BCX-EM

A biopharmaceutical candidate based on allogeneic mesenchymal stem cells (MSCs) for treatment of musculoskeletal system injuries in horses, i.e. ruptured tendons and complex bone fractures.

Product highlights

Bioceltix is working on the biopharmaceutical to contain allogeneic mesenchymal stem cells isolated from the adipose tissue of horses. The pharmaceutical, classified as a somatic cell therapy product, is currently at the stage of advanced scale-up preparations for pharmaceutical production. The active pharmaceutical ingredient of the product will be 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-EMmedicinal product will be a microbiologically pure suspension of mesenchymal stem cells for topical administration via injections (parenteral administration). The therapeutic indications will include injuries to the superficial digital flexor tendon (SDFT), and the deep digital flexor tendon (DDFT). The company has also plans to extend the use of the suspension to stimulating bone regeneration in cases of bone fractures. BCX-EM 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 directly after thawing.

Action

When used in the treatment of tendon ruptures, BCX-EM will act based on the immunomodulatory character of MSCs – the mesenchymal stem cells form an anti-inflammatory local environment, inhibiting the rapid proliferation of T- and B- cells and channelling the body’s response towards the reconstruction of damaged tissue structures.

In addition to the immunomodulatory properties of MSCs, these cells also demonstrate the ability to induce bone formation by accelerating osteoblast proliferation and mineralisation of the newly formed bone matrix.

These well-documented properties of MSCs constitute a reasonable ground for the development of a biopharmaceutical that will facilitate natural bone regeneration by reducing the time needed for the broken fragments to unite completely.

Clinical issue

Damage to the superficial digital flexor tendon (SDFT), and the deep digital flexor tendon (DDFT) are among the most common injuries in show-jumper horses and racehorses.

The structure and mechanics of the equine musculoskeletal system hinder the natural processes of tissue regeneration, as it is impossible to fixate limbs for a lengthy period of time to ensure stabilisation and healing of a ruptured tendon. As such, the animal is often euthanised.

This also poses a problem in cases of fractures, as without the means to fixate the broken limb, the bone healing rate becomes significantly reduced. Consequently, such fractures in horses very often result in the animal being euthanised.

Standard treatment

There are no effective medicinal products for horses currently available on the market that would lead to complete recovery after a tendon rapture. The available therapy with steroidal and non-steroidal anti-inflammatory drugs only relieves symptoms, i.e. alleviates pain and reduces inflammation.

Surgical tendon repairs guarantee no long-term effects, while the scarring severely weakens the mechanical properties of the tissue.

In cases of bone fractures, even fixations made with orthopaedic bone screws are insufficient to withstand the large pressures which the broken limb of the horse is exposed while the bone heals.