Chicago Tribune - September 26, 2007
Bruce Japsen, Tribune staff reporter, bjapsen@tribune.com

A "priority review" for the blood substitute, called PolyHeme, from the Food and Drug Administration would mean that the evaluation would be similar to those the agency does on certain treatments for cancer and AIDS drugs -- conducted over six months or less rather than the typical yearlong review.

"We feel strongly that there is a basis to move forward," Northfield Chairman and Chief Executive Dr. Steven Gould told about 40 shareholders at the company's annual meeting Tuesday at the Deer Path Inn in north suburban Lake Forest. "We believe we have the potential to transform the treatment of trauma. We believe PolyHeme has the potential to save lives."

Although Northfield has been working for more than 20 years on a blood replacement product, the push for a speedy review comes as it is running out of money. Like many other experimental biotech companies, Northfield does not generate any sales or profits because PolyHeme is the company's only product.

As of its fiscal year ended May 31, Northfield had about $40.7 million in cash, enough to fund operations for at least 18 months, a company spokesman said.

Meanwhile, Northfield has asked a four-member panel of independent investigators to examine each of the more than 700 patients who took part in the product's clinical trial to "tell us what's going on there," Gould told shareholders. The panel is expected to give Northfield its report by the end of the year.

Gould said the company is analyzing data that includes what Gould said were "protocol violations" by some of the trial investigators. A protocol violation can result in a patient withdrawing from the trial or in having data from certain patients disqualified for a variety of reasons, possibly skewing the outcome.

Northfield studies released this year showed that more trauma patients died within 30 days of receiving PolyHeme than those who received standard care. The final-stage trial also showed a higher rate of heart attacks for those receiving PolyHeme.

There were 11 patients who had heart attacks and other adverse events in the PolyHeme arm of the trial compared to three in the standard therapy arm.

Gould said more than 70 percent of patients in both arms of the trial had various heart issues that included abnormal electrocardiograms that could complicate the results.

Gould has said the company's eventual submission will include information showing how PolyHeme would provide particular benefits in rural areas where the trial could not be conducted because those areas lack the "infrastructure necessary" to conduct a trauma trial. The trial was largely conducted in urban settings that were within 15 to 30 minutes of a trauma center, Gould said.

Northfield believes PolyHeme can save lives in trauma situations by carrying oxygen through the body, which the saline now used during emergencies cannot do. A blood substitute also would be easier to transport, especially to battlefields and accident scenes, and does not require the sometimes complicated matching process that human blood does.

Shareholders are hoping the FDA looks beyond the fact that Northfield failed to meet its primary endpoint in the trauma trial, saying the product has performed well in earlier trials that have gotten the product to the final stage and next year's submission to the agency.

Shares of Northfield fell 10 cents, or 4.6 percent, Tuesday to $2.06 on the Nasdaq market. The share price is well off its 52-week high of $17.94 reached last December but more than double the $1-per-share price the stock traded at a month ago.

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