Clinical

P128:A topical therapeutic for prophylactic purposes –

Nasal clearance of S.aureus– first in human study (StaphTAME)

A clinical trial entitled “A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Pharmacokinetics, Immunogenicity, Safety and Tolerability of P128 Applied to Anterior Nares of Adult Healthy Volunteers (Part Aand Part B),a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Determine the Safety and Efficacy of P128 Applied to Anterior Nares of Patients with Chronic Kidney Disease who are on Dialysis and who are Nasal Carriers of S.aureus including Methicillin Resistant S.aureus (Part C) and a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Determine the Safety And Efficacy of P128 Applied to Anterior Nares of Patients clinically in stable condition who are otherwise generally healthy and who are Nasal Carriers of S.aureus including Methicillin Resistant S.aureus (Part D)” is completed.

This study was conducted in four parts: a single-dose, dose-escalating safety and PK evaluation in healthy volunteers (Part A); a multi-dose, dose-escalating safety and PK evaluation in healthy volunteers (Part B); safety and efficacy evaluation in chronic kidney disease patients who were on dialysis and were nasally colonized with S.aureus (Part C); and safety and efficacy evaluation in patients with any medical condition who were nasally colonized with S.aureus(Part D).

Study Rationale

Studies have shown that 25 to 30% of the human population is nasally colonized by S.aureus at any given time. A causal relationship between nasal colonization with S.aureus and subsequent infection at other sites has been established in various clinical and community settings. Several studies have demonstrated that the risk of nosocomial infections of both the bloodstream and the lower respiratory tract is higher among patients who carry S.aureus in their nares, and that carriers of S.aureus are two to nine times as likely as non-carriers to develop surgical-site infections. Therefore clearing nasal S.aureusis expected to result in reduction in incidence of infection in patients with wounds or otherwise compromised skin of various origins.

Study Design

This study was designed to accomplish two goals:

To determine the adverse event profile associated with application of P128 in a gel formulation (P128) to the nares of human subjects

To determine effectiveness of P128 in clearing nasal S.aureus

For more information about GangaGen’s clinical trials, please see www.clinicaltrials.gov.

"NCT01746654"

P128: Topical therapeutic application

Rate of Clearance of Staphylococcus infected venous ulcer

The second planned indication to be investigated is the treatment of S.aureus-infected Venous ulcer with P128 to clear the infection and improve healing. An exploratory, investigator-sponsored study to determine safety of P128 when applied to S.aureus-infected venous ulcers is being planned. Based on results of this study, a Phase 2 study to determine whether P128 can be effective in significant reduction of Staphylococcus CFU count which would in turn may improve the rate of healing of S.aureus-infected wounds will be conducted. If successful, pivotal studies will be conducted in a broader range of wound types.

P128: Systemic therapeutic application

There exists an unmet medical need for rapid acting agents that can reduce the complications of Bacteremia caused by the Staph genus. The ability of P128 to rapidly reduce the bacterial burden has been established in several in vitro and ex vivo models. P128 has also been shown to significantly augment the action of standard of care antibiotics in different animal models of infection.