Critical Therapeutics Licenses Exclusive Patent Rights to Novel Family of Compounds from University of Florida.LEXINGTON, Mass. -- Technology Provides Intellectual Property Pathway for Development of an Oral Therapy to Inhibit Cytokine Cytokine Any of a group of soluble proteins that are released by a cell to send messages which are delivered to the same cell (autocrine), an adjacent cell (paracrine), or a distant cell (endocrine). Production Critical Therapeutics, Inc. (Nasdaq: CRTX), a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases, today announced that it has licensed rights to a key patent from the University of Florida University of Florida is the third-largest university in the United States, with 50,912 students (as of Fall 2006) and has the eighth-largest budget (nearly $1.9 billion per year). UF is home to 16 colleges and more than 150 research centers and institutes. . The Company's license to U.S. Patent No. 5,977,144 provides exclusive composition of matter and method of use rights to a family of compounds known as cinnamylidene-anabaseines. These compounds target and stimulate the nicotinic nicotinic /nic·o·tin·ic/ (nik?o-tin´ik) denoting the effect of nicotine and other drugs in initially stimulating and subsequently, in high doses, inhibiting neural impulses at autonomic ganglia and the neuromuscular junction. alpha-7 cholinergic receptor cholinergic receptor n. Any of the sites in effector cells or at synapses through which acetylcholine exerts its action. Also called cholinoreceptor. . Pre-clinical studies have demonstrated that the alpha-7 receptor on the macrophage macrophage /mac·ro·phage/ (mak´ro-faj) any of the large, mononuclear, highly phagocytic cells derived from monocytes that occur in the walls of blood vessels (adventitial cells) and in loose connective tissue (histiocytes, phagocytic cell plays an important role in regulating the inflammatory response by inhibiting the release of cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. such as TNFalpha. The overexpression of cytokines is thought to play a major role in acute inflammatory diseases such as acute organ failure due to cardiopulmonary bypass cardiopulmonary bypass n. A procedure to circulate and oxygenate the blood during heart surgery involving the diversion of blood from the heart and lungs through a heart-lung machine and the return of oxygenated blood to the aorta. and sepsis, as well as in chronic inflammatory diseases such as 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 Crohn's disease Crohn's disease: see colitis. . Current available therapies that moderate cytokine activity include ENBREL(R) (etanercept) and HUMIRA(R) (adalimumab), which have combined worldwide annual sales in excess of $1.5 billion despite requiring an injection as the method of administration. Product candidates targeting the alpha-7 receptor on the macrophage could lead to novel therapies that are small molecules. "This license provides us with the opportunity to accelerate the development path for our alpha-7 program by gaining access to the intellectual property on a series of molecules known to be active," said Critical Therapeutics President and Chief Executive Officer Paul Rubin, M.D. "We are very encouraged by the activity these compounds have shown in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. and in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. . Looking ahead, we plan to further screen these cinnamylidene-anabaseines and other series as we begin to identify an appropriate candidate for clinical study in 2005. In addition, the composition-of-matter and use claims obtained from this patent provide added intellectual property to our existing patents by targeting the use of alpha-7 receptor agonists for the treatment of inflammatory disease." 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 is developing a sales and marketing infrastructure in connection with its in-licensed product, Zyflo(R), a tablet formulation of zileuton zileuton /zi·leu·ton/ (zi-loo´ton) an inhibitor of leukotriene formation, used as an antiasthmatic. Zileuton (Zyflo) . 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.criticaltherapeutics.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Any statements in this press release about future expectations, plans and prospects for the Company are forward-looking statements made under the provisions 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. The Company may, in some cases, use words such as "project," "believe," "anticipate," "plan," "expect," "estimate," "intend," "should," "would," "could," "will," "may" or other words that convey uncertainty of future events or outcomes to identify these 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 relating to: the results of clinical trials with respect to the Company's products under development; the timing and success of submission, acceptance and approval of regulatory filings; the Company's heavy dependence on the commercial success of Zyflo(R) and the controlled-release formulation of zileuton; the Company's ability to obtain additional funding required to conduct its research, development and commercialization programs; the Company's dependence on its strategic collaboration with MedImmune, Inc.; and the Company's failure to obtain, maintain and enforce patent and other intellectual property protection for its discoveries. These and other risks are described in great detail in the "Risk Factors" section of the final prospectus relating to the Company's initial public offering filed with the Securities and Exchange Commission on May 27, 2004 and other filings that the Company periodically makes with the SEC. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, the Company's 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, any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements publicly at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise. |
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