Critical Therapeutics Achieves Collaboration Milestone in HMGB1 Program; Demonstrates Efficacy of HMGB1 Antibodies in Preclinical Models of Inflammation.LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced the achievement of a preclinical, proof-of-concept milestone in its High Mobility Group Box 1 (HMGB1) program with MedImmune, Inc. The milestone resulted in a $1.25 million cash payment to Critical Therapeutics, some of which will be recognized as revenue in the fourth quarter of 2005. Along with the milestone payment, MedImmune will fund additional full-time employees at Critical Therapeutics through the end of 2006, representing an incremental commitment to the previous terms of the collaboration agreement. "Our collaboration with MedImmune has resulted in the development of fully human monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). (MAbs) that provide significant protection in preclinical models of rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and sepsis Sepsis Definition Sepsis refers to a bacterial infection in the bloodstream or body tissues. This is a very broad term covering the presence of many types of microscopic disease-causing organisms. ," said Walter Newman Walter Newman may refer to
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. to support the submission of an Investigational New Drug application." About Anti-HMGB1 MAb HMGB1, a pro-inflammatory protein secreted by different cell types, is part of the body's response to trauma and infection. HMGB1 is expressed at high levels beginning 12 to 72 hours after an injury, which is about the time inflammation-associated tissue damage begins. Because of the timing and duration of expression of HMGB1, it may be an important factor in the sequence of events that result in severe tissue damage following injury or during chronic inflammation chronic inflammation n. Inflammation that may have a rapid or slow onset but is characterized primarily by its persistence and lack of clear resolution; it occurs when the tissues are unable to overcome the effects of the injuring agent. . Preclinical data suggest that a blocking antibody blocking antibody n. 1. An antibody that combines with an antigen without a reaction but that blocks another antibody from later combining with that antigen. 2. to HMGB1 may provide protection in chronic diseases, such as rheumatoid arthritis, and in acute life-threatening conditions, such as sepsis. Inflammation is a key contributor to a number of chronic and acute diseases, including rheumatoid arthritis and sepsis, which have been the focus of the collaboration to date. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the Arthritis Foundation This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. , rheumatoid arthritis affects one percent of the U.S. population, or 2.1 million Americans, and the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. estimate that three quarter of a million people develop severe sepsis severe sepsis A condition defined clinically as 'Sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities (which include) …lactic acidosis, oliguria, or an acute alteration in mental status each year in the U.S. and that more than 200,000 of those people do not survive. About Critical Therapeutics Critical Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to ZYFLO(R) (zileuton zileuton /zi·leu·ton/ (zi-loo´ton) an inhibitor of leukotriene formation, used as an antiasthmatic. Zileuton (Zyflo) tablets), as well as other formulations of zileuton. ZYFLO is the only 5-lipoxygenase inhibitor approved for marketing by the U.S. Food and Drug Administration. The Company's commercialization efforts for ZYFLO are carried out by its 80-person specialty sales force. Critical Therapeutics also is developing treatments directed toward the severe inflammatory response in acute diseases and conditions that lead to admission to the emergency room or intensive care unit, and acute exacerbations of other chronic diseases that frequently lead to hospitalization. For more information, please visit www.crtx.com. Critical Therapeutics Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding the progress and timing of the HMGB1 program, whether the results of preclinical studies will be indicative of results obtained in later clinical trials and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Without limiting the foregoing, the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "will," "would" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the results of preclinical studies and clinical trials with respect to our products under development and whether such results will be indicative of results obtained in later clinical trials; conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the timing and success of submission, acceptance and approval of our regulatory filings; our heavy dependence on the commercial success of ZYFLO and the approval of the controlled-release formulation of zileuton currently in development; our ability to obtain the substantial additional funding required to conduct our research, development and commercialization activities; our dependence on our strategic collaboration with MedImmune, Inc.; and our ability to obtain, maintain and enforce patent and other intellectual property protection for ZYFLO, our drug candidates and our discoveries. These and other risks are described in greater detail in the "Factors That May Affect Future Results" section of our most recent Quarterly Report on Form 10-Q Form 10-Q See 10-Q. and other filings that we make with the Securities and Exchange Commission. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements. In addition, the statements in this release reflect our expectations and beliefs as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release. ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc. |
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