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-Company Also Comments on Eli Lilly's Market Withdrawal of Xigris-
TORONTO, Oct. 25, 2011 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI), a Phase III company developing the first theranostic treatment for patients with septic shock, today announced that it is expanding its U.S. Phase III EUPHRATES trial to Canadian clinical trial sites. The EUPHRATES trial is evaluating Spectral's theranostic product candidate for the treatment of patients with severe sepsis and septic shock.
In August of this year, the Company received approval from the U.S. FDA to increase the total number of clinical sites in its EUPHRATES trial from 15, to a total of 30, including international sites. Consultation with Health Canada and interested Canadian investigators has led to the decision to expand the trial into Canada.
"We believe that adding Canadian sites with a strong interest in participating in the EUPHRATES trial will help us to enroll the right type of patients, which are generally those at higher risk of sepsis-related mortality, and within our target timelines," said Dr. Paul Walker, Chief Executive Officer of Spectral Diagnostics. "We are targeting the receipt of interim data from the trial by the end of 2012."
Management also commented today on Eli Lilly's worldwide withdrawal of Xigris, its product for the treatment of severe sepsis.
"While the news on Xigris is disappointing for sepsis patients and clinicians, especially in the U.S., which has now lost the only approved treatment for many of these patients, we view this as positive news for Spectral because there remains a very large unmet medical need for an effective treatment for patients with severe sepsis and septic shock," said Dr. Walker. "To date, more than 80,000 patients worldwide have been treated with our Phase III product, and it is the most clinically advanced candidate product in the United States."
"One of the lessons learned from this development is that for a complex disease like sepsis, it is important to identify potential responder patients who may benefit from the treatment being used," added Dr. Walker. "One of the potential advantages of our distinctive theranostic approach to treating this disease, in which we combine a diagnostic and a therapeutic, is that we can target patients at greatest risk and most likely to respond to treatment."
Toraymyxin is Spectral's therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. Toraymyxin has been used safely on more than 80,000 patients worldwide and, when guided by Spectral's EAA™ diagnostic, has the potential to address this large unmet medical need, which is valued at more than $1 billion annually in the U.S. alone.
The FDA approved Xigris in November, 2001 for the reduction of mortality in adult patients with severe sepsis who have a high risk of death. Eli Lilly announced today it is withdrawing the drug in all markets following results of a European clinical study, which showed the trial did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment for severe sepsis and septic shock. Toraymyxin is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis. Spectral'sEUPHRATES trial is the world's first theranostics trial in the area of sepsis.
Toraymyxin has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively in more than 80,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin, and in November 2010, signed an exclusive distribution agreement for this product in Canada. More than 250,000 patients are diagnosed with severe sepsis and septic shock in North America each year, representing a greater than $1 billion market opportunity for Spectral. Spectral is listed on the Toronto Stock Exchange under the symbol SDI. For further information please visit www.spectraldx.com
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
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