ENGLEWOOD CLIFFS, N.J., Aug. 17 /PRNewswire-FirstCall/ -- EpiCept Corporation announced today that patient enrollment in its multi-center, randomized, double-blind, placebo controlled Phase III pivotal trial in Europe for the Company’s LidoPAIN(R) SP product candidate has been completed. LidoPAIN(R) SP is a sterile prescription analgesic patch designed to provide sustained topical delivery of lidocaine to a post-surgical or post-traumatic sutured wound while also providing a sterile protective covering for the wound. Currently, there is no marketed product similar to LidoPAIN(R) SP.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )
“We believe this Phase III trial is designed to adequately support a LidoPAIN(R) SP marketing application in Europe. In addition, as part of our strategic alliance with Adolor, clinical trials for this product candidate in North America are progressing. We anticipate being able to share the results of the Phase III trial later this month,” stated Jack Talley, President and CEO of EpiCept Corporation.
The potential applications for LidoPAIN(R) SP may include both inpatient and ambulatory surgical procedures: hernia repair, plastic surgery, puncture wounds, biopsy, cardiac catheterization, and tumor removal, among others. Mr. Talley continued, “Completing enrollment in this clinical trial marks a significant milestone in bringing LidoPAIN(R) SP closer to market. We are committed to developing easy-to-use, topically-delivered prescription analgesics, which will help to reduce the need for systemic delivery of narcotic analgesics and NSAIDS, and the negative side-effects that can result.”
About the Phase III Study
The clinical trial is a randomized, double-blind, placebo-controlled trial in which 569 subjects who underwent hernia repair received one 9.5 percent LidoPAIN(R) SP patch or a placebo patch for 48 hours. The primary endpoints are self-assessed pain intensity at various times from 4 to 24 hours as well as rescue medication. The secondary endpoints include pain intensity over the 48-hour duration of the study and global satisfaction among others.
About the Phase II Study
In December 2001, EpiCept initiated a randomized, double-blind, placebo-controlled Phase II clinical trial in 221 subjects who underwent hernia repair. The Company conducted the clinical trial in nine surgical centers in Germany. Subjects were randomized to receive two different doses of lidocaine, 9.5 percent and 3.5 percent, or placebo, in a patch applied once each day for two days. Subjects were not allowed to take any supplemental analgesics. EpiCept completed the analysis of this clinical trial in January 2003.
The primary endpoint was subject pain self-assessment at various intervals during the 48-hour period following the subject’s surgery and the secondary endpoint was the number of “rescues,” i.e., subjects receiving systemically-delivered analgesics to alleviate pain. The results of this trial indicate that the 9.5 percent formulation of LidoPAIN(R) SP provided an analgesic effect in the patients. A dose-related response was also observed, with subjects receiving the higher dose reporting a greater reduction in pain and fewer rescues. No significant adverse reactions were observed.
About EpiCept Corporation
EpiCept is an emerging specialty pharmaceutical company focused on unmet needs in the treatment of pain and cancer. The Company has a staged portfolio with several pain therapies in late-stage clinical trials, and a lead oncology compound (for AML) with demonstrated efficacy in a Phase III trial; the compound is intended for commercialization in Europe. EpiCept is based in New Jersey, and the Company’s research and development team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the efficacy, safety, and intended utilization of the Company’s product candidates, the conduct and results of future clinical trials, the sufficiency of the Company’s existing capital resources, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that the Company will not obtain approval to market its products, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in the Company’s periodic reports and other filings with the SEC.
EPCT - GEN
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comEpiCept Corporation
CONTACT: Robert W. Cook of EpiCept Corporation, +1-201-894-8980,rcook@epicept.com; or Francesca T. DeVellis of Feinstein Kean Healthcarefor EpiCept Corporation, +1-617-577-8110, francesca.devellis@fkhealth.com
Web site: http://www.epicept.com/
