Blood Substitute

[swatsurgeon]

it's getting closer to reality every week....Polyheme, by Northfield Labs is in late phase III trials and so far looking good. This product is likely to save lives, on the battlefield, in the trauma center and operating room. Here is the web address/link http://biz.yahoo.com/prnews/041013/nyw027_1.html
discussion to follow.

[Roguish Lawyer]

One of my clients was making one. I think they went bankrupt and someone else bought it, but not sure. Company is called Alliance Pharmaceutical. I think they called it "Oxygent."

[swatsurgeon]

I was wondering what happened to Polyheme...the human blood substitute that the Trauma and military folks have been waiting on and found this news item:


The Associated Press December 19, 2006, 5:46PM EST text size: TT
Northfield to review PolyHeme study


Northfield Laboratories Inc. said Tuesday it will reevaluate late stage study data on its PolyHeme red blood cell substitute because of discrepancies in preliminary data.

The company said it received the results from its contract researcher, but found two discrepancies in the dates of death for patients in the study. Mortality is the primary measurement for the study. The company has to "unlock" the study database in order to make the corrections. The Food and Drug Administration has been notified and the study results will not be submitted until they are final.

Shares of Northfield fell $2.90, or 20.3 percent, to close at $11.42 on the Nasdaq. The stock continued to nosedive, plummeting $5.74, or 50 percent, to $5.68 in after-hours electronic trading.

Northfield said it is releasing the preliminary results. Those results are mixed, the company said, depending on population from which the data were obtained. One population involving those who were randomized and received some treatment that did not meet the necessary threshold, while others in the "per protocol population" who received the correct treatment and did not violate protocol, met the study goal.

"This was a logistically complex study with many variables and a high incidence of protocol violations. We believe these preliminary results in the per protocol population represent the clearest evidence to assess the potential benefit of PolyHeme in this setting," said Dr. Steven A Gould, Northfield's chairman and chief executive in a statement.

Company officials could not be immediately reached for further comment on the results.

PolyHeme is a human hemoglobin based oxygen-carrying red blood cell substitute used to treat severely injured patients who need blood when it is not available

In other words, we're going to wait a while longer............

ss

[mugwump]

Yep, it's dead. Hemopure is the lady-in-waiting now. Good luck getting FDA/IRB approval on 'no consent' studies after these results.

[SPECWARDOC]

Yep, Hemopure is the product Biopure is producing, it looks good. Stable at room temps for years, and has been used pretty extensivly in trauma trials. The Navy is trying to get the FDA to allow use without consent in severe trauma cases in Iraq.

[Ambush Master]

Hey,

SpecWD!!! Did you read the message that came to you after you registered and FORGET, or simply ignor it and not follow the Directions?!?!?!

You need to go and read that message again, make an introductory Post here: http://www.professionalsoldiers.com/forums/showthread.php?t=13758&page=29

And then Lurk for a while until we forget about this transgression!!!

Have a Very SF Day!!!
Martin

[lssah2025]

I have been following this company for about 10 years. They use to be known as synthetic blood inc, now they are known as oxygen biotherapeutics. The company has been doing some studies for TBI, trauma, surgery, AMI, sickle cell crisis, decompression sickness etc. with this product.

http://www.oxybiomed.com/index.html

Oxycyte is the company’s perfluorocarbon (PFC) therapeutic oxygen carrier. It is designed to enhance oxygen delivery to damaged tissues. When used as an intravenous emulsion, Oxycyte can carry as much as five times more oxygen than hemoglobin, making it an effective means of transporting oxygen to tissues and carrying carbon dioxide to the lungs for disposal. Oxycyte is not a blood substitute. Because it is a PFC, and not based on hemoglobin, it does not have the safety issues associated with hemoglobin-based products. In fact, there have been no adverse events in company clinical trials that were related to Oxycyte.