European approval for QBiotics tigilanol tiglate

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Australian company QBiotics has announced the first registration for its small molecule, tigilanol tiglate, with the European Medicines Agency (EMA) approval of STELFONTA as an oncology veterinary pharmaceutical.

STELFONTA (tigilanol tiglate) is indicated for the treatment of non-resectable, non-metastatic subcutaneous MCT located at or distal to the elbow or the hock, and non-resectable, non-metastatic cutaneous MCT in dogs. 

MCTs are the second most frequent cancer diagnosed in dogs and the most common skin cancer, accounting for up to 21 per cent of skin cancer cases.

According to QBiotics veterinary oncologist, Dr Pam Jones, “The EMA approval of STELFONTA represents an exciting additional treatment option for MCT where surgical removal of the tumour mass is currently the standard of care. However, there are some challenges associated with surgery, as in some cases the tumour isn’t always easily accessible, and anaesthesia carries inherent risks - especially for older dogs and brachycephalic breeds.

“STELFONTA is administered by injection directly into the tumour mass. Generally, dogs undergoing treatment do not need to be sedated, or need local or general anaesthesia.”

It has thought that around one-in-four dogs will develop cancer at some time in their lives. Cancer is the leading cause of death in dogs, with almost 50 per cent of dogs over the age of 10 years dying of the disease.

“To date, there are only a very small number of registered treatments for cancer in companion animals, providing a significant opportunity for new treatments in this growing market,” said QBiotics’ CEO and managing director, Dr Victoria Gordon.

“Tigilanol tiglate is a new approach to the problem of cancer. The drug works largely through specific protein kinase C (PKC) activation, in which it locally stimulates the immune system, resulting in destruction of the tumour mass and the tumour’s blood supply, followed by rapid healing of the site with minimal scarring,” said Dr Gordon.

Approval for STELFONTA was based on a data package including a multicentre, randomised, blinded and untreated control study in 123 canine patients with MCTs. 

The study, which was conducted in eleven veterinary clinics, at 28 days post-treatment 75 per cent per cent of dogs achieved a Complete Response (tumour is completely destroyed) after a single intra-tumoural injection of STELFONTA compared to untreated controls. 

Dr Gordon added, “QBiotics and our partner, global veterinary pharma company Virbac, are gearing up for the launch of STELFONTA in early 2020, initially in the UK, France, Spain and Germany, and later in the USA, subject to FDA approval. This is an exciting time for QBiotics, adding global commercialisation of a novel pharmaceutical to our list of attributes.”