THERAPIES used extensively in
treating chronic pain in human
patients may soon be available for
the small animal market,
according to one of the speakers
in the “exhibitor stream” at the
BSAVA congress.
Professor David Gearing, chief
scientific officer with the Australian
biotechnology firm Nexvet
Biopharma, said his company’s
monoclonal antibody-based treatment
for osteoarthritis could be authorised
for use in veterinary patients within
the next two years.
Such products have become
standard approach to treating arthritis
in human patients, with seven of the
top 10 selling medicinal products
round the world being biological
products targeting inflammatory
disease.
But humanised monoclonal
antibodies are completely ineffective
in other species and to date there has
been little interest in developing
species-specific agents because of the
perceived high manufacturing costs
and the prospect of significant
regulatory hurdles, he explained.
However, the Melbourne-based company has developed technologies
that dramatically reduce the costs of
producing and purifying products
customised for use in canine, feline
and equine patients.
This PETisation (parsimonious
essential translation) technology has
initially been used to target nerve
growth factor, a cytokine produced in
white blood cells which both
modulates inflammatory pain and
stimulates growth of nerve cells in
affected joints.
Advantages
Monoclonal antibody-based therapies
offer several advantages over small
molecule-based treatments in having
exceptionally high potency, high
specificity and low toxicity.
The molecule is also cleared very
slowly from the body with a nine-day
half-life. So it is expected that
treatments could be given as
intravenous injections four to six
weeks apart.
Prof. Gearing described the results
of clinical trials in experimentally-
induced and naturally-occurring
osteoarthritis in dogs in independent
studies conducted by leading veterinary researchers in
Australia and the US.
These have
demonstrated statistically
significant improvements
in weight-bearing and
standard pain indices
with benefits apparent
within a day of starting
treatment.
He insisted that the
likely costs of treatment
will be considerably
lower than the thousands of pounds
per dose when the first human
products were introduced.
“Our production methods mean
that the yields are significantly higher
and the costs therefore much lower.
“The aim is to have a product that
is competitive in price terms with
conventional therapies. There is no
point in creating a product that has
such exorbitant costs that it can only
rarely be used,” he said.
The professor
believes that a cost-
effective treatment for
osteoarthritis would be
just the beginning in the
search for veterinary
applications for
monoclonal antibody
therapies.
The company is also
investigating the
potential value of this
form of treatment in veterinary oncology.
Nexvet staff are in regular contact with the US Department of
Agriculture which regulates the use of
veterinary drugs across the Atlantic
and have been assured that there the
procedure for fast-tracking licensing
applications under the MUMS (minor
use/minor species) regulations will
ensure that new products will be
made available for use in relatively
uncommon conditions.
