Diffusion Pharmaceuticals has completed enrolling 56 patients with newly diagnosed primary brain cancer (glioblastoma multiforme or GBM) in the Phase II trial of an anti-cancer compound, trans sodium crocetinate (TSC).
Patients were enrolled at 18 cancer institutions across the US for the study. The Phase II trial will evaluate the efficacy of TSC, when added to existing GBM standard-of-care therapies in significantly improving the survival times.
Diffusion Pharmaceuticals chief medical officer David Jones said the speed of accrual for its GBM trial has been significant.
“This speaks to the huge unmet medical need in GBM and the desire of clinicians to identify much-needed new therapies and move them forward as rapidly as possible,” Jones added.
“We are also quite pleased at the safety profile of TSC and believe this played a significant role in the rapid rate of patient enrollment.”
No dose-limiting toxicities were reported in Phase I study in which TSC was well tolerated by the patients.
Diffusion CEO David Kalergis said, “We expect most of it to be placed with our existing shareholders, although we may add several additional accredited investors from our network.”