Innovation Pharmaceuticals Inc (IPIX)

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SeekingAlpha News Alert: Cellceutix jumps on QIDP tag

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Micro cap Cellceutix (OTCPK:CTIX +22.1%) jumps on a 5x surge in volume after the FDA grants Qualified Infectious Disease Product (QIDP) status to Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The company is scheduled to meet with the FDA later this month on a planned Phase 3 trial evaluating the safety and efficacy of Brilacidin for ABSSSI.

Brilacidin is a member of a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the "front line" of defense in the human immune system.

In a Phase 2b clinical trial, a single dose of Brilacidin demonstrated equivalent effectiveness as a seven-day regimen of daptomycin (CBST +35.4%) for the treatment of ABSSSI.

Among the benefits of QIDP is Fast Track and Priority Review status and a five-period of market exclusivity if approved.