Virbac announces the approval of Stelfonta® (tigilanol tiglate injection)

11/23/2020

Virbac announces the approval of Stelfonta^Ⓡ (tigilanol tiglate injection), an innovative intratumoral injection treatment for canine mast cell tumors

We are delighted to announce that, through a collaboration with QBiotics, Virbac is providing veterinarians in the United States with a breakthrough injectable solution to treat mast cell tumors in dogs. STELFONTA^Ⓡ (tigilanol tiglate injection) 1mg/mL received FDA approval for the treatment of non-metastatic skin-based (cutaneous) mast cell tumors in dogs. With this new intratumoral treatment, Virbac once again demonstrates its commitment and ability to offer unique solutions for the advancement of veterinary medicine.

This innovative product will allow us to enter the oncology segment. According to the Morris Animal Foundation, cancer is the leading cause of death for dogs over one year of age. Dog owners are eager for new solutions to treat this disease and an improved quality of life for their dogs.

Mast cell tumors (MCTs) are the most common form of skin cancer in dogs (16 to 21% of skin tumors¹), and most often result in a nodule under or on the surface of the skin. Treatments such as chemotherapy, radiation and surgery exist, but they are not always possible or appropriate to the animal's specific case. They also involve either repeated use of medication or anesthesia that is potentially worrisome to the pet owner or contraindicated for the animal.

A breakthrough solution in the treatment of canine mast cells tumors

STELFONTA^Ⓡ is an intra-tumoral injection indicated for the treatment of non-metastatic cutaneous mast cell tumors and non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock in dogs.

Developed by QBiotics, STELFONTA^Ⓡ (tigilanol tiglate injection) contains tigilanol tiglate, a phorbol ester extracted from the seed of a shrub originating in the rainforest of North Queensland, Australia, and propagated in large gardens by QBiotics: Fontainea picrosperma. It’s an antineoplastic agent, proteinase kinase C activator, which does not require long-term drug treatment or general anesthesia.

When injected in a dog’s mast cell tumor STELFONTA^Ⓡ will:

Induce tumor cell death
Induce a rapid and localized inflammatory response at the tumor site
Directly destroy local blood supply to the tumor causing tumor breakdown (necrosis)
Promote complete wound healing at the tumor site, with minimal scar formation

Among dogs treated with STELFONTA^®:

75% of mast cell tumors achieved resolution of the target tumor with just one treatment
88% of dogs achieve resolution of the target tumor 28 days after either the first or 28 days after a second treatment.
12 weeks after a single injection, 96% of dogs remained disease free at the site of the treated tumor
In 98.2% of cases, full healing was observed within 3 months (bandaging, use of Elizabethan collars and topical or systemic antibiotics were only needed in rare circumstances)
Most wounds were completely re-epithelialized within 28 to 42 days of treatment, with good cosmetic outcomes
The treatment is generally well-tolerated and does not adversely affect quality of life

Stelfonta should not be used to treat subcutaneous MCTs located above the elbow or hock. Stelfonta may cause extensive wound formation at the tumor site, including cellulitis and severe tissue sloughing. The most common adverse reactions associated with Stelfonta were wound formation at the tumor site and injection site reactions, such as pain, swelling, reddening of the skin, bruising, thickening, scarring, and death of some cells in the tissues. Lameness in the treated leg, vomiting, diarrhea, hypoproteinemia, and hypoalbuminemia also occurred.

A new approach approved by veterinary oncologists

“STELFONTA^® (tigilanol tiglate injection) is a new therapeutic mechanism and a new route of administration for veterinary medicine. Efficacy and sustained response data are very promising. Although surgery remains the standard of care for the majority of tumors, I believe STELFONTA^® will change our approach to controlling localized mast cell tumors in many ways. STELFONTA^® is administered by injection directly into the tumor. Generally, dogs undergoing treatment do not require sedation or anesthesia, which carries a potential increased risk for older dogs and brachycephalic breeds.”

Chad M. Johannes

DVM, DACVIM (SAIM, Oncology)

Veterinary oncologist and assistant professor at Iowa State University.

An active innovation ecosystem at Virbac

Our innovation is guided by research into satisfying the current or emerging needs of veterinarians, farmers and animal owners (improving the diagnosis and treatment of animal diseases, facilitating veterinary practice). In addition to innovation resulting from its worldwide R&D teams, we regularly develop external partnerships with universities, public and private research laboratories, and biotechnology companies. Thanks to alliances with other companies, we pursue an active business and technological development policy, a source of innovative R&D projects. Our collaboration with QBiotics is an outstanding example.

"At Virbac, we are very proud that the fruitful collaboration with Qbiotics enables us to bring this breakthrough to the US veterinary oncologists and general practitioners. Stelfonta will allow them to propose a less invasive and less risky alternative to surgery. This will, for sure be well received by pet owners, always keen to avoid anesthesia for their pets.”

Sophie Favini

Executive Vice President US Commercial Operations

Virbac Corporation

“FDA approval is a pivotal achievement for both STELFONTA and QBiotics. STELFONTA has the potential to be a category igniter – given it is easy to administer, provides 75% complete tumor resolution after just one injection, and dogs quickly regain pre-treatment quality of life. European sales of STELFONTA have been impressive, and we are excited to be working with Virbac to bring the drug to the US market."

Dr. Victoria Gordon

CEO and Managing Director of QBiotics

For more information on STELFONTA^® (tigilanol tiglate injection) and the full product label, visit https://vet-us.virbac.com

1- Bostock DE. Neoplasms of the skin and subcutaneous tissues in dogs and cats. Br Vet.J 1986; 142: 1-19. Dobson JM, Samuel S, Milstein H, et al. Canine neoplasia in the UK: estimates of incidence rates from a population of insured dogs. J Small Anim Pract 2002;43:240–246.

Focusing on animal health, from the beginning

Virbac offers veterinarians, farmers and pet owners in more than 100 countries a practical range of products and services to diagnose, prevent and treat the majority of pathologies, while improving the animals’ quality of life. With these innovative solutions covering more than 50 species, Virbac contributes, day after day, to shape the future of animal health.

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