Dipexium Pharmaceuticals today provided an update of its development activities and announced its milestones to be achieved during 2011. Management announced that it has completed successfully initial six-months' stability testing on the original formulation of Locilex™ (pexiganan acetate 1% cream) and has moved on with its manufacturers to expand the batch size for clinical and commercial production. In addition, the Company has received formal and clear clinical guidance from the FDA to support its Phase 3 clinical and regulatory pathway to resubmission of its new drug application (NDA) for Locilex™ in the U.S.
The Company also announced that its critical milestones for 2011 include the following:
- Manufacturing: The Company anticipates completing the work required to support its chemistry, manufacturing and controls (CMC) meeting with FDA in May 2011;
- CMC Meeting: The Company anticipates convening a CMC meeting with FDA in August 2011 to finalize the Company's manufacturing plans and use of product supply in the upcoming Phase 3 program;
- Special Protocol Assessment (SPA) Filing: The Company intends to file for a SPA designation in September 2011 shortly after the tentatively planned scheduled CMC meeting.
"Successfully achieving these value-inflection points should significantly reduce the risk associated with completing the drug development of Locilex™ and position the Company for further financing or other strategic alternatives," stated David P. Luci, Co-Founder & Managing Partner.
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