CAMBRIDGE, Mass., Oct. 26 /PRNewswire-FirstCall/ -- Idera Pharmaceuticals, Inc. 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 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
Idera Pharmaceuticals, Inc.
CONTACT: Tim Sullivan of Idera Pharmaceuticals, Inc., +1-617-679-5500, ext5526, tsullivan@iderapharma.com; or Douglas MacDougall of MacDougallBiomedical Communications, +1-508-647-0209 ext. 12; or Laura Cavender ofGeorgetown University Medical Center, +1-202-687-5100
Web site: http://www.iderapharma.com/
