NEW YORK - Actinium Pharmaceuticals (NYSE:ATNM), Inc. (NYSE AMERICAN: ATNM), a biotechnology firm specializing in targeted radiotherapies, has announced significant results from its Phase 3 SIERRA trial of Iomab-B, a treatment for patients with a TP53 mutation suffering from relapsed or refractory acute myeloid leukemia (r/r AML). The findings will be presented at the 50th Annual meeting of the European Bone Marrow Transplant Society (EBMT) on April 17, 2024.
The SIERRA trial, which enrolled 153 patients, demonstrated that Iomab-B met its primary endpoint of durable Complete Remission (dCR) with high statistical significance. Notably, 100% of the patients treated with a therapeutic dose of Iomab-B achieved bone marrow transplant (BMT) access and engagement. This is particularly relevant for the 24% of patients in the trial with the TP53 mutation, which is typically associated with poor treatment outcomes.
Dr. Hannah Choe, Assistant Professor of Medicine at Ohio State University and a SIERRA trial investigator, will detail these findings in her presentation at the EBMT meeting in Glasgow, Scotland. The study's results highlight the potential of Iomab-B to overcome the challenges faced by high-risk leukemia patients, offering them a survival benefit where limited options were previously available.
Actinium's Chief Medical Officer, Dr. Avinash Desai, expressed excitement about the outcomes, especially for patients with TP53 mutations, and emphasized the company's commitment to bringing Iomab-B to patients globally. With Europe being the largest bone marrow transplant market, Actinium is strategically focused on this region in collaboration with its commercial partner, Immedica Pharma Ab.
Actinium Pharmaceuticals has been recognized for its development of Antibody Radiation Conjugates (ARCs) and aims to improve survival outcomes for those who have not found success with existing oncology therapies. The company holds an extensive patent portfolio and is advancing its pipeline candidates to address other blood cancers and to enhance cell and gene therapy outcomes.
This news is based on a press release statement from Actinium Pharmaceuticals, Inc.
InvestingPro Insights
Amidst the promising clinical advancements, Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) presents a mixed financial landscape according to InvestingPro data. The company's Price / Book ratio stands at a high 5.86 as of the last twelve months ending Q4 2023, which could indicate that the stock is trading at a premium compared to its book value. Additionally, Actinium's revenue has significantly declined by 92.14% during the same period, reflecting the challenges in monetizing its pipeline despite clinical progress.
InvestingPro Tips highlight that while Actinium holds more cash than debt, suggesting a solid balance sheet, analysts have concerns including a rapid cash burn and anticipation of a sales decline in the current year. Notably, the stock has experienced a large price uptick over the last six months, yet the company is not expected to be profitable this year. These insights could be crucial for investors who are weighing the company's clinical potential against its current financial health and future profitability.
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