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Exiqon Wins $3M Gov’t Grant to Develop Cancer-of-Unknown-Primary Diagnostic

Exiqon last week announced that it has received a DKK 14 million ($3 million) grant from the Danish National Advanced Technology Foundation to continue developing a microRNA-based diagnostic for identifying the source of cancers of unknown primary origin.
The company last week also reported its financial results for the first quarter, posting a 76 percent jump in revenues on strong product sales as operating expenses grew 110 percent.
Exiqon is developing the CUP test in collaboration with Danish hospital Rigshospitalet, but had been funding the effort entirely on its own, according to Exiqon President and CEO Lars Kongsbak. The new funding, however, will allow the partners to “speed up the clinical testing” of the diagnostic.
The oncology clinic at Rigshospitalet “is the leading cancer center in Denmark for work within cancer of unknown primary site,” Soren Moller, vice president of research and development at Exiqon, said in a statement. “Together … we intend to analyze the miRNA profile of a large number of cancers in order to establish a classification database, which, with a high degree of certainty, will enable us to determine the origin of a cancer tissue sample by comparing its profile with the classification database.”
According to the company, tumor origin is unknown in approximately 5 percent of all diagnosed cancer patients, or roughly 72,000 patients in the US each year. “Accurate diagnosis for cancer of unknown primary is critical in the process of determining the optimal treatment,” Exiqon said.
The firm has “for some time been looking for different partners” to obtain clinical samples that are “highly needed for such a complicated product,” Kongsbak told RNAi News this week.
Last month, Exiqon acquired California-based Oncotech, which has its own tumor tissue bank (see RNAi News, 4/10/2008), but “it’s very important to have different sources of material,” Kongsbak added.

“We have for some time been looking for different partners in order to get access to the clinical material, which is highly needed for such a complicated product.”

Rigshospitalet is also a “good partner” for Exiqon because of its expertise in running clinical trials, he added. “We have to test [a CUP diagnostic] in a clinical setting … and [the researchers at Rigshospitalet] know how to do that kind of research.”
Even with the support of the grant, however, Exiqon does not expect to introduce a CUP diagnostic until 2010.
As reported by RNAi News, the company expects its first miRNA diagnostics to replace Oncotech’s existing line of cellular-based extreme drug resistance tests for a variety of cancers including colon, breast, ovarian, and lung.
Exiqon’s first miRNA-based diagnostic, which will be based on the company’s locked nucleic acid technology, is still expected to be launched in the US late this year, but Kongsbak declined to specify the diagnostic’s indication.
“Probably within a few weeks we may be able to [disclose] that,” he said.
Exiqon is not the only company developing a miRNA-based diagnostic for CUP. Rosetta Genomics is developing a similar test that it plans to introduce in the US next year.
Earlier this year, Rosetta published data in Nature Biotechnology showing how a collection of 48 miRNA signatures could be used to pinpoint the origin of cancers of unknown primary with around 90 percent accuracy using a proprietary classification algorithm (see RNAi News, 3/27/2008).
Q1 Financials
In the first quarter, Exiqon reported that its net loss rose to DKK 24.8 million from DKK 11.2 million in the same period last year on increased R&D spending, which swelled to DKK 11.6 million from DKK 4.9 million. That rise is largely due to the costs associated with acquiring Oncotech.
Sales and marketing expenses, meanwhile, rose 107 percent to DKK 11.4 million, which was also largely a result of the acquisition.
Exiqon said administrative costs in the first quarter more than doubled to DKK 11.5 million on expenses associated with the expansion of its US facility to include both production and sales operations.
First-quarter revenues jumped to DKK 16.5 million from DKK 9.4 million in the year-ago quarter. According to the company, the increase was primarily due to a DKK 7.4 million rise in product sales amid strong growth in its research products business, which includes its miRCury LNA array product line.
As of March 31, Exiqon had cash and cash equivalents totaling DKK 271 million, up from DKK 18.3 million last year, reflecting money received through its initial public offering in Denmark a year ago.
Looking ahead, Exiqon said that expects to hire a new CSO and COO for its Oncotech subsidiary sometime before the end of June. Both officers will report to Kongsbak.
In addition, Exiqon continues to expect 2008 revenues to be in the range of DKK 140 million to DKK 150 million and its annual net loss to arrive between DKK 110 million and DKK 115 million.
The company also continues to expect it will become profitable by 2011 and for its research products business to break even by next year.

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