Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Talon Therapeutics has signed a pact with the US Food and Drug Administration (FDA) related to the special protocol assessment (SPA) for its intended Hallmarq Phase 3 trial to evaluate Marqibo (vincristine sulfate liposomes injection) in newly diagnosed acute lymphoblastic leukemia patients.
Subscribe to our email newsletter
The Phase 3 study is intended to be a confirmatory study to be completed following the accelerated approval of Marqibo.
Talon president and CEO Steven Deitcher said the SPA represents a written agreement between Talon and the FDA regarding the planned design, conduct, and analysis of Phase 3 ALL trial called Hallmarq.
"HAllmarq will be a global trial with initial clinical site openings expected in the US prior to the end of 2011," Deitcher said.