As we disclosed recently, we have submitted pre-IND documentation to the FDA.  We recently received a response from the FDA confirming a mid-June meeting in which we will be discussing our goals for Prurisol. I would highly encourage anyone that has not seen the potency of Prurisol as a new psoriasis treatment to visit our website and look at the images that we made public showing how much more effective Prurisol was compared to methotrexate in our laboratory studies. (Editor’s Note: That webpage is here.)  Personally, I think the dramatic difference is phenomenal and showcases what we may have with this drug.

Question:  Finally, let’s touch on KM-391.  I recently saw that MIT had a breakthrough with autism research.  How do you see Cellceutix in this space?

We feel that we are positioned at the forefront of the industry.  There has been very limited research addressing the core issues of autism.  Sure, there are drugs that try to treat the symptoms and, honestly, with limited success.  Drugs that only treat the symptoms are not a solution, they are a Band Aid.  The recently released research at MIT showed that their experimental drug reversed some of the major symptoms of Fragile X syndrome in mice and that is fantastic news.  Fragile X is known to be leading cause of autism.  Similarly, we have tested our autism drug, KM-391, in mouse models where we have replicated many of the core symptoms of autism related to brain plasticity and serotonin levels.  Autism is a difficult disease to grasp at a root level.  To put it into more easily understood terms, often serotonin and plasticity levels are out of kilter; keeping neurons from “talking” to each other correctly.  It would be like the Tower of Babel, one person speaking Japanese to another person that speaks Chinese, to another person that speaks English, and on and on.  They don’t understand each other. When on certain tasks the communication is understood, we see the incredible ability that many autistic people have.  KM-391 helps with the reorganization and the road map to get everything in the right place so the neuron communications are correct.  In laboratory studies with KM-391, brain plasticity and serotonin levels returned to levels found in a non-autistic brain and measurable behavioral characteristics returned to normal.  It is very encouraging research.  As we move Kevetrin and Prurisol into clinical trials, we will be once again focusing on KM-391 and the advancement of it into human trials as well.

Merger and Acquisitions are happening regularly in the biotech world.  Do you see Cellceutix as a target for an acquisition?

I’m asked this quite regularly and it’s always a difficult question to answer.  There certainly have been some major deals recently with large amounts of money being paid for promising drugs that are still in development.  Gilead paid $11 billion for Pharmassets because of their Hepatitis C drug while it was still in trials.  Just last week, Human Genome Sciences rejected a $2.6 billion takeover bid from GlaxoSmithKline (GSK), whom analysts suspect was looking to get control of their heart disease drug that’s in clinical trials, amongst other things.  We already know that some of the biggest pharmas in the world are watching us.  We have planned for Kevetrin to begin trials at the most prestigious cancer center in the world.  In addition we were selected for other studies to be done in combination with the world’s largest pharma’s drugs, so we are getting the type of tremendous exposure that most other biotechnology companies can only dream of.  It’s not just haphazard or that we are just lucky.  We have an incredibly strong pipeline of drugs that can represent billions in sales each year if they make it to market.  Big pharma knows this and that’s why they are watching us.  The fact is once we are in clinical trials and if we get the positive results that we anticipate, then, yes, I would think that we would make a very attractive acquisition target to many large biotechs.

Thank you for your time, Leo.  Any parting words that you’d like to tell investors?

First off, thank you for having me.  It’s been a pleasure.  I’d just like to say that this is a very exciting time for Cellceutix and its shareholders.  We have reached many milestones already, but I believe that the real excitement is right around the corner.

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