Oncoinvent Reports updated 18-Month Data from Phase 1 Ovarian Cancer Trial with Radspherin®: No new recurrences Demonstrate Continued Promise of Preventing Disease Progression
OSLO, Norway, April 28, 2025 /PRNewswire/ -- Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, today announced the 18-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin® in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis. The trial was closed for recruitment at the end of 2023 and patients are currently in long-term follow-up.
In this trial, 10 patients received a single intraperitoneal dose of 7 MBq Radspherin®. Oncoinvent reported 12-month data in November 2024, where only 1 out of the 10 receiving the selected dose had peritoneal recurrence. At the 18-month follow-up, no further patient had experienced recurrence. i.e., only 10% of patients treated have so far had a recurrence. In similar populations, receiving best standard of care, it is expected that approximately 40% of patients would have had disease recurrence at this time point[1],[2],[3].
"Ovarian cancer's characteristic peritoneal metastasis lead to frequent recurrences despite a comprehensive treatment approach," commented Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "I am proud to be part of a study program exploring whether Radspherin® may become a novel therapy that can prevent disease progression, offering hope for a better and longer life for my patients."
"These compelling results underscore Radspherin®'s potential to significantly reduce peritoneal recurrence in ovarian cancer patients," said Øystein Soug, CEO of Oncoinvent. "The data not only reinforce our confidence in Radspherin® but also support its advancement in Phase 2 trials, including the ongoing randomized controlled Phase 2 trial assessing progression-free survival in patients with peritoneal metastasis from ovarian cancer."
To discuss these promising clinical results, provide an update on operations, and discuss the ongoing Phase 2 trial, Oncoinvent has decided to move up its Quarterly Update from the previously announced May 27 to April 30 at 11:00 CEST.
About Oncoinvent
Oncoinvent is a clinical-stage biotechnology company developing novel radiopharmaceutical therapies against cancer. The lead product candidate, Radspherin®, uses the alpha-emitting radionuclide radium-224, directly targeting micro-metastases post-surgery, harnessing the benefits of modern radiopharmaceuticals without the complexities of biological targeting. Oncoinvent is investigating the safety and efficacy of Radspherin® in a clinical development program in two indications. Currently one Phase 1 trial, one Phase 1/2a trial and one randomized Phase 2 trial are ongoing in the US, UK and Europe. Preliminary clinical efficacy data are highly encouraging, and no serious toxicity or safety concerns have been reported to date. The Oncoinvent team consists of approx. 30 employees and runs a state-of-the-art manufacturing facility to produce drug products for clinical trials in Nydalen, Oslo. Oncoinvent is listed on the Euronext Growth Oslo.
About Radspherin
Radspherin® is an investigational radiopharmaceutical designed for the local treatment of cancer that has spread to body cavities. It consists of billions of calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the decay of radium-224 emitting alpha-particles, a highly potent form of ionizing radiation. Radspherin® is investigated in ongoing clinical studies to treat peritoneal carcinomatoses from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Oncoinvent's plans, estimates, or expectations will be achieved. These forward-looking statements represent Oncoinvent's expectations as of the date of this press release, and Oncoinvent disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers.
For further information, please contact:
Øystein Soug, Chief Executive Officer
Email: soug@oncoinvent.com
Tore Kvam, Chief Financial Officer
Email: kvam@oncoinvent.com
[1] Coleman et al. N Engl J Med. 2019 Nov 14;381(20):1929-1939
[2]Harter et al. N Engl J Med. 2021 Dec 2;385(23):2123-2131
[3] Shi et al. Lancet Oncol. 2021 Apr;22(4):439-449
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