Actinium Plans Phase 2 Trial With Actimab-A In Acute Myeloid Leukemia

NEW YORK - June 4, 2016 - PRLog -- Earlier this week, Actinium Pharmaceuticals (ATNM) provided an update to the ongoing Phase 1/2 clinical program with Actimab-A, the company's most advanced alpha particle immunotherapy (APIT) program, for the treatment of acute myeloid leukemia (AML) in elderly patients. The company hosted a webinar and the key takeaways were:

- Actimab-A has demonstrated excellent safety and tolerability so far in two Phase 1 clinical trials.

- During analysis of the Phase 1 and previous studies stemming from the HuM195 conjugated alpha particles program, an interesting trend emerged where patients with low peripheral blast burden experienced the best clinical response.

- CR/CRi/CRp for the dose Actinium plans to move forward with into Phase 2 (2 μCi/kg) in patients with low peripheral blast burden was 50%, matching the impressive data from Celator's VYXEOS™ at 48% reported in March 2016.

- Management plans to alter the protocol for the upcoming Phase 2 portion of the trial by pretreating patients with hydroxyurea to reduce peripheral blast count. This should increase the response rate for all patients treated with Actimab-A. Additionally, the required use of low-dose cytarabine has been removed by the FDA for the Phase 2 portion, which should greatly improve enrollment rates and interest among investigators.

- The Phase 2 trial is expected to begin in the next few months with initial data expected at ASH in December 2016.

Below is a detailed review of the Phase 1 results and key findings from Actinium's analysis of the data. Initiation of the Phase 2 trial represents yet another major catalyst for the shares. Interest in acute myeloid leukemia (AML) is high given Jazz Pharma's acquisition of Celator for $1.5 billion yesterday. Actinium, with two high-value AML candidates under development in Actimab-A and Iomab-B, looks very well-positioned.

Read the full update here >> http://www.bionapcfa.com/2016/06/actinium-plans-phase-2-t...