Arno Enrolls First Patient In Phase II Study Of AR-67

Arno Therapeutics (Arno) has reported 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 company said that 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, said the company.

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, said the company.

Volker Stieber, the principal investigator at FRCC and director of Stereotactic Radiation Oncology at FRCC, community based clinic participating in the GBM trial, said: “We are excited about the enrollment of the first patient in this Phase II study of AR-67 at Derrick 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.”