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EpiCept redesigning phase 3 clinical program for LidoPain SP
By Jennifer Lanning Drey
Portland, Ore., Oct. 19 - EpiCept Corp. is redesigning its phase 3 clinical program for LidoPain SP and plans to carry out a repeat phase 3 clinical trial, president and chief executive officer Jack Talley said at the 2006 BIO InvestorForum in San Francisco on Thursday.
The company previously announced that phase 3 data did not replicate the positive results demonstrated by LidoPain SP, an adhesive analgesic patch for post-surgical incision pain, in phase 2 clinical trials.
However, Talley said on Thursday that the company has studied the differences in the two trials and believes it has found a possible reason for the differing data: patients in the phase 3 clinical trial were permitted to have their wounds infiltrated with lidocaine before leaving the hospital, and patients in the phase 2 trial were not permitted to do so.
"In retrospect, [phase 2] was a better design, and that is the approach we intend to use in a repeat phase 3 trial here going forward," he said.
The company is also preparing to start a pivotal phase 2b clinical trial of LidoPain BP, its lidocaine adhesive analgesic patch. The company is studying the patch with Endo Pharmaceuticals Holdings Inc.
EpiCept has met with the Food and Drug Administration for an end-of-phase-2 meeting and is currently preparing LidoPain BP for scale up in acute back pain, he said.
The company's current cash burn rate is roughly $6.5 million per quarter. Cash and investments were $8.3 million at June 30, and EpiCept completed a debt refinancing during the third quarter that raised that number to about $18 million, according to Talley.
EpiCept is an emerging specialty pharmaceutical company located in Englewood Cliffs, N.J.
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