NZ firm has high hopes for cancer test

Pacific Edge Biotechnology chief executive David Darling says its test is almost a third cheaper than existing methods. Photo / Otago Daily Times

An investment of more than $18 million and almost a decade's effort should begin to get a payback this year with commercialisation of a New Zealand-developed test for bladder cancer.

Pacific Edge Biotechnology in Dunedin is finalising a clinical trial of the test, dubbed Cxbladder, which is based on detection of four biomarkers in the urine of people suspected of having the cancer.

While Pacific Edge chief executive David Darling was unwilling to disclose the trial results before the publicly listed company's shareholders were informed, he confirmed commercialisation plans were being put in place.

"We are awaiting the final clinical trial results but progressing the commercialisation process."

The stock exchange would be notified of the results "in the next couple of weeks".

Pacific Edge's two biggest shareholders are Auckland investors Peter Masfen, with about an 11 per cent stake, and Stephen Tindall, with about 8 per cent.

The aim of the trial, based on samples from 650 patients in New Zealand, Australia and Russia, was to show Cxbladder is more accurate than the cytology test relied on by GPs.

Pacific Edge is touting its non-invasive test as being almost a third cheaper than existing methods of detecting bladder cancer. It springs from the US-led Human Genome Project, which identified the roughly 30,000 genes in human DNA.

Geneticist Parry Guilford, the company's head of science, and one of its six founders, says decoding the genome opened the way for scientists to compare how particular genes were expressed in cancerous and non-cancerous cells from the same part of the body.

Pacific Edge was started with New Zealand Seed Fund backing, giving it the cash to buy intellectual property in the new field of microarray technology, being developed by cancer researchers at the University of Otago, of whom Guilford was one.

"We were early adopters of that technology in the university and the opportunity seen by the Seed Fund was to take that expertise and combine it with the mathematical modelling work of Nik Kasabov at AUT University," Guilford says.

"With the microarray you get these huge datasets - 30,000-odd genes, each of which can be turned on an off to an infinite number of levels - and we needed new ways to look at that data."

Kasabov, who heads AUT's Knowledge Engineering Discovery Research Institute, had skills in handling multi-dimensional data.

Cancer researchers already knew tumour growth was a result of the abnormal expression of certain genes. Guilford says what they weren't prepared for was just how many genes were involved.

"Probably about 15 per cent of the genes in the human genome - about 2000 - get screwed up by the cancer process, a much bigger number than we anticipated."

By comparing healthy and cancerous bladder tissue, Pacific Edge whittled that down to a handful of potential biomarkers by looking for the most over-expressed genes.

Bladder cancer was an obvious one to start with because, with a high recurrence rate, it's the most expensive to treat. More than 60,000 new cases are diagnosed in the United States each year, based on about a million tests costing up to US$1 billion ($1.3 billion).

Pacific Edge estimates Cxbladder could cut that cost by 30 per cent, and sees the US market as a "big prize". That will depend on getting urologists to use the test, which will be showcased at a urology conference in Perth next month.

Guilford says firefighters, perhaps through exposure to smoke, have a relatively high rate of bladder cancer, and are screened for the disease in parts of the US. Truck and taxi drivers, hairdressers, the elderly and smokers are also prone to the disease.

As with any cancer, sufferers' chances of survival are greatest the earlier it is detected. For about one in 10 of the New Zealand population, blood in the urine is an early sign of the disease.

"We would really like to take the test to those people who are at high risk and try to find the disease before they have symptoms that indicate the cancer has started to progress."

Pacific Edge intends building its own lab in Dunedin to do testing for New Zealand and Australia, where there are about 3000 new bladder cancer cases a year.

Bioinformatics, which marries information technology with molecular biology, has become a key part of cancer research, as borne out in the makeup of Pacific Edge's scientific team.

"Most of us are molecular biologists but we have a strong thread of bioinformatics skills as well," Guilford says.

"We probably spend more time in front of our computer screens these days than in the lab," Guilford says.

But the division of his time will change this year as he goes from devoting 80 per cent of it to Pacific Edge and 20 per cent to the cancer lab, to the other way around.

"In the end it still comes back to biology. We started off with our microarray experiments, we've done most of the bioinformatics, and then it comes back to checking whether the markers you've found really work in a clinical setting - getting what we call wet data again."

Cxbladder is the most advanced of tests Pacific Edge is working on. Others are for detection of cancers of the stomach and uterus, and for predicting the best treatment for colorectal (colon) cancer and melanoma.

A simple blood test for stomach cancer, instead of expensive x-rays, could have enormous potential in Asia, where the Japanese and South Korean governments have committed to free national screening for the disease for those aged over 40.

The colorectal cancer and melanoma tests are in the realm of what Guilford calls personalised medicine.

"By that we mean treating a patient in a way that is most suited to his or her disease rather than following a generic treatment."

Rather than diagnostic tests, they are prognostic, designed to predict the cancers' spread based on genetic markers for individual patients. Patients who show a low likelihood of cancer recurrence after initial surgery might be spared chemotherapy.

Guilford sees personalised medicine based on analysis of patient genetic information becoming the norm within 10 years.

"I think that's going to become necessary upfront information before starting the treatment process - no longer will the paradigm be to treat all patients the same.

"It will be very much, get a sample from the patient, analyse it and make predictions about how that patient will respond to treatment or how aggressive the disease might be."

Such an approach to medical practice was a long-term goal of the Human Genome Project, Guilford says, and developing the tests that make it possible is a competitive field.

"This is not just our idea. We do all right for the size of our company - we're reasonably competitive. If we can get just one product away I think we'll have justified our existence."

Darling is confident this will be Pacific Edge's year.

"It's going to be a huge year for us - we're a small company that is going to do a lot of growing."

CXBLADDER

* Pacific Edge is finishing a clinical trial of a new test for bladder cancer, called Cxbladder.
* It says the non-invasive test is almost a third cheaper than existing methods of detection.
* Cxbladder springs from the US-led Human Genome Project.
* Plans to commercialise the test are under way.