Fake blood passes early tests

Alicia Robinson

If all goes as Robert Nicora expects, doctors in surgery might

someday be calling for “more Oxycyte, stat!”

Nicora is president of Costa Mesa-based Synthetic Blood

International Inc. The company announced Tuesday that early testing

of Oxycyte, a blood substitute, in human subjects is showing success.

Oxycyte is synthetic blood made of liquid perfluorocarbon --

Teflon is a fluorocarbon solid -- emulsified in water and salt. Its

intended use is to temporarily replace blood in surgery and trauma

patients, Nicora said.

The first of three phases of clinical testing began after the U.S.

Food and Drug Administration granted approval for the testing in

April. Volunteer subjects were given low doses of the synthetic blood

and then monitored.

“We saw no side effects of any kind there,” Nicora said.

Tests with a higher dosage of the product began Wednesday, and the

third and highest dosage will be administered to subjects in a few

weeks, Nicora said. He expects initial testing to be finished by the

end of the year and a report of the results will be submitted to the

government in January.

“We have a pretty good idea what to expect already based on the

animal studies we’ve done,” he said.

Oxycyte replaces the liquid volume of lost blood and transports

oxygen to the body’s tissues and takes carbon dioxide to the lungs,

Nicora said.

“That’s all you really need blood to do on a short-term basis

during surgery,” he said. A blood substitute isn’t effective in the

long term because it lacks red blood cells and it only stays in the

body a few days.

But in some situations synthetic blood has advantages over the

real thing: It carries no risk of disease transmission, it can be

used in patients regardless of their blood type and its shelf life is

up to two years, compared with the 40-day life span of human blood,

Nicora said.

Because it doesn’t need to be refrigerated, it can be used easily

by medics in the field. Nicora also envisions Oxycyte being used

therapeutically for people who need more oxygen in their bodies, such

as heart attack and stroke victims or chemotherapy and radiation

patients.

While those promises are seductive, not everyone is as confident

that Oxycyte will end up on the market.

Other companies have explored synthetic blood, but the research

has always petered out during clinical trials.

“The fact of the matter is that there have been lots of touted

blood substitutes for many, many years, but none of them have been

licensed by the FDA,” said Dr. Ross Herron, medical director of the

American Red Cross Southern California Blood Services Region.

Synthetic blood would help some patients, but not people who need

chronic transfusions and require the benefits of red blood cells,

Herron said.

While an approved blood substitute would benefit the medical

community, Herron said, “I just don’t know if it’s ever going to

happen, because red blood cells and their function are very hard to

replace.”

Nicora acknowledged that other companies have failed at developing

blood substitutes. San Diego-based Alliance Pharmaceutical made it to

late-phase testing before its research was terminated, he said.

The FDA bases its approval of products on that late, “phase III”

research.

With all that is known from other companies’ trials and Synthetic

Blood International’s own tests to date, Nicora said, “we’re very

confident that we’re going to be able to start important clinical

testing in patients early next year.”

He’s already had interest from pharmaceutical giants such as

Baxter Pharmaceuticals and Johnson & Johnson, he said.

And if Oxycyte shows positive results early in the next phase of

tests, Nicora expects company stock to rise well above $1 a share.

“We’re penny stock now,” he said.