CHARLOTTESVILLE, VA, AUGUST 31, 2015 -- Diffusion Pharmaceuticals LLC today announced that Company
CEO David G. Kalergis, MBA/JD, will be a guest speaker at the 2015 American Cancer Society CAN
Virginia Research Breakfast, to be held September 17, 2015 at the Hilton Garden Inn, Glen Allen,
Virginia. His topic will be the possible impact of the Company’s transformative new drug trans sodium
crocetinate (TSC) on the treatment of cancer in years to come.
The other speakers will be Dr. Gordon D. Grinder, Director, Massey Cancer Center, VCU; Dr. Thomas P.
Loughran, Director, UVA Cancer Center; and Dr. Harold Sontheimer, Director Glial Biology, Disease and
Cancer Center, VT Carilion Research Center.
Diffusion Pharmaceuticals recently announced 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. The results demonstrated that people who received TSC plus radiotherapy and
chemotherapy benefited from an improvement in overall survival compared to the historical control
group who received radiotherapy and chemo alone.
TSC plus radiotherapy and chemotherapy increased the patients’ chance of survival at two years by 37
percent compared to the 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.
TSC currently has FDA Orphan Designations in GBM and metastatic brain cancer. In August 2015,
agreement was reached with the FDA on a proposed single Phase 3 GBM study design which, if
successful, could support TSC’s approval. Diffusion plans to initiate the study in 1H 2016.
In addition to moving TSC forward for the treatment of GBM, the Company is preparing it for clinical
trials in other solid tumor cancer indications.
About TSC – a novel approach to improving the treatment of cancer
Despite developments in cancer immunotherapy, radiation and chemo are the mainstays of cancer
treatment and are expected to remain so for many years. However, tumor hypoxia (oxygen deprivation)
occurs in most cancers, causing resistance to radiation and chemotherapy. Diffusion’s novel small
molecule TSC safely re‐oxygenates hypoxic tumor tissue, enhancing tumor response to treatment while
minimizing side‐effects. TSC has the potential to be targeted against all solid cancers currently treated
with radiation and chemotherapy and substantially improve patient survival.
Glioma (cancer of the glial cells) is the most common type of malignant primary brain tumor, accounting
for approximately one third of all diagnosed brain tumors. Glioblastoma (or glioblastoma multiforme,
GBM) is the most common and the most aggressive type of glioma. Globally, the incidence of
glioblastoma is approximately 1 to 2 in 100,000 people annually. Glioblastoma is considered one of the
most hypoxic (oxygen deprived) of all solid tumors.
About Diffusion Pharmaceuticals LLC
Headquartered in Charlottesville, Virginia since its founding in 2001, Diffusion Pharmaceuticals LLC has a
growing, industry‐recognized board of directors and management team, with substantial scientific and
clinical expertise, vital connections within the clinical community, and experience with the
commercialization of novel pharmaceutical intellectual property.
The Company has acquired all the rights to the TSC platform technology from the University of Virginia
and owns a robust patent portfolio protecting its technology throughout the major pharmaceutical
markets with patent coverage extending through 2030.
Diffusion is currently conducting a private financing and preparing for a possible IPO in 2016.
For more information, please visit www.diffusionpharma.com.
Contact: David G. Kalergis MBA/JD
Chief Executive Officer
Phone: 434 220‐0718