CRXA Corixa Corp (MM)

Corixa Corporation (Nasdaq:CRXA) today announced preliminary results of its first clinical trial of CRX-675, a toll-like receptor 4 (TLR4) agonist, in subjects allergic to ragweed. The study was a randomized, blinded, placebo-controlled trial of single doses of CRX-675 given intranasally prior to intranasal challenges with ragweed allergen. The primary objective of this clinical trial was to evaluate the safety of CRX-675 given as a single intranasal dose. Subjects were randomized to either a CRX-675 group (4 escalating dose levels n=12/group) or a placebo group (n=4/dose group; total n=16). Each subject in the study completed a series of direct nasal challenges with increasing concentrations of ragweed allergen to determine an allergen dose that would result in a 30 percent reduction in nasal volume (defined as the PD30 dose) during the screening period of the study. Two weeks later, each subject was challenged with their assigned PD30 dose of ragweed allergen and then monitored for safety and nasal volume (congestion), as well as total nasal symptom scores, to establish their baseline allergic response to ragweed. Fourteen days later, subjects were treated with either placebo or one of four single intranasal doses of CRX-675 (2, 20, 100 or 200 micrograms), 24 hours prior to a second PD30 ragweed challenge. Safety measurements, nasal congestion and total nasal symptom scores were evaluated following ragweed challenge. In order to assess any delayed effects of CRX-675, subjects were re-challenged with ragweed allergen 14 days after being treated with CRX-675 or placebo and evaluated for allergic responses. There were no serious or severe adverse events reported. The majority of the adverse events were mild (Grade 1) and either considered unrelated to the drug being evaluated or resolved without intervention. The adverse event profile of CRX-675-treated subjects was similar to that of placebo-treated subjects. These results confirm that intranasal administration of CRX-675 is safe. Other exploratory responses to CRX-675 were assessed by evaluating the percent change in nasal congestion and nasal symptom scores post ragweed challenge. There were no consistent trends for improvement in nasal congestion post ragweed challenge for the CRX-675 treatment groups beyond those observed in the placebo group. There was a consistent decrease in nasal symptom scores in the 100ug CRX-675 treatment group when compared to the placebo group. This trend in reduction of nasal symptom scores for the 100ug CRX-675 treatment group occurred both one day and 14 days after CRX-675 treatment when challenged with ragweed. The total nasal symptom scores were too low post ragweed challenge in the 20ug and 200ug CRX-675 treatment groups to adequately assess an effect at those dose levels in this study. As a result, no dose response relationship was detected. "We are satisfied with the safety profile of CRX-675 given as a single, intranasal dose in this patient population," stated Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "Meaningful data regarding the potential efficacy of CRX-675 in the setting of allergic rhinitis will have to wait for results from additional planned studies that are designed to examine the safety and efficacy of intranasal CRX-675 administered multiple times in a treatment cycle. Such randomized, placebo controlled studies could begin either late in 2005 or in 2006." About Corixa Corixa is a biopharmaceutical company developing vaccine adjuvants and immunology-based products that manage human diseases. Corixa's products are currently in multiple clinical development programs, including several that have advanced to and through late-stage clinical trials. The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa(TM) technology with the goal of making its potential products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, with additional operations in Hamilton, Montana. For more information, please visit Corixa's website at www.corixa.com. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding anticipated clinical milestones for CRX-675. Forward-looking statements are based on the opinions and estimates of management at the time the statements are made. They are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Factors that could affect Corixa's actual results include, but are not limited to, the "Factors Affecting Our Operating Results, Our Business and Our Stock Price," described in Corixa's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, copies of which are available from the company's investor relations department. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Additional Information About the Proposed Acquisition of Corixa by GlaxoSmithKline and Where to Find It Corixa has filed a definitive proxy statement in connection with the proposed acquisition of Corixa by GlaxoSmithKline, which was mailed to stockholders on or about June 7, 2005. Corixa urges investors and security holders to read the definitive proxy statement and any other relevant documents filed with the SEC because they contain important information about Corixa and the proposed transaction. Investors and security holders can obtain these documents free of charge at the website maintained by the SEC at www.sec.gov. Additionally, the definitive proxy statement and other documents filed with the SEC by Corixa are available free of charge on Corixa's website at www.corixa.com. Documents on Corixa's website are not a part of the filing. The definitive proxy statement and other relevant documents may also be obtained free of charge by contacting Georgeson Shareholder Communications, Inc. at 866-781-5469. Corixa's directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Corixa in connection with the transaction. A description of certain of the interests of directors and executive officers of Corixa is set forth in the definitive proxy statement.