TheraVet

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

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.