Oncoinvent Announces Dosing of First Patient with Radspherin[® ]in Phase 1 Clinical Trial
Radiopharmaceutical company starts first-in-human trial in colorectal patients suffering from peritoneal carcinomatosis
Oncoinvent AS, a clinical stage radiopharmaceutical company developing novel radioisotope-based therapies to provide new therapeutic options for cancer patients, today announced that the first patient has been dosed in the phase 1, first-in-human clinical trial of it’s lead candidate compound Radspherin®.
“Radspherin® represents a promising new approach for treating patients with metastates to the peritoneal cavity from colorectal cancer that may potentially provide a better outcome with longer progression free survival for patients that undergo cytoreductive surgery together with hypertherm intraperitoneal chemotherapy,” said Stein Gunnar Larsen, M.D., Section Leader Department of Surgical Oncology, Oslo University Hospital, Norway and lead clinical investigator in the trial. “We are always looking for opportunities to improve patient outcomes and give patients a better quality of life. Radspherin® has demonstrated preclinical activity in a range of cancer models, and we are excited to further investigate it in this Phase 1 study.”
“Radspherin® is a potentially transformative approach for a range of difficult-to-treat metastatic cancers,” said Øyvind S. Bruland, M.D., Chief Medical Officer of Oncoinvent. “The mode of action of Radspherin® is to deliver a lethal dose of short range alpha radiation to remaining tumour cells in the peritoneum after surgery. Radium-224 emits alpha particles with high linear energy transfer (LET).
There are no known cellular resistance mechanisms to this type of ionizing radiation, which may therefore be effective against dormant and chemo-resistant cancer cells remaining after surgical resection of macroscopic visible tumours and thereby increase the prospect of a complete response. We believe it could provide a profound benefit for patients that are in dire need of new therapies.”
About the Study
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.
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 be used to treat several forms of metastatic cancer.
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.