New Focused Ultrasound Foundation Program Funds Veterinary Clinical Trials

News — (Charlottesville, Virginia – April 24, 2018) In November 2017, the Focused Ultrasound Foundation launched a to develop focused ultrasound therapies for the treatment of companion animals. The Foundation is currently supporting trials to investigate treating cancer and promote wound healing in pets – and more studies are in the pipeline.

Advantages of Focused Ultrasound in Veterinary Medicine
"Traditionally, animals have served as models in comparative studies before expanding innovative therapies to human trials," said Foundation chairman Neal F. Kassell, MD. "With this program, we are starting a virtuous cycle where veterinarians will have new, innovative therapies to offer clients, and we can apply the experience obtained using focused ultrasound in pets to accelerate the adoption of the technology for human applications."

"New therapies are often slow to make their way into veterinary medicine, leaving veterinarians frustrated with the lack of options for their patients," adds Foundation Veterinary Program Director Kelsie Timbie, PhD. "We feel focused ultrasound could meet a critical need in veterinary medicine by both expanding and improving treatment for a range of conditions."

The goal of this research program is to offer a variety of benefits over traditional therapies in animals. Focused ultrasound is a noninvasive therapy that can reduce the risk of infection and eliminate the need for stitches, making recovery safer and less painful for the animals. One to three focused ultrasound treatments can achieve the same results as traditional therapy, without the need for surgery or radiation, which requires as many as 30 treatments. Additionally, the major barriers to adoption that exist in human medicine – regulatory and insurance reimbursement hurdles – are not as restrictive in veterinary medicine.

Treating Canine Cancer
A study to treat sarcomas and mast cell tumors in dogs is now under way at the at Virginia Tech in Blacksburg, Va. In the Foundation-funded trial, Clinical Assistant Professor of Radiology, Jeffrey Ruth, DVM, and his team are investigating focused ultrasound therapy to noninvasively destroy tumors and stimulate the dogs' own immune systems to fight the cancer. Researchers are using a device developed by French company Theraclion which was originally developed to treat breast and thyroid conditions in humans. However, its design allows it to easily be adapted for veterinary indications. "These canine tumors tend to occur on the limbs and may recur if they are not entirely removed. As a result, often amputation is required," says Dr. Ruth. "It is our hope that focused ultrasound will add to current treatment options by providing a way to non-invasively ablate the mass and also trigger an anti-tumor immune response."

Accelerating Healing
, and his team have begun another study investigating focused ultrasound's ability to speed wound healing at the Nonhealing wounds are caused by biofilm-forming bacteria and are difficult to treat, often requiring long-duration antimicrobial treatment, extensive surgical intervention, and in many cases, limb amputations. Dr. Ranjan and his team will use focused ultrasound to treat hygromas – a condition where repeated pressure on a bony joint produces significant swelling. These masses can become infected and painful and are very challenging to treat.

"Hygromas typically have poor blood flow and are slow to heal, so any incision during treatment can make the situation worse," says Dr. Ranjan. "Focused ultrasound offers multiple benefits over traditional therapy – it can noninvasively reduce the bacterial infections, while simultaneously improving the local delivery, and therapeutic effects of antibiotics. We expect this combined approach to significantly improve healing time, and prevent infection recurrence."

If successful, this application of focused ultrasound will not only be game-changing for veterinary medicine. The potential applications to human medicine are widespread as the therapy could be investigated for the treatment of bedsores, pressure ulcers and diabetic ulcers. In tandem with the work at Virginia Tech, researchers at the Oklahoma State University Center for Veterinary Health Sciences are also exploring the use of focused ultrasound for soft tissue tumors in dogs and cats. Dr. Ranjan leads the Laboratory of Nanomedicine and Targeted Therapy there, and to date, they have treated five canine and feline patients.

"Veterinary cancer types, site, growth and genetic features are comparable to those in human cancer," explains Dr. Ranjan. "Realizing these benefits, we recently initiated the clinical trials in our hospital to investigate the immunotherapeutic potentials of focused ultrasound against canine cancers. Early data suggest that this approach is clinically feasible, and Oreo is the perfect example of success that comes out of it."

