Toronto, Ontario | September 24, 2019
Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced that the first Investigator Meeting for the Tigris trial was held on September 20, 2019 in Philadelphia, PA. This meeting represents a pivotal milestone for Spectral as it indicates the readiness of the majority of study sites to begin recruitment.
“There were investigators and coordinators from most of the planned sites who enthusiastically discussed the details of the trial and committed to supporting this trial at the site level. In parallel with the general meeting, five study sites attended a Site Initiation Visit (SIV) specifically intended to prepare them for initiating the recruitment phase. This means that they will be able to start screening for eligible patients in the very near future,” said Debra Foster, Vice President of Clinical Development.
“The Tigris trial, designed with input from the FDA, will provide additional data to the EUPHRATES sub population who responded positively to treatment with the PMX cartridge and had a clinically meaningful 10% reduction in 28-day mortality. This group also showed improvement in organ function and reduction in the need for vasopressors. Spectral continues to be at the forefront of innovative clinical trials as the Tigris study analysis plan includes the use of Bayesian statistics which will leverage data already obtained in the EUPHRATES trial,” said Dr. Paul Walker, President and CEO of Spectral Medical.
The unmet need for new therapies for patients in septic shock remains a global challenge. In the United States alone, there are over 1.7 million new cases of sepsis each year with approximately 250,000 annual deaths recorded. Spectral remains committed to bring a focused, personalized approach to the treatment of septic shock to the market to reduce the burden on patients and health care funding.
Tigris is a follow on study that builds on knowledge gained from the EUPHRATES trial, a large prospective blinded trial performed in North America. Tigris will be run in ten sites, all in the U.S., who participated in the EUPHRATES trial. Tigris will be a prospective, open labelled trial of 150 patients with a 2:1 randomization favoring the treatment arm. The end point remains a reduction in the 28-day mortality using the PMX hemoperfusion cartridge versus standard of care.
About Spectral Medical Inc.
Spectral is a Phase III company seeking U.S. Food and Drug Administration (“FDA”) approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (“EAA™”), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 170,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 350,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for “DIMI” which is based on the same RRT platform but will be intended for home hemodialysis use.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
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, general economic, market and business conditions, as well as other risks and uncertainties which are more fully described in Spectral’s Annual Information Form dated March 27, 2019, and in other filings of Spectral with securities and regulatory authorities which are available at www.sedar.com. There is no guarantee that Spectral will obtain the FDA approval of PMX in the United States. Spectral does not undertake any obligation to update forward-looking statements should these assumptions change. Nothing in this document should be construed as either an offer to sell or a solicitation to buy or sell Spectral securities.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For further information, please contact:
Dr. Paul Walker
President & CEO
Spectral Medical Inc.
416-626-3233 ext. 2100
Spectral Medical Inc.
416-626-3233 ext. 2004
Capital Markets & Investor Relations