FamilyMan: Please see below. 45-60 sites. I don't believe that any company lists all recruiting sites on clinicaltrials.gov
The shorter fibrosis trial which the Galectin is reporting will complete next year with topline data 2nd half of 2016 is the one site trial. The site is the Brooke Army Medical Center at Fort Sam Houston. I believe that speaks volumes in itself for the drug's potential (both the physician involved with the trial and the location of the trial).
About the NASH-CX Study
A total of 156 patients at between 45 and 60 sites will be randomized to receive either 2 mg/kg of GR-MD-02, 8 mg/kg of GR-MD-02 or placebo, with 52 patients in each arm. The primary endpoint is a reduction in HVPG. Patients will receive a total of 26 infusions every other week for one year and will be evaluated to determine the change in HVPG as compared with placebo. HVPG will be correlated with secondary endpoints of fibrosis on liver biopsy as well as with measurement of liver stiffness (FibroScan(R)) and assessment of liver metabolism (13C-methacetin breath test, Exalenz), which are non-invasive measures of the liver that may be used in future studies. Data readout is expected in the fourth quarter of 2017. More information may be found at www.clinicaltrials.gov.
About the NASH-FX Study
The Company also expects to begin screening patients with advanced fibrosis (the NASH-FX trial) in a smaller, 30 patient study in August 2015, with 15 patients receiving 8 mg/kg of GR-MD-02 and 15 receiving placebo. That study will evaluate the safety and efficacy of GR-MD-02 on liver stiffness as assessed by magnetic resonance-elastography and FibroScan score, and on imaging of liver fibrosis using multi-parametric magnetic resonance imaging (LiverMultiScan(R), Perspectum Diagnostics). Top-line data is expected to be available in mid-2016. More information may be found at www.clinicaltrials.gov.
