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News Release - April 10, 2007
EpiCept Initiates Two Phase IIb Trials with NP-1Studies Intended to Broaden Market Potential for Neuropathic Pain Uses
TARRYTOWN, N.Y., April 10 (HSMN NewsFeed) -- EpiCept Corporation (Nasdaq and OMX Stockholm: EPCT) today announced the initiation of two Phase IIb trials with EpiCept(TM) NP-1, a topical prescription analgesic cream for the long-term relief from the pain of peripheral neuropathies. Peripheral neuropathy, a medical condition caused by damage to the nerves in the peripheral nervous system, affects more than 15 million people in the U.S. alone and is associated with such conditions as herpes zoster (shingles), diabetes, HIV/AIDS and other diseases.
The two Phase IIb trials will enroll a total of 700 patients. The first trial is a 200 patient, placebo- controlled study of NP-1 in patients with diabetic peripheral neuropathy (DPN). More patients suffer from DPN than any other type of neuropathic pain. Only two medications are currently approved for this use. The trial is intended to confirm and expand upon earlier work on a smaller scale which provided an efficacy signal in this type of neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. Preliminary results are expected by the fourth quarter of 2007.
The second trial is a 500 patient, placebo- and active-controlled trial in peripheral herpetic neuropathy (PHN). This trial will compare the efficacy and safety of NP-1 vs. gabapentin as well as placebo. NP-1 has already shown in a prior 149 patient, Phase II dose ranging study a pronounced efficacy signal vs. placebo in this type of neuropathic pain. This active comparator trial is one of the first such efforts to examine any candidate compound at this scale in neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. Preliminary results are expected in the first quarter of 2008.
The results of these trials are intended to broaden NP-1's labeling within peripheral neuropathies and raise the product candidate's future market potential. There are only four drugs approved for the treatment of neuropathic pain and three of the four have had annual sales in excess of $1 billion. NP- 1, were it to be approved, may have a similarly large market potential.
"We are pleased to advance this important product candidate and to have achieved another key milestone for EpiCept in 2007," stated Jack Talley, President and Chief Executive Officer of EpiCept. "We believe NP-1 has the largest market potential of any of our pain product candidates and is a valuable component of our diversified portfolio of pain management programs and high-potential compounds for the treatment of cancer. The results of our NP-1 Phase IIb trials should enable us to broaden the known therapeutic signal with NP-1 and establish the drug as a superior therapy compared to the market leader, gabapentin."
EpiCept's Approach to Treating Pain
EpiCept's pain product candidates are designed to topically deliver FDA- approved pain management therapeutics directly to the surface of the skin, thereby blocking the ability of peripheral nerve receptors to transmit pain messages to the brain, which in turn will provide significant pain relief, with fewer adverse side effects, fewer drug to drug interactions and lower potential for abuse than systemically delivered analgesics. In addition to NP- 1, EpiCept is also pursuing two other pain product candidates that are nearing pivotal scale clinical trials: LidoPAIN® SP, a sterile analgesic patch designed to provide sustained topical delivery of lidocaine to a post-surgical or post-traumatic sutured wound; and LidoPAIN® BP, a 24-hour patch that provides topical delivery of lidocaine for acute back pain. EpiCept has a worldwide commercialization agreement for LidoPAIN BP with Endo Pharmaceuticals Inc.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer. EpiCept has a staged portfolio of pharmaceutical product candidates with several pain therapies in late-stage clinical trials, and a lead oncology compound (for acute myeloid leukemia, or AML) with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound has been submitted in Europe. EpiCept is based in Tarrytown, N.Y., and its research and development team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis.
This news release and any oral statements made with respect to the information contained in this news release, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements which express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on EpiCept's current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risk that Ceplene will not receive regulatory approval or marketing authorization in the EU, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that the anticipated market potential for our product candidates is not realized, the risk that EpiCept will not obtain approval to market any of its product candidates, the risks associated with reliance on additional outside financing to meet its capital requirements, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; competition; litigation; risks associated with our ability to maintain our listing on The Nasdaq Capital Market; risks associated with our ability to have our common stock readmitted to trading on The Nasdaq Global Market; risks associated with prior material weaknesses in our internal controls; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in EpiCept's periodic reports, including its reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in EpiCept's filings which are available at www.sec.gov or at www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
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