Miraculins and the Fox Chase Cancer Center in Philadelphia plan to validate colorectal cancer biomarkers that Miraculins acquired last year from Europroteome, the companies said this week.
Using patient samples from the European Tumor Sample Institute, Miraculins has already conducted a study to verify the utility of the Europroteome biomarkers in diagnosing colorectal cancer, said Miraculins President Jim Charlton. In that study, the company found that a panel of colorectal cancer biomarkers discovered by Europroteome was able to identify colorectal cancer with a sensitivity of 80 percent and a specificity of 80 percent.
For the new project, the Fox Chase Cancer Center will provide about 150 to 200 samples for Miraculins to analyze using its colorectal biomarkers.
"Having an average accuracy of 80 percent from the discovery set means we probably won't need more than 200 samples to validate," said Charlton. "We should be able to complete this next step before the end of the year."
"We've already received two inquiries within the last 10 days from fairly large companies."
The next step after validation will be to develop a commercial diagnostic for colorectal cancer, said Charlton. Miraculins is currently looking for a partner to help develop, commercialize and market a colorectal diagnostic test.
"We've already received two inquiries within the last 10 days from fairly large companies," Charlton said without elaborating.
Currently, there is no in vitro test for colorectal cancer, Charlton pointed out. The standard test that is used to diagnose the cancer is a colonoscopy, which is invasive. More than 3 million colonoscopies are done every year in the United States, and that number is growing by 20 percent annually, Charlton said.
Fecal occult blood tests are also used, but more as a tool for confirming the cancer than for diagnostic screening.
"An in vitro diagnostic test [for colorectal caner] would be well appreciated by the market," said Charlton.
Aside from Miraculins, other companies that are working on developing a colorectal cancer test include Matritech, ChondroGene, Oxford Genome Sciences and Biosite.
Though Miraculins has its own biomarker-discovery program in prostate and breast cancer, the company decided in 2005 to buy Europroteome's intellectual property estate that gave it rights to biomarkers for colorectal and gastric cancer and additional ones in pancreatic and breast cancer.
"We only have five or six employees, and we were fully occupied looking at prostate and breast cancer before we got this acquisition," explained Charlton. "It was a tremendous boost for us to get all this information, especially for colorectal cancer, that would have taken at least three years to acquire."
According to Charlton, Germany-based Europroteome had about 30 employees and had spent about €30 million ($37.7 million) on biomarker discovery when it went into financial default. One of Europroteome's former employees had gone to work for Miraculins about six months before Europroteome's assets went into receivership to be sold by a German lawyer. This employee encouraged the leaders of Miraculins to make a bid for Europroteome's IP, Charlton said.
"We estimated that the value of their [IP] portfolio was at least $10 million [Canadian], and our company had only spent about $2 million or $3 million thus far," said Charlton. "We thought, 'If we make a modest bid, we might be successful in acquiring all that information and intellectual property.' And that is essentially what happened."
Miraculins, based in Manitoba, ended up paying less than CA$1 million ($902,771) for Europroteome's IP portofolio, Charlton said.
Like Miraculins, Europroteome used Ciphergen's SELDI platform to discover biomarkers for various cancers, Charlton said.
"They were doing essentially what we were doing," he said.
Other Miraculins Markers
Aside from its colorectal cancer program, Miraculins also has a fairly advanced program in prostate cancer. Using its own internal biomarker discovery platform called BEST, which is based upon SELDI, Miraculins researchers have identified a panel of markers in urine that have a sensitivity and specificity of about 90 percent, according to Charlton.
Interestingly, though Miraculins has been working on prostate cancer for longer than it has been working on colorectal cancer, outside companies have not been as interested in commercializing their prostate cancer biomarkers as they have been in commercializing the colorectal markers, Charlton said.
"We've been working on prostate cancer for the past four years, and we have not had the interest that we've had in colorectal" cancer, said Charlton.
Miraculins is also working on breast, gastric, and pancreatic cancers using biomarkers acquired from Europroteome.
— Tien Shun Lee ([email protected])