BCX-CM-S

A candidate for an allogeneic stem cell-based biopharmaceutical intended for use in treating generalised autoimmune and inflammatory diseases in dogs.

Product highlights

At Bioceltix, we are conducting intensive research to develop BCX-CM-S, which will contain the same active pharmaceutical ingredient as BCX-CM-J – the two products will vary in cell concentrations per dose, excipient composition, and administration. Due to the parenteral administration (into the bloodstream) of the product candidate, the safety and efficacy of BCX-CM-S will be verified in a separate clinical trial. The cells that constitute the active pharmaceutical ingredient of the product will be characterised in terms of the molecular phenotype, karyotype and microbiological purity.

Dosage form and administration

BCX-CM-S will be a suspension of mesenchymal stem cells, free of microbial contamination, administered via intravenous (drip) infusion. The therapy, based on mesenchymal stem cells administered intravenously, will be potentially helpful in situations where pathological changes across multiple joints are accompanied by chronic inflammation, and the extent of body surface area involvement is too severe for direct injections into the affected area. BCX-CM-S will be intended for use exclusively by a veterinary physician, available off the shelf from clinics in deep-frozen form, and ready to be administered via drip infusion directly after thawing.

Action

The therapeutic effect will be a function of the immunomodulatory action of MSCs, which reduce the chronic inflammation associated with generalised arthrosis. The product will also induce natural regenerative mechanisms, which, combined with the analgesic effect, will improve physical fitness and the patient’s well-being.

 

Clinical issue

Arthrosis is a degenerative joint disease that can affect the front and hind legs of the dog, and in some cases, the entire spine. Arthrosis that is not caused by injury can often affect several joints simultaneously. Overweight (acetabula wear out much faster in heavier dogs), limb dislocations, hip dysplasia, bone fractures, age (older dogs are particularly susceptible to arthrosis) or excessive exercise can all expose the joints to significant overload.

The disease process involves excessive degeneration of joint cartilage, which may involve the cartilage and/or the acetabulum becoming worn down, and the head of the bone becoming exposed, which results in joint pain. The symptoms in dogs include lameness, characteristic “popping” of the joints, pain on some types of movement and loss of muscle mass.

Standard treatment

Currently, the main aims of arthrosis treatment are to reduce pain and inhibit disease progression.

Non-steroidal analgesics are the primary drugs used in the treatment. Cartilage protective agents (chondroitin sulfate and glucosamine sulfate), which inhibit cartilage degradation, are also effective – they can be administered prophylactically to juvenile dogs. Another highly popular (especially in the United States) type of treatment is herbal therapy combined with dietary supplements (especially vitamins B3, B6, copper, magnesium, manganese, zinc, sulfur compounds, and the essential unsaturated omega-3 fatty acids).

Osteoarthritis can be treated surgically – in the most severe cases, the joint is replaced by an artificial endoprosthesis.