DFFN stock is running in after-hours trading on December 10, 2019.

DFFN stock running in after-hours trading (brown shaded area) on December 10, 2019.

Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it is needed most, announces the presentation of data signaling increased survival in inoperable glioblastoma multiforme (GBM) patients enrolled in the 19-patient lead-in portion of its open-label, dose-escalation Phase 3 study with Trans Sodium Crocetinate (TSC) plus standard of care (SOC). Chief Scientific Officer John Gainer, Ph.D. presented these findings today at the inaugural Glioblastoma Drug Development Summit in Boston, sponsored by Hanson Wade.

Dr. Gainer’s presentation included earlier research demonstrating that TSC safely reduces tumor hypoxia by a novel mechanism of action, making the tumor up to 3 times more susceptible to radiation and chemotherapy. In Phase 2 testing of TSC in newly diagnosed inoperable GBM patients, a nearly 4-fold increase in 2-year survival was seen compared with historical controls.

The current Phase 3 INTACT (INvestigating Tsc Against Cancerous Tumors) study – an open-label, randomized, controlled trial – was designed to examine this finding in a fully powered safety and efficacy registration study.  The study was further designed to test a new TSC dosing regimen under which, in addition to the 18 injections of TSC administered during the radiation therapy phase, patients receive 18 additional injections of TSC during the post-radiation chemotherapy phase, at doses up to 6-times higher than those received during radiation. The addition of this high-dose regimen was based on research performed by Dr. Gainer over the last three years in his laboratory at Diffusion’s headquarters.

In the randomized portion of the INTACT trial, subjects will be randomized at baseline to SOC for first-line treatment of GBM plus TSC, or to SOC alone. The SOC for GBM is temozolomide plus radiation therapy for 6 weeks, followed by 28 days of rest, then by 6 cycles of post-radiation temozolomide treatment.

In the 19-patient open-label, dose-escalation, lead-in portion of the INTACT trial, safety was demonstrated in all patients receiving TSC at all dosing levels.  Further, the Company believes that, while the number of high dose patients (7) is small, the addition of the 18 higher-dose treatments of TSC may be having a positive effect on survival.  In his talk, Dr. Gainer presented a Kaplan-Meier survival plot highlighting the difference in survival seen with the addition of high-dose TSC treatment compared with both SOC and the earlier Phase 2 study. The current data show an 86% “Fraction Surviving,” with 38% for the completed Phase 2 TSC study and 13% for SOC. 

The ability of patients to perform daily activities as measured by Karnofsky performance scores also increased from baseline following completion of high-dose treatment with TSC, with scores showing a differential of 15% improvement over the Phase 2 results at 18 weeks, which is the time at which a decline rather than an improvement normally occurs.

Dr. Gainer’s slide presentation is available at http://investors.diffusionpharma.com/Presentations and includes graphics of these data.

“Even when taking into account the small number of patients enrolled, the difference in results with the new TSC dosing regimen compared with both the former TSC regimen and the standard of care is notable,” said David Kalergis, Diffusion Pharmaceuticals CEO. “We are gratified by the continued clean safety profile of TSC.  We also believe that observed survival differences of this magnitude send a meaningful signal about TSC, further de-risking the INTACT Phase 3 study during the randomized phase.”

Mr. Kalergis continued, “Patients diagnosed with inoperable GBM have a dire prognosis and very limited treatment options.  Given TSC’s proven safety profile and observed efficacy signals, we need to make all efforts to provide a new treatment option to these patients.” 

The Company is seeking a partner to continue development of TSC in the inoperable GBM indication, and has begun patient enrollment in its Phase 2 on-ambulance trial with TSC for the treatment of stroke.

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