Cancer and chronic pain are two of the most widespread conditions afflicting humanity today. Developing therapeutics for either one of these targets is daunting enough for any life sciences company. But EpiCept Corporation (Nasdaq: EPCT), a Tarrytown, New York-based pharmaceutical company, is tackling both.
Acute myeloid leukemia (AML) is the most common form of leukemia in adults. According to the National Cancer Institute, approximately 12,000 people in the U.S. will be diagnosed with and 9,000 will die from AML in 2010. An estimated 47,000 patients in the European Union currently suffer from AML. Many AML patients are successfully treated with chemotherapy drugs, typically experiencing complete remission. However, the majority (75-80%) of patients will experience a relapse of leukemia, usually within one to two years. There are currently no approved, effective remission therapies for AML in the U.S.
EpiCept’s lead product, Ceplene, is approved for marketing in the EU for the maintenance of first remission in patients with AML. The drug is administered in conjunction with a low-dose form of the cancer drug interleukin. In a Phase III study, Ceplene increased leukemia-free survival among AML patients in remission. Ceplene has been granted Orphan Drug Status by the U.S. Food and Drug Administration.
The company has two other cancer fighters in its pipeline: Crolibulin and EP90745, both formulated to induce apoptosis (cell death) in tumor cells. Myrexis Pharmaceuticals (MYRX) (formerly Myriad Pharmaceuticals) has agreed to handle the development and commercialization of EP90745, a series of apoptosis-inducing anticancer compounds. One of the compounds, Azixa, is undergoing clinical trials to treat brain cancer as well as metastatic melanoma.
EpiCept is also developing an analgesic cream for the relief of peripheral neuropathy (nerve pain) due to diabetes, chemotherapy or shingles in adults. EpiCept NP-1 cream contains two FDA-approved drugs, amitriptyline (an antidepressant) and ketamine (used as an anesthetic). The cream has been tested on over 850 patients in 7 trials to date, and was found to be significantly superior compared to placebo in a Phase IIb trial of 360 patients with post-herpetic neuralgia.