Arno Therapeutics announces dosing of first patient in Phase II clinical study of AR-67

Dec 17 2009

Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing oncology therapeutics, today announced the dosing of the first patient in a Phase II clinical study of its third-generation camptothecin compound, AR-67, in patients with Glioblastoma Multiforme (GBM), an aggressive form of brain cancer.

The Phase II, open-label study in up to 56 patients is designed to evaluate the efficacy of AR-67 dosed intravenously for five days on a 21-day cycle until the onset of toxicity requiring discontinuation or tumor progression, and will include two-cohorts. One cohort will enroll patients who have progressed rapidly after treatment with Avastin^® (Genentech), a drug recently approved to treat GBM, and the other cohort will enroll patients who have not recently received treatment with Avastin^®. The study is being conducted as a multi-centered study led by Duke University, a leading center in the treatment of brain cancer. The primary objective of the Phase II study is to evaluate the progression free survival of patients with GBM treated with AR-67. Secondary endpoints include response rate, and overall survival rate.

“Based upon the improved stability of the active lactone metabolite and the increased lipophilicity of this topoisomerase I inhibitor, we believe there is a significant opportunity for AR-67 to cross the blood-brain barrier and aid in the treatment of GBM,” stated. James Vrendenberg, M.D., the principal investigator and Medical Director, Adult Clinical Services, Professor of Medicine at The Preston Robert Tisch Brain Tumor Center at Duke University.

“We are excited about the enrollment of the first patient in this Phase II study of AR-67 at Derrick L. Davis Forsyth Regional Cancer Center (FRCC). We believe that if the findings of this trial are positive, then there may be a significant opportunity for AR-67 to fill the unmet medical need in the treatment of GBM, which is the most prevalent and deadly form of brain cancer,” said Volker Stieber, M.D., the principal investigator at FRCC and Director of Stereotactic Radiation Oncology at FRCC, the only non-academic, community based clinic participating in the GBM trial.

“Based upon the clinical activity seen to date, safety profile and pharmacokinetic characteristics observed in our previous studies of AR-67, we are excited to advance AR-67 into our second Phase II clinical,” stated David Tanen, President of Arno Therapeutics. “We are extremely pleased to have the involvement of these and other prestigious centers in our clinical trial.”