Oncoinvent receives manufacturing authorization for clinical trial material
Oncoinvent is pleased to announce that it has received a manufacturing authorization (GMP certificate) for production of Radspherin® clinical trial material from the Norwegian Medicine Agency.
Jan A. Alfheim, Oncoinvent CEO commented, “We are very pleased to have accomplished this important milestone in such a short time after the inauguration of our production facility. The approval provides Oncoinvent with the necessary capacity and flexibility with full control over the production of clinical trial material of Radspherin® for the upcoming clinical studies expected to start later this year. After having sent in the clinical trial application earlier this month the company is now fully prepared to start the clinical development of Radspherin®”
For further information, please contact:
Jan A. Alfheim, Chief Executive Officer
Cell: +47 46 44 00 45
Tore Kvam, Chief Financial Officer
Cell: +47 95 93 41 99
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 treat several forms of metastatic cancer. The first clinical indication for Radspherin® will be treatment of peritoneal carcinomatosis originating from ovarian cancer. Peritoneal carcinomatosis is one of the most serious complications of gastrointestinal and gynecological malignancies.
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.