NEW YORK – Actinium Pharmaceuticals (NYSE:ATNM), Inc. (NYSE AMERICAN: ATNM) has shared results from its Phase 3 SIERRA trial for Iomab-B, a targeted radiotherapy aimed at conditioning patients for bone marrow transplants (BMT) as a potential cure for relapsed or refractory Acute Myeloid Leukemia (r/r AML). The trial revealed that Iomab-B led to a significant increase in durable Complete Remission (dCR) and Event-Free Survival (EFS) among older patients.
The SIERRA trial, which enrolled 153 patients aged 55 and above, compared Iomab-B followed by BMT against the standard of care, which includes salvage chemotherapy followed by BMT. The results showed that 22% of patients in the Iomab-B arm achieved a dCR of at least six months post-BMT, a significant improvement over the 0% in the control arm. Additionally, Iomab-B demonstrated a notable improvement in EFS, with a Hazard Ratio of 0.22.
Despite these promising outcomes, the trial did not meet the secondary endpoint of overall survival on an intent-to-treat basis, mainly due to a high crossover rate, with nearly 60% of patients in the control arm eventually receiving Iomab-B.
Dr. Sergio Giralt, a leading investigator in the trial, emphasized the significance of Iomab-B in providing improved access to potentially curative hematopoietic stem cell transplants and better outcomes compared to current chemotherapy regimens. However, he expressed disappointment that the results would not support immediate approval for Iomab-B, citing a significant unmet medical need in the patient population.
Actinium announced on August 05, 2024, that the FDA requires a randomized head-to-head trial to demonstrate an overall survival benefit for Iomab-B before considering a Biologics License Application (BLA) filing, as the SIERRA trial alone was deemed inadequate.
The company is now seeking a strategic partner to further develop Iomab-B in the U.S. and plans to finalize additional Phase 3 trial specifics following its interactions with the FDA. The SIERRA trial's publication in the peer-reviewed Journal of Clinical Oncology marks a step forward for the field of BMT and targeted radiotherapeutics, particularly for patients with relapsed and refractory AML.
Actinium's portfolio includes other targeted radiotherapy candidates with the potential to extend survival for people with advanced blood cancers. The company, with a strong intellectual property portfolio, is also exploring Iomab-B's application in other blood cancers and aims to improve outcomes for cell and gene therapies with its next-generation conditioning candidate, Iomab-ACT.
This article is based on a press release statement from Actinium Pharmaceuticals.
In other recent news, Actinium Pharmaceuticals has been making strides with its Iomab-B and Iomab-ACT programs. The company's Iomab-B program faced a setback as the U.S. Food and Drug Administration (FDA) required a new trial for its approval, following the SIERRA trial's insufficient design and analysis. In response, Actinium is planning a new trial without allowing crossover and is seeking a strategic partner for Iomab-B in the U.S. Despite this, Actinium remains in a strong financial position, with a reported first-quarter cash balance of $84.05 million.
On a brighter note, Actinium has received FDA clearance for an Investigational New Drug application to study Iomab-ACT in patients with sickle cell disease undergoing bone marrow transplant. This trial, in collaboration with Columbia University, aims to offer a less toxic alternative to current chemotherapy-based conditioning. It also has the potential to revolutionize treatment for sickle cell disease, according to Dr. Markus Mapara.
Moreover, Actinium's broader goal is to improve access and outcomes for patients needing cellular or gene therapies, with Iomab-ACT positioned to address a growing market. The company's pipeline also includes candidates like Actimab-A, with over 230 patents and applications in targeted radiotherapies. These are recent developments in the company's pursuit to deliver value to its shareholders.
InvestingPro Insights
Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) has recently provided updates on its Phase 3 SIERRA trial for Iomab-B, showcasing the potential of its targeted radiotherapy for bone marrow transplants in older patients with Acute Myeloid Leukemia. As the company navigates the path towards FDA approval and seeks strategic partnerships, investors and stakeholders are closely monitoring Actinium's financial health and market performance. Here are some key insights from InvestingPro that shed light on the company's current status:
InvestingPro Data indicates that Actinium's revenue for the last twelve months as of Q2 2024 stands at $0.08 million, with a remarkable revenue growth of 80%. Despite this growth, the company's gross profit margin remains at 100%, indicating that while revenues are increasing, they are still relatively small in absolute terms. Additionally, the company's operating income adjusted for the same period is at a deficit of $46.71 million, reflecting the significant investment and expenses associated with advancing its clinical trials.
InvestingPro Tips reveal that analysts have recently revised their earnings upwards for the upcoming period, which could be a signal of confidence in the company's future performance. However, they also anticipate a sales decline in the current year and do not expect the company to be profitable this year. The stock has experienced high price volatility and has fared poorly over the last month, with a 1-month price total return of -16.04%.
For investors interested in a deeper dive into Actinium Pharmaceuticals' performance and future prospects, InvestingPro offers additional tips and analysis. As of now, there are 12 more InvestingPro Tips available, which could provide valuable insights for making informed investment decisions. To explore these tips, visit InvestingPro's dedicated page for Actinium at https://www.investing.com/pro/ATNM.
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