Dr Hal Rice|||Associate Professor James St John

Gold Coast a new hub for clinical trials

Kathy Kruger | November 2017

From Phase 1 human trials for a Malaria vaccine, to studies aimed at treating osteoporosis and a number of trials into innovative life-saving stroke treatment, the Gold Coast Health & Knowledge Precinct is fast gaining a reputation as a leading location for clinical trials.

And led by the world-leading Institute for Glycomics at Griffith University, there’s real potential for the city to be the home of a new blockbuster drug.

The trial of a malaria vaccine developed by the Institute’s Professor Michael Good could potentially save millions of lives and is the most well-known study to date, and a variety of trials occurring across both the Gold Coast University Hospital (GCUH) and the university offer the promise of exciting innovations targeting a diversity of diseases and health conditions.

The Malaria trial has been done in conjunction with GCUH, with Professor Good volunteering himself in the first safety and efficacy phase, and promising results seeing the trial move to the next stage, as fundraising efforts to keep the momentum going are spearheaded by Rotary International.

As a study participant, Professor Good had to step back from his usual research role in the “first-in-man” clinical trial.

“I wouldn’t ask people to do what I wouldn’t be prepared to do, and we couldn’t do this without the volunteers who give their time to us knowing they are helping further work towards a cure,” Professor Good said.

“I wasn’t nervous, because I knew I was in good hands. The primary issue is safety and we have all the controls in place. I was excited.”

Researchers have shown the world-first whole blood-stage malaria parasite vaccine PlasProtecT®, is safe and induces an immune response in humans.

The deadly Strep A bacteria is being targeted through a unique nasal delivery vaccine, also co-developed in the highly-capable hands of Professor Good, and moving into clinical trials in partnership with Chinese biopharmaceutical company Olymvax. The potentially mega-lucrative licensing deal, could be worth $1 billion a year worldwide, if successfully brought to market.

The Gold Coast community benefits with patient access to the latest innovative treatments.

Within the advanced tertiary hospital setting of GCUH, trials occur across a range of specialities, involving inpatients and outpatients.

Neurologist Dr Arman Sabet has been involved in approximately ten clinical trials, with a primary focus on improving treatment for stroke and other neurological conditions. Dr Hal Rice has been working with a new flow diversion device to treat intercranial aneurysms and Gold Coast Health led the way as the top global contributor to the safety and efficacy standards for this device.

Dr Sabet is particularly proud of Gold Coast Health’s participation in a ground-breaking clot retrieval international trial that has had positive treatment implications for Ischemic stroke worldwide.

“The trials are making a significant difference in outcomes for stroke patients – both in innovation to enable better treatment and recovery, and in follow-up medication to prevent future strokes,” said Dr Sabet.

With Associate Professor James St John recently expanding his team, primarily based at Griffith on the Gold Coast, and rapidly moving forward with exciting evolutions of the earlier research of Australian of the Year, Professor Alan Mackay-Sim, a clinical trial of a potentially life-changing therapy for spinal injury patients could be just two years away.

Associate Professor St John hopes to combine their unique therapy to build 3D spinal nerve bridges utilising Olfactory cells, with an integrated program of rehabilitation for patients involving industry and clinical partners, in what would be an extensive, holistic trial.

Griffith University’s Clinical Trials Unit was recently established as a purpose-built core research facility to the university. Already the unit has seen significant growth in the number of trials and interest from researchers, collaborators from Gold Coast Health and private clinicians, as well as an increasing number of commercial opportunities with pharmaceutical, biotech, nutraceutical and complementary medicine companies.

Clinical Trials Unit Director Associate Professor Evelin Tiralongo said the unit offered GCP compliant facilities for small Phase 1 trials, which focus on the earliest stage of human testing of new drugs or treatment protocols, to Phase 4 trials, which follow-up on the efficacy of new and existing therapies and medications.

“We have a 3 bed procedure room with emergency and IV infusion equipment, 6 consultation rooms, a study coordinator room with 10 workspaces, a phlebotomy room, and a specialised drug preparation and storage room,” Associate Professor Tiralongo said.

Patient comfort is also catered to with a lounge and kitchenette.

Various academics conduct their clinical projects in the unit including researchers from the National Centre for Neuroimmunology and Emerging Diseases and from Griffith’s Menzies Health Institute Queensland, some of whom currently investigating new treatment options for allergic rhinitis.

In addition, pharma trials are run by the unit’s experienced study coordinators, with osteoarthritis, Ross River virus induced arthralgia, Alzheimer’s and obesity and diabetes trials currently underway.”

See Australia’s Gold Coast for more.

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