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Idera Pharmaceuticals Initiates Phase 1 Trial of IMO-2125 in Hepatitis C
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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Idera Pharmaceuticals (AMEX: IDP) today announced that the first patient has been dosed in a Phase 1 trial evaluating IMO-2125 for the treatment of patients with hepatitis C virus (HCV) infection. IMO-2125 is a novel agonist of Toll-like Receptor (TLR) 9.
"IMO-2125 is a TLR9 agonist that Idera designed to induce endogenous interferon-alpha along with other immune response factors to treat hepatitis C," said Sudhir Agrawal, D. Phil., Chief Executive Officer and Chief Scientific Officer. "IMO-2125 is the second novel TLR9 agonist from our portfolio to enter the clinic following IMO-2055 for cancer. We generated both of these drug candidates using our chemistry-based drug discovery approach which allows us to design TLR-targeted drug candidates which act as agonists for TLR7, 8 or 9 or as TLR antagonists for a broad spectrum of indications."
"The preclinical data that we have generated, including data demonstrating potency in the HCV replicon assay of cytokines and chemokines present in the blood of non-human primates treated with IMO-2125, provides a strong rationale for evaluating IMO-2125 in patients with HCV infection," commented Robert Karr, M.D., President.
The Phase 1 trial evaluating IMO-2125 is being conducted in HCV patients who have failed to respond to previous combination therapy with ribavirin and pegylated interferon-alpha. The trial is designed to assess the safety and tolerability of IMO-2125 at different dose levels as well as determine the effect of IMO-2125 on HCV RNA levels and parameters of immune system activation. Four doses of IMO-2125 are being investigated. IMO-2125 will be administered subcutaneously once a week and treatment will continue for four weeks. The target enrollment for the trial is 40 patients with ten patients per cohort. Of the ten patients per cohort, eight are randomized to receive IMO-2125 treatment and two are randomized to receive placebo treatment. The trial is expected to be conducted at five or more U.S. sites. The lead investigator of this trial is John McHutchison, M.D., Associate Director, Duke Clinical Research Institute and Director, GI/Hepatology Research Program and Professor of Medicine, Division of Gastroenterology, Duke University School of Medicine.
About IMO-2125
IMO-2125 is a novel DNA-based TLR9 agonist being evaluated for the treatment of HCV. IMO-2125 was designed to induce endogenous interferon-alpha along with other immune response factors to treat hepatitis C. In preclinical studies, IMO-2125 induced high levels of endogenous interferon-alpha, as well as other cytokines and chemokines, in non-human primates and in human immune cell cultures. The cytokines induced by IMO-2125 in human immune cell cultures and in non-human primates have shown potent activity in inhibiting HCV replication in an in vitro assay (HCV replicon assay).
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's second TLR9 agonist, IMO-2125, is currently in a Phase 1 trial for the 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 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.
Contacts
Idera Pharmaceuticals, Inc.
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