"The work described in the Nature Immunology article provides important new insight into the mechanism by which HMGB1 exerts pro-inflammatory activity," said Gregory LaRosa, Ph.D., Critical Therapeutics' Vice President of Discovery Research. "The preclinical data suggest that HMGB1 may contribute to the disease pathology of lupus and supplement earlier research suggesting that a therapeutic antibody to HMGB1 may provide protection in chronic inflammatory disease. As we work in collaboration with MedImmune, Inc., to develop monoclonal antibodies (MAbs) directed towards HMGB1, this new information as to how HMGB1 provides a pro-inflammatory stimulus will help guide our efforts."
The collaboration with MedImmune and Critical Therapeutics is working to discover and develop novel therapeutics for both severe, acute inflammation, and for chronic allergic and autoimmune inflammatory diseases. The collaborative HMGB1 therapeutic antibody project is one of the key development efforts at Critical Therapeutics, and with MedImmune, has made progress towards the identificatio n of a first clinical candidate, and has added significantly to the understanding of the activities of HMGB1.
Critical Therapeutics has a strong HMGB1 intellectual property position that includes 6 U.S. and 17 foreign patents that have issued and 15 U.S. and 53 foreign patents that are currently pending issuance. Critical Therapeutics' HMGB1 patent estate is exclusively licensed to MedImmune for the treatment and prevention of diseases, such as arthritis and lupus. In addition, Critical Therapeutics licensed its HMGB1 diagnostic rights to Beckman Coulter, Inc., which is developing immunoassays to detect and manage inflammatory diseases.
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.
Arthritis is a term that describes a group of more than 100 medical conditions that collectively affect nearly 70 million adults and 300,000 children in the United States alone. All of these conditions affect the musculoskeletal system and specifically the joints - where two or more bones meet. Arthritis-related joint problems include pain, stiffness, inflammation and damage to joint cartilage and surrounding structures. Rheumatoid arthritis is one of the most serious and disabling forms of the disease, affecting about 2.1 million Americans.
Lupus is a widespread and chronic autoimmune disease that causes the immune system to attack the body's tissue and organs, including the joints, kidneys, heart, lungs, brain, blood, or skin. Approximately 1.5 million Americans have a form of the disease, which has no known cause.
About Critical Therapeutics
Critical Therapeutics, headquartered Lexington, MA, is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to ZYFLO(R) (zileuton tablets), which is marketed in the United States for the prevention and chronic treatment of asthma in patients 12 years of age and older. Critical Therapeutics is working to expand its zileuton franchise by developing a twice daily, controlled-release formulation for the prevention and chronic treatment of asthma and an injectable formulation for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is collaborating with MedImmune, Inc. to design antibody therapies that treat acute and chronic diseases triggered by the inflammatory cytokine HMGB1. Research pipeline programs include lifecycle management to extend the zileuton franchise and an alpha-7 project for the treatment of inflammation. For more information, please visit www.crtx.com.
Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, regarding the potential role of HMGB1 in diagnosing and treating disease; the progress, timing and plans for the HMGB1 program; the timing and success of regulatory filings, regulatory approvals and product launches; the efficacy of our drug candidates; prospects, plans and objectives of management; 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 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-l ooking 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: future development and commercialization efforts for the HMGB1 program; 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; the timing and success of submission, acceptance and approval of our regulatory filings; 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 "Risk Factors" section of our most recent Annual Report on Form 10-K and other filings that we make with the Securities and Exchange Commission (SEC). 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.
(1) Ar thritis Foundation
(2) The Lupus Foundation of America
Critical Therapeutics, Inc.
Linda S. Lennox, 781-402-5708
Vice President, Investor & Media Relations