Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon is primarily developing Marqibo for the treatment of Ph- adult ALL. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.
Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
Manufactured and packaged commercial lots of Marqibo® for the treatment of Philadelphia chromosome negative adult acute lymphoblastic leukemia (ALL) patients in second or greater relapse or whose disease has progressed following two or more prior lines of anti-leukemia therapy.
• Increased number of clinical sites to 88 with enrollment reaching 164 patients in the Phase 3 Marqibo® trial, named OPTIMAL 60, for elderly patients with newly diagnosed non-Hodgkin's lymphoma (NHL). Initiation of the additional sites in 2013 is expected to accelerate patient accrual.
• Completion of enrollment in the Phase 2 trial of Menadione Topical Lotion (MTL) sponsored and conducted by the Mayo Clinic. The study assessed the effectiveness of MTL in preventing skin toxicities for patients taking biologic and small molecule EGFR inhibitors for anti-cancer therapy. The Mayo Clinic will perform analysis from data collected on the subjects.
• Publication of the Marqibo® relapsed and refractory adult ALL trial results in the Journal of Clinical Oncology in February 2013. In March 2013, the Cancer Chemotherapy and Pharmacology Journal published our paper titled, "Marqibo® improves the pharmacokinetics and pharmacodynamics of vincristine." Additional papers have been submitted to various journals and are awaiting journal acceptance
That may be true but look at the label warnings. No wonder that they cant find a partner
to report to shareholders after several months. They also state that they have no
experience in commercializing their product so they are in big trouble. I wonder if they
will even host a conference call? I sure would like to know why the focus of this quarterly
report was to extensively highlight the label warnings of marqibo.