Investors are aware of the difficulty of getting a drug or medical solution developed, tested, approved and eventually, sold. In recent years, the chances of getting new medicines to market have been cut in half.
In a Reuters article on the subject Alan Eisenberg, head of emerging companies and business development for the biotech trade group Biotechnology Industry Organization (BIO), summed up the difficulty: "It ain't getting any easier to develop new therapies."
That it ain't. Therefore, knowledge and savvy investing are paramount. "Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing," he said.
But the good news for Citius and its shareholders is that, 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. In addition, current and potential shareholders should be pleased to know that once a drug therapy or medical solution has entered Phase III trials, there is an approximately 80% chance the product will be approved, according to 2011 figures.
The Phase 3 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.
Citius has begun recruitment of sites for the trial. The first patient is expected to be enrolled in early 2017. Medpace, (NASDAQ GS: MEDP), based in Cincinnati, OH, has been designated as the trial management clinical research organization (CRO).
In a previous press release, Mr. Myron Holubiak, President and CEO stated, "This is a major milestone for Citius as our lead product is entering registration trials. Mino-Lok™ has the potential to become a standard of care (SOC) for treating CRBSIs."
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