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Miraculins Prepares to Validate Biomarkers For Dx Use in Pancreatic, Stomach Cancer

Further utilizing a technology portfolio it acquired last year, Miraculins will begin validating biomarkers that it hopes cold be used to diagnose pancreatic and stomach cancer, the company announced recently.  
Miraculins acquired the biomarkers — along with biomarkers for colorectal and breast cancer — in May 2005 as part of its purchase of Europroteome [See PM 06/15/06].
Added to the validation work it had already begun on breast, colorectal, and prostate cancer biomarkers, Miraculins, based in Manitoba, Winnipeg, is now developing diagnostic tools for five cancers.
For its validation research on pancreatic and stomach cancer biomarkers, Miraculins will use between about 150 to 200 serum samples, Christopher Moreau, the company’s vice president of business development, said this week. The company had not yet chosen the source of the samples, he said.
If no new analytes are discovered, or if no complications arise during validation, the company could announce the findings of its pancreatic and stomach cancer validation work in the second or third quarter of 2007, Moreau said.
If new analytes are found, Miraculins would have to purify them, then sequence them and do IP-related work.
This year an estimated 34,000 Americans will be diagnosed with pancreatic cancer while another 30,000 are expected to be diagnosed with stomach cancer. By comparison, this year 234,000 men in the US will be diagnosed with prostate cancer and 213,000 women and 1,700 men in the country will be told they have breast cancer.
But Moreau maintained that the relatively small markets for pancreatic and stomach diagnostics have not deterred Miraculins from proceeding.
“You don’t always look at it and say ‘What’s the bottom line?’ The value is we have a relatively well-developed process that’s very efficient and economically solid, and I think that we can, within relatively reasonable budgets, discover biomarkers that have useful utility both for diagnostics and therapeutics,” Moreau said.
“Low incidence doesn’t mean that those cancers don’t deserve to be looked at. Sometimes you can consider them niche markets but … in essence, I think that those are opportunities for a small company like ours to capitalize [on],” he added.
The field for diagnostic tests that can detect pancreatic and stomach cancer in early stages is wide open. For pancreatic cancer, in particular, current diagnostic exams have not proven to be especially effective in detecting the disease early enough to prolong a patient’s life.
According to Liz Thompson, director of research and scientific affairs at the Pancreatic Cancer Action Network, a patient advocacy group, only 1 percent of patients diagnosed with the disease survive beyond 5 years after diagnosis. Many die within 6 months after diagnosis, she said.
“Would we love to have [a diagnostic test] for our cancer? Absolutely,” Thompson said, adding pancreatic cancer, with more than 30,000 deaths occurring each year, has now taken prostate cancer’s place for having the fourth-highest number of deaths among all cancers.
“One of the reasons that prostate cancer has fallen to the number five slot and pancreas cancer is now in the number four slot is we have a test to diagnose prostate cancer,” she said. “Despite large investments in cancer therapies, none have shown great success in patients with late-stage cancers.”
Neither a blood- nor urine-based diagnostic test is currently available for pancreatic cancer. Diagnosis is primarily done through a needle biopsy, computed tomography scan, or magnetic resonance imaging.
Others who are developing pancreatic diagnostic tests include GenTel, which is developing a cancer chip targeting prostate and pancreatic cancer [See PM 5/25/06],and Advanced Ideas in Medicine, which is working on software technology that filters through mass spectra of diseased and control samples. Pancreatic cancer is one of the diseases the tool is being developed to detect [See PM 12/23/05].

“You don’t always look at it and say ‘What’s the bottom line?’ The value is we have a relatively well-developed process that’s very efficient and economically solid, and I think that we can, within relatively reasonable budgets, discover biomarkers that have useful utility both for diagnostics and therapeutics.”

In the case of stomach cancer, diagnostic exams include gastroscopies and upper-gastrointestinal barium studies. Gastroscopies have shown to be very effective diagnostic tests, and in countries with high incidents of stomach cancer, such as Japan, gastroscopies are used as screening tests. However, they cost thousands of dollars.
A fecal occult blood test also exists but its usefulness as a diagnostic tool is largely dismissed by the medical community because of its low specificity.
“It’s worthless as a diagnostic test,” said Herman Kattlove, medical editor for the American Cancer Society. “People can have blood in the stool for many reasons. To have blood in the stool from gastric cancer means you’re bleeding a lot and you’re late in the game.”
Indeed, while declining to speak specifically about Miraculins’ blood-based test in development, Kattlove said that most blood-based cancer tests have questionable utility because of a high rate of false positives.
Miraculins is also in the process of finishing up validating biomarkers for colorectal and prostate cancer, Moreau said. In colorectal cancer, the company may be ready to announce its results during the first quarter of 2007 depending on whether new analytes are discovered.
Miraculins has validated three biomarkers for prostate cancer and is in the process of purifying them and getting their IP position secured, Moreau said. Once that occurs, it will begin looking for a commercialization partner.

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