Citius Pharmaceuticals Co-Founder and CEO Talks Promising Results from a Phase III Clinical Trial for Mino-Lok, a Treatment Designed to Salvage Catheters in Patients with Central-Line Associated Infections

PE: Citius recently announced positive topline results from the pivotal Phase III clinical of Mino-Lok, which is designed to salvage catheters in patients with central line-associated infections or catheter-related bloodstream infections. Can you briefly explain what the data found?

Mazur: Basically, there’s two arms. One was the Mino-Lok arm, which was a treatment arm. And the other arm was something we call a home-brew, which is something that the hospital mixes up on their own at times when a patient’s catheter is infected and they no longer have access points to remove and replace, they have to try and salvage that catheter. So, they’ll mix up something and attempt to dollars a catheter that way. This trial was designed to cap an endpoint of time to catheter failure. It's a negative event in reality. The p-value success that we had was probably record breaking in terms of statistical significance between the two arms. Actually, everybody was surprised. That was our primary endpoint.

PE: What enables Mino-Lok to salvage catheters in these two scenarios?

Mazur: Mino-Lok is a very unique formulation, and I think the minocycline in it. The inventor of it had worked for years to try and find the ideal combination to be able to salvage a catheter within a time frame that would not compromise the integrity of the IV treatment. That’s a key part. With Mino-Lok, you’re able to do this in a way that’s administered two hours at a time, two hours a day. That means that the solution gets injected into the catheter. It’s hemodynamically locked, so the solution does not go into the human body. After two hours, the nurse comes back in and aspirates out the content, and the patient has 22 hours of uninterrupted IV flow. That’s not really part of the trial per se, but in the real world, that means an awful lot, because those IV lines are critical.

We have this formulation consisting of minocycline, disodium EDTA, and alfarol, and that combination is what allows it to work. It’s due to minocycline being brought back into the market.

I was the co-founder of a dermatological company that made acquisition called tryouts, and we would acquire dermatological products. So, we acquired minocycline from Wyeth, and it's mainly an antibiotic for acne. Around a year and a half after acquiring it, we got a call one day from the Department of Defense, and they wanted to see if we could put the IV form back on the market. They were treated soldiers that were wounded in Iraq and Afghanistan in a German hospital for an infection that they found minocycline gave them the best result. The only difficulty was that they couldn’t continue treatment in the United States. The reason they gave was because Wyeth discontinued the IV form when they launched another hospital-based antibiotic, and they didn't want to have two of them out there. I said “Listen, we’re a derm company, we’re not a hospital company, we’re not anything remotely resembling that.” He begged me to bring it back.

So, I sat down with my late partner at the time, and I happen to be a Marine veteran. I said “We’re going to lose money on this proposition all the way, but I think it's the patriotic thing to do. Let's bring this thing back.” It took us a year, but we got it, we sourced it, we did everything, and all we could afford were to put two salespeople on the road. A couple of months go by, and I notice we’re getting all this buying from MD Anderson Hospital in Houston. I go down there meet with the chief of infectious disease, and I found out he wasn’t buying this drug to treat, but for experimental purposes. When it became available, he all of the sudden had something new to experiment with, and that’s how this drug came to be.

Everybody tried all different combinations and most of the time, they would have to keep the solution inside the catheter and a line for hours on end. His name is Issam Raad, and he’s the inventor of it. He did a great job in terms of getting everything formulated.