Actinium Pharmaceuticals, Inc. ATNM announced positive recommendation by an Independent Data Monitoring Committee (“DMC”) for a pivotal phase III SIERRA study, evaluating its lead pipeline candidate, Iomab-B (apamistamab).
Notably, Lomab-B is being developed for conditioning patients prior to a bone marrow transplant (BMT) with relapsed or refractory acute myeloid leukemia (AML) aged 55 years and above.
The phase III study will enroll 150 patients in total with 75 heads per arm. The trial is evaluating the candidate in comparison to chemotherapy as per physician’s choice on AML patients followed by a BMT, also referred to as a hematopoietic stem cell transplant. While the primary endpoint of the study is durable Complete Remission (dCR) at six months post treatment, the secondary endpoint is overall survival at one year.
Additionally, the company stated that it may also request for two ad-hoc efficacy analyses after 70 and/or 110 patients receive the treatment and are given enough time to achieve the primary endpoint.
Significantly, DMC reviewed the initial safety data from the first 20 patients enrolled in the trial in late November. The DMC recommended to continue enrollment for the study. The company said that it expects completion of the trial enrollment by the end of 2018, in line with the prior forecast.
Actinium’s shares have underperformed the industry so far this year. The stock has lost 19.5% against the industry’s gain of 9.8%.
It is important to note that the company expects to open the phase III study at five to seven additional sites including Canada. In May, Actinium received clearance to initiate the study from Health Canada.
We remind investors that Iomab-B has been granted with an Orphan Drug Designation by the FDA and the European Medicines Agency for the aforementioned indication. On successful completion of the phase III program, the company aims to file marketing applications in both the United States as well as the EU.
Incidentally, there are no effective treatments approved by the FDA for conditioning patients prior to BMT. As BMT is the only potential cure for AML patients, thus safer conditioning prior to BMT may have a major impact on the outcomes of treatment of patients. Hence approval of the candidate will cater to the largely unmet needs of patients seeking a BMT with improved survival outcomes.
Actinium Pharmaceuticals, Inc. Price
Actinium Pharmaceuticals, Inc. Price | Actinium Pharmaceuticals, Inc. Quote
Zacks Rank & Other Key Picks
Actinium carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the health care sector include Corcept Therapeutics Incorporated CORT, Achillion Pharmaceuticals, Inc. ACHN and AcelRx Pharmaceuticals, Inc. ACRX, each carrying a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Corcept’s earnings per share estimates have been revised upward from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 14.32%. Share price of the company has skyrocketed 158.8% year to date.
Achillion’s loss per share estimates have narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2018 over the last 60 days. The company came up with positive earnings surprises in two of the last four quarters with an average beat of 4.51%.
AcelRx has seen the Zacks Consensus Estimate for current-year loss per share being narrowed from $1.10 to $1.07 and from $1.03 to 99 cents for 2018 over the last 30 days.
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