Pharmaceutical firm to get patient consent before testing blood substitute.

Non-Consenting Patients: Amid national controversy surrounding the testing of a blood substitute on badly hemorrhoraging victims without their consent, the San Diego Business Journal sought an update from a local biotech with a similar product: Oxygent.

Alliance Pharmaceutical Corp. Chief Executive Officer Duane Roth, who also serves as CEO of Connect, the area's life sciences and technology networking group, said Alliance's blood substitute will be in its last phase of testing by the end of this year.

Last week, the FDA was expected to hold a closed-door hearing about whether Hemopure, a blood substitute made by Cambridge, Mass.-based Biopure Corp., could continue a trial that involved badly hemorrhaging trauma patients who would be unable to give informed consent. The issue has drawn interest from the Wall Street Journal and a prime time TV news magazine.

The FDA has blocked the company from conducting the trial three times in the past year, as well as canceled a previous Hemopure study, after patients had high rates of heart attacks, hypertension and other serious cardiac problems.

But the FDA is reconsidering after much prodding from Biopure and the U.S. Navy, which say that one of the panel members overseeing Hemopure decisions at the FDA had a conflict of interest. The Navy proposed the non-consensual trials in 2004.

Roth said Alliance does not plan to do any studies without consent of the patients involved. He said the company will test Oxygent in a surgery setting with prior consent--not in an emergency room or ambulance setting.

While hemoglobin in Hemopure is derived from animal or human matter, Oxygent is made from chemicals, Roth said.

"The differences are really profound when it comes to manufacturing," he said. "If one cow or human has a problem, it can be dangerous. (The company) can lose a great deal of money just trying to Clean the product because of processing."

Alliance temporarily halted Oxygent trials in 2001 as a result of higher than expected rates of strokes in patients. In 2002, Baxter Healthcare Corp. pulled out of an agreement with Alliance to help develop the blood substitute.

"Since that time, we have not been able to get organized to get back into the clinic," Roth said.

Over the years, the firm has dwindled from 200 employees and a stock price that topped $20 in 2000 to only a few employees today.

Alliance, which saw its stock price fall nearly 10 percent to 1 cent July 10, was founded in 1983 and trades as ALLP.OB on the Over the Counter Bulletin Board.

The firm reported a net loss of nearly $3 million and cash of $4 million as of March 31. The firm had $11.4 million in debt as of that federal filing. Roth said as part of the company's plan to get out of debt and move forward with Oxygent, it sold FDA-approved Imagent, an ultrasound imaging agent, to Photogen Technologies Inc. in 2002.

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