The company’s application to start the clinical phase I/IIa study, Tumorad-01, with the candidate drug 177Lu-SN201 in cancer patients has been approved.
The first patient is expected to be included shortly, states the company.
“We are very excited and strongly motivated to now start the first clinical study with Tumorad. The study is designed in such a way that we can expect initial data showing the biodistribution and accumulation of 177Lu-SN201 in tumors of cancer patients early in the phase I part of the study. With a favorable distribution of radiation to tumors versus the rest of the body, 177Lu-SN201 has good potential for becoming an effective drug against cancer,” says CEO Mats Hansen.
Bring Tumorad to cancer patients quickly and cost-effectively
Full approval to start the study has been obtained from the ethics review committee at St. Vincent’s Hospital in Melbourne, and it has been registered with the Australian Therapeutic Goods Administration (TGA). Site initiation is being conducted immediately and patient recruitment is expected to follow immediately thereafter.
In addition to competent clinics, Australia offers several regulatory and financial advantages that allow the company to bring Tumorad to cancer patients quickly and cost-effectively. The possibility for substantial reimbursement of R&D costs is a great advantage, as is the familiarity of authorities and hospitals with radiopharmaceuticals and access to local manufacturing and distribution of the radioisotope lutetium-177, states Spago Nanomedical.
About the Phase I/IIa study
The approved clinical study is a phase I/IIa, dose escalation and dose expansion, first-in-human study in patients with advanced cancer. The primary aim of the entire study is to evaluate safety, tolerability and initial efficacy of 177Lu-SN201. The phase I part of the study will include up to 30 cancer patients with the aim to identify a possible therapeutic dose based on safety and biodistribution, to be further tested in selected groups of patients during the phase IIa part. A favorable distribution of radiation to tumors versus the rest of the body provides good conditions for 177Lu-SN201 to become an effective pharmaceutical against cancer.
The study will initially be conducted at number of sites in Australia and as the study progress, sites in other countries may also be included. The aim is for the first patient to be included in the fourth quarter of 2023.
Photo of Mats Hansen, CEO, Spago Nanomedical, and Tumorad: Spago Nanomedical