Completed & Ongoing Studies
In the 6 years to February 2013, ACS completed or is finalizing sixty-five (65) clinical trials; this work is summarized in the table below. Around 75% of our studies have been in patient populations and 25% in healthy volunteers.
ACS is now seen as a centre of excellence for hepatitis patient studies through its cooperation with Professor Ed Gane and the Auckland City Hospital Liver Unit. ACS has also conducted patient studies in oncology, dermatology, gastroenterology and nephrology. ACS has access to other patient populations through its close cooperation with other Auckland specialists.
ACS has conducted many healthy volunteer studies ranging from entry-in-human single ascending dose trials to bioequivalence/food effect studies. Many of these studies have been “critical path” for the sponsors and ACS has been able to meet the timelines on all occasions.
De-identified examples of both patient and healthy studies are shown below.
Patient study examples
Code name "Venus":
ACS first became involved in developing a novel oral compound for the treatment of hepatitis C under the Sponsorship of US biotech, Pharmasset, a company subsequently acquired by Gilead Sciences Inc. Since that date, ACS has been integrally involved in the Phase 2 development of the compound (now known as sofosbuvir) under the study name Electron. Ground-breaking results of this study were recently published in the New England Journal of Medicine (N Engl J Med 2013;368:34-44).
Read more here.
Code name "Gemini":
A major European sponsor requested ACS to be lead site in a landmark Phase I multi-centre study to evaluate the safety, tolerability and antiviral activity of two investigational medicinal products used in combination in chronic hepatitis C patients. This study was particularly difficult in that it involved a 15-day in-patient stay. ACS randomised 53 of the 88 study subjects; its Principal Investigator, Associate Professor Ed Gane, presented results at AASLD and EASL. This study was published in The Lancet Vol 376 October 30th, 2010.
Code name "Shrek":
ACS was asked to conduct a Phase I Absorption, Distribution, Metabolism & Excretion (ADME) study of a C14-labelled oncology agent. Working with an oncologist from University of Auckland and the Department of Nuclear Medicine at Auckland City Hospital, ACS dosed 8 subjects with a single infusion of the IMP. The subjects were inpatient for approximately 8 days until >85% of radiation was recovered. Continuous urine and fecal collections were made for liquid scintillation counting and blood samples collected for PK analysis.
Code name "Triton":
ACS was asked to join a study as a “rescue site” to evaluate a monoclonal antibody in a Phase II study in patients with moderate to severe psoriasis. ACS expedited ethics and regulatory approval and worked with a consultant dermatologist to recruit and randomize 8 subjects in a short time-frame.
Healthy volunteer study examples
Code name "Cobra":
This Phase 1 study evaluated the pharmacokinetics and safety of a biosimilar in healthy volunteers. The challenge was to recruit, randomise and dose 200 subjects in a 3-month timeframe. In collaboration with sister-company CCST, regulatory and Ethics Committee approval was gained in two weeks for both sites under one application. Screening to last subject dosed was achieved in the 3-month timeframe.
Code name "Pelorus":
This randomized, open label, four treatment, four way crossover Phase I study explored the effects of low doses of one compound on a single dose of the IMP in 48 healthy volunteers; it was a critical path study for a major European sponsor. ACS’ application was considered by the ethics committee (EC) at a meeting on Day 1, given final EC approval on Day 22, first dosed on Day 32 and last dosed Day 92. The timeline targets of the sponsor were exceeded and data considered excellent.
Code name "Pecan":
This is an ongoing entry-in-human single ascending dose study of a monoclonal antibody originally started by ACS’ sister-company, CCST. The inclusion/exclusion criteria for the study make recruitment extremely difficult. The strength of two related early-phase Clinical Pharmacology Units working together to meet the sponsor’s objectives will see this study successfully completed. The study features the use of Electronic Data Transfer (EDT) of lab results from our lab provider, LabPLUS.
Code name "Lace":
This entry-in-human study evaluated the safety and efficacy of single ascending doses of a topical IMP as a wound healing agent in 43 healthy volunteers. Working with an infectious diseases physician and a dermatologist, a series of punch biopsies were made and IMP dosed. The wounds were assessed histologically, photographically and visually at follow-up visits. This was a challenging study and successfully completed within agreed timelines.