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Cytel announces Phase II results with Cylexin in lung injury trial.


SAN DIEGO--(BUSINESS WIRE)--April 30, 1996--Cytel Corporation (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:CYTL) announced today that results of a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 with its selectin blocker, Cylexin(TM), demonstrated evidence of a clinical benefit suggesting reduction of reperfusion injury reperfusion injury

damage to renal blood vessels during periods of hypotension does not become apparent until reperfusion occurs in the recovery stage of the vascular incident.
 following pulmonary thromboendarterectomy (PTE PTE

The ISO 4217 currency code for the Portugese Escudo.
), the surgical removal of chronic blood clots Blood Clots Definition

A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut.
 from the lungs. The trial was conducted under the direction of Dr. Kenneth M. Moser, Professor of Medicine, Director of Pulmonary and Critical Care Medicine at the University of California, San Diego UCSD is consistently ranked among the top ten public universities for undergraduate education in the United States by U.S. News & World Report.[3] It is a Public Ivy. [1] For graduate studies, most of UCSD's Ph.D.  (UCSD UCSD University of California, San Diego (La Jolla, California)
UCSD User Centered System Design
UCSD Urbana-Champaign Sanitary District (Illinois)
UCSD Ultra Cool Sexy Dudes
), one of the leading centers worldwide for this procedure.

The three most important measurements of efficacy were the overall clinical impression of lung injury and two objective measures of potential lung injury. The overall clinical impression achieved statistical significance (p=0.036) and demonstrated the risk of injury to be twice as great in the placebo group than in the Cylexin group. Statistical significance was not achieved for the objective measures of lung injury; however, one of the objective measures of lung injury, the lung injury score was in the direction of less injury in the Cylexin group (p=0.128) based largely on the measure of successful oxygen exchange. "Reliance exclusively upon such apparently objective measures as the lung injury score can be misleading," stated Dr. Moser, "because other confounding clinical conditions can alter that score. We believe the clinical impression of the physician experienced in the care of these patients is the most accurate measure of which patients developed acute lung injury."

This lung injury study was conducted to give Cytel the opportunity to evaluate the activity of Cylexin in a well-defined surgical population with a high occurrence of acute reperfusion re·per·fu·sion
n.
The restoration of blood flow to an organ or tissue that has had its blood supply cut off, as after a heart attack.
 lung injury. In this blinded trial, 51 patients were randomly assigned to receive either Cylexin or placebo intravenously prior to initiation of surgery and then a continuous infusion of drug for the subsequent 10 hours. "The positive trends in this study were important to us because reperfusion injury in these patients is the leading cause of post-operative morbidity and mortality Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
," said Dr. Moser. "This study is the first indication that selectin blockage may modulate this form of acute lung injury."

Patients that are treated with PTE number fewer than 500 per year, thus this indication would represent an orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the  indication for Cylexin. Cytel's initial target market for Cylexin is the reperfusion injury that occurs upon restoration of blood flow following treatment for heart attack. Cytel is conducting a Phase II trial with Cylexin in reperfusion injury resulting after angioplasty treatment for myocardial infarction myocardial infarction: see under infarction. , which will be completed later this year. The company is also planning to evaluate Cylexin's ability to prevent reperfusion injury following thrombolytic therapy Thrombolytic Therapy Definition

Thrombolytic therapy is the use of drugs that dissolve blood clots.
Purpose

When a blood clot forms in a blood vessel, it may cut off or severely reduce blood flow to parts of the body that are served by
 for acute myocardial infarction acute myocardial infarction (·kyōōtˑ mī·ō·karˑ·dē· .

Cytel is jointly developing Cylexin with Schwarz Pharma AG (Schwarz) of Monheim, Germany. Schwarz has sole responsibility for marketing products in Europe; Schwarz and Cytel share marketing responsibility in North America. Marketing rights for the Far East were granted to Sumitomo Pharmaceuticals Co. Ltd. Cytel retains all worldwide manufacturing rights and has entered into a supply agreement with Schwarz for the joint territories.

Cylexin, a selectin blocker, is a complex carbohydrate and is believed to be the first of its class to enter clinical trials. Cytel has developed a chemical and enzymatic synthesis technology that allows cost effective manufacture of Cylexin. This proprietary technology is also applicable to the synthesis of other complex carbohydrates for use in therapeutic or non-therapeutic settings and was the basis for a collaboration with Abbott Laboratories announced earlier this year, whereby Abbott obtained an option to a worldwide license for use of Cytel's technology in the manufacture of carbohydrates for addition to nutritional products.

Cytel Corporation, founded in 1987, is a leader in the discovery, design and development of immunotherapeutics, a new class of drugs which the Company believes will be more selective and have fewer side effects than drugs currently on the market. Utilizing Cytel's advanced understanding of the immune system's operation both in disease and in health, the Company is developing drug candidates under two distinct approaches: the immune suppression program targets inflammatory diseases and reperfusion injury through the use of cell adhesion blockers that prevent the excessive migration of white blood cells White blood cells
A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system.

Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies
 into surrounding tissue, and the immune stimulation program is directed to the development of therapeutic vaccines to treat infectious diseases and cancers by stimulating production of antigen- specific cytotoxic T-lymphocytes by the immune system.

Actual results may differ materially from the above forward- looking statements due to a number of important factors, including but not limited to the timing and cost of conducting human clinical trials and the possibility that further testing of Cylexin may not support the results of the data described above or may reveal undesirable and unintended side effects or other characteristics that may prevent or limit its commercial use. These factors are more fully discussed in the Company's most recent Form 10-K and Form 10-Qs.

CONTACT: Cytel Corporation, San Diego

Karin Eastham, Vice President and Chief Financial

Officer, 619/552-3000
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Apr 30, 1996
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