The development of veterinary oncology technologies has been of great significance to Oasmia’s product development over the years and the Company has some of the first products in this area.
The Company possesses two key products within the field of chemotherapy for companion animals for which they own worldwide distribution rights, with exception for Japan:
Paccal Vet is a patented formulation of the well-known substance paclitaxel and XR17. There is currently no pharmaceutical Taxol© comparison to Paccal Vet in veterinary medicine. Veterinarians generally use drugs designed for humans by adapting the dosage levels for animals. It has not been feasible to give Taxol© to dogs due to severe adverse effects.
Doxophos Vet, a patented formulation of doxorubicin and Oasmia’s patented XR17 technology, is currently under development for the treatment of lymphoma, the most common cancer in dogs. Doxophos Vet has been granted MUMS designation by the FDA for the treatment of lymphoma in dogs. The product candidate is presently in clinical Phase II/dose confirmation trial.
Oasmia’s key objective within veterinary medicine is to successfully transition the products on a broader scale to a larger number of veterinary clinics.
Prior to this announcement, Paccal Vet-CA1 has been available to a limited number of oncology specialists. Oasmia anticipates that changing the treatment regime by lowering the dose to reduce side effects and improve comfort for companion animals, the product will become far more attractive to veterinarians and pet owners.
To help achieve this goal, the Company has withdrawn its current label which is conditionally approved and plan to initiate a new study confirming the changed dosing regimen. The Company plans a proof of concept/dose intensity study. The clinical program with Doxophos Vet is ongoing, with the expectation to communicate the results from a proof of concept study during the spring of 2017.
In order to provide an ideal environment for Oasmia’s veterinary division to successfully achieve strategic development and collaborations, all rights for Paccal Vet and Doxophos Vet intend to be transferred to the fully owned subsidiary in the United States.
These strategic changes are expected to be implemented during 2017.