Statistics Show that the Phase III Trial Therapy Has an 80% Chance of FDA Approval
SANTA MONICA, CA / ACCESSWIRE / January 12, 2017 / Online Media Group covers Citius Pharmaceuticals, Inc. (OTC PINK: CTXR). The difficulty of getting a drug or medical solution developed, tested, approved and eventually sold, isn't news to investors in this risky space. In recent years, the chances of getting new medicines to market has been cut in half. Some never make it to Phase II trials, and even fewer don't make it to Phase III trials.
In fact, while some 63 percent of drugs in Phase I testing advanced to Phase II, only 33 percent of Phase II drugs made it to Phase III, which is typically final stage of human testing before a new drug is submitted to regulators. The difficulty of getting this far on the road to commercialization illustrates the magnitude of Citius Pharmaceuticals' success. Luckily for Citius Pharmaceuticals, a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, when medicines do beat the odds and make it into Phase III trials, there's an 80% probability they will be approved by the FDA.
Recently, Citius announced that the clinical trial activities for the pivotal Phase III trial for its flagship therapy, Mino-Lok™. an antibiotic lock solution used to salvage infected central venous catheters (CVCs) and to treat catheter related bloodstream infections (CRBSIs), was underway. This represents a significant milestone for Citius whose chances of brining Mino-Lok™ to market just increased exponentially.
Recently, Citius announced that the manufacturing of the clinical trial components (which consists of minocycline HCl in the first pre-mix component and a solution of disodium EDTA and ethanol in the second component) have been finalized; and, the two components are being assembled for distribution to the clinical trial sites.
Citius has stated that the clinical trial startup activities are underway and the company is in the process of the recruiting and qualifying trial sites, with the patient expected to be enrolled in the first quarter of 2017.
The Phase III trial is a multi-center, randomized, double-blind study of 700 subjects. The primary endpoint is the measurement of a significant proportion of subjects having overall success in maintaining the treated CVCs at the test of cure at week 8. Secondary endpoints include the safety and tolerability as described by adverse events, serious adverse events (SAEs), vital signs, clinical laboratory evaluations, and physical examinations.
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