EpiCept Corporation announced positive results from a phase II b trial evaluating the efficacy and safety of EpiCept NP-1 (NP-1) in Chemotherapy-induced Peripheral Neuropathy (CPN). EpiCept NP-1 is a topical analgesic cream containing two FDA-approved drugs, amitriptyline and ketamine, in development for the relief of pain from various peripheral neuropathies.
The multi-centre, double-blind, randomized, placebo-controlled study was conducted by the National Cancer Institute (NCI)-funded Community Clinical Oncology Program. More than 460 cancer survivors suffering from painful CPN were enrolled in the six-week study. The results of the trial in the Intent To Treat (ITT) population demonstrated that the change in average daily neuropathy intensity scores in the NP-1 group achieved a statistically significant reduction in CPN intensity versus placebo (p<0.001), which was the trial's primary endpoint.
Additionally, a pre-specified subgroup of the ITT population, those patients who previously received taxane chemotherapy, also showed a statistically significant reduction in average daily neuropathy intensity scores (p=0.034). This subgroup constituted more than 50 per cent of the ITT population. Secondary efficacy endpoints confirmed the superiority of NP-1 vs. placebo. Furthermore, the safety profile of NP-1 was comparable to placebo.
“CPN is an area of great unmet medical need,” said Jack Talley, EpiCept president and CEO. “Millions of cancer survivors suffer from the effects of their chemotherapy and no treatment is yet approved for this painful indication. We are very excited about the positive results achieved by NP-1 in this trial and are highly optimistic about its potential to be a new and effective treatment option for sufferers of CPN. We look forward to discussing these results with prospective partners for the phase III development and commercialization of NP-1.”
The National Cancer Institute estimates that 30-40 per cent of cancer patients treated with chemotherapy experience symptoms of CPN, which impairs their quality of life and ability to function. The debilitating, chronic pain of CPN is one of the most common reasons why cancer patients stop their treatment early. More than one million breast cancer survivors in the United States alone suffer from this disease, for which there is no effective therapy.
The results of this trial build upon EpiCept's clinical development of NP-1 in both diabetic and post-herpetic neuropathies. The Company has enrolled more than 1,700 patients into clinical trials of NP-1, including a 360-patient trial that studied NP-1's efficacy compared with gabapentin and placebo in post-herpetic neuropathy, for which positive results were previously reported.
EpiCept NP-1 cream is a patented formulation containing two FDA-approved drugs, amitriptyline (a widely-used antidepressant) and ketamine (an NMDA antagonist that is used as an anaesthetic), designed to provide effective, long-term relief from the pain of peripheral neuropathies. Peripheral neuropathies are medical conditions caused by damage to the nerves in the peripheral nervous system.
The peripheral nervous system includes nerves that run from the brain and spinal cord to the rest of the body. Peripheral neuropathies are associated with conditions that injure peripheral nerves, including herpes zoster, or shingles, diabetes, chemotherapy, HIV and other diseases. Peripheral neuropathies can also be caused by trauma or may result from surgical procedures.
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain and its lead product is Ceplene, approved in the European Union for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukaemia (AML) in first remission.