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.
“This is an important step in the development of AR-67 in GBM and a key milestone for our clinical program”
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."
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