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Amid litigation, Cellceutix aims for late-stage trial of antibiotic next year

As Beverly biotech Cellceutix Corp. fights back against recent attacks by investors, it’s not slowing down plans to begin late-stage trials early next year of an antibiotic that would take on recently-approved ones by The Medicines Company as well as older ones by Cubist used to treat skin infections.

Executives at Cellceutix (OTC: CTIX) believe the company’s drug in development, called brilacidin, boast that the drug has several advantages which over existing antibacterials for acute bacterial skin and skin structure infections (called ABBBSI for short). A so-called defensin-mimetic, it’s a synthetic version of a baceria fighting protein in the body which is also believed to reduce inflammation. It’s also an entirely new class of antibiotic from those in development at local biotechs like Tetraphase Pharmaceuticals (Nasdaq: TTPH), Paratek Pharmaceuticals (Nasdaq: PRTK) or those created by the former Lexington biotech Cubist, which was bought by Merck & Co. (NYSE: MRK) earlier this year in a $9.5 billion deal.

That’s important, says Dan Jorgensen, the company’s chief medical officer, because it presumably means bacteria would take longer to grow resistant to brilacidin than others.

“Bacteria have already been exposed to them,” he said of existing classes of antibiotics like tetracyclines or glycopeptides. “When you have a newer version of on older class of antibiotic, bacteria can become resistant to it pretty easily.”

But new classes are considered much harder to discover and develop. Cellceutix bought brilacidin from a Pennsylvania biotech that went bankrupt in April 2013 after finishing Phase 2a trials of the drug. CEO Leo Ehrlich told me shortly after Cubist’s acquisition that the $5 million purchase “made it look like we were absolute geniuses,” since the drug had already been largely developed.

Another distinguishing factor of brilacidin, said Jorgensen, is that it would just require a single intravenous administration. That also differentiates it from Cubicin, Cubist’s flagship antibiotic approved in 2003, which requires patients to take pills for a week after the IV. In fact, Ehrlich says there is only one approved drug that can be given a single time for treating ABSSSI, Orbactiv, approved by the FDA last year and marketed by The Medicines Company (Nasdaq: MDCO).

Today Cellceutix issued an update largely to say that it has smoothed out the manufacturing process for brilacidin in anticipation of the start of a Phase 3 trial by the end of March of next year. In total, the company expects to test the drug in 1,400 patients in two Phase 3 trials, but has not said how long it expects the trials to take.

Meanwhile, the company reently hired Michael Sullivan, the former U.S. attorney in Massachusetts who is now a partner at Ashcroft Law Firm, to investigate a shareholder lawsuit. The suit was filed in response to a shareholder lawsuit filed last month by New York-based Rosen Law Firm which itself appears to be based on a lengthy, anonymous blog post on the investor website Seeking Alpha which claimed Cellceutix is a “shell” company and it’s drugs are worthless. I debunked some of those claims in a blog post in August.

http://www.bizjournals.com/boston/blog/bioflash/2015/10/amid-litigation-cellceutix-aims-for-late-stage.html?ana=yahoo