Oncology—More than 100 patients with end stage cancer and bone metastases from a variety of primary tumor types were enrolled in multiple North American Phase 1/2 trials using tin-117m-DTPA therapy. Results indicate that the product is safe and effective in reducing pain caused by the metastases, and in slowing the rate of growth of some of the tumors. A trial using a new high specific activity formulation of tin-117m-DTPA has been accepted into the National Cancer Institute Experimental Therapeutics program and will receive significant support, beginning with a Phase 2 thrapy trial in patients with bone metastases in 2020. Clinical trials in a variety of other oncologic indications have been designed, including other prostate therapeutics, gastrointestinal cancers (GEPNET) and localized cancer treatment devices.
Arthritis—Tin-117m colloid (SynovacollTM) has been authorized by Health Canada to begin a Phase 1B trial for the treatment of patients with refractory rheumatoid arthritis, osteoarthritis and other arthritides.
Cardiovascular—Patients with unstable vascular plaque who underwent carotid endarterectomy surgery were treated with [tin-117m]-DOTA-annexin V in Phase 1/2 trials. Results indicate that the product is safe, and that vulnerable and unstable plaque in coronary and carotid arteries, and abdominal aortic aneurysms can be imaged. Additional trials are planned to examine therapeutic utility.
Oncology—Successful tin-117m-DTPA animal toxicology, imaging and therapeutic trials have been completed.
Cardiovascular– Targeting agents for CD68 macrophages have been developed and [tin-117m]-DOTA-annexin V has been used in apoE genetically modified mice with induced vulnerable plaque. These studies indicated specific and highly localized binding to these macrophage sites, and proved that localized binding can safely result in in vivo imaging and therapy (reversal) of vulnerable plaque.
Tin-117m isotope is routinely produced for Serene at reactor and cyclotron sites around the world, enabling the production of a range of medical products based on this isotope. Commercial and clinical products are currently manufactured at several cGMP sites in the United States.