The first stem cell-based biopharmaceutical for veterinary use developed by Bioceltix, classified as a somatic cell therapy product, is currently in the stage of safety studies (TAS, Target Animal Safety). The active substance of the drug is a suspension of live allogeneic mesenchymal stem cells obtained from adipose tissue.
BCX-CM-J will be manufactured as a somatic cell therapy product free of microorganisms, in the form of a suspension of live allogenic mesenchymal stem cells intended for intraarterial injection. Its therapeutic indications include chronic osteoarthritis with early and moderately advanced degenerative lesions manifested as pain and lameness of the animal. BCX-CM-J will be intended to be administered only by a veterinarian. The medicinal product will be available off the shelf in the deep-frozen form and ready to be administered immediately after thawing.
As demonstrated by numerous studies, the use of MSCs for the treatment of osteoarthritis in dogs’ results in a significant reduction of inflammation, leading to a considerable relief of pain and enabling the initiation of the natural regenerative processes of the tissue damaged by the disease.
Diseases of the musculoskeletal system are among the most commonly diagnosed medical conditions in animals. Giant and fast-growing dog breeds, highly popular among breeders and animal owners, are particularly prone to malformations of the skeletal system, which include mainly osteoarthritis (OA) and dysplasia.
According to the Animal Health Monitoring Systems Programme, more than 20% of dogs in USA alone suffer from degenerative joint lesions, which are considered to be the main cause of chronic pain in dogs. For more than a decade, musculoskeletal system dysfunctions have been considered the predominant cause of chronic pain in dogs. They are among the ten most commonly diagnosed diseases in these animals.
Additionally, obese and older dogs are at an increased risk of osteoarthritis (OA is estimated to affect two thirds of dogs over 7 years of age), which has a much more severe course than in younger dogs.
Chronic inflammation caused by osteoarthritis leads to a progressive degeneration of articular cartilage. The disease mainly affects the hip, stifle, shoulder, elbow, carpal, hock and intervertebral joints. The most important factors favouring the development of OA include genetic predisposition (dysplasia), dog breed, age and body weight. The primary symptoms of OA are the discomfort of the animal caused by chronic pain and manifested by lameness, unstable and stiff gait, difficulty getting up from a resting position, reluctance to exercise, atrophy of hind limb muscles, and licking of sore joints. Symptoms of OA can appear in dogs at any age – ranging from just a few months to several years.
Currently, the mainstay of treatment of degenerative lesions of joints in dogs still remain classical chemical pharmaceuticals based on non-steroidal and steroidal anti-inflammatory drugs. This treatment is mainly symptomatic and thus has a limited efficacy, and when used long-term may cause numerous side effects such as Cushing’s syndrome, diarrhoea, muscle atrophy, gastric ulcers or hepatopathy. Therefore, an alternative to chemical drugs are MSC-based biopharmaceuticals which, in addition to treating symptoms, also have causative effects, which makes them more effective and safer in the treatment of diseases with an inflammatory background.
Pharmaceutical product candidates