Organization and Description of Business	6 Months Ended
Jun. 30, 2011
Organization and Description of Business [Abstract]
Organization and Description of Business	1. Organization and Description of Business EpiCept is a specialty pharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company’s strategy is to focus its development efforts on innovative cancer therapies and topically delivered analgesics targeting peripheral nerve receptors. The Company’s lead product is Ceplene^®, which when used concomitantly with low dose interleukin-2 (“IL-2”) is intended as remission maintenance therapy in the treatment of acute myeloid leukemia, or AML, for adult patients who are in their first complete remission. In addition to Ceplene^®, the Company has two other oncology compounds and a late-stage pain product candidate for the treatment of peripheral neuropathies in clinical development. The Company believes this portfolio of oncology and pain management product candidates lessens its reliance on the success of any single product or product candidate. In January 2010, EpiCept completed an agreement with Meda AB of Sweden to market and sell Ceplene^® in Europe and certain Pacific Rim countries. The commercial launch of Ceplene^® commenced in the United Kingdom in April 2010 and launches are continuing in other European countries. In December 2010, Ceplene^{^®}was approved for marketing in Israel. Following Ministry of Health approval of labeling and other technical matters, Megapharm Ltd., EpiCept’s marketing partner, is expected to commence the commercial launch of Ceplene^®. In October 2010, the Company conferred with the United States Food and Drug Administration (“FDA”) and verbally agreed on the design of a new confirmatory study of Ceplene^® comparing the efficacy of Ceplene^® plus low-dose IL-2 to standard of care in this indication. Based on FDA guidance, the primary endpoint of the trial will be overall patient survival. In May 2011, EpiCept submitted to the FDA a detailed Phase III protocol. The Company received initial written responses from the FDA in June 2011. Among those responses, the FDA noted that in contrast to its earlier position it is now proposing that the trial attempt to isolate Ceplene’s effect by including an IL-2 monotherapy arm in the trial protocol. The Company is expected to meet with the FDA to reconcile the major protocol elements later in 2011. The Company’s other oncology compounds include crolibulin^TM, a novel small molecule vascular disruption agent (“VDA”) and apoptosis inducer for the treatment of patients with solid tumors and lymphomas. In December 2010, the National Cancer Institute (“NCI”) initiated a Phase II clinical trial for crolibulin^TM to assess the drug’s efficacy and safety in combination with cisplatin in patients with anaplastic thyroid cancer (“ATC”). Trial enrollment has progressed to the second dosing cohort and the combination is demonstrating good tolerability. Azixa^TM, an apoptosis inducer with VDA activity licensed by the Company to Myrexis, Inc., as part of an exclusive, worldwide development and commercialization agreement, is currently in Phase II clinical trials in patients with primary glioblastoma and cancer that has metastasized to the brain. The Company’s late-stage pain product candidate, AmiKet^TM cream (formerly known as EpiCept^TM NP-1), is a prescription topical analgesic cream designed to provide effective long-term relief of pain associated with peripheral neuropathies. In February 2011, the Company presented data from its Phase IIb trial for AmiKet^TM in chemotherapy-induced peripheral neuropathy (“CIPN”). The multi-center, double-blind, randomized, placebo-controlled study was conducted within a network of approximately 25 sites under the direction of the NCI funded Community Clinical Oncology Program (“CCOP”). More than 460 cancer survivors suffering from painful CIPN 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 AmiKet^TM group achieved a statistically significant reduction in CIPN intensity versus placebo (p<0.001), which was the trial’s primary endpoint. Secondary efficacy endpoints confirmed the superiority of AmiKet^TM vs. placebo. Furthermore, the safety profile of AmiKet^TM was comparable to placebo. During the second quarter of 2011, the Company commenced designing a Phase III program intended to support a New Drug Application (“NDA”) of AmiKet™ for this indication. A Phase III clinical trial protocol is in preparation and is anticipated to be reviewed with the FDA later this year. A Special Protocol Assessment will be sought for this program. A successful outcome of an end of Phase II meeting with the FDA will provide clarity with respect to clinical data required for approval in CIPN and will help successfully advance ongoing partnership discussions. Other than Ceplene^®, none of the Company’s drug candidates has received FDA or foreign regulatory marketing approval. In order to grant marketing approval, the FDA or foreign regulatory agencies must conclude that the Company’s clinical data and that of its collaborators establish the safety and efficacy of its drug candidates. Furthermore, the Company’s strategy includes entering into collaborative arrangements with third parties to participate in the clinical development and commercialization of its products. In the event that third parties have control over the preclinical development or clinical trial process for a product candidate, the estimated completion date would largely be under control of that third party rather than under the Company’s control. The Company cannot forecast with any degree of certainty which of its drug candidates will be subject to future collaborations or how such arrangements would affect the Company’s development plan or capital requirements. The Company is subject to a number of risks associated with companies in the specialty pharmaceutical industry. Principal among these are risks associated with the Company’s ability to obtain regulatory approval for its product candidates, its ability to adequately fund its operations, dependence on collaborative arrangements, the development by the Company or its competitors of new technological innovations, the dependence on key personnel, the protection of proprietary technology, the compliance with the FDA and other governmental regulations. The Company has yet to generate significant product revenues from any of its product candidates. The Company has financed its operations primarily through the proceeds from the sales of common stock, warrants, debt instruments, cash proceeds from collaborative relationships and investment income earned on cash balances and short-term investments.

