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Biotech / Medical : Alexion Pharmaceuticals, Inc. (ALXN) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (286)	7/22/2003 1:19:50 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 824

AAT is deep space R&D, I think. They stopped talking about tpo agonist recently, and today soft sell these development efforts. "T-cell Mabs" is category shown as farthest along; the only ATT product projected for clinic. As for engineering, this may be a peak at what they can do--but I can't say for sure if this is product of Prolifaron core. Sounds cool to me. An engineered bifunctional recombinant molecule that regulates humoral and cellular effector functions of the immune system. Pizzolato MC, Fodor WL. Alexion Pharmaceuticals, Inc., Cheshire, CT, USA. BACKGROUND: Humoral and cellular defense mechanisms mediate the rejection of transplanted cells, tissues, and organs after allogeneic or xenogeneic transplantation. Inhibition of complement and T-cell costimulation are strategies aimed at increasing transplant survival. METHODS: Engineered novel fusion proteins that contain the functional domains of human CD152 (hCTLA4) or porcine CD152 (pCD152) and human CD59 (hCD152-hCD59, pCD152-hCD59) were developed to form bifunctional chimeric proteins that retain the effector functions of both moieties. Porcine aortic endothelial cells and murine Balb/3T3 cells were transduced or transfected to express the novel fusion proteins. RESULTS: Fluorescence-activated cell sorter analysis of hCD152-hCD59 transduced primary porcine aortic endothelial cells or hCD152-hCD59 and pCD152-hCD59 transfected Balb/3T3 cells determined that the molecules were expressed on the cell surface, and that they retained conformational epitopes. We demonstrate that hCD152-hCD59 and pCD152-hCD59 chimeric proteins inhibit complement-mediated cell lysis. In addition, hCD152-hCD59 or pCD152-hCD59 expression resulted in a significant reduction in T-cell activation as the result of CD152 engagement of porcine CD86 or murine CD80 in when Jurkat cells were cocultured with the hCD152-hCD59 or pCD152-hCD59 expressing cells. Antibody-blocking experiments or phosphatidylinositol phospholipase C removal of the glycosyl-phosphatidylinositol-linked molecules resulted in increased serum-mediated cytolysis and eliminated the costimulatory blockade. CONCLUSIONS: These data illustrate that a single molecule can confer resistance to humoral and cellular immune attack.

To: Icebrg who wrote (286)	8/4/2003 4:22:01 PM
From: Icebrg	Read Replies (1) \| Respond to of 824

Alexion Pharmaceuticals Reports Preliminary Results Of Its Phase III PRIMO-CABG Trial Monday August 4, 4:15 pm ET Conference Call Scheduled for Tuesday, August 5 at 9:00 a.m. Eastern Time CHESHIRE, Conn., Aug. 4 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN - News) announced today preliminary results of its Phase III study in a large, multinational trial consisting of greater than 3,000 patients undergoing coronary artery bypass graft ("CABG") surgery with cardiopulmonary bypass, a study referred to as "Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery," or PRIMO-CABG. The primary endpoint in this trial was a composite of the incidence of death or myocardial infarction, measured at 30 days post-procedure, in patients undergoing CABG without concomitant valve surgery. Although there was reduction in the primary endpoint, it was not achieved with statistical significance. However, key pre-specified secondary endpoints consisting of the same composite in the total study population, which included all patients undergoing CABG with or without concomitant valve surgery, were achieved. Several other pre-specified secondary endpoints were met as well. The company announced that further details of PRIMO-CABG will be provided after all data analyses are complete, and will be presented by Dr. Verrier in the Late-Breaking Clinical Trials Session of the 2003 Scientific Sessions Meeting of the American Heart Association in Orlando, Florida, during the second week of November. Dr. Edward D. Verrier is William K. Edmark Professor and Chief of Cardiovascular Surgery at the University of Washington, and Chairman of the PRIMO-CABG Steering Committee. "These preliminary observations are encouraging in that they support the role of pexelizumab in potentially further improving patient outcomes in bypass surgery," noted Dr. Verrier. "I look forward to presenting the exciting PRIMO-CABG clinical results at the AHA scientific sessions this November." "Although our objective to achieve statistical significance in the primary endpoint was not met, this study has provided us with encouraging clinical information, which extends important positive results seen in our Phase II trial," said Dr. Leonard Bell, Chief Executive Officer of Alexion. "The achievement of the composite of death or myocardial infarction in the total population reinforces our enthusiasm for progressing pexelizumab development and we feel that the fully completed analysis will lead to findings that have the promise of significant clinical, scientific, and commercial merit. We look forward, in collaboration with Procter & Gamble Pharmaceuticals, to completing the final data analysis and discussing with the FDA the next steps in going forward."