EpiCept to conduct Phase III study of EpiCept NP-1 for treatment of chemotherapy induced peripheral neuropathy

EpiCept Corporation has announced that it will study EpiCept NP-1, its patented topical cream formulation of two FDA-approved drugs, 4% amitriptyline and 2% ketamine, for the treatment of chemotherapy induced peripheral neuropathy (CPN) in the ATTRACT-CPN Phase III Study (Assessment of Topical Treatment Response with Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy).

The study will be conducted within a network of approximately 25 sites under the direction of the National Cancer Institute (NCI) funded Community Clinical Oncology Program (CCOP).

Peripheral neuropathy, a painful condition caused by damage to the nerves in the peripheral nervous system, affects over 15 million people in the United States. CPN is the result of the toxicity of a number chemotherapeutic agents. The risk of neuropathy increases with cumulative exposure. The first symptoms are paresthesias, with dysesthesias occurring after a few courses of chemotherapy, and often followed by severe neuropathic pain.

The Study Chair, Professor Robert H. Dworkin stated, "I am pleased that EpiCept and the CCOP are working together to address this unmet medical need. CPN is becoming a more prevalent issue with the wider use of more active chemotherapeutic agents."

"We are excited that the NCI funded CCOP has chosen to conduct this clinical trial of EpiCept NP-1," remarked Jack Talley, President and Chief Executive Officer. "We believe the results of this study will build upon the body of clinical evidence which demonstrates the ability of NP-1 to provide long-term relief from the pain resulting from peripheral neuropathies."

The topical delivery mechanism of EpiCept NP-1 could provide important clinical advantages in treating CPN patients, including the reduction of systemic side effects and drug interactions.

The Phase III trial is expected to be initiated before the end of the third quarter of 2007. The double-blind, randomized placebo-controlled study will enroll approximately 400 patients suffering from painful CPN for at least 28 days following the conclusion of chemotherapy.

The trial will be 12 weeks in duration, with the primary endpoint being the change in average daily pain intensity scores from baseline to the end point. The secondary endpoints include the percentage of patients whose pain intensity decreases greater or equal to 30% from baseline and various other measures.

EpiCept NP-1 Clinical Development

EpiCept has initiated two additional Phase IIb trials for EpiCept NP-1, enrolling 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. Only two medications are currently approved for this use. The trial is intended to confirm and expand upon earlier work which provided an efficacy signal in this type of 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 by the fourth quarter of 2007.

The second trial is a 500 patient, placebo- and active-controlled trial in peripheral herpetic neuropathy (PHN). This trial will compare the efficacy and safety of NP-1 vs. gabapentin as well as placebo. 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 trial. Preliminary results are expected in the first quarter of 2008.