Oncoinvent ASA Announces Positive Safety Review of Lead-In Cohort, Advances to Randomised Part of Ongoing Phase 2 Trial of Radspherin® in Ovarian Cancer Patients
Oncoinvent, a clinical-stage radiopharmaceutical company developing innovativetreatments for solid cancers, today announced that the safety data from thepatients in the safety lead-in cohort of its ongoing Phase 2 trial evaluatingRadspherin® for the treatment of peritoneal carcinomatosis from ovarian cancerhas been reviewed by the company and study investigators. No safety concernswere identified, and based on this review, the company is pleased to confirmthat the randomised part of the trial is now initiated, with the first patientsuccessfully enrolled.Radspherin® is a novel alpha-radiation therapy designed for targeted, directtreatment of cancers that have spread to body cavities. The Phase 2 is arandomised, open label, multicentre trial (NCT06504147) assessing the efficacyand safety of Radspherin® in patients with peritoneal metastases from ovariancancer following complete surgical resection and pre-operative chemotherapy."The positive outcome of the safety review is consistent with the safetyprofileobserved in earlier studies," said Oystein Soug, CEO of Oncoinvent. "Thisallowsus to confidently move forward into the randomised part of the trial, tocontinue exploring Radspherin®'s potential as a treatment for peritonealcarcinomatosis."About OncoinventOncoinvent is a clinical-stage biotechnology company developing novelradiopharmaceutical therapies against cancer. The lead product candidate,Radspherin®, uses the alpha-emitting radionuclide radium-224, directlytargetingmicro-metastases post-surgery, harnessing the benefits of modernradiopharmaceuticals without the complexities of biological targeting.Oncoinvent is investigating the safety and efficacy of Radspherin® in aclinicaldevelopment program in two indications. Currently two phase 1/2a trials andonerandomized phase 2 trial are ongoing in the US, UK and Europe. Preliminaryclinical efficacy data are highly encouraging, and no serious toxicity orsafetyconcerns have been reported to date. The Oncoinvent team consists of approx.30employees and runs a state-of-the-art manufacturing facility to produce drugproducts for clinical trials in Nydalen, Oslo. Oncoinvent is listed on theEuronext Growth Oslo.Forward-Looking StatementsAll statements other than statements of historical facts contained in thispressrelease are forward-looking statements and are not a representation thatOncoinvent's plans, estimates, or expectations will be achieved. Theseforward-looking statements represent Oncoinvent's expectations as of the dateofthis press release, and Oncoinvent disclaims any obligation to update theforward-looking statements. These forward-looking statements are subject toknown and unknown risks and uncertainties that may cause actual results todiffer materially, including with respect to whether the results of clinicalorother studies will support the use of our product offerings, the impact ofresults of such studies, our expectations of the reliability, accuracy andperformance of our tests, or of the benefits of our tests and productofferingsto patients, providers and payers.For further information, please contact:Oystein Soug, Chief Executive OfficerEmail: [email protected] Kvam, Chief Financial Officer Email: [email protected]://newsweb.oslobors.no/message/642115