Celtaxsys, Inc., a private biopharmaceutical company developing a new class of drugs to treat chronic inflammatory disorders, today announced the initiation of a first-in-human Phase 1 clinical study of CTX-4430, which blocks the pro-inflammatory enzyme Leukotriene A4 Hydrolase (LTA4H).
“With first subjects dosed in our Phase 1 study of CTX-4430, Celtaxsys has achieved an important milestone,” said Michael Hanley, PhD, Chief Executive Officer of Celtaxsys. “CTX-4430 is a first-in-class, once-daily oral treatment with exciting potential to alleviate inflammation associated with cystic fibrosis and other pulmonary conditions.”
The Phase 1 clinical trial CTX-4430-HV-001 is a randomized, double-blind, placebo-controlled, ascending and repeat dose study aimed at evaluating the safety, tolerability and pharmacokinetics (PK) of CTX-4430 oral capsules. The trial is expected to enroll 96 subjects. Study results are expected in the first half of 2013, with the initiation of Phase 2 studies in the first line indication, Cystic Fibrosis, planned to start later in the year.
CTX-4430 is a clinical-stage drug candidate designed to treat a broad range of chronic inflammatory disorders including Cystic Fibrosis and serious pulmonary inflammatory diseases such as Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. CTX-4430 works by inhibiting Leukotriene A4 Hydrolase (LTA4H), the major rate-limiting step in Leukotriene B4 (LTB4) production. LTB4 stands out as an early chemoattractant mediator of many types of pulmonary and systemic inflammation. Orally administered, CTX-4430 has been shown to reduce LTB4 production and to improve clinical signs and symptoms of the inflammatory disease state. CTX-4430 has the potential to become a novel treatment that combines successfully with new and current therapies in pulmonary and other inflammatory disorders.
Celtaxsys is a privately-held clinical stage drug discovery and development company focused on developing new treatments for inflammatory diseases by modulating innate immunity. The company is building a sustainable pipeline of first-in-class drugs with novel mechanisms of action. For more information, please visit www.celtaxsys.com.
Forward Looking Statements
Statements included in this press release that are not a description of historical facts may be forward looking statements. The inclusion of forward looking statements should not be regarded as a representation by Celtaxsys that any of its plans will be achieved. Actual results may differ materially from those anticipated or set forth in this press release due to the risks and uncertainties inherent in Celtaxsys's business including, without limitation, statements about difficulties or delays in developing, obtaining regulatory approval, manufacturing and commercializing its products, unexpected performance or side effects of its products, the scope and validity of its products' patent protection, competition from other companies and its ability to obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this statement and Celtaxsys undertakes no obligation to revise or update this press release to reflect events or circumstances occurring after the date hereof.
MacDougall Biomedical Communications
Elizabeth Valente, 650-339-7533
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