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New Cancer Treatment For Australian Dogs With APVMA Approval Of Qbiotics’ Stelfonta®

  • STELFONTA® (tigilanol tiglate) is now approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA) for the treatment of canine non-metastatic mast cell tumours (MCT).
  • APVMA approval follows marketing authorisation (registration) and launch of STELFONTA® in the major companion animal markets of the US, Europe, and the United Kingdom.
  • STELFONTA® will be available to Australian veterinarians, including oncologists and general practitioners, in October 2021 through QBiotics’ marketing and distribution partner, Virbac – a global animal health company.

BRISBANE, Australia, July 6, 2021 — QBiotics Group Limited (QBiotics), an Australian life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals, is pleased to announce the Australian Pesticides and Veterinary Medicines Authority (APVMA) has approved* its lead veterinary product STELFONTA® (tigilanol tiglate). This approval represents Australia’s first pharmaceutical treatment available for all grades of canine non-metastatic MCT.


STELFONTA® is indicated for the treatment of non-metastatic (WHO staging), cutaneous MCT (located anywhere on the body, legs or head in dogs), and non-metastatic subcutaneous MCT located at or distal to the elbow or hock in dogs. Tumours may be of any cytological grade, must be less than or equal to 10 cm3 in volume, and must be accessible to intratumoral injection.

QBiotics’ CEO and Managing Director, Dr Victoria Gordon said “APVMA approval of STELFONTA® marks an important milestone for QBiotics. As an Australian company with a strong heritage in discovery, research and development, we are proud that our lead molecule will now be available to treat cancer in Australian dogs.”

Approval for STELFONTA® is based on a QBiotics sponsored, pivotal, US multi centre, randomised, blinded and untreated controlled study in 123 canine patients with MCT. In this study, a single injection of STELFONTA® induced a 75% Complete Response (where the tumour is completely destroyed), compared to untreated control dogs (p=0.001). An 88% Complete Response was achieved with two injections. There was no tumour recurrence in 89% of evaluable cases 12 months post-treatment.[1]

Australian regulatory approval follows the marketing authorisation of STELFONTA® by the US Food and Drug Administration (FDA-CVM), European Medicines Agency (EMA), the Veterinary Medicines Directorate (VMD) in the United Kingdom and Swissmedic, with subsequent sales in all major markets.                   

STELFONTA® will be available to all Australian veterinarians, including oncologists and general practitioners, in October this year through QBiotics’ marketing and distribution partner, the global animal health company, Virbac.

Dr Gordon said “QBiotics is also currently investigating tigilanol tiglate, the active pharmaceutical ingredient in STELFONTA®, in a series of human Phase I and Phase II clinical trials targeting head and neck squamous cell carcinoma, and melanoma as both a monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor. Plans for a human clinical trial in soft tissue sarcoma are also underway.

QBiotics develops products simultaneously for the human and veterinary markets. Results from tigilanol tiglate canine studies not only underpinned the registration of a new veterinary anticancer product, they also inform our human clinical program. In addition, revenue from sales of STELFONTA® financially supports our human product development,” said Dr Gordon.

* STELFONTA® (tigilanol tiglate injection) APVMA Application no.: 121236; Product registration no.: 88412 


QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing pharmaceuticals for human and veterinary markets. Its lead molecule, tigilanol tiglate, is a small molecule 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.


Tigilanol tiglate is a small molecule being developed as an intratumoural treatment for solid tumours. It has a multimodal action that involves injected tumour responses as well as systemic responses in non-injected tumours. Complete destruction of the injected tumour is mediated via tumour vascular disruption, death of tumour cells by oncosis and immune-mediated mechanisms.1 Following tumour destruction, rapid wound healing has been shown to ensue. A human clinical Phase I tigilanol tiglate monotherapy trial (QB46C-H01/2) has been completed in 22 patients. QBiotics currently has two human clinical trials underway in head and neck squamous cell carcinoma (monotherapy QB46C-H03) and unresectable, Stage IIIB to IV M1c melanoma (in combination with Keytruda® NCT04834973).

[1] De Ridder et al., (2020). Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cell tumors with tigilanol tiglate. J. Vet. Inter. Med. 1-15.

SOURCE QBiotics Group Limited

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Companion Animal Ear Infection Treatment Market Size To Reach $877.3 Million By 2028: Grand View Research, Inc.

