- 81 patients enrolled
Enrollment:
- Robust enrollment activity since the end of October, with 81 patients enrolled to date,
- Seven patients enrolled over the last eight weeks
- Screening activity at current sites remains strong with 100+ patients screened per week
- Closing in on the interim enrollment target of 90 patients (“Interim Enrollment”); at Interim Enrollment,
Baxter has the option to make the second milestone payment to Spectral to maintain its PMX exclusive distribution rights. - Crude mortality results at both 28-day (primary endpoint) and at one year, thus far, continue to exceed efficacy targets.
Trial Sites:
- Currently 20 Tigris trial sites, with near term onboarding of new, high quality clinical sites.
- Clinical Trial Agreements (“CTA”) either executed or in final revision phase at six new clinical sites.
EDEN Study:
- Completed the EDEN study, a parallel observational study, in which data is collected on patients with septic shock even if ineligible for Tigris. The EDEN study is among the largest ever to examine the full range of septic shock and its relation to organ failure and endotoxin activity. These data will inform subsequent discussions with the FDA on labelling for PMX and provide important data on potential expanded indications for PMX.
Dr.
“We are pleased with the pace of enrollment activity since holding our Investigator Meeting this past May. The sustained enrollment activity over these past seven months has put Spectral within striking distance of our interim enrollment milestone of 90 patients, which is expected to play as a major catalyst for the Company,” said
As a reminder, under the exclusive distribution agreement between
About Spectral
Spectral is a Phase 3 company seeking
PMX is approved for therapeutic use in
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.
Spectral is listed on the
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 company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, 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.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For further information, please contact:
Capital Markets & Investor Relations | US Investor Relations | CEO |
416-962-3300 | 212-671-1020 | |
am@spinnakercmi.com | edt@crescendo-ir.com | cseto@spectraldx.com |
Source:
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