Facts at a Glance
Facts at a Glance

EpiCept is pursuing numerous commercial opportunities targeting large, growing and underserved patient populations. A primary therapeutic focus area of the Company is in the development of product candidates with significant competitive advantages to treat cancer. Cancer is the second leading cause of death in the U.S. Half of all men and one third of all women in the U.S. will develop cancer during their lifetimes.

Concurrently, EpiCept is focused on the development of prescription topical pain therapies. According to Wolters Kluwer Health data, the total U.S. market for prescription pain management pharmaceuticals equaled $18.7 billion in 2005, representing approximately a six percent compound annual growth rate since 2001. In 2005, analgesics were the fourth most prescribed class of medications in the U.S., with over 246 million prescriptions written.

Therapeutic targets of EpiCept’s product candidates include:



Acute Myelod Leukemia (Target of Ceplene®)

  • Ceplene® (histamine dihydrochloride) has received marketing authorization by the European Commission and will be launched in Europe by Meda AB in 2010.
  • Acute Myeloid Leukemia (AML) is the most common form of acute leukemia in adults.
  • There are an estimated 47,000 AML patients in the EU and over 30,000 AML patients in the U.S.
  • The majority of AML patients who enter into complete remission, experience a relapse of leukemia, usually within one to two years.
  • There are currently no approved relapse-preventative medical therapies available to AML patients.
  • Currently, the standard of care for AML patients in remission is no treatment.
  • An NDS was filed in Canada during 2009 and an NDA filing is expected in 2010.

Peripheral Neuropathy (Target of EpiCept™ NP-1)

  • Peripheral neuropathy, a medical condition caused by damage to the nerves in the peripheral nervous system, affects over 15 million people in the U.S.
  • Post-herpetic neuralgia (PHN), a specific peripheral neuropathic pain associated with herpes zoster, or shingles, affects over 100,000 people in the U.S. each year.
  • Diabetic peripheral neuropathy is the most common type of neuropathic pain, affecting over 320,000 people in the U.S.

Solid Tumors (Target of Crolibulin™)

  • Crolibulin™ is a novel small molecule vascular disruption agent, or VDA, and apoptosis inducer for the treatment of patients with solid tumors.
  • In May 2009 EpiCept announced the completion of a Phase Ia study that determined Crolibulin’s maximum tolerated dose and provided evidence of clinical symptomatic activity and radiographic evidence of efficacy in end-stage cancer patients. The Company is making preparations to initiate a Phase Ib trial for the compound in combination with other chemotherapeutic agents.
  • 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.
  • In preclinical tumored animal models, combination therapy has demonstrated synergistic activity.