EpiCept Launches Two Studies in Peripheral Neuropathy

EpiCept has initiated two Phase IIb trials with EpiCept NP-1, a topical analgesic cream for the long-term relief from the pain of peripheral neuropathies. Peripheral neuropathy is associated with such conditions as shingles, diabetes and HIV/AIDS.

The two trials will enroll a total of 700 patients. The first trial is a 200-patient, placebo- controlled study of NP-1 in patients with diabetic peripheral neuropathy (DPN). More patients suffer from DPN than any other type of neuropathic pain, according to EpiCept, and only two medications are currently approved for this use. The trial is intended to confirm and expand on earlier efficacy data. The primary endpoint for this trial is the change in pain intensity over the four-week duration of the trial. Preliminary results are expected by the fourth quarter of 2007.

The second trial is a 500-patient, placebo- and active-controlled trial in peripheral herpetic neuropathy. This trial will compare the efficacy and safety of NP-1 versus gabapentin as well as placebo. NP-1 has already shown in a prior 149-patient, Phase II, dose-ranging study a pronounced efficacy signal versus placebo in this type of neuropathic pain. This active-comparator trial is one of the first such efforts to examine any candidate compound at this scale in neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four-week duration of the trial. Preliminary results are expected in the first quarter of 2008.

The results of these trials are intended to broaden NP-1's labeling within peripheral neuropathies and raise the product candidate's future market potential.

"We believe NP-1 has the largest market potential of any of our pain product candidates and is a valuable component of our diversified portfolio of pain management programs and high-potential compounds for the treatment of cancer," Jack Talley, president and CEO of EpiCept, said. "The results of our NP-1 Phase IIb trials should enable us to broaden the known therapeutic signal with NP-1 and establish the drug as a superior therapy compared to the market leader, gabapentin."