|Creating the next generation of cancer treatments
December 17, 2009
Arno Therapeutics Announces Enrollment of First Patient in Phase II Study of AR-67 in Patients with Glioblastoma Multiforme (GBM)
PARSIPPANY, N.J., December 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 thirdgeneration 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 twocohorts. 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.”
AR-67 is a novel, third-generation camptothecin analogue that inhibits Topoisomerase I activity, and has demonstrated clinical activity and an excellent safety profile in clinical studies, as well as improved pharmacokinetic properties, compared with approved first and second-generation products Hycamtin® (Topotecan) and Camptosar® (Irinotecan), respectively, as demonstrated by the increased stability of the active lactone form of AR-67 in blood. Arno has completed a Phase I single agent, clinical study of AR-67 in patients with advanced solid tumors. A separate Phase II study for the treatment of myelodysplastic syndrome (MDS) is currently enrolling patients who have progressed following regimens containing hypomethylating agents.
About Arno Therapeutics
Arno Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops and commercializes innovative products for the treatment of cancer patients. In addition to AR-67, Arno's lead clinical compound is AR-12, a potentially first-in-class, orally available PDK1 inhibitor that blocks the PI3K/Akt pathway and induces autophagy and the endoplasmic reticulum stress pathway, which is currently enrolling patients in a Phase I clinical study. Arno is also developing AR-42, an orally available targeted pan-HDAC inhibitor that received FDA acceptance of its IND in 2009.
For more information on Arno please visit www.arnothera.com.
Brian Lenz, CPA
Chief Financial Officer
Arno Therapeutics, Inc.
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 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 presentation and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.