes
progression-free survival is a more rigorous measure than time to
progression because it accounts for any patients who died prior to
disease progression.
Preliminary data from the trial were announced October 1, 2008. The
Simon first-stage requirement of greater than 1 response was not met in
any group during the trial; therefore, the second stage was not
initiated.
About IMO-2055
In December 2007, Idera entered into a worldwide licensing and
collaboration agreement with Merck KGaA, Darmstadt, Germany, for the
research, development, and commercialization of Idera’s TLR9 agonists
for the treatment of cancer. IMO-2055 is a novel DNA-based agonist of
TLR9 and at present is in a phase 1b clinical study in combination with
Tarceva and Avastin in patients with advanced non-small cell lung
cancer. IMO-2055 is also being evaluated in a second phase 1b clinical
study in combination with Erbitux and a Camptosar-containing regimen in
patients with advanced colorectal cancer.
Interim data from the phase 1b trial evaluating IMO-2055 in combination
with Tarceva and Avastin in patients with non-small cell lung cancer
were presented September 23, 2009, during the joint 15th Congress of the
European CanCer Organisation (ECCO) and 34th Congress of the European
Society for Medical Oncology (ESMO) in Berlin, Germany (Abstract number
9.148).
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat infectious
diseases, autoimmune and inflammatory diseases, cancer, and respiratory
diseases, and for use as vaccine adjuvants. Our proprietary drug
candidates are designed to modulate specific Toll-like Receptors (TLRs),
which are a family of immune system receptors that direct immune system
responses. Our pioneering DNA and RNA chemistry expertise enables us to
create drug candidates for our internal development programs and our
partnered programs, and generates opportunities for additional
collaborative alliances. For more information, visit www.iderapharma.com.
Idera Forward Looking Statements
This press release contains forward-looking statements concerning Idera
Pharmaceuticals, Inc. that involve a number of risks and uncertainties.
For this purpose, any statements contained herein that are not
statements of historical fact may be deemed to be forward-looking
statements. Without limiting the foregoing, the words "believes,"
"anticipates," "plans," "expects," "estimates," "intends," "should,"
"could," "will," "may," and similar expressions are intended to identify
forward-looking statements. There are a number of important factors that
could cause Idera's actual results to differ materially from those
indicated by such forward-looking statements, including whether results
obtained in preclinical studies or early-stage clinical trials will be
indicative of results obtained in future clinical trials; whether
products based on Idera's technology will advance into or through the
clinical trial process on a timely basis or at all and receive approval
from the United States Food and Drug Administration or equivalent
foreign regulatory agencies; whether, if the Company's products receive
approval, they will be successfully distributed and marketed; whether
the Company's collaborations with Novartis, Merck & Co., and Merck KGaA
will be successful; whether Idera's cash resources will be sufficient to
fund the Company's operations; and such other important factors as are
set forth under the caption "Risk Factors" in Idera's Quarterly Report
on Form 10-Q for the three months ended June 30, 2009, which important
factors are incorporated herein by reference. Idera disclaims any
intention or obligation to update any forward-looking statements.
Tarceva is a registered trademark of OSI Pharmaceuticals, Inc. Avastin
is a registered trademark of Genentech, Inc. Erbitux is a registered
trademark of ImClone Systems Incorporated. Camptosar is a registered
trademark of Pfizer.
Source: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Kelly Luethje, 617-679-5519
kluethje@iderapharma.com
or
MacDougall
Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com
