To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ISHLT MEETING: Drug Reduces Ventilation Times After Lung Transplants URL: http://www.pslgroup.com/dg/6CD46.htm Doctor's Guide April 16, 1998
NEEDHAM, MA -- April 16, 1998 -- Positive Phase I/II results of T Cell Sciences, Inc.'s lead drug candidate, TP10, in patients undergoing lung transplantation were presented today at the 18th annual meeting of the International Society for Heart and Lung Transplantation in Chicago, IL. Results in these patients showed that TP10 therapy appears safe and well tolerated and demonstrated significant efficacy. Each of the 59 patients participating in the randomised, placebo-controlled, double-blinded study received a single dose of 10 mg/kg of TP10 or placebo as an intravenous infusion over 30 minutes prior to lung transplant surgery. Patients were examined for efficacy over 28 days and for safety over six months after surgery. By the end of the first post-operative day, 41 percent of evaluable TP10-treated patients no longer required ventilation compared to 19 percent of control patients. Additionally, in transplant patients also on cardiopulmonary by-pass, those who received TP10 showed significantly decreased ventilation and intubation times which were both reduced by an average of 17 days. This result excludes six patients, three on TP10 and three on placebo, who died while on ventilation. There was also a trend toward shorter stays in the ICU, which were decreased by more than six days compared with controls. "We are excited by the benefit that TP10 appears to provide patients who underwent lung transplantation surgery," noted Dr. Shaf Keshavjee, director of Toronto Lung Transplantation Program at the Toronto Hospital and lead clinical investigator. "It may be particularly beneficial to patients undergoing lung transplantation with cardiopulmonary by-pass." The longer the amount of time a patient spends after surgery intubated with an endotracheal breathing tube in place and on mechanical breathing support, the poorer are the typical long-term health outcomes. Poor lung function after transplantation as measured by the need for intubation and mechanical ventilation is a major cause of morbidity, mortality and increased cost. An overnight stay in the ICU can cost in excess of $10,000 a day. Safety was monitored for six months following surgery with a review of adverse events including survival and episodes of infection and rejection. TP10 had no significant effect on the rates of infection and there were no adverse events directly attributed to TP10. Additionally, TP10 had no effect on rejection or patient survival. TP10, the product name for soluble Complement Receptor 1 (sCR1), is the first product candidate among a new class of therapeutics T Cell Sciences is developing based on inhibiting complement activation. Complement is a family of immune system proteins that circulate in the blood and play a part in the body's natural defences. Excessive complement activation, however, is involved in a wide range of diseases, including ischemia (heart attack, stroke), organ transplant rejection, and chronic inflammatory diseases (arthritis, multiple sclerosis). Each year in the United States approximately 363,000 persons undergo coronary bypass surgery, 78,000 have open heart surgery and another 434,000 have angioplasty performed. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.