On December 3, 2019 QBiotics Group Limited (QGL), a life sciences company developing novel anticancer and wound healing pharmaceuticals, reported 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) (Press release, QBiotics, DEC 3, 2019, View Source [SID1234551905]).
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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.