CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 23, 2009--
Idera Pharmaceuticals (Nasdaq: IDRA) today presented interim data from a
phase 1b, single arm clinical trial evaluating IMO-2055, an agonist of
Toll-like Receptor (TLR) 9, in combination with Tarceva® and
Avastin® in patients with non-small cell lung cancer (NSCLC).
The data were presented 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).
“Interim data in this trial show that the triple combination of
IMO-2055, Tarceva, and Avastin has demonstrated some anti-tumor activity
in NSCLC patients who had progressed during or after one or more prior
therapy regimens. These data are encouraging in light of the recent
results reported for the Tarceva-Avastin combination in a similar
patient population,” said Dr. Alice Bexon, MBChB, Vice President of
Clinical Development. “A dose level was selected for further study.”
The trial is designed to determine the tolerability and safety of
IMO-2055 in combination with Tarceva and Avastin. Interim data presented
at the meeting show:
-
IMO-2055 was tolerated at dosages up to 0.48 mg/kg/week in combination
with Tarceva plus Avastin
-
The most common possibly-related adverse events were injection site
reactions, fatigue and fever
-
Six grade 3 adverse events were reported: injection site reactions
(2), diarrhea (2), fatigue (1) and low potassium (1)
-
8 of 16 patients remained on treatment at least 18 weeks
-
Of the 13 evaluable patients, 3 had a partial response and 8
experienced stable disease
Recruitment of additional patients is continuing at the anticipated
recommended phase 2 dose level for IMO-2055 in this combination.
The presentation was made by David Smith, M.D., of US Oncology in
Vancouver, WA.
About the Trial
The phase 1b trial evaluating IMO-2055 is being conducted in patients
with advanced or metastatic NSCLC who have progressed on previous
therapy. The trial is designed to assess safety of the IMO-2055,
Tarceva, and Avastin combination and to determine the recommended dosage
of IMO-2055 for use in a subsequent phase 2 trial. IMO-2055 is
administered subcutaneously on days 1, 8, and 15 of a 3-week cycle.
Avastin and Tarceva are used in the care of NSCLC. A standard dosage of
Tarceva is given daily and a standard dosage of Avastin is given on day
1 of each cycle. The target enrollment for the trial is up to 40
patients. Patients will continue therapy until disease progression as
determined by standard guidelines to evaluate the response to treatment
in solid tumors (RECIST).
IMO-2055 dosages of 0.08, 0.16, 0.32, and 0.48 mg/kg/week were evaluated
in the dose escalation portion of the trial.
Preclinical studies have shown increased anti-tumor activity when a TLR9
agonist similar to IMO-2055 is combined with targeted agents such as
Tarceva and Avastin. TLR9 agonists, in addition to being immune
modifiers, affect epidermal growth factor receptor (EGFR) and vascular
endothelial growth factor (VEGF) pathways. Tarceva is an inhibitor of
EGFR, and Avastin is an inhibitor of VEGF.
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, in addition to the trial presented at the Congress, is also
being evaluated in a second phase 1b clinical study in combination with
an Erbitux® and Camptosar® containing regimen in
patients with advanced colorectal cancer.
Final data from a phase 2 trial evaluating IMO-2055 monotherapy in
patients with renal cell carcinoma will be presented during the Eighth
International Kidney Cancer Symposium taking place September 25-26,
2009, in Chicago.
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
interim clinical data from a clinical trial will be indicative of the
final results of the trial; 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
Idera Pharmaceuticals, Inc.
Kelly Luethje, 617-679-5519
kluethje@iderapharma.com
or
MacDougall
Biomedical Communications
Chris Erdman, 508-647-0209
cerdman@macbiocom.com
