Actinium Pharmaceuticals Inc (ATNM)

[blukky]

NEWS - Actinium Pharmaceuticals announces dosing of 38th patient and 25% enrolment in Iomab-B pivotal SIERRA trial.

Wed Oct 10 02:32:24 2018 EDT

On 26 Jun 2018, Actinium Pharmaceuticals Inc, announced that it has dosed the 38th patient in the pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly Relapse Refractory Acute Myeloid Leukaemia) study of Iomab-B, reaching 25% of patient enrolment. As a result, the trial's independent Data Monitoring Committee (DMC) will review the trial data at its next meeting, which has been scheduled for Aug 2018. The SIERRA trial is a 150 patient, randomized, and controlled multi-centre trial that is currently open at 16 leading transplant centres in the US. The company highlighted the recent initiatives taken to strengthen the outlook for the trial. Based on the higher than anticipated crossover rate previously announced after the first DMC meeting, the company deemed it appropriate to increase the number of additional treatment options acceptable for utilization in the control arm. This was done to accommodate requests from the principal investigators at various sites. The amended protocol now allows additional treatment options in the control arm including Mylotarg, Venetoclax, and the FLT3 inhibitors Midostaurin and Sorafenib. Importantly, the company notes that these treatments may be used based on the preference and discretion of the treating physician in keeping with the design of the study's control arm and are not approved treatments for this patient population. The recent protocol changes have been implemented following review by the FDA and IRB approvals. The company has also made valuable additions to its clinical organization. The company also materially strengthened its clinical operations group with the addition of two directors, two clinical trial associates and a clinical education and support specialist nurse. These initiatives taken since the first DMC update have enabled the recent milestone and are expected to ensure the continued strong progress of the SIERRA trial including both site expansion and enrolment. Following successful enrolment of 25% of patients in the SIERRA trial, the company expects to activate additional clinical trial sites in the US and Canada with a continued emphasis on leading high-volume BMT centres. In addition, Actinium intends to open clinical trial sites in Europe where Iomab-B has been granted Orphan designation by the European Medicines Agency (EMA) and received Scientific Advice establishing a clear pathway to submit for EU marketing authorization upon successful completion of the SIERRA trial. Based on current forecasts, Actinium expects to complete patient enrolment in 2019. In anticipation of trial completion, Actinium is taking necessary steps to prepare for a Biologics License Application (BLA) submission and is undertaking pre-commercialization activities. The SIERRA trial will have multiple data readouts including scheduled DMC safety analyses after twenty-five, fifty and seventy-five percent of patients have been enrolled. In addition, Actinium, at its discretion, may request efficacy analyses by the DMC after 70 and 110 patients have reached the primary endpoint of durable complete remission (dCR) of at least 180 days. Original Source: Actinium Pharmaceuticals, 2018. Found on website: http://www.globenewswire.com.

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