Biotechnology company Diffusion Pharmaceuticals has announced the completion of a Phase I brain cancer trial of trans sodium crocetinate (TSC) in nine patients with glioblastoma (GBM).
Phase I patient safety data was reviewed by a Safety Monitoring Committee, which authorised the open enrolment for a consequential Phase II study.
Go deeper with GlobalData
The Phase II trial is expected to enrol around fifty patients by early 2013 in the US.
Diffusion Pharmaceuticals CEO David Kalergis said the safety confirmation has prompted the immediate expansion of treatment to a larger number of newly diagnosed GBM patients.
"The timely opening of Phase II means that statistically-powered efficacy data should be available on schedule later in 2013," Kalergis said.
The Phase II trial is designed to assess the effect of TSC when combined with radiation therapy in recently diagnosed GBM patients.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataEndpoints of the study include TSC’s effects on tumour regrowth as determined by MRI, the patient’s quality-of-life during and after the treatment, and overall survival at one and two years after treatment.
TSC received an FDA orphan drug status for its use in GBM in 2011, and an orphan drug designation for its use in brain metastases is awaiting.
Image: Diffusion Pharmaceuticals is enroling patients in Phase II trial of trans sodium crocetinate. Photo: Courtesy of CrystlBluPersuason.
