Thinly traded nano cap Actinium Pharmaceuticals (NYSEMKT:ATNM) slumps 22% premarket on robust volume in response to its announcement of a public offering of 8M shares of common stock at $1.25. Underwriters over-allotment is an additional 1.2M shares. Net proceeds should be ~$9.3M. Closing date is October 4.
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.
Actinium Pharmaceuticals (NYSEMKT:ATNM) announces that the pivotal Phase 3 clinical trial, SIERRA, for lead product candidate Iomab-B has been initiated. Iomab-B is intended to be an induction and conditioning agent used to prepare patients with relapsed or refractory acute myeloid leukemia (AML) who are over the age of 55 for a hematopoietic stem cell transplant (HSCT), commonly referred to as bone marrow transplant (BMT). There are currently no effective treatments for this patient population.
According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint, durable complete remission six months following HSCT, is April 2018.
Iomab-B, a radioimmunotherapy comprised of the monoclonal antibody BC8 coupled with the radioisotope Iodine-131, is designed to deliver targeted payloads to cells that express CD45, a pan-leukemic antigen expressed on white blood cells and stem cells.