SUCCESS STORIES

Maddi Lynn is a 9-year-old Cocker Spaniel
During a routine grooming appointment, a technician noticed a small growth on Maddi's front leg. Her owner, Kitty Smith of Christiansburg, Va., acted quickly and arranged to have it examined by her veterinarian. A number of tests confirmed her worst fear: Maddi Lynn had a malignant sarcoma.

"There was no question in my mind that I would go to the Virginia Tech Vet School for treatment," recalls Smith. It was there that she learned about the new focused ultrasound trial. After some careful consideration and discussion with her family members, Smith decided that the trial offered the best options for Maddi. In late March, Maddi Lynn was the first patient to be treated in the trial at Virginia Tech.

Dr. Jeff Ruth and his team used focused ultrasound to shrink the tumor noninvasively, and then surgically removed the remaining mass. Now, a few weeks after treatment, Maddi Lynn's outlook is positive. Follow-up appointments have indicated that she is cancer-free.

"Her aftercare was so easy," said Smith. "The first two nights she was home, I gave her pain medication in order that she would be comfortable and rest through the night. She has recovered beautifully. I felt so fortunate that my Maddi was chosen to be the first dog treated in the study. To be perfectly honest, I don't know if I could have afforded this treatment on my own. It would have been difficult to come up with funds to pursue this care."

The trial is being funded by the Focused Ultrasound Foundation, and owners are not responsible for the majority of treatment costs.

Oreo is a 9-year-old Shetland Sheepdog
Oreo's owners sought medical care after noticing that he had developed a growth on his lower right lip. After a biopsy, veterinarians determined he had a plasmacytoma and traditional treatment options included surgery and/or radiation.  However, researchers at the Oklahoma State University Center for Veterinary Health Sciences presented another option – a focused ultrasound clinical trial.

Oreo received two focused ultrasound treatments, each lasting less than five minutes. During the treatment, multiple ultrasound beams were focused on the tumor. Much like when you use a magnifying glass to burn a hole in a leaf, the ultrasound energy converges on the tumor and heats – and destroys – the tissue. Over the next several days, veterinarians noticed significant tumor regression, and the mass was completely gone after three weeks. Interestingly, the focused ultrasound also activated Oreo’s immune system, and immune cells were noted in the tumor margins. Today, Oreo remains cancer-free.

Pet owners who are interested in learning more about these studies should contact:

Virginia-Maryland College of Veterinary Medicine in Blacksburg, Virginia Mindy Quigley – Clinical Trials Coordinator, VMCVM (540) 231-1363 [email protected]

Oklahoma State University in Stillwater, Oklahoma Dr. Martin Furr, Interim Director, Veterinary Medical Teaching Hospital (405) 744-8751 [email protected]

For researchers and veterinarians:
The Focused Ultrasound Foundation is actively seeking to promote interest in focused ultrasound within the veterinary community and plans to host discussion forums on the topic. Interested researchers and veterinarians should contact the Foundation's director of the veterinary program, Kelsie Timbie, PhD, at [email protected].

About Focused Ultrasound
Multiple intersecting beams of ultrasound are directed and concentrated on a target; much like a magnifying glass can focus beams of light on a single point to burn a hole in a leaf. Where each individual beam passes through the tissue, there is no effect. But, at the focal point, the beams of ultrasound energy can produce many important biological effects. Today, focused ultrasound is approved in the United States to treat essential tremor, uterine fibroids, and the prostate, as well as reduce pain from bone metastases. The technology is also being studied for more than 90 other diseases, including Parkinson's, Alzheimer's, hypertension, and tumors of the brain, liver, breast, and pancreas. Focused ultrasound has certain attributes that create the potential for a unique role in cancer immunotherapy when compared to the other modalities, and several preclinical and clinical studies have demonstrated that FUS can elicit an immune response.

About the Focused Ultrasound Foundation
The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of focused ultrasound, an early-stage noninvasive therapeutic technology with the potential to transform the treatment of many medical disorders. The Foundation is dedicated to ensuring that focused ultrasound finds its place as a mainstream therapy within years, not decades, and works to fund research, foster collaboration, and build awareness among patients and professionals. Since its establishment in 2006, it has become the largest non-governmental source of funding for focused ultrasound research.

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