Arno Therapeutics, Inc. (OTCBB: ARNI) announced today that its Phase II clinical study of AR-67 has met pre-defined interim goals for patients with glioblastoma multiforme (GBM) who were not previously treated with Avastin ® and will continue toward completion.
AR-67 is a novel, third-generation camptothecin analogue that inhibits Topoisomerase I activity. This open-label multi-center study is designed to evaluate the efficacy of AR-67 in the treatment of GBM, an aggressive form of brain cancer, in patients who have not received treatment with Avastin ®. Study participants received standard concomitant and adjuvant temozolomide and radiotherapy for newly diagnosed GBM until evidence of disease progression and then received AR-67 intravenously for five days on a 21-day cycle. There have been no discontinuations to date as a result of AR-67 toxicity.
Jeffrey Raizer, M.D., assistant professor of neurology at Northwestern University, director of medical neuro-oncology at the Robert H. Lurie Comprehensive Cancer Center and a principal investigator for this study stated: “The results of the interim analysis for the first 16 patients in this trial are encouraging enough to warrant further clinical testing of this novel agent to confirm these preliminary findings. AR-67 has the potential to be an important new treatment option for patients with GBM, which remains a difficult form of brain cancer to treat. We look forward to enrolling additional patients in this study.”
“This is an important step in the development of AR-67 in GBM and a key milestone for our clinical program,” said Glenn Mattes, President and Chief Executive Officer of Arno. “We believe AR-67 represents a promising new approach to treating brain cancer and potentially other solid tumors and that the results of this study will help determine the development and registration pathway for the drug.”About Arno Therapeutics Arno Therapeutics is a clinical-stage biopharmaceutical company developing innovative products for the treatment of cancer. Arno has exclusive worldwide rights to develop and market three innovative clinical-stage anti-cancer product candidates with unique mechanisms of action. These compounds are in clinical testing as potential best- or first-in-class products to treat hematologic malignancies and solid tumors. For more information about the company, please visit www.arnothera.com. Forward Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding the potential of AR-67 to safely and effectively treat GBM and other tumor types, the timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings, as well as our strategy, future operations, outlook, milestones, the success of Arno’s product development, future financial position, future financial results, plans and objectives of management, are forward-looking statements. We may not actually achieve these plans, intentions or expectations and Arno cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make. Such factors include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of our product candidates, our ability to finance the development of our product candidates, regulatory risks, and our reliance on third party researchers and other collaborators. Arno is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
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