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Biotech Alliance’s return to clinical trials may cause product delays

Alliance Pharmaceutical Corp. said preliminary data showed its experimental blood substitute Oxygent was not linked to strokes, which led the company to halt late-stage human trials in January.

The March 13 announcement is good news for the San Diego-based biotech firm, which decided to stop the trials voluntarily.

However, the re-initiation of clinical trials marks a significant setback for Alliance in terms of seeking drug approval from the Food and Drug Administration and with the product launch.

Alliance Chairman and CEO Duane Roth said in a company statement the firm will continue developing Oxygent with pharmaceutical partner Baxter Healthcare Corp.

However, both firms will not make a decision until May or June whether to continue the halted study or start an entirely new Phase III trial, the last of three stages required by the FDA for drug approval, said Gwen Rosenberg, Alliance’s spokeswoman.

“We have to analyze further whether we think it would be worthwhile restarting the study,” Rosenberg said. “We have to make changes to the study protocol to ensure (that we don’t end up in the) same situation as before.”

If the study is continued, Alliance would use data derived from 398 patients enrolled in the cardiac surgery study, and treat 200 additional patients under the revised protocol, Rosenberg said.

If the firms decided to initiate a new trial, enrollment would not begin until this fall, Rosenberg said.

The coronary artery-bypass study was already well on its way.

Still, Alliance decided to halt it, because it couldn’t explain why the number of patients suffering strokes was lower than projected in the control group.

This caused an imbalance in the overall figures, Rosenberg said in January.

Oxygent is designed to imitate the ability of red blood cells to carry oxygen to the body’s tissues and is given to patients mainly to avoid the use of donor blood during surgery.

“To date, neither the company, the study investigators, the study Data Safety Monitoring Board, nor independent expert consultants believe that Oxygent is causally implicated in adverse findings,” Alliance reported.

A final report of the safety findings will be available in May.

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