TheraVet: Launch of BIOCERA-VET® Canine Osteosarcoma Study Conducted by the Prestigious University of Florida

• Study assessing the efficacy of BIOCERA-VET^® Osteosarcoma Cementoplasty associated with stereotactic radiotherapy¹
• Evaluation of the effect on lameness and the risk of pathological fracture
• University of Florida is ranked #7 among veterinary medical colleges nationwide by U.S. News & World Report

GOSSELIES, Wallonia, Belgium--(BUSINESS WIRE)--Regulatory News:

TheraVet (ISIN: BE0974387194 – ticker: ALVET), a pioneering company in the management of osteoarticular diseases in pets, announces the launch of a clinical study assessing the efficacy of BIOCERA-VET^® Osteosarcoma Cementoplasty combined with Stereotactic Radiotherapy (SRT) in patients with osteosarcoma. The study will be led by Dr Marilia Takada (DVM, PhD, DACVR Radiation Oncology, Assistant Professor and Radiation Oncology Service chief, and by Dr Judith Bertran (DVM, MRCVS, DACVS (SA), ACVS Fellow in Surgical Oncology) Assistant Professor and Surgical Oncology Service Chief at the University of Florida.

Canine osteosarcoma is commonly treated by limb amputation for local tumor control, and adjuvant chemotherapy to delay the onset of metastases. Standard limb-sparing surgery, used as alternative to amputation, suffers from high complication rates and is only suitable at specific locations; therefore, novel limb-sparing technique options are currently more and more sought-after as an alternative to amputation.

A promising alternative to the previous limb-sparing techniques is percutaneous cementoplasty. This procedure consists in a percutaneous injection of a bone cement - such as BIOCERA-VET^® Osteosarcoma - into the bone tumor site thus providing analgesia, bone consolidation, and preventing pathological fractures². This procedure can be combined with ablation techniques, with adjuvant chemotherapy, and/or radiation therapy. Among the latter, SRT, while acting on tumor’s cells and locally controlling the progression of the tumor and improving lameness, is associated with a high rate of pathological fracture (41%) due to bone weakening³. The combination of SRT with percutaneous cementoplasty could therefore be an option to counteract the consequences of the radiotherapy by strengthening the bone.

In this context, a study assessing the combination of percutaneous cementoplasty and SRT in 10 dogs suffering from appendicular osteosarcoma will be conducted by Dr Marilia Takada and by Dr Judith Bertran at the University of Florida.

The dogs will be treated by SRT followed two weeks later by a percutaneous cementoplasty using BIOCERA-VET^® Osteosarcoma. The objectives of the study will be to evaluate the effect on lameness by using objective measurements (i.e., force plate analysis) and to assess the risk of pathological fracture. Patients will be followed monthly for the first 3 months and then every three months until the patients end of the life. First patient enrolment is expected in December 2023. With an estimated enrolment phase of 6 months, the study will be conducted over a period of 18 months, with first results expected in a year.

Dr. Judith Bertran, Assistant Professor and Surgical Oncology Service Chief at the University of Florida, stated: “As osteosarcoma is a devastating local and systemic disease, investigation of new strategies to ensure local disease control and comfort for our patients is imperative. As researchers, this pilot study is extremely important to investigate the benefits of the percutaneous cementoplasty in dogs undergoing SRT for osteosarcoma. Collected data will serve as the basis of larger clinical trials to investigate further the best protocols for SRT combined with cementoplasty to preserve limb function, comfort level and acceptable disease-free intervals and survivals for canine patients.”

About the University of Florida
Ranked #7 among veterinary medical colleges nationwide by U.S. News & World Report, University of Florida College of Veterinary Medicine teaches the veterinarians of the future and provides leading-edge care to animal patients from throughout the Southeast through the UF Veterinary Hospitals. Its programs in biomedical research advance the science of animal, human and environmental health.

About TheraVet SA
TheraVet is a veterinary biotechnology company specializing in osteoarticular treatments for companion animals. The Company develops targeted, safe and effective treatments to improve the quality of life of pets suffering from joint and bone diseases. For pet owners, the health of their pets is a major concern and TheraVet’s mission is to address the need for innovative and curative treatments. TheraVet works closely with international opinion leaders in order to provide a more effective response to ever-growing needs in the field of veterinary medicine. TheraVet is listed on Euronext Growth^® Paris and Brussels, has its head office in Belgium (Gosselies) with a US subsidiary.
For more information, visit the TheraVet website or follow us on LinkedIn / Facebook / Twitter

About BIOCERA-VET
In close collaboration with an international scientific board, THERAVET^® has developed a new line of calcium-phosphate and biological bone substitutes, BIOCERA-VET^®. BIOCERA-VET^® is a full range of innovative, easy-to-use, efficient & cost-effective bone substitutes indicated in bone surgeries where a bone graft is required and as a palliative alternative in the management of canine osteosarcoma. Based on extremely promising clinical results, this line offers the possibility of a better, more convenient and more efficient orthopedic surgery.

• BIOCERA-VET^® is declined in different lines:
• BIOCERA-VET^® BONE SURGERY RTU, a ready-to-use highly injectable self-hardening calcium-phosphate cement
• BIOCERA-VET^® SMARTGRAFT, a naturally osteoconductive bone graft
• BIOCERA-VET^® GRANULES, an affordable biocompatible calcium-phosphate bone substitute
• BIOCERA-VET^® OSTEOSARCOMA RTU, a ready-to-use highly injectable calcium-phosphate bone substitute for cementoplasty
• BIOCERA-VET^® COMBO-CLEAN, a local and long-lasting antibiotic delivery calcium-phosphate bone substitute

For more information, visit BIOCERA-VET website.

¹ Stereotatic radiotherapy (SRT) is defined as focused radiation beams targeting a well-defined tumor allowing high dose of radiation at the tumor site and lower at the surrounding tissue.
² Article under review
³ Wormhoudt Martin T et al. Outcome and prognosis for canine appendicular osteosarcoma treated with stereotactic body radiation therapy in 123 dogs. Vet Comp Oncol. 2021 June ; 19(2): 284–294. doi:10.1111/vco.12674