Safety Monitoring Committee review of third dose-level cohort allows progression of Phase 1 RAD-18-002 study to fourth and final cohort dose level cohort
Oslo 11, January 2020
Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, today announced that the trial Safety Monitoring Committee approved its first-in-human Phase 1 clinical study of Radspherin® in colorectal cancer patients suffering from peritoneal carcinomatosis to progress to the fourth level dose cohort. Enrollment in this cohort, where patients will receive 7MBq of Radspherin®, is expected to begin imminently. Furthermore, Oncoinvent announced today the expansion of its clinical sites to include Uppsala University Hospital, Sweden. Radspherin® is also being evaluated in an ongoing Phase 1 study in ovarian cancer patients with peritoneal carcinomatosis.
“Radspherin® is a potentially transformative product candidate that leverages the unique properties of alpha-emitting microparticles to deliver a localized and specific higher Linear Energy Transfer (LET) form of radiation, and has demonstrated good safety margins to date. This exciting progress, along with the expansion of our clinical sites to include Uppsala University Hospital, brings us one step closer to developing a treatment for patients with metastatic cancers in body cavities,” said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. “We look forward to advancing the trial and reporting dose-ranging data in the first quarter of 2021.”
The Phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety and tolerability of Radspherin®, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from colorectal carcinoma following complete cytoreductive surgery and HIPEC. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.
Radspherin® is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin® has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.
Oncoinvent AS is a clinical stage company developing innovative radiopharmaceutical technology that delivers precise, alpha-emitting particles across solid cancers. By leveraging internal manufacturing and supply chain capabilities to enable a clinical supply of radioisotopes, the company is advancing a pipeline of novel products that use alpha particles, a higher Linear Energy Transfer (LET) form of radiation, that can potentially eradicate cancer cells. Oncoinvent’s lead candidate, Radspherin®, is designed for treatment of metastatic cancers in body cavities, and its versality allows it to be deployed for the treatment of a variety of cancer indications. Radspherin® is in two ongoing Phase 1 studies to treat peritoneal carcinomatosis from both ovarian cancer and colorectal cancer.
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