Country for PR: China
Contributor: PR Newswire Asia (China)
Tuesday, December 03 2019 - 10:58
QBiotics Announces First Patient Dosed in its Phase I/II Clinical Trial of Tigilanol Tiglate for Head and Neck Cancer
BRISBANE, Australia, Dec. 3, 2019 /PRNewswire-AsiaNet/ --

- First patient successfully dosed in QBiotics' Phase I/II clinical trial of 
tigilanol tiglate in patients with Head and Neck Squamous Cell Carcinoma 
- Tigilanol tiglate is a novel, small molecule that is being tested as a single 
injection treatment for solid tumours 
- The Phase I/II clinical trial is a dose escalation study in HNSCC patients 
designed to determine optimal dosage, safety and tumour response 
- The QBC46-H03 trial is being run in Australia and India

QBiotics Group Limited (QGL), a life sciences company developing novel 
anticancer and wound healing pharmaceuticals, today announced that it has dosed 
its first patient in a Phase I/II clinical trial evaluating the optimal dosing 
and safety of its lead product, tigilanol tiglate, in patients with head and 
neck squamous cell carcinoma (HNSCC).

Dr Victoria Gordon, Managing Director and CEO of QBiotics, said, "We are 
delighted to announce the treatment of our first patient in our multi-site 
clinical study, which includes trial sites in Australia and India. Cancers of 
the head and neck rank as the sixth most common cancer diagnosed worldwide[1] 
with more than 2 million[2] new cases each year. The high rate of HNSCC is 
largely driven by tobacco use, and increased infection with human 
papillomavirus (HPV)."

Dr Gordon continued, "This study marks an important advancement for QBiotics' 
oncology pharmaceutical. It follows our successful first-in-man QBC46-H01 
study[3] in a range of solid tumours, which demonstrated patients with squamous 
cell carcinoma, the most common type of head and neck cancer, had encouraging 
tumour responses when treated with tigilanol tiglate."

Surgery and radiotherapy are currently the primary local treatments for HNSCC. 
However, these treatments can come with challenges such as damage to healthy 
tissue and impacting a person's ability to breathe, hear, see, smell, swallow 
or taste as well as adversely affecting appearance. Better local therapies are 
therefore needed. Direct intratumoural injection with tigilanol tiglate may 
offer advantages as it directly targets tumour cells and reaches infiltrating 
cancer cells that can be missed by surgery. This approach limits exposure and 
damage to surrounding healthy tissues, reducing the risk of functional or 
cosmetic impairment. Intratumoural injection also offers the potential for 
reduced toxicity due to localised (target site) treatment, compared to systemic 
toxicity induced by chemotherapeutic agents.

The Phase I/II open label "QBC46-H03" study, is a dose escalation study in 
patients with HNSCC aimed at determining the maximum tolerated dose (MTD) and 
recommended dose level for further studies. The study will also investigate 
safety, tolerability and tumour response following a single or multiple (two to 
three) doses of tigilanol tiglate. It will enrol up to 40 patients from the 
Tata Medical Centre in Kolkata, the Tata Memorial Hospital in Mumbai, the 
Princess Alexandra Hospital in Brisbane, and other clinical sites in Australia.


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.


Tigilanol tiglate is a novel, small molecule that is being tested as an 
intratumoural injection treatment for solid tumours. Its effect on tumours is 
multimodal and involves direct local effects on the injected tumour as well as 
effects on distal, non-injected tumours. Complete destruction of the injected 
tumour is mediated via tumour vascular disruption as well as death of tumour 
cells by oncosis. Following tumour destruction, rapid wound healing has been 
shown to ensue.

A single injection of tigilanol tiglate has been shown in canine patients to 
ablate (completely destroy) 75% of treated tumours[4]. Veterinary use of 
tigilanol tiglate (branded STELFONTA®) has recently received a majority vote by 
the European Medicines Authority (EMA) for marketing authorisation in Europe as 
a treatment for canine mast cell tumours, and is also under review by the US 
Food and Drug Administration - Center for Veterinary Medicine (FDA-CVM) for 
marketing in the USA. STELFONTA® is partnered with Virbac, a global animal 
health company for marketing and distribution in the EU and USA pending 
regulatory approval.  Launch of the product is expected  early 2020 in both 

[1] Union for International Cancer Control (UICC), WHO Essential Medicines 
(accessed 26 November 2019).
[2] Globocan, 2018. Sum of lip, oral cavity, larynx, hypopharynx, salivary 
glands, nasopharynx and oesophagus based on ICD-10 codes.
[3] Panizza, B. et al., 2019. Phase I Dose-Escalation Study to Determine the 
Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of an 
Intratumoral Injection of Tigilanol Tiglate (EBC-46). EBioMedicine: in press.
[4] Data on file.

SOURCE: QBiotics Group Limited