Oncoinvent updates: Phase I dose escalation completed successfully in two indications Phase 2 A inclusion has started
Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, today announced strong progress with clinical trials, including patient recruitment and efficacy signals. Further updates will be provided in an upcoming investor conference call.
- Successful completion of the dose escalation stage of both ongoing Phase 1/2A clinical studies RAD-18-001 (ovarian cancer) and RAD-18-002 (colorectal cancer); Radspherin® has demonstrated attractive biodistribution, favorable tolerability and potential signals of efficacy.
- Ovarian cancer study includes new centers in Spain that have already treated their first patients with Radspherin.
- The 12 Patients that received the recommended clinical dose of 7 MBq in the RAD-18-002 study remain disease free in the peritoneal cavity at the 12-months read out time point.
- 15-month and 18-month progression free survival data from RAD-18-002 to be published later this year
- Company to host investor conference call on February 17 at 9:00 CET
“We are pleased with the progress of our Radspherin® clinical studies, particularly with the progression of the RAD-18-002 study where we are now beginning to see potential signs of efficacy. Peritoneal carcinomatosis is an area of high unmet medical need, and we continue to believe in the potential of Radspherin® as an adjuvant therapy to cytoreductive surgery in metastatic colorectal cancer patients suffering from peritoneal carcinomatosis” said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. “The initial efficacy data along with the preliminary safety results published at ASCO last year, which showed that all dose levels were well tolerated without any dose limiting toxicity, are quite encouraging. We are looking forward to the completion of the RAD-18-002 phase 1/2A study and to the progression free survival data at 15-months and 18-months from the study.”
The company intends to publish 15-month and 18-month progression free survival data in the same group of patients at conferences later this year The company will also provide an update of the RAD-18-001 clinical study in ovarian cancer patients suffering from peritoneal carcinomatosis and plans for the further clinical development of Radspherin® during the conference call.
The phase 1/2A open-label 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.
The phase 1/2A open-label 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 cancer 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 various cancers. By leveraging internal manufacturing and supply chain capabilities to enable a clinical supply of radioisotopes, the company is advancing therapy based on 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 versatility allows it to be deployed for the treatment of a variety of cancer indications. Radspherin® is in two ongoing clinical studies to treat peritoneal carcinomatosis from both ovarian cancer and colorectal cancer.
For further information, please contact:
Jan A. Alfheim, CEO
Cell: +47 46 44 00 45
Courtney Turiano, Stern Investor Relations