Spectral Announces Approval of Tigris Trial by the US FDA

Spectral Medical (TSX:EDT) has announced that the Tigris clinical trial has been approved by the US FDA as an amendment to the original EUPHRATE’s IDE trial.

As quoted in the press release:

Patients will be enrolled in the Tigris trial using the same eligibility criteria as those that showed a clinically significant mortality benefit within the EUPHRATES trial.

TIGRIS will use the same primary endpoint of 28 day mortality, is expected to enroll 150 septic shock patients with a MODS score >9 and Endotoxin Activity Assay (EAA) levels between 0.60 and 0.90, will be randomized 2:1 for treatment vs control arm and will be open label. The study will employ a Bayesian statistical approach to combine data from the EUPHRATES trial with data from the Tigris trial. Tigris will be run exclusively in US hospital sites experienced in using the PMX cartridge and who demonstrated a good enrollment rate in the EUPHRATES trial.

“The Company has been engaged in a detailed interactive process with the US FDA to determine the optimal pathway forward with the Toraymyxin™ (“PMX”) cartridge,” said Dr Paul Walker, President and CEO of Spectral. “We are pleased with the guidance from the US FDA, and are confident in the program we have designed to demonstrate efficacy and safety to support a future application for approval of this potentially lifesaving treatment. The incidence of sepsis and septic shock continues to rise in the United States and continues to carry an unacceptably high mortality rate, which in this patient group has been shown to be in excess of 40%.

We anticipate that the Tigris trial will begin enrollment in the near future, and will provide necessary efficacy and safety confirmatory data for the use of Toryamyxin (PMX) in septic shock patients.  Identifying patients most likely to respond to this treatment based on knowledge gained from the EUPHRATES trial remains a unique aspect of this trial. The EUPHRATES trial demonstrated that when the endotoxin activity was in the critical treatment range of 0.6 to 0.9 a clinical benefit of mortality reduction and improvement in organ function was seen.  The EAA remains the only assay cleared by the FDA for measurement of endotoxin activity.

Click here to read the full press release.