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Fri Dec 15 13:15:39 GMT 2006

FDA Panel Votes Against Blood-Substitute Study Despite Push From Navy,
Test of Biopure's Treatment
Fails to Win Endorsement
By *ZACHARY M. SEWARD* and *THOMAS M. BURTON*
December 15, 2006; Page B2

Bucking heavy pressure from the U.S. Navy, a federal advisory panel
recommended against carrying out a controversial study of Biopure Corp.'s
blood substitute. The treatment carries significant safety risks and often
would have been administered to human trauma victims without their consent.

The Food and Drug Administration usually follows advisory panels' advice,
but it doesn't have to. The decision on testing Hemopure is vital for its
developer, Biopure<http://online.wsj.com/quotes/main.html?type=djn&symbol=BPUR>Corp.,
of Cambridge, Mass. Hemopure currently is only approved for limited
human use in South Africa.

The panel vote was 11 against, eight in favor and one abstention. Biopure's
chairman and chief executive, Zafiris G. Zafirelis, declined to comment on
the outcome immediately following the meeting. "I need to digest the
comments," he said.

Hemopure is controversial because it has been consistently linked to serious
complications in earlier studies, documents show.

Nevertheless, the Navy, whose medics treat wounded Marines in battle zones,
contends that Hemopure may lower the death rate among severely injured
trauma patients by possibly 15% from what it believes will be about a 58%
death rate among patients getting standard therapy. Saline solution, the
standard therapy administered in the ambulance, merely raises blood
pressure, while Hemopure is an oxygen-carrying resuscitative fluid that can
be carried onto the battlefield and doesn't require matching blood types, as
would real human blood.

John Mateczun, the Navy's deputy surgeon general, told the committee that
90% of military trauma fatalities occur before the soldier reaches
"hospital-level care," where they could receive real human blood. "In terms
of benefit, we believe that many lives might be saved in Operation Iraqi
Freedom with this capability," Dr. Mateczun said, referring to Hemopure. "It
would be worth our efforts if it saved only one life."

Among those addressing the panel in Silver Spring, Md., was Sgt. Eddie
Wright, who was struck by a rocket-propelled grenade outside of Fallujah,
Iraq, in 2004. He said he was willing to accept "a slight risk to my health"
for the benefits of Hemopure in combat. "Any risks that I've been hearing
today are not applicable to my situation," Sgt. Wright said.

Some committee members expressed skepticism that results from any trial
among citizens in the U.S. could be applied to the use of Hemopure during
war. They also questioned whether the potential benefits to the military in
combat should be weighed in considering a stateside study.
[image: [chart]]

The FDA had sought to hold the Biopure/Navy hearing behind closed doors in
July. After The Wall Street Journal wrote about the issue of the planned
closed hearings, the consumer group Public Citizen brought a lawsuit and the
FDA rescheduled yesterday's hearing as a public one.

Hemopure has shown an elevated level of medical "serious adverse events" in
a large study of the blood substitute in orthopedic-surgery patients, 353 of
whom got Hemopure and 340 of whom received donor blood. Government documents
show the Hemopure patients had 25 deaths, versus 14 in the blood group; 54
cases of heart failure and fluid overload, compared with 22 who got blood;
and 14 heart attacks, against four in the donated-blood population. The same
sorts of imbalances arose when Hemopure was compared with other
resuscitative fluids, including saline solution, in other surgical studies.

The FDA's reviewer on the proposed Navy/Biopure study, Laurence Landow, has
consistently opposed the Navy's plans. Dr. Landow has declined to comment on
the issue.

The FDA has acted with apparent inconsistency on the blood-substitute issue,
blocking the Navy study while allowing a competing trauma study by Biopure
competitor Northfield
Laboratories<http://online.wsj.com/quotes/main.html?type=djn&symbol=NFLD>Inc.
to proceed. The Northfield trial finished enrolling patients this
summer. Northfield is expected to release some results this month.

The importance of Hemopure to Biopure was underscored as the company
released financial results for the year ended Oct. 31. It said that it
expects its independent accountants to include a "going concern" warning in
its annual report because Biopure said it has only enough money to survive
through August and needs to raise additional funds even though it just
completed an offering of stock and warrants that raised $16.6 million.

For the fourth quarter, Biopure reported a net loss of $6.3 million, or 13
cents a share, narrowed from a year-earlier net loss of $8.2 million, or 34
cents a share. Revenue rose to $431,000 from $328,000. Biopure shares fell
four cents to 59 cents in 4 p.m. Nasdaq Stock Market composite trading.

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FDA Panel Votes Against Blood-Substitute Study