Diffusion Pharmaceuticals, a Virginia-based clinical-stage biotech company, has completed patient enrolment in a Phase II trial of an anti-cancer compound, trans sodium crocetinate (TSC).
A total of 56 patients with newly diagnosed primary brain cancer (glioblastoma multiforme or GBM) were recruited at 18 cancer institutions across the US.
The study will assess if the addition of TSC to the existing GBM standard-of-care therapies can significantly improve the survival times.
Diffusion Pharmaceuticals chief medical officer Dr 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 said.
"We are also quite pleased at the safety profile of TSC and believe this played a significant role in the rapid rate of patient enrolment."
After the completion of Phase I safety lead-in study, the open enrolment in the Phase II study was commenced in November 2012.
An independent Safety Monitoring Committee determined the absence of any dose-limiting toxicities and the tolerance of TSC in all patients in the Phase I study.
The company has opened a new financing round to raise funds to advance the clinical development.
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."
Photo: The Diffusion study will determine the efficacy of TSC when added to current standard-of-care treatment for GBM. Image Courtesy of CrystlBluPersuason.