Major points from today's News: FDA submission is on the way, then the approval for human trial:
Dr. Charles Maitz presented a summary of the results of our clinical study on canine sarcoma at the University of Missouri. That study demonstrated the safety of IsoPet® therapy for the patient, therapist, and pet parents, while delivering a very high dose of therapeutic radiation directly to the tumor with negligible dose to surrounding normal tissues.
The primary objective of the study was to evaluate safety and dose delivery. The PET-CT images showed good distribution of IsoPet® within the tumor. The additional data on clinical outcomes collected in this study confirm that IsoPet® is effective at killing tumor cells. In addition, based on the study results and as part of our ongoing work to further develop and refine the Isopet® therapy, we intend to put greater emphasis on treating the margins surrounding the primary tumor to further reduce the chance of recurrence. A detailed scientific article on this study and the results from the feline sarcoma study at Washington State University is expected to be published soon in the journal Cancer Biotherapy & Radiopharmaceuticals.
Overall, feedback and interest in IsoPet® was very positive. Veterinarians that we spoke with confirmed that IsoPet® is the only therapy that can deliver high single dose radiation to the tumor site with minimal impact to adjacent normal tissue. This contrasts with external beam therapy, that can only deliver a fraction of the prescribed dose and involves multiple treatments. In addition, external beam therapy requires substantial capital investment to be made by the treatment facility. Veterinarians were impressed that IsoPet® can be shipped on-demand and treatment can be delivered in a 15-minute, one-time procedure. The up-front capital and set-up costs are minimal, especially for facilities that already possess a radioactive material license.
We first introduced IsoPet® at last year’s conference. At that time, we had minimal data on a single dog that had been treated for sarcoma. This year we presented much more data and built on the momentum of experience gained over the year. We had significantly more interest from clinics across the country and internationally. These are promising contacts for establishing additional regional clinics in the future.
One theme we heard repeatedly is that veterinary professionals expect to see more data on new technologies. We are committed to complement our current commercial development strategy with additional clinical studies that will generate data to be reported in professional publications and at future conferences.
IsoPet® is an exciting new tool offering a solution that can extend the life of many beloved pets suffering from cancerous tumors.
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