- STELFONTA® (tigilanol tiglate) approved by the European
Medicines Agency (EMA), making it the first pharmaceutical
treatment available for all grades of canine non-metastatic mast
cell tumours (MCT)[1]
- The approval marks the first registration of QBiotic's, lead
compound tigilanol tiglate, which is also under review by the US
Food and Drug Administration - Center for Veterinary Medicine
(FDA-CVM) and the Australian Pesticides and Veterinary Medicines
Authority (APVMA);
- Approval is supported by a full technical data package focused
on safety and efficacy including a pivotal study in 123 canine
patients where a single injection of STELFONTA® completely removed
(Complete Response) 75% of treated MCT;[2]
- QBiotics have partnered with Virbac, who will be launching
STELFONTA® across key EU markets in the coming months.
BRISBANE, Australia,
Jan. 20, 2020 /PRNewswire/ --
Australian life sciences company, QBiotics Group
Limited (QBiotics) is today announcing the first registration for
its small molecule, tigilanol tiglate, with the European Medicines
Agency (EMA) approval of STELFONTA as an oncology veterinary
pharmaceutical.
STELFONTA (tigilanol tiglate) is indicated for the treatment of
non-resectable, non-metastatic (WHO staging[3])
subcutaneous MCT located at or distal to the elbow or the hock, and
non-resectable, non-metastatic cutaneous MCT in dogs. Tumours must
be less than or equal to 8 cm[3] in volume and must be
accessible to intratumoural injection.[1]
MCTs are the second most frequent cancer diagnosed in dogs and
the most common skin cancer, accounting for up to 21% of skin
cancer cases.[3]
QBiotics Veterinary Oncologist, Dr Pam
Jones said, "The EMA approval of STELFONTA represents an
exciting additional treatment option for MCT where surgical removal
of the tumour mass is currently the standard of care.[4]
However, there are some challenges associated with surgery, as in
some cases the tumour isn't always easily accessible, and
anaesthesia carries inherent risks - especially for older dogs and
brachycephalic breeds."
"STELFONTA is administered by injection directly into the tumour
mass. Generally, dogs undergoing treatment do not need to be
sedated, or need local or general anaesthesia," said Dr Jones.
Worldwide, as many as 1 in 4 dogs will develop cancer at some
time in their lives. Cancer is the leading cause of death in dogs,
with almost 50% of dogs over the age of 10 years dying of the
disease.[5,6]
"To date, there are only a very small number of registered
treatments for cancer in companion animals, providing a significant
opportunity for new treatments in this growing market," said
QBiotics' CEO and Managing Director, Dr Victoria Gordon.
"Tigilanol tiglate is a new approach to the problem of cancer.
The drug works largely through specific protein kinase C (PKC)
activation, in which it locally stimulates the immune system,
resulting in destruction of the tumour mass and the tumour's blood
supply, followed by rapid healing of the site with minimal
scarring,"[7] Dr Gordon said.
Approval for STELFONTA was based on a full data package
supporting the safety and efficacy of STELFONTA. This included a
QBiotics sponsored, pivotal, multi centre, randomised, blinded and
untreated control study in 123 canine patients with MCTs. This
study was conducted in accordance with the principles of Good
Clinical Practice (GCP) as outlined in 'Guidance for Industry
Guideline #85 of the USA Food and
Drug Administration (FDA), Center for Veterinary Medicine Good
Clinical Practice: VICH GL9, Final Guidance May 2001.
In this pivotal study conducted in eleven veterinary clinics, at
28 days post treatment 75% percent of dogs achieved a Complete
Response (tumour is completely destroyed) after a single
intra-tumoural injection of STELFONTA compared to untreated
controls (p=0.0001). Importantly, STELFONTA® was very well
tolerated and animals had a good quality of life during and after
treatment.[2]
Dr Gordon said "QBiotics and our partner, global veterinary
pharma company Virbac, are gearing up for the launch of STELFONTA
in early 2020, initially in the UK, France, Spain
and Germany, and later in the
USA, subject to FDA approval. This
is an exciting time for QBiotics, adding global commercialisation
of a novel pharmaceutical to our list of attributes."
ABOUT QBIOTICS
QBiotics is a public unlisted Australian life sciences company
which discovers, develops and commercialises novel anticancer and
wound healing products for human and veterinary markets.
Its lead product, tigilanol tiglate, is an anticancer
pharmaceutical targeting a range of solid tumours across multiple
species.
QBiotics' business model is to develop products that have
application in both veterinary and human markets. Success in the
veterinary programs validates QBiotics technology and de-risks
human development, while generating early, non-diluting
revenues.
https://qbiotics.com
REFERENCES
|
[1]
QBiotics Group Ltd., Data on file. 2020.
|
[2] QBiotics Group Ltd., Data on
file. 2019.
|
[3] Garrett, LD. 2014. Canine mast
cell tumors: diagnosis, treatment, and prognosis. Veterinary
Medicine: Research and Reports, Vol 5.
https://doi.org/10.2147/VMRR.S41005
|
[4] Vail
DM, Thamm DH and Liptak JM (editors) 2020. Small Animal Clinical
Oncology, edition 6, Elsevier Inc, St Louis, Missouri.
|
[5] Kelsey
JL, et al. 1998. Epidemiological studies of risk factors for cancer
in pet dogs. Epidemiology Review 20:204-217.
|
[6]
Withrow SJ. and Vail DM 2007. Small Animal Clinical Oncology,
edition 4, Elsevier Inc, St Louis, Missouri. 402-421.
|
[7] Boyle
G et al. 2014. Intra-lesional Injection of the Novel PKC Activator
EBC-46 Rapidly Ablates Tumors in Mouse Models, PLOS ONE, Vol 9,
Issue 10
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