Download diffusion announces phase 1/2 study results of tsc plus radiotherapy

DIFFUSION ANNOUNCES PHASE 1/2 STUDY RESULTS OF
TSC PLUS RADIOTHERAPY AND CHEMOTHERAPY IN
PEOPLE WITH AN AGGRESSIVE FORM OF BRAIN CANCER
Charlottesville, Virginia, July 13, 2015 ‐‐ Diffusion Pharmaceuticals LLC today announced preliminary
results from its recently completed phase 1/2 TSC GBM study in 59 patients with newly diagnosed
glioblastoma (GBM), the most common and aggressive form of primary brain cancer. These results
demonstrated that people who received TSC (trans sodium crocetinate) plus radiotherapy and
temozolomide chemotherapy benefited from a substantial improvement in overall survival (OS)
compared to the historical control group who received radiotherapy and temozolomide chemotherapy
alone.
TSC plus radiotherapy and chemotherapy increased the patients’ chance of survival at two years by 37
percent compared to the historical control group. In the subgroup of patients considered inoperable,
the chance of survival at two years for those who received TSC was increased by over 100 percent. No
negative safety findings were observed in the TSC GBM study and no serious adverse events were
attributed to TSC in any patient.
“We are gratified that people in the study with newly diagnosed glioblastoma who received TSC plus
radiotherapy and chemotherapy had an improved chance of survival at two years, which is considered
the most important indicator of clinical trial success,” said John L. Gainer, PhD, Chief Science Officer of
Diffusion Pharmaceuticals. “The positive results in the inoperable patient population are particularly
striking, as this is the group that traditionally is considered to have the worst prognosis.”
Currently, the Company is moving TSC forward for the treatment of GBM and preparing it for entry into
clinical trials in other solid tumor cancer indications.
Additional TSC GBM study results
• An independent review committee assessment of progression free survival (PFS) is on‐going, with
results expected to be reported in October, 2015.
• 70 percent of people treated with TSC were alive at one year compared to 62 percent of people in the
historical control group. 37 percent in the TSC group were alive at two years compared to 27 percent in
the control.
• In the sub‐group of inoperable patients, 40 percent in the TSC group were alive at two years compared
to less than 20 percent in the control.
• Health‐related quality of life measures including global health status and physical, social and motor
functioning remained stable or improved in most TSC‐treated patients during the trial.
• No serious negative safety findings attributed to TSC were observed in the TSC GBM study and adverse
events were consistent with those seen in previous trials of GBM featuring radiation therapy and
temozolomide chemotherapy.