Oncoinvent Announces Progression of Radspherin® to Third Dose Level Cohort in Ongoing RAD-18-001 Phase 1 Trial in Platinum Sensitive Recurrent Ovarian Cancer Patients with Peritoneal Carcinomatosis
Safety Monitoring Committee review of second dose-level cohort allows advancement of Phase 1 RAD-18-001 study to third cohort dose level cohort
OSLO, Norway–(BUSINESS WIRE)–Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, today announced the advancement of its ongoing Phase 1 clinical study of Radspherin® in ovarian cancer patients suffering from peritoneal carcinomatosis to the third level dose cohort following approval from the trial Safety Monitoring Committee. In this cohort, patients will receive 4MBq of Radspherin®, and enrollment is expected to begin imminently. Radspherin®, a versatile α-emitting radionuclide therapy, is also being evaluated in an ongoing Phase 1 study in colorectal cancer patients with peritoneal carcinomatosis.
Peritoneal carcinomatosis is a very serious complication of ovarian cancer, often leaving patients with a poor prognosis, and we believe that Radspherin® represents a potentially safe and transformative product candidate, offering patients a new treatment option,” said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. “Radspherin® leverages the unique properties of alpha-emitting microparticles to safely deliver localized radiation to cancer cells, while also minimizing off-target effects and the killing of healthy tissue. We are excited by our continued progress, and look forward to reporting dose-ranging data in the second quarter of 2021.”
“I am pleased to see how, when administered, Radspherin® is well tolerated and seems quite evenly distributed in the abdominal cavity of the patients that have been recruited to the RAD-18-001 study here at the Radium Hospital. With the safety results that have been seen in both the RAD-18-001 and RAD-18-002 studies, I am looking forward to initiating treatment of patients at the 4 MBq dose level.” Said Dr. Yun Wang, Principle Investigator for the RAD-18-001 study at the Radium Hospital.
RAD-18-001 is an ongoing 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 ovarian cancer following complete cytoreductive surgery. 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.
Oncoinvent Announces Progression of Radspherin® to Third Dose Level Cohort in Ongoing RAD-18-001 Phase 1 Trial in Platinum Sensitive Recurrent Ovarian Cancer Patients with Peritoneal Carcinomatosis | Business Wire
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