FDA blocks Biopure trial
Biopure Corp., a Cambridge biotech company that has struggling to stay afloat while it seeks federal approval for its novel blood substitute, got another dose of bad news this week.
The Food and Drug Administration blocked the US Naval Medical Research Center from launching a clinical trial to see whether Biopure's product, Hemopure, could successfully be used to treat casualties when traditional blood transfusions are unavailable, Biopure said late Tuesday.
The FDA told the medical center that it put a clinical "hold" on the trial for several reasons, including concerns that the tests could exacerbate patients' bleeding and because of high mortality rates in trials with other blood products in the past. Regulators also raised concerns about the information brochure prepared for researchers who would conduct the trial. Biopure said it wasn't sure how the Navy research center would respond.
The news sent Biopure shares down as much as 35 percent in early morning trading today to 14 cents a share. In November, Biopure said it let go most of its employees and cut salaries of others to conserve cash. The company has been trying to raise additional money, but many biotech executives say it is a challenging time to raise money. Biopure says Hemopure, which is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic, can help deliver oxygen to the body's tissues. It has sells a related product aimed at treating anemia in dogs.
(By Todd Wallack, Globe staff)
I noticed when reading this article that there are 2 grammatical errors and one of them is within the first sentence. There should be better editing done on these articles even though they are online and not in newspaper format. Thanks.