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Biotech / Medical : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?

To: webster who wrote (844)	4/22/1998 9:00:00 AM
From: Jim Roof	Respond to of 1432

Fill me in on what is being said about CMSI? I have heard rumors too but is anything official? On possible dilution, I do not like that but it is often a fact of life. I owned QLGC for a while and when they offered the new shares the stock jumped ahead for big gains and the level of the new shares served as solid support. It is not always a bad picture if the demand is there. And of course, lest we forget, the secondary offering (if and when it happens) is for the benefit of the company. Jim

To: webster who wrote (844)	4/28/1998 11:40:00 PM
From: Mark A. Voelker	Read Replies (2) \| Respond to of 1432

I obtained a copy of the scientific paper Steve How and Jim Roof have been discussing. This paper is the third citation in the Hextend Phase 3 results poster paper presented at the San Juan meeting last Jan. 20. The complete citation for this paper is: "Evaluation of a New Hydroxyethyl Starch Preparation (Hextend) on Selected Coagulation Parameters" by Rodger L. Bick, MD, FACS Clin Appl Thrombosis/Hemostasis v.1 n.3 p.215-229 (1995) Published by Raven Press, Ltd, New York Dr. Bick studied the coagulation properties of Hextend when compared to normal saline solution. The coagulation properties of eight different mixtures each of Hextend+plasma and saline+plasma were compared using a battery of standard clinical laboratory tests. Here is the last paragraph of Dr. Bick's paper: "As summarized above, there are many reports of alterations in various components of the factor VIII macromolecular complex, including three case reports of acquired von Willebrand's disease. Those so reporting feel these changes impair hemostasis at a clinically significant level. However, our study is unable to confirm any of these findings, with our results demonstrating perfectly normal levels of all components of factor VIII. Others report changes in the thrombin time or reptilase time, suggestive of a potential 'disfibrinogenemia' induced by hydroxyethyl starch (HES). Our results, however, demonstrate normal functional fibrinogen at all levels and dilutions and, therefore, no evidence of Hextend-induced disfibrogenemia. Some reports have only assessed global or nonspecific changes in hemostasis primarily consisting of changes in the PTT, PT, and/or platelet count, which most authors attribute to effects of HES beyond that anticipated by hemodilution. Again, our results reveal no adverse effects of Hextend on global tests of coagulation. Many studies report no significant changes in hemostasis when using HES in a variety of clinical situations, including bypass surgery, orthopedic surgery, shock, and other clinical settings. Our results are in complete agreement with these studies, as we find no alterations of hemostasis, except those expected by dilution. In particular, our studies reveal no adverse effect of this new HES preparation, Hextend, on aPTT, PT, functional fibrinogen, factor VIII:C, factor VIII:vW, factor VIII:RAG, or von Willebrand's multimers." These are unequivocal statements in a paper published in a peer-reviewed scientific journal; i.e. they are hard scientific facts. These facts mean that Hextend does not cause coagulation problems (coagulopathy) beyond those expected by simple dilution. The reports of coagulation problems in patients given generic HES-in-saline must then be due, not to HES, but to the saline solution component of these solutions. But that is precisely where the formulation of Hextend differs from generic HES-in-saline: Hextend's aqueous component is not simple saline solution, but a more complex solution of salts, sugars, buffers etc. that more closely mimics the chemistry of natural human plasma than does saline solution. It's this aqueous mixture of electrolytes which BioTime has patented for use in all its solutions. That is why Abbott chose to exercise (at significant cost to Abbott) is option to retain the rights to manufacture and market PentaLyte. PentaLyte is Hextend with the hetastarch replaced by pentastarch. The results reported by Dr. Bick are entirely consistent with the results of the Hextend Phase 3 clinical trials. In these trials, Hextend was compared with generic HES-in-saline in actual human patients. Results of the clinical trials: "There were fewer study-drug related bleeding complications in Hextend treated patients." (page 12 of the clinical trial poster paper) From Table 5 of that paper: No. of patients with adverse events related to study drug: 8 for HES-in-saline, 3 for Hextend No. of patients with coagulation related adverse events related to study drug: 8 for HES-in-saline, 2 for Hextend To state things bluntly: If you're going to be needing a plasma volume expander due to loss of blood, you're less likely to suffer complications due to bleeding if you get Hextend than if you get the existing FDA approved solutions. This means Hextend is a superior product when compared to what's available now. This means that Hextend will replace the existing solutions as soon as it becomes available. Furthermore, during the clinical trials, Hextend was administered to 25 of the 60 Hextend patients in quantities greater than the present recommended maximum dose of 20ml/kg for HES solutions. Still, the better results were obtained. This means that Hextend will be used more widely and in greater amounts than the presently approved solutions. --Mark A. Voelker, PhD