Vivesto AB announced that the first patient has been dosed in the company?s Paccal Vet open-label, pilot clinical trial in dogs with splenic hemangiosarcoma following splenectomy. An interim analysis is expected by the end of 2024. The study will include four treatment cycles of Paccal Vet (paclitaxel micellar) and it is planned to investigate two cohorts.

Each cohort is planned to include a maximum of 23 patients. The study will be conducted at six clinical sites in Washington and Oregon. If promising results in either cohort are shown, the study will be followed by a pivotal study designed to confirm the initial findings of this pilot study and to gather further evidence on the safety and efficacy of Paccal Vet in dogs with splenic hemangiosarcoma.

Vivesto's drug candidate Paccal Vet consists of paclitaxel formulated with the company's proprietary XR-17 technology. Vivesto has previously shown good safety of Paccal Vet in the treatment of various types of cancer in dogs. The absence of the solvent cremophor, to which dogs are particularly sensitive, may reduce the risk of serious side effects and death associated to the treatment.

Paccal Vet also does not require the addition of human albumin, which when used in dogs can cause hypersensitivity reactions and reduced treatment effectiveness. Previous clinical studies performed by Vivesto has demonstrated safety in more than 300 dogs. Also, anti-tumor activity has been shown in squamous cell carcinoma and non-resectable mammary carcinoma of stage III-V.