- 93 patients enrolled
- February represents a second record breaking consecutive month for patient enrollment
Enrollment:
- Robust enrollment activity continues throughout 2024:
- 93 patients enrolled to-date
- Six patients enrolled in the month of February – follows the six patients enrolled in January
- Twelve patients enrolled in the first two months of 2024 – represents the most robust enrollment rates since the start of the Tigris study
- 93 patients enrolled to-date
- With 57 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial
- To support sustained enrollment, Spectral to host an in-person Investigator Meeting
March 12 th & 13th in conjunction with the 29thInternational Conference on Advances in Critical Care Nephrology inSan Diego
- To support sustained enrollment, Spectral to host an in-person Investigator Meeting
Trial Sites:
- Currently 21 Tigris trial sites, with continued progress opening an additional four new, high quality clinical sites
The Institute for Extracorporeal Life Support (San Antonio, TX ) finalized and executed the Tigris clinical trial agreement- Expect significant site onboarding activity throughout Q1/24, with final training scheduled at three of the remaining four sites
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 | CEO |
416-962-3300 | |
am@spinnakercmi.com | cseto@spectraldx.com |
Source:
2024 GlobeNewswire, Inc., source