NEW YORK - Actinium Pharmaceuticals (NYSE:ATNM), Inc. (NYSE AMERICAN: ATNM) revealed results at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting, showcasing the efficacy of Iomab-B in treating patients with relapsed or refractory acute myeloid leukemia (r/r AML). The Phase 3 SIERRA trial data indicated that Iomab-B, a targeted radiotherapy, met its primary endpoint of durable Complete Remission with high statistical significance.
The trial included a subset of 37 patients with a TP53 mutation, a genetic alteration often linked to poor outcomes in AML. Results showed that the median overall survival for patients treated with Iomab-B was 5.49 months, significantly longer than the 1.66 months for those who did not receive the treatment.
Iomab-B was also highlighted for its ability to deliver high doses of radiation directly to diseased bone marrow while minimizing exposure to healthy organs. This targeted approach allows for higher radiation levels than those achieved with total body irradiation, a common treatment for AML.
In addition to its potential in hematology, Actinium's novel linker technology for solid tumor indications was presented. This technology demonstrated lower kidney and liver uptake in preclinical models, suggesting improved targeted radiotherapy delivery.
Sandesh Seth, Actinium's Chairman and CEO, expressed the company's commitment to advancing its pipeline of Antibody Radiation Conjugates (ARCs) and highlighted the potential of Iomab-B to treat high-risk AML patients and overcome challenging mutations.
The SNMMI Annual Meeting is a key platform for presenting advances in nuclear medicine and molecular imaging, with this year's event hosting discussions on Actinium's proprietary Actinium-225 cyclotron-based manufacturing technology, which aims to produce medical grade Actinium-225 at scale and reduced cost.
Actinium Pharmaceuticals focuses on targeted radiotherapies, with Iomab-B nearing pre-BLA & MAA (EU) stages and Actimab-A on a pivotal development path with the National Cancer Institute. The company holds a robust patent portfolio, including several patents related to Ac-225 isotope production.
The information in this article is based on a press release statement from Actinium Pharmaceuticals, Inc.
In other recent news, Actinium Pharmaceuticals has been making significant strides in the medical field. The company's Iomab-B treatment, designed for unfit relapsed or refractory acute myeloid leukemia (AML) patients, has shown promise in the pivotal Phase 3 SIERRA trial, leading to an Overweight rating from Stephens. The potential of Iomab-B to change the treatment landscape for AML patients has also been highlighted, with a successful filing and subsequent regulatory approval anticipated, setting the stage for Actinium's first commercial product launch in 2025.
In parallel, Actinium Pharmaceuticals has launched a strategic initiative for the production of Actinium-225, a medical isotope used in cancer treatment. The company's proprietary cyclotron-based manufacturing technology aims to provide a cost-effective and scalable solution. Actinium plans to make multi-million-dollar investments and pursue global collaborations to scale its technology and meet the growing demand for Ac-225.
Furthermore, Actinium is advancing its Iomab-ACT program, with a new clinical trial led by the University of Texas Southwestern Medical Center. The trial aims to replace traditional chemotherapy conditioning regimens with Iomab-ACT, potentially improving access and outcomes for patients requiring cellular or gene therapies.
InvestingPro Insights
Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) has captured the attention of the medical community with its promising results for Iomab-B in treating r/r AML, as reported at the SNMMI Annual Meeting. The success of Iomab-B is a beacon of hope for patients with this aggressive form of leukemia, especially those with the challenging TP53 mutation.
InvestingPro data highlights the financial landscape of Actinium Pharmaceuticals, reflecting a complex picture. The company's revenue for the last twelve months as of Q1 2024 stands at $0.08 million, with a gross profit margin of 100%. However, the operating income margin tells a different story, showing a significant loss at -61,645.68%. This underpins the high costs associated with the development and trials of cutting-edge treatments like Iomab-B.
Despite the financial challenges, the company's stock has seen a large price uptick over the last six months, with a 49.62% return, indicating investor optimism possibly tied to the clinical progress and potential of Actinium's therapies. Additionally, the stock is trading at 93.31% of its 52-week high, reflecting strong investor interest.
InvestingPro Tips suggest that analysts have revised their earnings upwards for the upcoming period, which may be a response to the promising clinical outcomes. However, they also anticipate a sales decline in the current year and do not expect the company to be profitable this year. Actinium is a niche player in the targeted radiotherapy industry, and while it operates with a moderate level of debt, it has sufficient liquid assets to cover short-term obligations.
For investors looking to delve deeper into Actinium Pharmaceuticals and its market potential, there are 9 additional InvestingPro Tips available at https://www.investing.com/pro/ATNM. These tips could provide valuable insights, especially when considering the volatile nature of biotech investing. To access these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, offering a comprehensive analysis to guide investment decisions.
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