another excerpt from the prospectus, followed by an abstract.....
SCIENTIFIC ADVISORY BOARD
The Company has established a Scientific Advisory Board, whose members
review the Company's research, development and clinical activities and are
available for consultation with the Company's management and scientific staff
relating to their respective areas of expertise. Dr. Whalen, Senior Vice
President and Chief Scientific Officer of the Company, is Chairman of the
Company's Scientific Advisory Board. The other members of the Company's
Scientific Advisory Board and their primary academic or professional
affiliations are listed below:
GORDON R. BERNARD, M.D. chairs the Steering Committee for National
Institutes of Health ("NIH") ARDS Clinical Trials, and is currently a Professor
of Medicine at the Vanderbilt University School of Medicine. In addition, Dr.
Bernard has served as principal investigator for clinical trials of
glutathione-repleting agents in ARDS.
MITCHELL P. FINK, M.D. is Surgeon-in-Chief of Beth Israel Deaconess
Hospital and Professor of Surgery at Harvard Medical School. Dr. Fink serves on
the Editorial Board of several key journals, such
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as Critical Care Medicine, Journal of Trauma, and Shock. Dr. Fink's major
research interests include the role of neutrophils in septic and traumatic shock
and development of novel therapeutic agents for septic shock.
NORMAN K. HOLLENBERG, M.D., PH.D. is a Professor of Medicine at Harvard
Medical School and the Brigham and Women's Hospital. Dr. Hollenberg's research
interests include renal perfusion and function, and the genetic underpinnings of
hypertension and renal injury.
JOHN E. REPINE, M.D. is the Director of the Webb-Waring Institute for
Biomedical Research, and Professor of Medicine and Associate Dean for Student
Affairs at the University of Colorado Health Sciences Center. Dr. Repine has a
distinguished research record on oxidative stress and disease pathology.
ROBERT T. SCHOOLEY, M.D. is Professor of Medicine and Head of the
Infectious Disease Division at the University of Colorado Health Services
Center. His research includes work on AIDS, immunology, and infectious diseases.
Dr. Schooley served as Chair of numerous groups at the NIH, including the Core
Immunology Committee of the AIDS Clinical Trials Group.
STEVEN R. TANNENBAUM, PH.D. is a Professor of Chemistry and Toxicology at
the Massachusetts Institute of Technology. Dr. Tannenbaum's research efforts
include the chemistry of free radicals in biological systems, and leading work
on N-nitroso compounds and other environmental carcinogens and mutagens.
(snip)
Chest 1997 Jul;112(1):164-172
A trial of antioxidants N-acetylcysteine and procysteine in ARDS. The
Antioxidant in ARDS Study Group.
Bernard GR, Wheeler AP, Arons MM, Morris PE, Paz HL, Russell JA, Wright PE
Center for Lung Research, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center,
Nashville, Tenn, USA.
OBJECTIVE: To determine the levels of glutathione and cysteine in patients with ARDS and examine the effect of treatment
with N-acetylcysteine (NAC) and L-2-oxothiazolidine-4-carboxylate (Procysteine; Clintec Technologies Inc; Chicago [OTZ])
on these levels and on common physiologic abnormalities, and organ dysfunction associated with ARDS. DESIGN:
Randomized, double-blind, placebo-controlled, prospective clinical trial. SETTING: ICUs in five clinical centers in the United
States and Canada. PATIENTS: Patients meeting a predetermined definition of ARDS and requiring mechanical ventilation.
INTERVENTION: Standard care for ARDS and I.V. infusion, every 8 h for 10 days, of one of the following: NAC (70
mg/kg, n=14), OTZ (63 mg/kg, n=17), or placebo (n=15). MAIN RESULTS: Both antioxidants effectively repleted RBC
glutathione gradually over the 10-day treatment period (47% and 49% increases from baseline values for NAC and OTZ,
respectively). There was no difference in mortality among groups (placebo, 40%; NAC, 36%; OTZ, 35%). However, the
number of days of acute lung injury was decreased and there was also a significant increase in cardiac index in both treatment
groups (NAC/OTZ [+]14%; placebo [-]6%). CONCLUSIONS: Our findings suggest that repletion of glutathione may safely
be accomplished with NAC or OTZ in patients with acute lung injury/ARDS. Such treatment may shorten the duration of acute
lung injury, but larger studies are needed to confirm this. |
