LONDON, UK / ACCESSWIRE / October 26, 2016 / Active Wall St. blog coverage looks at the headline from Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) as the company's stock price plunged 78% on October 25th, 2016, following news that the Phase 3 trial of the drug maker's treatment for diabetic foot ulcers failed to meet its goals. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.
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Dipexium Pharmaceuticals announced that the OneStep-1 and OneStep-2 Phase 3 clinical trials of Locilex® in patients with mild infections of diabetic foot ulcers (Mild DFI) did not meet the primary clinical endpoint of superiority versus vehicle plus standardized wound care and also did not show any meaningful difference in wound closure rate between the Locilex arm and the vehicle arm in each study. Neither trial met the secondary endpoint of demonstrating a higher rate of eradication of bacteria for the Locilex arm. While the overall adverse event incidence was comparable to vehicle alone, serious adverse events with Locilex included higher than anticipated osteomyelitis and cellulitis in the Locilex arm of each study.
David P. Luci, President and CEO of Dipexium, stated:
"Although we are disappointed with these results, we are continuing to evaluate the data and will consider potential regulatory pathways forward in other possible clinical indications based on an evaluation of all data emerging from the Phase 3 studies."
Robert J. DeLuccia, Executive Chairman of Dipexium, emphasized:
"The OneStep trials were the first ever 'placebo'-controlled studies conducted for mildly infected diabetic foot ulcers. In these studies, the 'placebo' was the cream vehicle without pexiganan, the active pharmaceutical ingredient in Locilex. These complex trials required stringent standardized wound care, in both study arms, including ulcer debridement, daily wound dressing changes and pressure off-loading devices. Since antibiotics are generally used by clinicians to treat an infected ulcer, no clinical trial in diabetic foot infection has ever established a 'response rate' for an ulcer infection that had standardized wound care but was untreated with an antibiotic."
What is OneStep-1 and OneStep-2 Pivotal Phase 3 Clinical Trials?
OneStep-1 and OneStep-2 were identical, double-blind, placebo-controlled clinical trials conducted simultaneously that enrolled a total of 389 patients at 59 separate centers in the United States. These trials were conducted to establish the clinical superiority and safety of topical Locilex® plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of Mild DFI. Patients were randomized 1:1 to receive topical Locilex® plus standard local wound care or placebo cream plus standard local wound care for 14 days, with final evaluation at day 28. The FDA had agreed to a Special Protocol Assessment (SPA) with Dipexium for Locilex®'s pivotal Phase 3 clinical trial program in Mild DFI.
The trial failure comes as a major blow to Dipexium as it was one of the major products in its pipeline. In its earnings results announced on August 4th, Dipexium reported a net loss of $5.4 million compared to a net loss of $4.0 million for the three months ended June 30, 2015. Net cash used in operating activities for the six months ended June 30, 2016, was $9.7 million, and as of June 30, 2016, the Company had cash and short-term investments of $22.6 million. The Company's cash balance is currently anticipated to fund operations through 2017 and with the failure of the current trial it might need to raise more capital or achieve breakthrough from the trial, which looks a bit difficult considering the recent results.
On Tuesday, the stock closed the trading session at $2.80, nose-diving 78.04% from its previous closing price of $12.75. A total volume of 21.97 million shares have exchanged hands, which was higher than the 3-month average volume of 63.39 thousand shares. The stock currently has a market cap of $27.94 million.
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SOURCE: Active Wall Street