Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) is flying in the market this morning, trading on gains of well over 100%. The gains come after the company announced early findings from its lead-in portion of a key Phase 3 clinical trial. Here’s what’s happening:
DFFN Stock Rockets On Data
In a press release issued early this morning, Diffusion Pharmaceuticals announced increased survival in inoperable glioblastoma patients enrolled in a 19-patient Phase 3 clinical trial. In the trial, the comapny is assessing the efficacy of Trans Sodium Crocetinate plus the standard of care.
In the release, DFFN said that its CSO, John Gainer, Ph.D., will present the details of the data at the inaugural Glioblastoma Drug Development Summit held December 10 and 11.
Previously presented data has been positive. In fact, in the Phase 2 study of TSC in newly diagnosed glioblastoma multiforme brain cancer patients, nearly a 4-fold increase in 2 year survival was seen against historical controls.
In the release, DFFN said that the Phase 3 trial is sending positive safety signals across all patients receiving TSC. Moreover six of the seven patients who received high dose TSC treatments are still alive. Median survival to date is 14.3 months. This is incredible considering that the historical standard for survival in this patient population is only 9.2 months.
Importantly, Median Survival has not yet met its full potential, considering that six of the seven patients in the high-dose TSC arm are still alive. In a statement, Dr. Gainer, CSO at DFFN, had the following to offer:
We are encouraged by these early findings showing that patients enrolled in the lead-in portion of the INTACT trial have experienced increased survival with our new protocol. Although final conclusions will depend on the completion of the randomized portion of the trial, we believe that TSC helps to eradicate the low oxygen status of cancerous tumors, and it appears this may also result in a survival benefit compared with the current standard therapy.
Why Investors Are So Excited
At the end of the day, there are several good reasons that the stock is seeing such incredible gains on the data. Here’s how I see it:
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