... Company on track to transform profile from focus on early-stage to later-stage clinical development during 2016.
Actinium's profile is expected to change significantly in 2016 as the Company transitions to a later stage clinical development enterprise upon the start of the pivotal Phase 3 Iomab-B trial and the Phase 2 Actimab-A trial. S everal milestones are anticipated for the Company in 2016 including:
?Orphan Drug Designation for Iomab-B ?Clinical trial site and IRB contracts executed with top BMT centers ?Initiation of pivotal Phase 3 Iomab-B clinical ?Filing of EU Orphan Medicine Designation applications for Actimab-A ?Progress on EU Orphan Medicine application process for Iomab-B ?Initiation of Phase 2 portion of Actimab-A Phase 1/2 clinical trial ?Interim data from Actimab-A Phase 2 clinical trial ?Enrollment updates from Iomab-B clinical trial via Data Safety Monitoring Board readouts ?KOL days focused on Iomab-B and Actimab-A, respectively ?Pipeline and strategic initiative updates Actinium entered 2016 with a strong balance sheet with approximately $25 million cash and has built a team comprised of highly motivated and experienced professionals led by proven pharmaceutical executives. These strengths along with a dedication to improving the lives of Acute Myeloid Leukemia patients and patients suffering from other difficult to treat cancers with targeted payload immunotherapeutics will drive the Company's efforts in 2016.
Beyond the patient subsets by age or disease progression, there is significant cytogenic variation between AML patients that make various subsets respond and not respond to standard induction. I think Actinium has the potential to be the next Celator, and I'm keeping a keen eye on the story in 2016.
Actinium initiates mid-stage clinical trial of Actimab-A in patients with AML over age 60; shares rise 5% premarket
Sep 27 2016, 08:37 ET | About: Actinium Pharmaceuticals, ... (ATNM) | By: Mamta Mayani, SA News Editor
Actinium Pharmaceuticals (ATNM) initiates a Phase 2 clinical trial of Actimab-A in patients newly diagnosed with Acute Myeloid Leukemia (AML) who are over the age of 60. Actimab-A, Actinium's most advanced alpha particle immunotherapy (APIT) program, consists of the CD33-targeting monoclonal antibody, HuM195, and the alpha-emitting radioisotope, Actinium-225.
Actinium-225 gives off high-energy alpha particles as it decays which kills cancer cells.
The open-label study will enroll 53 patients. The primary endpoint is the complete response rate defined as complete remission or complete remission with incomplete platelet recovery. The secondary endpoint is overall survival. Top-line data should be available in H2 2017.