EMA Gives Thumbs-Up To Actinium’s Phase 3 SIERRA Program

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This morning, Actinium Pharmaceuticals (ATNM) announced that the company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for Iomab-B. According to the press release, correspondence from the EMA notes that the trial design, primary endpoint and planned statistical analysis of the U.S. pivotal Phase 3 SIERRA trial are acceptable and can serve as the basis for submission of a Marketing Authorization Application (MAA) in Europe.

In addition, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies on Iomab-B prior to reviewing the MAA. The EMA did request some supporting data; but, management noted that this information is already being collected as part of the U.S. pivotal Phase 3 SIERRA trial.

The Update We Were Hoping For!

The full acceptance of SIERRA as a registration quality study by the EMA is fantastic news for Actinium. Recall, this process started last fall when management announced they would seek advice from the EMA on the regulatory path for Iomab-B in Europe. Talking to the EMA made perfect sense for Actinium. Iomab-B had been designated as an Orphan Drug in October 2016 and in August 2016, Actinium qualified for “small and medium-sized” (SME) status. Companies granted SME status are eligible for administrative and regulatory support including scientific advice, scientific services, pre-authorization inspection and post-authorization procedures. In addition, financial support is provided with fee reductions up to 100% in certain instances.

In February 2017, I laid out some near-term catalysts for Actinium investors. With respect to Iomab-B, I noted that the Phase 3 SIERRA trial initiated last July 2016 continued enrollment with the first planned Data Monitoring Committee (DMC) update expected around the middle of the year once 25% of the patients are treated. A second DMC update at 50% completion is expected late 2017 / early 2018. There will be a third update once 75% of the target population has completed, and top-line safety and efficacy data are expected during the second half of 2018.

The second thing I noted was that investors could expect an update on the Scientific Advice from the EMA shortly. Below is a snap-shot of what I said in February 2017. Based on today’s press release from Actinium, it looks like the company received the most bullish response we were hoping for.