Maurice Wilkins Centre & University of AucklandThursday 30 August 2012, 4:07PM
Media release from Maurice Wilkins Centre for Molecular
Biodiscovery A Centre of Research Excellence hosted by The
University of Auckland
Faculty of Medical and Health Sciences, The University of
Local cancer drug approved for first clinical trial in United
States and New Zealand
The US Food and Drug Administration (FDA) has granted approval for
PR610, an anticancer "stealth" drug invented in New Zealand, to
move forward to human clinical trials through its approval of an
Investigational New Drug (IND) Application for the drug.
The first clinical trial, a phase I/II study, will be conducted at
Auckland City Hospital, Waikato Hospital and sites in the United
Patient enrolment is expected to commence in the coming weeks.
Initially, the trial will recruit small groups of study-eligible
patients to different dose levels of PR610 followed by monitoring
of its side-effects, blood levels and anti-tumour activity.
PR610 belongs to an exciting new class of hypoxia-activated
pro-drugs for the treatment of cancer, designed by Dr Jeff Smaill
and Dr Adam Patterson from the Auckland Cancer Society Research
Centre (ACSRC) and Maurice Wilkins Centre for Molecular
It is licensed to Proacta Incorporated, a San Diego based
biotechnology company that last year engaged in the
collaboration for research, development, and commercialisation of
PR610 in Japan with Yakult Honsha Co., Ltd. (Tokyo: 2267). Proacta
announced today that the IND had been approved, allowing this novel
first-in-class treatment to enter human trials.
Initial development of PR610 will focus on patients with non-small
cell lung cancer who have become resistant to reversible tyrosine
kinase inhibitors such as erlotinib and /or gefitinib. Currently
there is no effective treatment when these patients relapse.
The phase I part of the phase I/II trial will investigate suitable
doses in patients with solid tumours, before moving on to focus on
patients with this type of cancer in the phase II part of the
PR610, which specifically targets low-oxygen (hypoxic) regions in
tumours, has shown promising activity in the laboratory. "The
tumour dose intensity achieved by this hypoxia targeting technology
results in striking anti-cancer activity," says Dr Smaill. "We were
particularly impressed when we compared PR610 to existing clinical
candidates," adds Dr Patterson. "Only PR610 was able to shrink the
drug-resistant lung cancer models."
"PR610 will be the second novel hypoxia prodrug from the Auckland
Cancer Society Research Centre to be taken to clinical trial by
Proacta, and speaks to the continued innovation achieved by our
staff in cancer chemotherapy," says ACSRC Co-Director Distinguished
Professor Bill Denny.
"It's especially pleasing to see clinical trials of new drugs
being held in New Zealand," says John Loof, CEO of the Cancer
Society Auckland Division. "Local patients can be some of the first
involved in furthering our understanding of how these targeted
medicines can make such a difference. Cancer Society donors and
supporters can feel well satisfied that they have underpinned yet
another exciting step forward in cancer medicine."
"This exciting new therapy ushers in a new era of personalised
medicine in New Zealand. For the first time we will be screening
patients for the genetic mutation that causes drug resistance and
then enrolling them in a trial of a New Zealand drug designed to
target that mutation," says ACSRC Co-Director, Associate Professor
Mark McKeage, the Clinical Oncologist leading the Auckland City
Hospital trial, referring to the phase II part of the phase I/II
"Our scientists are inventing drugs at the forefront of the
international fight against cancer," says Professor Rod Dunbar,
Director of the Maurice Wilkins Centre. "The progression of this
first-in-class cancer drug to clinical trials is a great credit to
New Zealand and offers further hope for our cancer patients."