Spectral Diagnostics Inc. has provided a general, corporate update on its activities.
"2011 was a significant year for Spectral," said Dr. Paul Walker, President and CEO of Spectral Diagnostics.
"The Company received approval from the U.S. Food and Drug Administration to expand its Phase III EUPHRATES trial in severe sepsis and septic shock, completed a $10 million financing and expanded its investor base. Collectively, these developments should help the Company achieve its clinical milestones over the next few years."
Management anticipates there are several factors that could impact Spectral's valuation in 2012 and beyond. These include:
Spectral is well financed and its common shares are more liquid
• As at December 31, 2011, Spectral has approximately $18.5 million cash and cash equivalents
• The Company's shareholder base has increased to an estimated 7,000 retail and institutional shareholders
• In 2011, liquidity saw a fourfold increase in daily average trading volume versus 2010
Expansion of the EUPHRATES trial
• The FDA approved the expansion of the trial to 30 clinical trial sites (from 15), including international locations
• Spectral obtained additional market rights for Toraymyxin in Canada and announced the planned expansion of the trial into Canada
• Spectral reorganized for the expansion, including contracting with a new contract research organization
• Interim clinical data is targeted for the end of 2012, or early 2013, depending on the site uptake and patient enrolment rates, with receipt of final data approximately one year later
The severe sepsis market, estimated to be worth more than $1 billion, has lost its only approved product
• Eli Lilly withdrew Xigris, the only approved drug for severe sepsis, after failing to demonstrate efficacy in a post marketing study
Competitors' trials continue to face recruitment and efficacy challenges that Spectral has planned for
• In addition to Xigris, Eisai's Eritorin failed to demonstrate efficacy in its Phase III trial for severe sepsis
• A common challenge for these, and other failed or ongoing trials, has been the balancing of a desire for rapid patient recruitment against the need to get the right patients, who are sick enough, into the trial in order to demonstrate efficacy
"There are no shortcuts when it comes to running a successful sepsis clinical trial," added Dr. Walker.
Dr. Walker continued, "Our focus continues to be on carefully selecting high performing clinical sites and enrolling only those endotoxemic patients at highest risk of sepsis-related mortality. The EUPHRATES trial is the only late-stage sepsis trial to use a biomarker, the EAA™ measurement for endotoxin, as entry criteria to identify patients most likely to respond to treatment. In this way, we believe that our EUPHRATES trial is best positioned to have the greatest likelihood of success."