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Oncoinvent Announces Dosing of First Patient with Radspherin[® ]in a Second Phase 1 Clinical Trial

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Radiopharmaceutical company starts first-in-human trial in a second patient population; ovarian cancer patients suffering from peritoneal carcinomatosis

Oslo 11. June 2020

Oncoinvent AS, a clinical stage radiopharmaceutical company developing novel radioisotope-based therapies to provide new therapeutic options for cancer patients, today announced that a second phase 1 clinical trial of it’s lead candidate compound Radspherin® has been initiated. The first ovarian cancer patient has been treated with Radspherin® at the Radium Hospital in Oslo under the guidance of clinical investigator Dr. Yun Wang, M.D., Ph.D.

Both the phase 1 trial in ovarian cancer patients and the recently announced phase 1 trial in colorectal cancer patients are currently being carried out at the Radium Hospital in Oslo. 

Professor Ignace Vergote, MD PhD FACS FSPS Chairman, Department of Obstetrics and Gynaecology Gynaecological Oncologist, University Hospital Leuven Belgium and lead clinical investigator in the ovarian cancer trial commented, “Having studied the effects of radioisotopes on ovarian cancer,  I believe that alpha-emitting radiopharmaceuticals represent a promising new approach for treating patients suffering from advanced ovarian cancer, who have been debulked to no residual tumor. All opportunities to improve the lives of ovarian cancer patients should be explored. Radspherin® has demonstrated compelling preclinical activity in multiple cancer models, and I am looking forward to further investigate it in this phase 1 study.”

“We are pleased that both phase 1 trials are now underway,” said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. “This is a major milestone for the company.  These studies are the first step in the clinical development of Radspherin®, and we expect them to provide important information about safety and distribution of the product candidate in the peritoneal cavity of patients suffering from peritoneal carcinomatosis.  With the high unmet need in this underserved patient population and based on our encouraging preclinical data, we hope that Radspherin® may provide ovarian cancer and colorectal cancer patients with better outcomes.  We are excited to have started the Phase 1 clinical program and we look forward to working closely with the hospitals and clinical researchers to advance the clinical development of Radspherin® as quickly as possible.”

About the Study

The phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety and tolerability of Radspherin®, an alpha-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.

About Radspherin®

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.

About Oncoinvent

Oncoinvent AS is a privately held Norwegian company based in Oslo, Norway. The company is committed to developing new innovative products to provide better treatment options to cancer patients. The company's founders started Oncoinvent in 2010 with a view to designing better cancer treatments by applying known physical and chemical principles of selected novel materials in new ways to maximize their medical benefit while minimizing potential safety concerns. This approach has allowed the company to explore and develop multiple technological avenues before selecting a lead product candidate for preclinical testing.

For further information, please contact:

Jan A. Alfheim, Chief Executive Officer
Cell: +47 46 44 00 45
Email: alfheim@oncoinvent.com

IR enquiries:

Tore Kvam, Chief Financial Officer 
Cell: +47 95 93 41 99 
Email: kvam@oncoinvent.com

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Having studied the effects of radioisotopes on ovarian cancer, I believe that alpha-emitting radiopharmaceuticals represent a promising new approach for treating patients suffering from advanced ovarian cancer, who have been debulked to no residual tumor. All opportunities to improve the lives of ovarian cancer patients should be explored. Radspherin® has demonstrated compelling preclinical activity in multiple cancer models, and I am looking forward to further investigate it in this phase 1 study.
Professor Ignace Vergote, MD PhD FACS FSPS Chairman, Department of Obstetrics and Gynaecology Gynaecological Oncologist, University Hospital Leuven Belgium and lead clinical investigator
We are pleased that both phase 1 trials are now underway. This is a major milestone for the company. These studies are the first step in the clinical development of Radspherin®, and we expect them to provide important information about safety and distribution of the product candidate in the peritoneal cavity of patients suffering from peritoneal carcinomatosis. With the high unmet need in this underserved patient population and based on our encouraging preclinical data, we hope that Radspherin® may provide ovarian cancer and colorectal cancer patients with better outcomes. We are excited to have started the Phase 1 clinical program and we look forward to working closely with the hospitals and clinical researchers to advance the clinical development of Radspherin® as quickly as possible.
Jan A. Alfheim, Chief Executive Officer of Oncoinvent