|By Staff and file_manager.php Wire Reports|
|Thursday, 01 March 2012 07:11|
The Tarrytown, New York EpiCept is a specialty pharmaceutical company seeking to address areas of high, unmet medical needs in cancer and pain through its innovative technologies, but it has remained relatively undiscovered by most biotech speculators. That may start to change as the investment community becomes more aware of the firm's pipeline and clinical progress achievements.
In an exclusive video interview, Jack V. Talley, Chief Executive Officer, President and Director of EpiCept Corporation tells investors that his firm is breaking new ground with promising results.
“2012 promises to be a new chapter in the history of Epicept primarily because of the results we've achived for AmiKet™ in chemotherapy-induced peripheral neuropathy (CPN),” explained Talley. “This gives us the opportunity to invest in a drug for a disease that has a huge unmet medical need and a very reasonable path as well as a time and cost in order to get to a new drug application.”
Talley told the markets on Wednesday that one of the firm’s most significant milestones was the outcome of their End-of-Phase II meeting with U.S. Regulators at the Food and Drug Administration (FDA) concerning AmiKet™. “We were pleased to receive FDA approval to start Phase III activities and delighted with the encouragement they received from the FDA to file for Fast Track status.
“The granting of Fast Track status should provide us the opportunity to regularly consult with the FDA in order to determine the optimum path towards approval. We believe that the meaningful guidance provided to us by the FDA will positively advance our ongoing discussions with several potential partners,” said Talley.
The Company believes that its cash is sufficient to fund operations into the third quarter of 2012. The Company has reduced certain R&D and G&A expenses in 2012 compared with 2011 and raised cash via a repricing of expiring stock purchase warrants in January 2012 and a $2 million registered direct financing in February 2012.