1. Organization and Description of Business

EpiCept is a specialty pharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company’s strategy is to focus its development efforts on innovative cancer therapies and topically delivered analgesics targeting peripheral nerve receptors. The Company’s lead product is Ceplene^®, which when used concomitantly with low dose interleukin-2 (“IL-2”) is intended as remission maintenance therapy in the treatment of acute myeloid leukemia, or AML, for adult patients who are in their first complete remission. In addition to Ceplene^®, the Company has two other oncology compounds and a late-stage pain product candidate for the treatment of peripheral neuropathies in clinical development. The Company believes this portfolio of oncology and pain management product candidates lessens its reliance on the success of any single product or product candidate.

In January 2010, EpiCept completed an agreement with Meda AB of Sweden to market and sell Ceplene^® in Europe and certain Pacific Rim countries. The commercial launch of Ceplene^® commenced in the United Kingdom in April 2010 and launches are continuing in other European countries. In December 2010, Ceplene^{^®}was approved for marketing in Israel. Following Ministry of Health approval of labeling and other technical matters, Megapharm Ltd., EpiCept’s marketing partner, is expected to commence the commercial launch of Ceplene^®.

In October 2010, the Company conferred with the United States Food and Drug Administration (“FDA”) and verbally agreed on the design of a new confirmatory study of Ceplene^® comparing the efficacy of Ceplene^® plus low-dose IL-2 to standard of care in this indication. Based on FDA guidance, the primary endpoint of the trial will be overall patient survival. In May 2011, EpiCept submitted to the FDA a detailed Phase III protocol. The Company received initial written responses from the FDA in June 2011. Among those responses, the FDA noted that in contrast to its earlier position it is now proposing that the trial attempt to isolate Ceplene’s effect by including an IL-2 monotherapy arm in the trial protocol. The Company is expected to meet with the FDA to reconcile the major protocol elements later in 2011.

The Company’s other oncology compounds include crolibulin^TM, a novel small molecule vascular disruption agent (“VDA”) and apoptosis inducer for the treatment of patients with solid tumors and lymphomas. In December 2010, the National Cancer Institute (“NCI”) initiated a Phase II clinical trial for crolibulin^TM to assess the drug’s efficacy and safety in combination with cisplatin in patients with anaplastic thyroid cancer (“ATC”). Trial enrollment has progressed to the second dosing cohort and the combination is demonstrating good tolerability. Azixa^TM, an apoptosis inducer with VDA activity licensed by the Company to Myrexis, Inc., as part of an exclusive, worldwide development and commercialization agreement, is currently in Phase II clinical trials in patients with primary glioblastoma and cancer that has metastasized to the brain.

The Company’s late-stage pain product candidate, AmiKet^TM cream (formerly known as EpiCept^TM NP-1), is a prescription topical analgesic cream designed to provide effective long-term relief of pain associated with peripheral neuropathies. In February 2011, the Company presented data from its Phase IIb trial for AmiKet^TM in chemotherapy-induced peripheral neuropathy (“CIPN”). The multi-center, double-blind, randomized, placebo-controlled study was conducted within a network of approximately 25 sites under the direction of the NCI funded Community Clinical Oncology Program (“CCOP”). More than 460 cancer survivors suffering from painful CIPN 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 AmiKet^TM group achieved a statistically significant reduction in CIPN intensity versus placebo (p<0.001), which was the trial’s primary endpoint. Secondary efficacy endpoints confirmed the superiority of AmiKet^TM vs. placebo. Furthermore, the safety profile of AmiKet^TM was comparable to placebo. During the second quarter of 2011, the Company commenced designing a Phase III program intended to support a New Drug Application (“NDA”) of AmiKet™ for this indication. A Phase III clinical trial protocol is in preparation and is anticipated to be reviewed with the FDA later this year. A Special Protocol Assessment will be sought for this program. A successful outcome of an end of Phase II meeting with the FDA will provide clarity with respect to clinical data required for approval in CIPN and will help successfully advance ongoing partnership discussions.

Other than Ceplene^®, none of the Company’s drug candidates has received FDA or foreign regulatory marketing approval. In order to grant marketing approval, the FDA or foreign regulatory agencies must conclude that the Company’s clinical data and that of its collaborators establish the safety and efficacy of its drug candidates. Furthermore, the Company’s strategy includes entering into collaborative arrangements with third parties to participate in the clinical development and commercialization of its products. In the event that third parties have control over the preclinical development or clinical trial process for a product candidate, the estimated completion date would largely be under control of that third party rather than under the Company’s control. The Company cannot forecast with any degree of certainty which of its drug candidates will be subject to future collaborations or how such arrangements would affect the Company’s development plan or capital requirements.