SAN FRANCISCO, June 30, 2021 — The global companion animal ear infection treatment market size is expected to reach USD 877.3 million by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 6.56% from 2021 to 2028. The increasing prevalence of ear infections in companion animals is one of the factors responsible for the market growth. An ear infection is a second-most common condition in canines. Otitis Externa is a common disorder and one of the top reasons for increased vet visits.

Key Insights & Findings:

  • The anti-bacterial product segment accounted for the largest revenue share in 2020 and will retain the leading position throughout the forecast period
  • This growth can be credited to the rising incidence of ear diseases in pets associated with the bacterial infection
  • The topical segment is anticipated to have significant growth owing to the availability of a wide range of products and high demand for topical treatments
  • The cats animal type segment is estimated to register the fastest CAGR from 2021 to 2028 owing to increased concerns regarding the health and hygiene of cats
  • The otitis externa disease segment is projected to register considerable growth as it is one of the most common and recurrent problems

Read 150 page market research report, “Companion Animal Ear Infection Treatment Market Size, Share & Trends Analysis Report By Disease Type (Otitis Externa, Otitis Media), By Product, By Mode of Administration, By Animal Type, And Segment Forecasts, 2021 – 2028“, By Grand View Research.

The COVID-19 pandemic acted as a catalyst for rapid business and economic changes. Moreover, popular trends, such as “bring your pet to work”, are also supporting the market growth. Companies operating in this market are widely accepting different approaches to treat otitis in companion animals. For instance, in April 2020, Virbac introduced Easotic, a prescription medicine specified for the topical treatment of otitis externa in canines.

The rising number of pet owners and awareness about animal health and hygiene will boost the market growth. For instance, as stated by the American Pet Products Association’s National Pet Owners Survey 2019-2020, 63.4 million U.S. households own dogs. Thus, increasing pet ownership along with growing research & development activities in animal health accelerates the market growth. For example, Dechra Pharmaceuticals spent USD 40.31 million (£28.4 million) on R&D in 2020, while USD 35.62 million (£28.4 million) in 2019. Moreover, the humanization of pets further contributes to market growth.

Grand View Research has segmented the global companion animal ear infection treatment market on the basis of product, disease type, mode of administration, animal type, and region:

  • Companion Animal Ear Infection Treatment Product Outlook (Revenue, USD Million, 2016 – 2028)
    • Anti-bacterial
      • Aminoglycosides
      • Fluoroquinolones
      • Others
    • Anti-fungal
    • Corticosteroids
    • Others
  • Companion Animal Ear Infection Treatment Disease Type Outlook (Revenue, USD Million, 2016 – 2028)
    • Otitis Externa
    • Otitis Media
    • Otitis Interna
  • Companion Animal Ear Infection Treatment Mode of Administration Outlook (Revenue, USD Million, 2016 – 2028)
    • Topical
    • Oral
    • Otic
  • Companion Animal Ear Infection Treatment Animal Type Outlook (Revenue, USD Million, 2016 – 2028)
    • Dogs
    • Cats
    • Others
  • Companion Animal Ear Infection Treatment Regional Outlook (Revenue, USD Million, 2016 – 2028)
    • North America
      • U.S.
      • Canada
    • Europe
      • U.K.
      • Germany
      • France
      • Italy
      • Spain
    • Asia Pacific
      • China
      • India
      • Japan
    • Latin America
      • Brazil
      • Mexico
      • Argentina
    • Middle East and Africa
      • South Africa
      • Saudi Arabia
  • List of Key Players of Companion Animal Ear Infection Treatment Market
    • Zoetis
    • Elanco
    • Dechra Pharmaceuticals
    • Merck & Co., Inc.
    • Vetoquinol
    • Penn Veterinary Supply, Inc.
    • Virbac S.A.
    • Ceva Sant√© Animale
    • Vedco, Inc.

Check out more studies on Companion Animal Health & Diagnostics, by Grand View Research:

  • Companion Animal Health Market – Global companion animal health market size was valued at USD 18.67 billionin 2020 and is expected to grow at a compound annual growth rate (CAGR) of 9.2% from 2021 to 2028.
  • Companion Animal Postoperative Pain Management Therapeutics Market – Global companion animal postoperative pain management therapeutics market size was estimated at USD 228.90 million in 2018 and is expected to witness a CAGR of 6.7% during the forecast period.
  • Companion Animal Diagnostics Market – Global companion animal diagnostics market size was valued at USD 2.1 billion in 2018 and is expected to grow at a compound annual growth rate (CAGR) of 8.4% from 2019 to 2026.

Browse through Grand View Research’s coverage of the  Global Animal Health Industry.

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About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

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SOURCE Grand View Research, Inc.