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Idera Pharmaceuticals Initiates Phase 1b Trial IMO-2055


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Idera Pharmaceuticals Initiates Phase 1b Trial of IMO-2055 in Combination with Targeted Agents in Non-Small Cell Lung Cancer

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Idera Pharmaceuticals (Nasdaq: IDRA) today announced that the first patient has been dosed in a Phase 1b trial evaluating IMO-2055 in combination with Tarceva® and Avastin® in patients with non-small cell lung cancer (NSCLC). IMO-2055 is a novel agonist of Toll-like Receptor (TLR) 9. Tarceva and Avastin are targeted agents approved by the U.S. Food and Drug Administration for the treatment of NSCLC.

“Initiation of this Phase 1b trial in NSCLC is part of our previously announced oncology clinical development strategy. Following analysis of the Phase 1b results, we plan to conduct a four-arm randomized, placebo controlled Phase 2 trial evaluating Tarceva alone, IMO-2055 and Tarceva, Tarceva and Avastin, and IMO-2055, Tarceva and Avastin,” said Sudhir Agrawal, D. Phil., Chief Executive Officer and Chief Scientific Officer. “Our preclinical studies have demonstrated increased anti-tumor activity when IMO-2055 is combined with approved targeted agents such as Avastin and Tarceva compared to the activity of any of these agents alone.”

The Phase 1b trial evaluating IMO-2055 is being conducted in patients with advanced or metastatic NSCLC who have progressed on first line chemotherapy. The trial is designed to assess safety of the IMO-2055, Tarceva and Avastin combination and to determine the recommended dose of IMO-2055 for use in the subsequent Phase 2 trial. Three doses of IMO-2055 are being investigated with standard doses and schedules of Tarceva and Avastin. IMO-2055 is administered subcutaneously once a week. The target enrollment for the trial is 40 patients. Patients will continue therapy until disease progression as determined by standard guidelines to evaluate the response to treatment in solid tumors (RECIST). The trial is expected to be conducted at seven U.S. sites. The lead investigator is David Johnson, M.D., the Cornelius A. Craig Professor of Medical and Surgical Oncology, Director of the Division of Hematology/Oncology at Vanderbilt University Medical Center, and Deputy Director of Vanderbilt-Ingram Cancer Center.

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, an agonist of TLR9, is currently in a Phase 1b trial in combination with Tarceva and Avastin in non-small cell lung cancer and is being evaluated in a Phase 2a trial in renal cell carcinoma and in a Phase 1/2 chemotherapy combination trial in solid tumors. Idera’s second TLR9 agonist, IMO-2125, is currently in a Phase 1 trial for the treatment of hepatitis C virus infection. Idera has also identified discovery-stage, DNA-based compounds which have been shown to act as antagonists to TLRs 7 and 9 in preclinical studies and are being evaluated in preclinical disease models of lupus, collagen-induced arthritis and multiple sclerosis. 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 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 November 13, 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.

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