BCX-FM

A stem cell-based biopharmaceutical intended for use in treating chronic feline gingivostomatitis (CFGS). Intended for parenteral administration (injection).

Product highlights

At Bioceltix, we are working on the first biopharmaceutical based on allogeneic mesenchymal stem cells intended for cats. The pharmaceutical, classified as a somatic cell therapy product, is currently at the stage of scaling-up for production. The active pharmaceutical ingredient of the product will be allogeneic mesenchymal stem cells isolated from the adipose tissue of eligible donors. The cells will be characterised according to their molecular phenotype, karyotype, microbiological purity, and other criteria.

Dosage form and administration

BCX-FM medicinal product will be a microbiologically pure suspension of mesenchymal stem cells administered into the bloodstream via intravenous (drip) infusion. The indications for use will include chronic feline gingivostomatitis (CFGS). BCX-FM will be intended for use exclusively by a veterinary physician, available off the shelf from clinics, and ready to be administered via drip infusion directly after thawing.

Action

The therapeutic action will rely on the increasingly established immunomodulatory properties of MSCs. The expected effects after administration include alleviation of inflammation and induction of regenerative processes to restore the damaged oral mucosa.

The literature data from preclinical studies indicate that mesenchymal stem cells have a high therapeutic potential in the treatment of CFGS, which in many cases resulted in periods of remission longer than 20 months – a result unattainable with standard therapies. The therapeutic effect was based on downregulating the auto-aggressive immune response (thereby alleviating inflammation), as well as inducing natural regenerative processes that restore the damaged oral mucosa.

Clinical issue

Chronic feline gingivostomatitis (CFGS) is a severe chronic disease marked by the infiltration of activated T- and B-cells around the oral mucosa and soft gum tissues.

The primary clinical symptom is severe oral pain. The disease can occur in different age groups (the average being 5-7 years) and affects up to 12% of the entire cat population.

The aetiology of CFGS has not been fully understood, but it is believed that it is caused by an autoimmune response.

Standard treatment

As the causes of CFGS are not fully understood, conservative treatment is used to relieve clinical symptoms – most importantly, pain and inflammation.

During the initial stage of the treatment, antibiotics are used to control the bacterial infections that frequently develop on the mucosa due to immunodeficiency. Steroid or non-steroid anti-inflammatory drugs are also used concurrently, in some cases supported by small doses of chemotherapeutics.

Unfortunately, this treatment becomes ineffective over time, and the emerging oral hyperplastic lesions require a surgical intervention. The surgery entails the extraction of some or all premolars and molars, which guarantees complete recovery in 70% of all cases at best. The remaining 30% of patients will be forced to undertake life-long treatment with antibiotics and non-steroidal and steroidal anti-inflammatory drugs.

Due to the debilitating nature of the disease and often inadequate treatment effectiveness, many animals are ultimately euthanised.