BioTime Reports Results From Independent Hextend R Study
BioTime, Inc. (NYSE Amex:BTIM) reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime's commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.
The non-randomized observational trial was the largest involving Hextend in any group of surgical patients and was conducted by a team of physicians led by Kenneth G. Proctor, Ph.D. at the University of Miami Ryder Trauma Center, a Level 1 trauma center, from June 2008 through December 2008. The results were presented at the prestigious Southern Surgical Association 2009 Annual Meeting in December by Drs. Alan S. Livingstone, chair of Miami's Department of Surgery, and Michael P. Ogilvie, the study's first author. Dr. Proctor's team prospectively evaluated 1,714 patients, of which 805 patients received standard of care fluid resuscitation plus up to one liter of Hextend within the first two hours of arrival at the trauma center and 909 patients received standard of care fluid resuscitation without Hextend. Results of the study showed that overall mortality for the patients treated with Hextend was significantly lower at 5.2 percent compared to 8.9 percent (p=0.0035) for the patients receiving fluid resuscitation without Hextend. Additionally, similar benefits were seen in penetrating injuries (p=0.0016) and in those severely injured, as defined by Glasgow Coma Score <9 (p=0.0013) or Injury Severity Score >26 (p=0.0142). While survival was improved in those receiving Hextend, a higher proportion of these patients required ICU admission and transfusions of blood or plasma, consistent with lower mortality and a higher percentage of patients surviving to require subsequent critical care. All results were confirmed using univariate analysis.
"The U.S. Army has deployed Hextend for initial resuscitation of battlefield casualties because less Hextend is required compared to commonly used saline solution to achieve the same plasma volume expansion effect. This offers a major logistic advantage for a combat medic who has to carry all his supplies in his backpack," said Dr. Proctor. "Our team was one of the first to evaluate the potential use of Hextend as a resuscitation fluid in the laboratory but no one had evaluated the safety and efficacy specifically in trauma patients even though there had been several other studies by other investigators in various other types of surgical patients." Dr. Proctor cautioned that their "...study design has several limitations, but that the results are encouraging and warrant a randomized controlled clinical trial." He also stated that it is "...extremely rewarding to provide solid evidence that our heroes in Iraq and Afghanistan are receiving state of the art fluid resuscitation on the battlefield."
"We are gratified that Dr. Proctor and his distinguished team conducted this fully independent clinical trauma study of our first therapeutic product, Hextend," said Michael D. West, Ph.D., Chief Executive Officer of BioTime. "The results verify our long-held belief about the clinical benefits of Hextend. Under our exclusive manufacturing and marketing licenses to Hospira, Inc., and CJ CheilJedang, Hextend has been a consistent revenue generator for our company. Our financial model anticipates revenues from sales of Hextend, stem cell research products, and research grants contributing to the funding of future stem cell-based human therapeutic products," Dr. West concluded.
Hextend is a formulation of 6% hetastarch combined with a physiologically balanced crystalloid carrier that more closely mirrors plasma electrolyte balance than 6% hetastarch in 0.9% sodium chloride. The hetastarch component creates oncotic pressure, which would normally be provided by blood proteins, and permits retention of intravascular fluid. The crystalloid carrier provides electrolytes necessary for physiologic functions and has a composition resembling that of the principal ionic constituents of normal plasma. Hextend contains a normal physiological level of calcium.
An abstract of the study, along with the program of the Southern Surgical Association 2009 Annual Meeting, is available online here. The complete study will be published in the Journal of the American College of Surgeons in mid 2010.
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