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Biotech / Medical : SANGUINE CORP. (SGNC) -- Ignore unavailable to you. Want to Upgrade?

To: drdan who wrote (2073)	6/29/1998 3:31:00 PM
From: Hyrulean King	Read Replies (1) \| Respond to of 5402

Just read posts from smtg thread - the product discussed is called "Optro" is this the same product as HemAssist?? Bottom line is Optro or HemAssist is an Hb product created by cloned DNA in ecoli. IMO pher-02's advantages are in cost, sterilization, shelf-life and testing - since it is an improved product from 1st generation FDA approved product. chief

To: drdan who wrote (2073)	6/29/1998 3:36:00 PM
From: Hyrulean King	Read Replies (1) \| Respond to of 5402

MUST READ RE: HEMASSIST To: Rinks (438 ) From: RCMac Tuesday, Mar 31 1998 9:22AM ET Reply # of 441 Bad news from BAX HemAssist clinical trials in trauma. This may increase the number of shares SMTG shareholders will receive: >>Tuesday March 31, 7:22 am Eastern Time Company Press Release SOURCE: Baxter Healthcare Corporation Baxter Ends U.S. Trauma Study of HemAssist(TM)(DCLHb) European Trauma and U.S. Surgery Trials Continue on Track DEERFIELD, Ill., March 31 /PRNewswire/ -- Baxter Healthcare Corporation announced today that it has ended its U.S. Phase III trauma trial investigating the efficacy of its oxygen-carrying solution, HemAssist(R)(DCLHb), for the treatment of severe traumatic hemorraghic shock. Baxter decided to stop the trial, which had enrolled approximately 100 of its expected 850 participants, following an interim data review by the trial's independent data monitoring committee. The committee found that patients in the treatment group had an increased mortality compared to those in the control group. Baxter and its clinical investigators are studying the data to better understand why there was a difference in mortality between the patient groups. They are assessing the impact of many factors, including the combined results of the trial's design and protocol, the timing of the administration of HemAssist(R)(DCLHb) and other medical treatments, the wide range of patient injuries and the severity of patient injuries in the two patient groups. ''We are evaluating options for trauma applications in the United States,'' said Thomas Schmitz, Ph.D., general manager of Baxter's Hemoglobin Therapeutics division. ''We are confident that HemAssist(R)(DCLHb) will be of critical importance for both surgeons and emergency-medicine physicians. ''The European trauma trial, where physicians are administering HemAssist(R)(DCLHb) at the trauma site, is continuing on track. Our U.S. Phase III surgery trial moves forward as well.'' Baxter continues to expect to bring HemAssist(R)(DCLHb) to market in late 1999 or early 2000. Significant Differences in Emergency Care The ongoing European trauma trial is investigating the product's efficacy in the pre-hospital setting, where doctors administer the product as a first- line therapy at the trauma site. In contrast, U.S. doctors infused HemAssist(R)(DCLHb) in the hospital after patients had been in shock for much longer periods of time. The company noted that in light of the U.S. trauma results the European trauma study has been evaluated by its independent data monitoring committee and that committee has determined that the trial will continue on course. The patients enrolled in the U.S. trauma trial were gravely ill -- victims of severe trauma, such as motor vehicle accidents, knife and gun shot wounds -- and had a high expected mortality. Patients involved in the HemAssist(R)(DCLHb) trial were among the most severely injured of all trauma victims, with only about 3 percent of all trauma patients eligible for trial inclusion. All individuals enrolled in the study received standard emergency care, including transfusions of blood, resuscitative fluids, and surgical intervention as required. This U.S. trauma study was conducted under regulations issued by the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) governing clinical-research practices in emergency medicine. These regulations are designed to protect patients' rights and well-being, while also allowing for an exception to informed consent in narrowly defined life-threatening situations. Several rigorous safety checks and patient protections are required of studies conducted under this ruling, including interim data analysis by an independent data monitoring committee. All institutions involved in the trial worked with their communities to inform them about the potential risks and benefits of the HemAssist(R)(DCLHb) trial. The results of the U.S. trauma study will be made public when the data are fully analyzed. Baxter's Phase III U.S. surgery trial is investigating the use of HemAssist(R)(DCLHb) as an alternative to blood in patients undergoing elective surgery, such as hip and knee replacements, aortic repair and abdominal pelvic procedures. Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX - news). Baxter International, through its subsidiaries, is a global leader in the development of products and technologies related to the blood and circulatory system. The company has market-leading positions in four areas: blood therapies, cardiovascular medicine, kidney-disease therapy and medication delivery. Through a combination of technological innovation and global expansion, Baxter is advancing medical care and improving the lives of millions of people worldwide. This news release contains forward-looking statements that involve risks and uncertainties, including technological advances in the medical field, product approval, demand and market acceptance. <<