CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 6, 2007--Idera
Pharmaceuticals, Inc. (AMEX: IDP), today announced interim results
from a Phase 1 clinical trial being conducted by the Company
evaluating IMO-2055, the Company's lead Toll-Like Receptor (TLR) 9
agonist, in combination with gemcitabine and carboplatin in patients
with advanced solid tumors. The data were presented in a poster
entitled "Initial phase 1 results of gemcitabine, carboplatin and
IMO-2055, a toll-like receptor agonist, in patients with advanced
solid tumors," by Shakun Malik, M.D., Chief of the Center for Thoracic
Medical Oncology at the Lombardi Comprehensive Cancer Center at
Georgetown University Medical Center, and principal investigator for
the trial, during the 12th World Conference on Lung Cancer taking
place in Seoul, Korea, September 2-6, 2007.
The Phase 1 study presented in the poster is the Phase 1 portion
of a Phase 1/2 study the Company designed to evaluate the combination.
The purpose of the Phase 1 portion was to evaluate the safety of the
combination. The Company enrolled 22 patients with advanced,
previously treated solid tumors in the study before closing enrollment
in July 2007. The data presented in the poster concern 19 patients
evaluated for safety and also for efficacy prior to June 2007,
including eight patients with non-small cell lung cancer (NSCLC).
Patients received three-week cycles of fixed-dose gemcitabine and
carboplatin with three escalating doses and three dosage schedules of
IMO-2055. Interim data from the 19 patients suggest that it is
feasible for the combination to be administered in patients with
advanced solid tumors. The only dose-limiting toxicities observed in
these patients were neutropenia and thrombocytopenia, which are common
side effects observed with gemcitabine and carboplatin. In these 19
patients, the response rate, progression-free survival (PFS) and
overall survival are 5%, 4.1 months, and 12.9 months, respectively. In
the subset of eight patients with NSCLC, the response rate, PFS and
overall survival are 13%, 6.5 months and 12.9 months, respectively.
The Company expects to announce final data of this study by the end of
2007.
"Over the course of this trial, we have conducted additional
preclinical studies of IMO-2055 in combination with targeted agents,
including Tarceva(R), Avastin(R), and Erbitux(R), and have observed
encouraging antitumor activity," said Sudhir Agrawal, D. Phil., Chief
Executive Officer and Chief Scientific Officer. "As previously
announced, we are intending to initiate clinical studies of IMO-2055
in combination with Tarceva and Avastin in NSCLC and in combination
with Erbitux in colorectal cancer by the end of the year."
Idera's Oncology Program
-- Idera intends to initiate clinical trials to investigate
IMO-2055 in combination with Tarceva, and in triple
combination with Tarceva and Avastin, in patients with NSCLC
as second-line therapy. The Company is preparing to initiate a
Phase 1b trial in the third quarter of this year to assess the
safety of the combinations with multiple doses of IMO-2055.
The Company plans to conduct a four-arm, randomized,
placebo-controlled Phase 2 trial of the combinations following
analysis of the results of the Phase 1b trial.
-- The Company also plans to initiate clinical trials to
investigate IMO-2055 in combination with Erbitux and Camptosar
in patients with colorectal cancer as second-line therapy. The
Company expects to initiate a Phase 1b trial in the fourth
quarter of this year to assess the safety of this combination
with multiple doses of IMO-2055. The Company plans to conduct
a randomized, placebo- controlled Phase 2 trial of the
combination following analysis of the results of the Phase 1b
trial.
-- In Idera's Phase 2, Stage A, clinical evaluation of IMO-2055
monotherapy in patients with renal cell carcinoma (RCC), the
Company completed enrollment of the planned 46 treatment-naive
patients and enrolled 45 of the intended 46 second-line
patients before closing enrollment of patients on June 29,
2007. The Company expects that when final data are available,
it will report the results at an appropriate scientific
meeting and decide on the next steps for evaluation of
IMO-2055 in RCC. The Company will not be able to obtain a
complete set of data from the trial until such time as all
patients have ceased to receive treatment in the trial. The
Company expects that initial data from this trial will be
available in the fourth quarter of 2007 or the first quarter
of 2008.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is a drug discovery and development company
that is developing drug candidates to treat cancer and infectious,
respiratory, and autoimmune diseases, and for use as vaccine
adjuvants. Idera's proprietary drug candidates are designed to
modulate specific TLRs, which are a family of immune system receptors.
Idera's pioneering DNA chemistry expertise enables it to identify drug
candidates for internal development and creates opportunities for
multiple collaborative alliances. Idera's most advanced clinical
candidate, IMO-2055, is an agonist of TLR9 and is currently in a Phase
2 trial in oncology and in a Phase 1/2 chemotherapy combination trial
in oncology. Idera has filed an Investigational New Drug application
on a second TLR9 agonist, IMO-2125, for treatment of hepatitis C virus
infection. Idera is collaborating with Novartis International
Pharmaceutical, Ltd. for the discovery, development, and
commercialization of TLR9 agonists for the treatment of asthma and
allergy indications. Idera is also collaborating with Merck & Co.,
Inc. for the use of Idera's TLR7, 8 and 9 agonists in combination with
Merck's therapeutic and prophylactic vaccines in the areas of
oncology, infectious diseases, and Alzheimer's disease. For more
information, visit www.iderapharma.com.
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 early clinical studies or in
preclinical studies such as the studies referred to above will be
indicative of results obtained in future clinical trials or warrant
additional trials; whether interim results of clinical studies, such
as the results referred to above, will be reflective of the final
results of the studies; 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 and Merck will be successful; whether
Idera's cash resources will be sufficient to fund product development
and clinical trials; and such other important factors as are set forth
under the caption "Risk Factors" in Idera's Quarterly Report on Form
10-Q filed on August 1, 2007, 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.
CONTACT: Idera Pharmaceuticals, Inc.
Kelly Luethje, 617-679-5519
kluethje@iderapharma.com
or
MacDougall Biomedical Communications
Chris Erdman, 508-647-0209
cerdman@macbiocom.com
SOURCE: Idera Pharmaceuticals, Inc.