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Encouraged By Positive FDA Feedback, Ciphergen Awaits Validation Results

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Touting customer success as the key indicator of business success, Ciphergen said that results from a number of cancer biomarker validation studies performed by researchers who used its flagship SELDI technology will be released this financial quarter.

“To date we have over 300 publications with real scientific results from researchers who used our technology,” said Matthew Hogan, chief financial officer of Ciphergen, who spoke at the UBS Global Life Sciences Conference in New York this week. “That’s an indication of our customer success.”

Results of a 1,500-sample trial to validate the three protein biomarkers discovered by Daniel Chan’s research group at John’s Hopkins using Ciphergen’s SELDI chip technology will be presented next week in Scotland, said Gail Page, the president of Ciphergen’s diagnostic division. The presentation will include data from 790 of the 1500 patients.

In addition, results from the first 400 prostate cancer samples out of a 1,100 sample validation study will be presented during this fiscal quarter, Hogan said. The samples were collected from seven different sites.

Publications that are in the pipeline include a paper on an early detection prostate cancer study that is expected to come out in the fall in the journal Clinical Chemistry, and a paper describing a 176-patient breast cancer validation study that is slated for publication by the spring of next year.

“If we can get one or two [diagnostic tests] unveiled and onto the market, we’ll have shown that we’ve got the team and we can do it,” said Page.

She added that the US Food and Drug Administration has been pleased with the cross-sectional representation of samples in studies that use Ciphergen’s SELDI technology to find and validate biomarkers, and the agency’s comfort with the data produced by Ciphergen-using scientists may help in ultimately getting biomarkers approved.

“[The FDA] was relieved that we don’t just feed in samples and out comes the data,” said Page. “They were pleased with our cross-validation and they loved the fact that we identified the proteins.”

Chan’s research, which was published in the August issue of Cancer Research, showed that when three protein biomarkers identified using Ciphergen’s SELDI technology were combined with the standard CA125 ovarian cancer biomarker, the combination detected early stage ovarian cancer in 74 percent of the women study patients who had the disease (See ProteoMonitor 8/20/04).

Chan’s group used serum samples from five clinical centers to screen for initial potential biomarkers. Once they had honed in on the three most successful biomarkers, they tested them out on serum from a cohort of 41 healthy women and 41 women with ovarian cancer who had been treated at the Johns Hopkins Medical Institutions.

When CA 125 was used alone with the same samples, it correctly identified cancer 65 percent of the time — a sensitivity that was not statistically lower than the 74 percent identified by Chan’s biomarkers, given the sample size of patients. However, when cutoff values for CA125 were adjusted to below current standards, the new biomarkers combined with CA125 correctly identified cancer 83 percent of the time — an amount significantly higher than CA125 alone.

Results from the 1,500 sample validation study are expected to better show the difference in sensitivity for detecting ovarian cancer between the new biomarkers in combination with CA125 and CA125 alone.

Page said that the fact that researchers believe in Ciphergen enough to give them their samples to use in conducting studies is a sign of Ciphergen technology’s success.

“It is so hard to find stage one ovarian cancer samples,” said Page. “We probably have the most pedigreed samples of anyone in the industry.”

If a diagnostic test for ovarian cancer is approved by the FDA, the market for it will be “huge,” said Page. She estimated that approximately four million to five million tests would be done each year, and each test would cost about $300.

SELDI technology accounts for about 15 percent of the Ciphergen’s revenues, said Hogan. The other parts of the company’s revenues come from instrument sales (48 percent), services (14 percent), and other consumables (18 percent).

Over the last 18 months, Ciphergen has been automating the chip manufacturing process. The automation should bring the cost of chips down by one third, and improve the quality of the chips, said Hogan.

Page said that Ciphergen is looking for additional partners to collaborate with in the development of products and in clinical trial validations, but that the company will remain responsible for strategic marketing and manufacturing of products.

—TSL

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