Financially embattled Biopure (Cambridge, Massachusetts) could be seeing some small rays of hope in initiating a clinical trial for Hemopure, its blood oxygenating therapy.
Just a few scant weeks after Biopure reduced its staff by 60% to cut costs the company reported Tuesday that it has been in discussions with the FDA to initiate a clinical trial of Hemopure for patients suffering from Acute Myelogenous, or Leukemia.
"We haven't gotten the protocol written yet regarding how many patients will be involved in the trial," Tiana Gorham, a spokeswoman for Biopure told Medical Device Daily. "We're very much at the beginning stages of discussion with the FDA."
Hemopure [hemoglobin glutamer 250 (bovine)], or HBOC 201, is approved for sale in South Africa for the treatment of acutely anemic surgical patients.
Biopure has proposed to study use of Hemopure in patients suffering from Acute Myelogenous Leukemia (AML) who refuse transfusion with blood components.
Currently, AML patients who do not accept blood transfusions are unable to undergo potentially life-saving induction chemotherapy because of the profound anemia the chemotherapy causes. Patients would give informed consent before being enrolled in this study.
Hemopure, consists of hemoglobin that has been taken out of the red blood cells of cattle and then purified, chemically cross-linked for stability and formulated in a balanced salt solution similar to Ringer's lactate. The resulting hemoglobin solutions do not contain any cells.
"Hemopure is an attractive application because it doesn't need to be refrigerated and it is universal," Gorham said. "There is no need for a type or cross match."
According to the company, an effective treatment for this patient population represents an unmet medical need because of an expected 100% mortality within six months in the absence of induction chemotherapy. The purpose of the study would be to assess the efficacy of Hemopure in providing an oxygen carrier in lieu of transfusion with red blood cells, as an adjunct to other special procedures, following induction chemotherapy for AML.
Biopure has U.S. and European approval to market the veterinary product to treat anemia in dogs, but has struggled to get U.S. approval for the human product.
The company goes on to say that if this proposed trial is successful it could be pivotal to establish an intended use for Hemopure in this clinical setting.
"We are very excited at the possibility of initiating a new clinical trial with Hemopure in the U.S. If this trial provides convincing evidence of benefit in this high mortality population, it has the potential to become a pivotal trial for Hemopure's use as an adjunct to AML induction chemotherapy when transfusion with blood components is refused by the patient," said Zafiris Zafirelis, Biopure president/CEO. "By serving as an oxygen delivery bridge following chemotherapy-induced suppression of red blood cell count, use of Hemopure, as part of a bloodless treatment regimen, may potentially reduce mortality in these patients, who currently have no hope."
For years the development of blood substitutes, also known as oxygen therapeutics, has been rife with controversy and hurdles throughout the years.
The round of contention came in the form of a huge spat between Biopure and the Journal of the American Medical Association (JAMA), (Medical Device Daily, June 11, 2008).
Biopure strongly protested an article surrounding JAMA's meta-analysis of a number of hemoglobin-based oxygen carrier (HBOC) trials that indicated a 30% increase in the risk of death and a nearly threefold chance of having a heart attack.
The article in JAMA's June edition went so far as to suggest that no further Phase III studies be conducted considering these dangers.
Biopure responded to JAMA asking for a retraction and apology for the article. JAMA refused citing that Biopure had already posted a rebuttal to the article, which was placed on the Cambridge company's web site thereby making it public domain.
Currently, Biopure has four ongoing Phase II trials of Hemopure for these indications: during percutaneous coronary intervention; for patients undergoing coronary artery bypass graft surgery; for use in lower limb amputation resulting from critical limb ischemia; and in-hospital use in trauma patients.
Biopure also is developing Hemopure, with support from the U.S. Navy, for a potential out-of-hospital trauma indication.
The company failed to win approval for a Phase III trial for pre-hospital treatment of hemorrhagic shock resulting from traumatic injury a year and a half ago (MDD, Dec. 17/Dec. 18, 2006).
Financially the company is in dire straits. Last month the company let go nearly 50 of its staff; cuts it said would keep it going at least until this fall.
The company, which had an all-time high this year of $4.85 a share, now closes at roughly 55 cents a share.
Biopure makes oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues.