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EpiCept Corporation
Medical Devices & Tech
777 Old Saw Mill River Road
Tarrytown, NY 10591 USA
phone:914 606-3500
fax:
Symbol EPCT.PK
Exchange OTC
Founded 1993
Employees 14
www.epicept.com
Research Sector Medical Devices & Tech
Summary Description
Pharmaceutical products for the treatment of cancer and pain.
Management
John V. Talley, President and CEO; Robert W. Cook, CFO and SVP Finance and Administration; Stephane Allard, Chief Medical Officer; Dileep Bhagwat, SVP, Pharmaceutical Development
Ownership
Financials Mkt Cap :19
* numbers in thousands
 

Keywords
Oncology, Ceplene, AML, acute myeloid leukemia, neuropathic pain, NP-1, PHN, post herpetic neuralgia, vascular disruption agent, VDA, AML remission maintenance

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Updated: Feb. 01, 2012

Description
EpiCept Corporation is a specialty pharmaceutical company that develops novel therapies in the areas of cancer and pain. Ceplene® is the Company’s lead product, and has been granted full marketing authorization by the European Commission for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in their first complete remission. Ceplene® is available in the EU and Israel, and is now in Phase III development in the US. The Company also has two oncology drug candidates currently in clinical development, which were discovered using in-house technology and have been shown to act as vascular disruption agents against a variety of solid tumors. Additionally, this later-stage biotechnology company is advancing prescription pain products that use a topical delivery approach, rather than systemic or injectable modes, to treat acute and chronic pain; the Company’s pain portfolio includes EpiCept NP-1, a prescription analgesic cream in late-stage clinical development that is designed to provide effective long-term relief from pain associated with peripheral neuropathies.
Products / Services
1. Name: Ceplene
Indication: Acute Myeloid Leukemia Remission Maintenance Therapy
Description: Ceplene (histamine dihydrochloride), which has received marketing authorization by the European Commission, is administered in conjunction with low dose interleukin-2 (IL-2), for maintenance of first remission in patients with Acute Myeloid Leukemia (AML). AML is the most common type of leukemia in adults. There are approximately 12,000 new cases of AML and 9,000 deaths caused by this cancer each year in the U.S. There are approximately 47,000 AML patients in the EU, with 16,400 new cases occurring each year. There are currently no other effective medical-based remission therapies for AML patients.

AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis, and typically become free of detectable leukemia ("complete remission"). However, the majority of patients will experience a relapse of leukemia, usually within one to two years. The survival prognosis after a leukemic relapse is poor. Approximately 75-80 percent of patients who achieve their first complete remission will relapse, and the median time in remission before relapse is only 12 months with current treatments.

Treatment with Ceplene in conjunction with low dose IL-2 is designed to prevent leukemic relapses in AML patients in remission and prolong leukemia-free survival while maintaining a good quality of life for patients during treatment.

In a Phase III clinical study of 320 patients, Ceplene met its primary endpoint of increased leukemia-free survival (p <0.01) among AML patients in remission. The results of this trial were published in Blood, a leading scientific journal in hematology, (Blood; The Journal of the American Society of Hematology, volume 108, number 1, pp. 88-96, July 1, 2006).


2. Name:Azixa
Indication: Brain Cancer
Description:EP90745 is a series of apoptosis inducer compounds for the treatment of cancer. In December 2003, EpiCept granted an exclusive, worldwide development commercialization agreement for the EP90745 series to Myrexis, Inc. Myrexis (formerly Myriad Pharmaceuticals, Inc.) has taken on the responsibility for the clinical development and commercialization of this series of compounds, which includes Azixa (MPC6827). The license agreement calls for Myrexis to pay milestone payments, license fees and research support, as well as a royalty to EpiCept on sales of EP90745-related products, assuming successful commercialization of any compound within the EP90745 series.

In August 2006, Myrexis reported positive clinical results for Azixa, the lead compound in the series, in a total of 66 patients ? the first confirmed clinical proof of concept for EpiCept?s proprietary live cell high-throughput caspase-3 screening technology. Myrexis reported that in a Phase I study of Azixa in cancer that has metastasized to the brain, the drug achieved its maximum tolerated dose in patients. Myrexis also noted a measured reduction in tumor size in certain patients, suggesting evidence of activity. Azixa? is now in Phase II clinical development.

In November 2009 Myrexis announced interim results of its trial of Azixa in melanoma metastases in which ten of the 22 patients treated achieved stable disease and two patients achieved confirmed partial responses. The median progression-free survival was 2.8 months. Azixa has received orphan drug status in the United States for the treatment of glioblastoma.

In June 2010, Myrexis provided an update at the meeting of the American Society of Clinical Oncology (ASCO). In the glioblastoma trial, six subjects achieved stable disease and two subjects had achieved partial responses. One subject?s partial response duration was 7.8 months; the additional patient?s response was, at the time of the ASCO report, 16 months in duration and has been classified as almost a complete response.

In November 2010, Myrexis presented a poster with updated results from ongoing open?label Phase II monotherapy study of Azixa in treatment-experienced patients with glioblastoma multiforme (GBM) at the Society for Neuro-Oncology Scientific Meeting and Education Day in Montreal Canada.

In December 2010, EpiCept reported that Myrexis had initiated a controlled two-arm Phase IIb study of Azixa as a front-line treatment for GBM. The study will enroll up to 120 newly diagnosed GBM patients in the U.S. and India in order to evaluate Azixa combination therapy as a first line GBM treatment. The trial will compare standard of care in this disease with standard of care in combination with Azixa.

The dosing of the first patient in a Phase III trial triggers a milestone payment to EpiCept.


3. Name:Crolibulin
Indication: Solid Tumors
Description: Crolibulin is a novel small molecule vascular disruption agent and apoptosis inducer for the treatment of patients with advanced solid tumors. Crolibulin has shown promising vascular targeting activity with potent anti-tumor activity in pre-clinical in vitro and in vivo studies. The molecule has been shown to induce tumor cell apoptosis and selectively inhibit growth of proliferating cell lines, including multi-drug resistant cell lines. Murine models of human tumor xenografts demonstrated crolibulin inhibits growth of established tumors of a number of different cancer types. Two manuscripts on this compound were published in the November 2004 issue of Molecular Cancer Therapeutics.

Pre-clinical studies suggest that the anti-tumor effects of crolibulin may be the result of a dual mechanism, a direct effect on disruption of tumor vascular endothelial cells leading to hypoxia and central tumor necrosis, as observed with vascular disruption agents, and a second effect on tumor apoptosis.


4. Name: AmiKet
Indication: Relief of pain associated with neuralgia due to diabetes (DPN), chemotherapy (CPN) or shingles in adults (PHN)
Description: AmiKet is a prescription topical analgesic cream 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. It is estimated that these conditions affect more than 15 million people in the U.S. These conditions are caused from injured peripheral nerves, following herpes zoster, or shingles, diabetes, chemotherapy, HIV and other diseases. Peripheral neuropathies can also be caused by trauma or may result from surgical procedures. AmiKet? 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 anesthetic).

A four-week, Phase IIb 200-patient trial in diabetic peripheral neuropathy (DPN) has been performed (Neuracept) in this type of neuropathic pain, the results of which were reported in February 2008. The Neuracept trial was a double blind, placebo-controlled study of AmiKet in 215 DPN patients who completed the trial. The data demonstrated that the primary endpoint, the difference in changes in pain intensity between AmiKet and placebo over the four week duration of the trial, nearly reached statistical significance (p=0.0715). Key secondary endpoints measured in the trial indicate that 60% of patients in the AmiKet treatment arm achieved a reduction of pain scores of at least 30% compared with 48% of patients in the placebo arm (p=0.076). In addition, 33% of patients in the AmiKet treatment arm achieved a reduction in pain scores of at least 50% compared with 21% of patients in the placebo arm (p=0.078). All pain scores measured trended in favor of the AmiKet treated patients over the placebo group, indicative of an analgesic effect. The preliminary data derived from the trial support the continued study of AmiKet in a late-stage pivotal clinical trial.

In January 2009, the results of a four-week, Phase IIb, 360- patient trial in post-herpetic neuralgia (PHN) were reported. The trial compared the efficacy and safety of AmiKet against both gabapentin and placebo. The data demonstrated that AmiKet achieved statistically significant superior efficacy compared with placebo (p=0.024). An additional primary endpoint, to demonstrate that AmiKet was not inferior to gabapentin in reducing pain, was also met. A key secondary endpoint measured in the trial from a responder analysis indicated that 63% of patients in the AmiKet treatment arm achieved a reduction in pain scores of at least 30%, significantly higher than that of patients in the placebo arm (p=0.033). Data results further indicate that AmiKet achieved a superior safety profile when compared with gabapentin, especially with regard to dizziness and somnolence, as evaluated by the reporting of adverse events.
Competitors / Substitutes / Alternatives
There is no treatment available that reduces the risk of relapse in AML patients. Ceplene is the only therapy approved (in the E.U.) for this purpose.

The market for neuropathic pain is currently served by products from Pfizer, Lilly, and Endo. However, no product appears to work in more than half of the patients and a significant need exists for more effective therapies.