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Manufacturing
Tin-117m is routinely produced for Serene at several reactor and cyclotron sites around the world, providing a range of products based on this isotope. Commercial products are currently produced at Theragenics Corporation, which has expertise in manufacturing and international distribution of human radioactive devices.

Development
Ongoing development of Serene’s tin-117m-based radiopharmaceuticals and medical devices is undertaken at IsoTherapeutics Group, LLC, often in collaboration with academic centers for oncology, cardiovascular therapeutics and other indications.

Preclinical

Osteoarthritis–Rats have been treated in non-GLP and GLP trials using a Lewis rat meniscal tear model of osteoarthritis.  The non-GLP trial demonstrated safety, efficacy, and dosing information, and validated the joint retention of >99%.  A larger GLP trial has been completed, which validated the results of the non-GLP trial. Nearly 100 canine elbows have also been safely and successfully treated in clinical trials using Synovetin-OATM which has been commercially launched in the US.

Rheumatoid arthritis–Over 50 rats have been treated in trials using a Lewis rat collagen-induced model of rheumatoid arthritis.  A small GLP trial has been completed which demonstrated safety. 

Oncology—Successful tin-117m-DTPA animal toxicology, imaging and therapeutic trials were completed and followed by tin-DTPA human clinical trials for the treatment of pain from bone metastases from prostate, breast, lung and other malignancies.

Cardiovascular– Targeting agents for CD68 macrophages were developed and [tin-117m]-DOTA-annexin V was 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 could safely result in in vivo imaging and therapy (reversal) of vulnerable plaque.

Veterinary
Equine laminitis—Synovetin-OATM will be used to treat this devastating hoof condition in a future trial.

Canine osteoarthritis—Serene successfully completed three clinical trials using client-owned dogs with elbow arthritis. This product, Synovetin-OATM, is being commercialized by Exubrion Therapeutics, a spin-out of Serene.

Human

Arthritis—A trial treating patients with rheumatoid arthritis, osteoarthritis and other arthritides involving synovitis using homogeneous tin-117m colloid (SynovacollTM) will commence enrollment in 2019. Additional multi-national trials for this indication are being designed for 2021.

Oncology—More than 100 patients with end stage cancer and bone metastases from a variety of primary tumor types were enrolled in multiple international Phase 1/2 trials using tin-117m DTPA. Results indicate that the product is safe, and that it was effective in reducing pain caused by the metastases, and in slowing the rate of growth of some of the tumors. Clinical trials in a variety of other oncologic indications have been designed, including other prostate therapeutics, GI cancers (GEPNET) and localized cancer treatment devices.

Cardiovascular (carotid artery stenosis)—Patients with critical carotid artery stenosis unstable vulnerable plaque who were undergoing 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 plaque in coronary and carotid arteries and abdominal aortic aneurysms can be localized and imaged. Additional Phase 2/3 trials are planned to examine therapeutic utility.

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