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CELL THERAPEUTICS, INC. FILES FOURTH IND FOR TREATMENT OF SEPTIC SHOCK

 SEATTLE, Oct. 29 /PRNewswire/ -- Cell Therapeutics, Inc. announced today it has filed its fourth IND for its lead compound, ProTec(TM) (CT-1501R), for the prevention and treatment of septic shock.
 In preclinical testing CT-1501R was significant in reducing the signaling and production of potent mediators of inflammation such as TNF, IL-1, and IL-6 following an otherwise lethal dose of bacterial endotoxin. When administered as a single injection simultaneously with a dose of endotoxin that causes 100 percent lethality, 90 percent of the animals survived compared to 0 percent of controls (p equals 0.01, Fisher's Exact T Test). Even if administered 2, 4, or 6 hours after a lethal dose of endotoxin -- well after the inflammatory cascade was initiated -- significant protection was observed (60 percent, 50 percent, 30 percent survival respectively vs. 0 percent for controls.)
 CT-1501R is the first in a class of small molecule LPAAT (lysophosphatidate acyltransferase) inhibitors developed by the Company to enter clinical trials. LPAAT is a key enzyme identified by Company scientists that controls the production of a unique species of Phosphatidic acid, a lipid signaling intermediate coupled to a variety of pro-inflammatory cytokines. Company scientists have demonstrated that TNF and IL-1 (via their type-1 receptors), PAF (platelet activating factor) and PDGF (platelet derived growth factor), signal through this phospholipid pathway. Even the direct activation of inflammatory cells by bacterial endotoxin activates this pathway, dubbed the Bursten Pathway, after one of the scientific founders of the Company.
 In vitro studies demonstrate CT-1501R also prevents the activation of inflammatory cytokines in response to gram positive cell wall and fungus, while animal studies demonstrate no deleterious effects on normal immune responses to treated gram positive, gram negative, or fungal infections.
 According to Dr. Bianco, CTI President and Chief Executive Officer, "Rather than targeting a single cytokine in a complicated syndrome characterized by elevation of multiple inflammatory mediators, our therapeutic approach appears to target a central pathway which controls abnormal cell activation. Therefore, in addition to reducing inflammatory cytokine production, CT-1501R has the potential to stop the inflammatory activation once TNF or IL-1's signal has been transduced. No biologic therapy, when administered with a similarly lethal dose of endotoxin, has shown potential to improve survival as late as 6 hours after the insult. In addition, because it is a small synthetic organic pharmaceutical, CT-1501R can be administered either orally or intravenously and has an estimated cost of goods significantly below that of biologic based therapies."
 CTI is also developing CT-1501R as adjunctive therapy to prevent toxicity in cancer patients. Earlier this year CTI initiated four Phase I trials in cancer patients at ten centers in the U.S. With more than 30 patients enrolled, both safety and early efficacy data are being accrued.
 -0- 10/29/93
 /CONTACT: James A. Bianco, M.D. of Cell Therapeutics, Inc., 206-284-5774, or Fred Spar of Kekst and Company, 212-593-2655/ CO: Cell Therapeutics, Inc. ST: Washington IN: MTC SU: PDT


TS -- NY023 -- 8403 10/29/93 10:05 EDT
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Publication:PR Newswire
Date:Oct 29, 1993
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