News and Announcements
FDA Allows Prescient IND for Leukemia Phase Ib & II Trials
- Published January 08, 2016 11:21AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
8th January 2016, ASX Announcement
Highlights:
- PTX has four FDA approved INDs demonstrating the strength of its cancer treatment assets
- Follows Phase I study that demonstrated 17 out of 32 patients achieved disease stabilization. These were patients with advanced leukemia with few remaining treatment options
Clinical stage oncology company Prescient Therapeutics Ltd (PTX) has secured US Food and Drug Administration (FDA) approval for its Investigational New Drug (IND) application for the forthcoming Phase Ib and Phase II clinical trial and program in acute myeloid leukemia (AML).
The study will combine PTX’s lead drug candidate, the novel AKT inhibitor PTX-200, together with the chemotherapeutic agent cytarabine, in refractory or relapsed patients with AML.
The Phase Ib and Phase II studies will be lead by hematologist Professor Jeffrey Lancet at the Moffitt Cancer Center and Research Institute (Moffit) in Tampa, FL USA.
To read the full announcement, please click here.
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