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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Robert K. who wrote (9015)	3/9/1999 8:33:00 AM
From: BostonView	Respond to of 17367

He hears our cries...news update: XOMA Continues Patient Enrollment in NEUPREX Meningococcemia Phase III Pivotal Trial BERKELEY, Calif.--(BW HealthWire)--March 9, 1999--XOMA Ltd. (Nasdaq:XOMA - news) today announced that an independent Data Safety Monitoring Board (DSMB) has advised the Company that it should continue to enroll patients in its Phase III NEUPREX® meningococcemia trial until the prespecified overall mortality number is met. The DSMB has not identified any safety issues. The double-blinded, placebo-controlled pivotal trial has enrolled 370 patients to date in hospitals in the United States and United Kingdom. ''With the United Kingdom providing the majority of our patients, total enrollment has been higher than anticipated, but the overall mortality rate in the trial has been lower than originally projected,'' said Jack Castello, Chairman, President and CEO of XOMA. ''Nonetheless, we believe that we are now close to reaching the specified number, allowing us to conclude accrual with the statistical power called for in our trial design.'' The Company is in consultation with European and U.S. regulatory authorities about its filings to both agencies. Once enrollment is complete there will be a 90-day follow-up period on the last patients enrolled before results are available and analysis can begin. Meningococcemia is a deadly bacterial infection caused by Neisseria meningitidis, which can also cause meningitis. In meningitis, the bacteria infect the membranes around the brain and spinal column (''meninges'') causing high fever and a characteristic painful stiff neck. In meningococcemia, these gram-negative bacteria enter the bloodstream, where they and their endotoxins (poisonous components of the bacterial cell wall) can fuel a systemic inflammatory response that can lead, within hours, from flu-like symptoms to shock, organ failure and death. Survivors may suffer loss of limbs and neurological damage. The NEUPREX® product has been shown to kill gram-negative bacteria and block the inflammatory response by binding to and neutralizing bacterial endotoxins. An open-label pilot study initiated in 1995 treated 26 severely ill meningococcemia patients with NEUPREX®; 25 survived the disease. In August 1996, the Food and Drug Administration (FDA) granted Subpart E designation to expedite the evaluation of the product for this indication. XOMA began the pivotal trial at centers in the United States in October 1996. Results from the pilot study were published in November 1997 in the British medical journal, The Lancet. In January 1997, the first U.K. study center was added. In June, 1998, the FDA granted Orphan Drug status for this indication. XOMA Ltd. develops and manufactures biopharmaceuticals at facilities located in Berkeley and Santa Monica, California. The Company's medical targets include bacterial and fungal infections, infectious complications (such as those that may follow trauma or surgery), immunologic and inflammatory disorders. BPI (bactericidal/permeability-increasing protein), a human protein that has multiple anti-infective properties, is XOMA's primary drug development platform. BPI was discovered in white blood cells by Peter Elsbach, MD, and Jerrold Weiss, PhD, at New York University School of Medicine (NYU). XOMA has collaborated with NYU since 1991 to extend and apply BPI-related research to commercial pharmaceutical development. The Company recently completed a shareholder-approved reorganization that changed its legal domicile from Delaware to Bermuda. The statements made in this press release related to the timing of clinical trials, release of data and other aspects of product development, regulatory approvals, and plans for sales and marketing, or that otherwise relate to future periods, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions which may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. These risks, including those related to the timing or results of pending or future clinical trials, changes in the status of the Company's collaborative relationships, uncertainties regarding the legal standards applicable to biotechnology patents, and actions by the U.S. Food and Drug Administration or the U.S. Patent and Trademark Office, are discussed in the Company's most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in evaluating XOMA's prospects.