By Herina Ayot
"EpiCept marked several important achievements since our last quarterly report,” stated Jack Talley, EpiCept president and CEO. "We are delighted with the excellent clinical data we recently reported from the EpiCept NP-1 trial studying chemotherapy-induced peripheral neuropathy (CIPN), which we believe confirms NP-1′s utility in meeting a high unmet medical need in a large patient population. We also made important progress late last year by gaining agreement with the U.S. Food and Drug Administration that a trial for Ceplene/IL-2 with survival as the primary endpoint need not isolate the contribution of Ceplene in the regimen, but would need to show a statistically significant overall survival advantage for remission maintenance of patients suffering from acute myeloid leukemia. We believe this study has a very good probability of success."
Ceplene was approved in the European Union and Israel for administration with low-dose interleukin-2 for the remission maintenance and prevention of relapse of patients with Acute Myeloid Leukemia (AML) in first remission. AML is the most deadly form of leukemia in adults.
In October 2010, EpiCept reached an agreement with the FDA on a regulatory path leading to a resubmission of a New Drug Application for Ceplene. EpiCept agreed to undertake a new confirmatory clinical trial to demonstrate Ceplene’s activity in conjunction with low-dose IL-2 as remission maintenance therapy for AML patients in first complete remission with overall survival as the primary endpoint. The company expects to begin the trial in the second half of 2011. Ceplene has been granted orphan drug status in the United States, which provides seven years of market exclusivity from the approval date.
EpiCept NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies, which affect more than 15 million people in the U.S. alone. Earlier this month, EpiCept announced positive results from a Phase IIb trial evaluating the efficacy and safety of EpiCept NP-1 in CIPN. The debilitating, chronic pain of CIPN is one of the most common reasons why cancer patients discontinue their treatment prematurely. More than one million breast cancer survivors in the United States alone suffer from this disease, for which there is no effective therapy.
EpiCept’s net loss for the fourth quarter of 2010 was $3.0 million, or $0.06 per share, and for the year was $15.5 million, or $0.32 per share. As of December 31, 2010, EpiCept had approximately 55.0 million shares outstanding. EpiCept’s loss per share and shares outstanding reflect a 1:3 reverse split that was effected in January 2010.
EpiCept has previously presented at OneMedForum SF 2011, the 13th Annual Bio CEO and Investor Conference, The Lippert/Heilshorn Life Sciences & MedTech Virtual Conference, and most recently at The Wall Street Analyst Forum 22nd Annual Investor Conference.