Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN)
Shares of Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) gained 20.5% after the clinical stage biotechnology company received a final protocol guidance from the U.S. Food and Drugs Administration (FDA) for its lead compound Trans sodium crocetinate (TSC). The company is a preparing for Phase 3 trials of the compound in patients newly diagnosed with inoperable Glioblastoma multiforme, a type of brain cancer.
DFFN Stock Investor’s Reaction
The stock spiked by 35% as investors reacted to the favorable FDA ruling. However, the stock continues to trade in a downtrend after coming under pressure for the better part of the year. Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) is down by more than 50% for the year.
Renewed investor interest comes on reports that the company responded to all outstanding points raised by the FDA on protocols for a protracted Phase 3 trial. The trial will compare the survival rates at two years for both the patients receiving the Trans sodium crocetinate and patients receiving chemotherapy and radiation as part of standard care.
“This Phase 3 study will focus on treating newly diagnosed GBM patients who have been judged by their medical team to be inoperable because of the size or location of the tumor. In Diffusion’s Phase 2 proof-of-concept trial, the inoperable GBM patients who were treated with TSC plus standard of care showed a nearly four-fold increase in survival at two years compared with standard of care patients only,” said CEO David Kelergis.
TSC Phase 3 Trial
Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) has already contracted a research organization to oversee to oversee the Phase 3 TSC trial as per the FDA standards. The company plans to carry out the trials in about 100 sites spread across the U.S. and Europe. Patient enrollment should begin before the end of the year.
Phase ½ clinical trial of TSC showed a 380% increase in survival rates at two years in inoperable patients. Trial results also indicate that 71% of the people treated by TSC were alive at one year compared to 61% of the people on historical group control.
A major difference between Phase ½ and Phase 3 will be the inclusion of TSC during Chemotherapy. In Phase ½, it was administered prior to radiation.
Glioblastoma is the most aggressive among known tumors and usually leads to death in one or two years. Standard care treatment consists of surgery to resect the tumor.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.