Oncoinvent Unveils Encouraging Results from Phase 1 Trial of Radspherin for Ovarian Cancer Treatment
Introduction
Oncoinvent ASA, a pioneering radiopharmaceutical company at the clinical trial stage, has announced positive conclusions from the 24-month follow-up of its Phase 1 trial evaluating Radspherin® for ovarian cancer treatment. This innovative drug focuses on treating patients with platinum-sensitive recurrent ovarian cancer along with peritoneal carcinomatosis.
Overview of Phase 1 Trial
The trial, officially named RAD-18-001, included 21 participants who were recruited across research facilities in Norway, Belgium, and Spain. The main objective was to assess the safety and efficacy of direct intraperitoneal administration of Radspherin®, employing a strategic dose escalation approach. Participants were administered doses beginning from 1 MBq, escalating to 2, 4, and ultimately a recommended dose of 7 MBq.
Among the 10 patients who received this maximum dose, results revealed that only 1 patient experienced peritoneal recurrence—yielding a remarkably low recurrence rate of 10%. Oncoinvent highlighted in their findings that, in comparable patient populations receiving the conventional standard of care, recurrence rates typically hover around 55-60% by the 24-month mark. This figure starkly emphasizes the promising impact of Radspherin® in this challenging oncological landscape.
In addition to the patients with peritoneal recurrence, two other individuals developed lymph node metastases, leading to an overall recurrence rate of 30%. This is particularly significant as lymph node recurrences often correlate with a better survival prognosis compared to peritoneal relapses. Dr. Luis Chiva, the Principal Investigator at Clinica Universidad de Navarra in Spain, stated, "These results are tremendously encouraging, indicating Radspherin® could potentially assist in delaying disease progression and providing hope for prolonged, healthier lives for patients."
Company Insights
The CEO of Oncoinvent, Oystein Soug, expressed his gratitude towards all participants and emphasized the company's commitment to drive Radspherin® into future clinical stages. His statement reflects Oncoinvent's ambition to expedite this innovative treatment to market as swiftly as possible, stimulating hope within the oncology community and among patients alike. He also mentioned, "We are excited for the interim results from our Phase 2 study, anticipated next year."
Development of Radspherin®
Radspherin® utilizes the alpha-emitting radionuclide radium-224, specifically targeting micro-metastases that may remain post-surgery. This method stands out for its capability to offer the potency of conventional radiopharmaceuticals without the complexities associated with biological targeting. As part of its ongoing clinical endeavors, Oncoinvent is currently conducting further trials, including a randomized Phase 2 study in regions spanning the US, UK, and Europe.
Conclusion
The promising results from the Phase 1 trial of Radspherin® signify a notable advancement in the fight against ovarian cancer, particularly in addressing persistent challenges presented by peritoneal metastases. As Oncoinvent advances towards subsequent trial phases, the biotechnology community watches with anticipation, hoping for continued success and the eventual resolution of one of the most daunting challenges in modern oncology. With no serious safety concerns noted to date, the landscape looks increasingly optimistic for innovative cancer therapies like Radspherin®, bringing new possibilities to many patients in need.