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

To: BigDaddyMac who wrote (625)	6/14/1998 11:49:00 PM
From: Profiteer	Read Replies (1) \| Respond to of 5402

Mitchell: Thanks for you wise advice. That's what most of us were here doing until the thread was disrupted by a few. If you find more information, that is valid, please bring it to our attention. Thank you!

To: BigDaddyMac who wrote (625)	6/15/1998 1:38:00 AM
From: sdheart	Respond to of 5402

Mitch, you wrote:a bio-tech company in california who where the first to place an IND with the FDA for this type of blood just pulled it from the FDA after only three months of review because people started dying from it USE OF FLUOSOL WITH HUMANS IF ANYONE TELLS YOU IT HAS NOT BEEN TRIED ON HUMANS JUST POINT THEM HERE! Int J Radiat Oncol Biol Phys 1993 Jul 15;26(4):649-652 It takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved. seems that they have already past this phase.... Lack of complications in long-term survivors after treatment with Fluosol and oxygen as an adjuvant to radiation therapy for high-grade brain tumors. Evans RG, Kimler BF, Morantz RA, Batnitzky S Department of Radiation Oncology, University of Kansas Medical Center, Kansas City 66160-7321. PURPOSE: A Phase I/II trial was initiated in 1987 to determine the toxicity/efficacy of the perfluorochemical emulsion Fluosol-DA 20% and 100% oxygen as an adjuvant to conventional radiation therapy for high-grade brain tumors. METHODS AND MATERIALS: Three grade 3 and 15 grade 4 patients received 1 Fluosol administration (8 mL/kg) per week with daily oxygen breathing prior to and during radiation therapy. Megavoltage radiation was delivered to the whole brain at 25 x 1.8 Gy, followed by 10 x 2 Gy to a boost volume, resulting in a total tumor bed dose of 65 Gy in 7 weeks. RESULTS: Of the 18 patients, 10 (nine grade 4, one grade 3) survived more than 1 year postsurgery, six (all grade 4) lived more than 2 years, four of these patients lived more than 3 years, and three patients are alive at times ranging from 250 to 276 weeks. The median survival of the Fluosol group was 75 weeks, not statistically different from 54 weeks for a historical, matched control group. However, a Gehan-Wilcoxon test applied to those patients that survived > 1 year revealed a significant difference (p = 0.0013) in favor of the Fluosol group. Periodic clinical evaluations showed no evidence of any functional or neurological defects that could be attributed to radiation therapy and/or Fluosol. Radiographic studies (computed tomography and magnetic resonance imaging) revealed no structural alterations outside the original tumor volume, and changes within the tumor region were easily assignable to expected effects of tumor, surgery, or radiation alone. CONCLUSION: These results indicate that, although Fluosol/oxygen added to conventional radiation therapy does not enhance survival of patients who succumb to their disease early, it does confer a significant benefit to patients that survive past 1 year. The minimal acute side effects and no long-term deleterious effects suggest that Fluosol/oxygen sensitizes only hypoxic cells, with no effect on well-oxygenated normal tissues within the brain. We have been impressed by the quality of life of the surviving patients following radiation therapy with adjuvant Fluosol+oxygen. OVERVIEW OF PERFLUOROCARBONS IN MEDICINE Transfus Med Rev 1993 Apr;7(2):84-95 Perfluorocarbon-based red blood cell substitutes. Biro GP Department of Physiology, Faculty of Medicine, University of Ottawa, Ontario, Canada. Since our review 5 years ago, a new generation of PFC emulsion has been developed and is undergoing extensive testing. This new generation is the result of the application of physicochemical principles, applied to both the choice of the PFC itself and the emulsifier, as well as advances in emulsion-producing technology. The efficacy of PFCs in general for oxygen transporting capability has been fully recognized, as exemplified by the limited license issued to Fluosol. The latter also represents the recognition of the relative absence of major toxicity of PFCs in general. The development of new products owes much to the lessons learned during the past 20 years and to advances made in the physical chemistry of PFCs. These advances now permit the rational selection or design of the most appropriate PFC and the design of emulsifiers best suited for the purpose. Perflubron represents a clear advance over the Fluosol-DA-type formulation. It is only one but the most advanced of the second-generation products. At least three other commercial entities (Hema-Gen/PFC, Green Cross, Adamantech) are also developing products based on the above principles. Five years ago we concluded that, in spite of the enormous complexity of PFC emulsions as large volume parenterals, they have shown remarkable biocompatibility. The advances in the past 5 years have confirmed this conclusion. The advances occurring during the past 5 years show that the application of the proper technology can lead to product improvement, and that PFC preparations with significant transfusional and nontransfusional potential are, in fact, feasible. It remains to be seen whether high PFC-content emulsion can be successfully deployed in initial, prehospital resuscitation situations. The high PFC content will reduce the absolute requirement for the maintenance of FIO2 > 0.8 in the case of Fluosol-DA for optimal efficacy. The second-generation products also seem to lend themselves to intraoperative use, because they can be removed from the blood postoperatively by plasmapheresislike methods. They are also suitable in combination with autologous blood donation/transfusion. All of these potential applications are in various stages of exploration and, if found to be efficacious, will likely conserve the supply of whole blood and blood components. The nontransfusional applications, particularly those in diagnostic imaging, seem to show substantial promise. Because they involve smaller doses than transfusional applications, they may enter clinical use earlier. The applications in radiation and chemotherapy of malignant diseases represent an intermediate position between the transfusional and nontransfusional uses. for more info see Info thread sdheart