Study to be Conducted at Georgetown University Medical Center Includes Phase 2
Component in First-Line Non-Small Cell Lung Cancer
CAMBRIDGE, Mass., Oct. 26 /PRNewswire-FirstCall/ -- Idera Pharmaceuticals,
Inc. (Amex: IDP) announced today that it has initiated a new Phase 1/2
clinical trial of HYB2055 in combination with the chemotherapy agents
gemcitabine (Gemzar(R), Eli Lilly and Company) and carboplatin. The trial is
now open to patient enrollment at the Lombardi Comprehensive Cancer Center at
Georgetown University Medical Center. HYB2055 (also known as IMO-2055 or
IMOxine(R)) is Idera's lead Toll-like Receptor 9 (TLR9) agonist for the
treatment of cancer and is based on Idera's proprietary Immune Modulatory
Oligonucleotide (IMO(TM)) technology.
"Our preclinical studies in animal tumor models demonstrated a significant
added benefit from IMO treatment combined with several standard
chemotherapies," said Tim Sullivan, Vice President of Development Programs at
Idera. "As a result, we have initiated the trial and are seeking to enroll 12
to 18 refractory solid tumor patients in the Phase 1 portion of the trial. We
plan to use the Phase 1 data for dose selection for the subsequent Phase 2
portion of the trial in the treatment of naive non-small cell lung cancer
patients."
"We have direct experience with HYB2055, because the initial Phase 1
oncology trial of HYB2055 was conducted by us at Georgetown," said Shakun
Malik, M.D., Chief of the Center for Thoracic Medical Oncology, and Principal
Investigator for the trial. "Gemcitabine plus carboplatin is a well
established doublet regimen for first-line non-small cell lung cancer, and we
look forward to the evaluation of safety for the three-way combination with
HYB2055 immunotherapy."
About the Trial
The Phase 1/2 trial is a two-phase, open-label, dose escalation study of
the safety and efficacy of HYB2055 combined with a standard
gemcitabine/carboplatin treatment regimen. The primary endpoint of the Phase
1 portion of the trial is to establish an appropriate HYB2055 dose in
combination with a fixed dose of gemcitabine/carboplatin in patients with
solid tumors. In the Phase 2 portion of the study, the primary endpoint is
overall response rate and toxicity of the triplet combination in previously
untreated, advanced non-small cell lung cancer patients. HYB2055 will be
administered by subcutaneous injection once per week. Intended Phase 1 dose
levels are 4, 12, and 36 mg/week.
Gemcitabine (Gemzar(R), Eli Lilly and Company) has first-line indications
in the U.S. for breast, pancreatic, and non-small cell lung cancers.
About HYB2055
HYB2055 (also known as IMO-2055 or IMOxine(R)) is Idera's lead Toll-like
Receptor 9 (TLR9) agonist for the treatment of cancer and is based on Idera's
proprietary Immune Modulatory Oligonucleotide (IMO(TM)) technology. The
Company recently announced an amendment of its ongoing Phase 2 trial of
HYB2055 monotherapy in patients with renal cell carcinoma, with expansion of
the enrollment targets to 46 treatment-naive and 46 second-line patients. The
Company has previously conducted a Phase 1 monotherapy trial of HYB2055 in
solid tumor oncology patients at Georgetown University Medical Center, data
from which was reported at ASCO 2005 (Abstract 2503). In addition to the
chemotherapy combination trial described in this press release, the Company is
planning additional trials for HYB2055 in other oncology indications.
About Toll-like Receptors (TLRs)
Toll-like Receptors are a family of receptors that control modulation of
immune responses. Idera's IMO compounds mimic bacterial DNA and are
specifically identified by TLR9. When TLR9 is activated, it stimulates a
response that involves multiple immune system components acting to fight
disease through both innate and adaptive immunity. Idera's IMO drug
candidates have potential applications in a wide variety of diseases,
including cancer, infectious diseases and asthma/allergies, and can be used in
combination with vaccines.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc. is a biotechnology company focused on the
discovery, development, and commercialization of targeted immune therapies
based on modulation of Toll-like receptors (TLRs). Idera has identified novel
chemical entities that modulate immune responses through interactions with
TLR9. The Company continues to identify new drug candidates specific to
various diseases, including cancer, infectious diseases and asthma/allergies,
based on the differentiated biological activities of its proprietary
compounds. The Company's website is located at http://www.iderapharma.com.
Idera Pharmaceuticals (Amex: IDP) is based in Cambridge, Massachusetts.
In addition to the HYB2055 oncology program, Idera is collaborating with
Novartis for the discovery, development, and commercialization of IMO drug
candidates targeting asthma and allergies.
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 products based on Idera's technology such as HYB2055 will
advance 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 the Company will complete
enrollment of clinical trials in the time expected; whether the FDA will
comment on the clinical protocols for HYB2055; whether, if the Company's
products such as HYB2055 receive approval, they will be successfully
distributed and marketed; 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 9, 2005, which important factors are incorporated
herein by reference. Idera disclaims any intention or obligation to update any
forward-looking statements.
Contacts:
Idera Pharmaceuticals, Inc. MacDougall Biomedical
617-679-5500, x5526 Communications
Tim Sullivan 508-647-0209 x12
E-mail: tsullivan@iderapharma.com Douglas MacDougall
Georgetown University Medical Center
Laura Cavender
202-687-5100
SOURCE Idera Pharmaceuticals, Inc.
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Related links:
http://www.iderapharma.com
CONTACT:
Tim Sullivan of Idera Pharmaceuticals, Inc.,
+1-617-679-5500, ext 5526, tsullivan@iderapharma.com; or Douglas
MacDougall of MacDougall Biomedical Communications,
+1-508-647-0209 ext. 12; or Laura Cavender of Georgetown
University Medical Center, +1-202-687-5100
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