CellCeutix pharmaceutical company

Audio link

Part1

http://www.thestreetbeat.com/street-beat-video-charts-35/video-podcast-394-cellceutix-otcbbctix-molecule-drugs-for-severe-conditions-part-1.aspx

Part 2

http://www.thestreetbeat.com/street-beat-video-charts-35/video-podcast-395-cellcuetix-otcbbctix-molecule-drugs-for-severe-conditions-part-2.aspx

Welcome to The Street Beat’s CEO Interview Series, Leo.

Thank you.  It’s a pleasure to be here with you.

Question:  Leo, can you give the listeners a synopsis of the Cellceutix pipeline of drug candidates?

Sure.  Cellceutix has a portfolio of eight very promising compounds for a wide range of indications.  Our flagship compound, Kevetrin™, is an exciting anti-cancer drug that is set to enter clinical trials at Harvard’s Dana-Farber Cancer Institute and its partner hospitals including Beth Israel Deaconess Medical Center.  Kevetrin is truly revolutionary as its Mechanism of Action has shown to re-activate p53, which is often referred to as the “Guardian Angel of the Human Genome.”  It’s a critical pathway that cancer researchers have been trying for decades to find success with and we are the first that we know of to do so without damaging any DNA.  We are also moving forward with Prurisol™, a new drug for psoriasis, with a meeting scheduled with the FDA in coming weeks to discuss the necessary protocol for us to try and achieve a 505(b)(2) designation, which would allow us to take Prurisol straight into a Phase 2/3 clinical trial.  The third compound that we are actively developing is a drug targeting the core issues of autism called KM-391.  Although we don’t speak a great deal about it because Kevetrin and Prurisol are closer to human trials, we are very excited about the potential of KM-391 because it represents a potential drug for a terrible disease that affects so many people, including millions of children.

Question:  You said that Cellceutix is slated to have clinical trials for Kevetrin hosted at Harvard’s Dana-Farber Cancer Center and partners.  Can you give us an update on the commencement of the human trials?

Absolutely.  The day is drawing nearer for the trials to begin. We anticipate having the IND submitted in mid May.  After a 30 day FDA review process and upon approval of the IND,the hospitals would be allowed to begin the trials as early as mid June.

Question: I understand you recently started collaborations with Beth Israel Deaconess Medical Center.  Could you elaborate a bit more on that relationship?

Honestly, we are very excited about this relationship.  Beth Israel Deaconess is a teaching hospital of Harvard Medical School and will be a part of our company-sponsored clinical trials for Kevetrin.  Separate from the clinical trials, though, they approached us about studying Kevetrin because of its unique mechanism of activating p53.  Of course we jumped at the chance to gain more knowledge about our compound as they will be researching Kevetrin in combination with another drug for indications which we have not yet studied.It is a major stepping stone for us to have our lead drug studied at some of the most well-known and prestigious cancer centers in the world.

Question: What kind of research will they be doing?

They proposed putting Kevetrin alongside some of Pfizer’s drugs. In previous work, they’ve found that similar multikinase drugs can enhance the effects of HDM2 antagonists. Since Kevetrin acts through the p53-MDM2 pathway to induce apoptosis, it may be a good candidate for this combination study. In other words, after looking at what may possibly be complementary mechanisms of action, they hypothesized that the compounds may work well together against certain cancer tumors. 

Question:  And what type of cancers are they looking into and how do they know if they are in fact working?

Great question. Renal Cell Carcinoma, which originates in the kidneys, and Melanoma, the most dangerous type of skin cancer, were each chosen because they harbor wild type p53.  First they will be looking at the compound’s effects and mechanisms of action with only the cancer cells in test tubes. Then, this will be followed up with in-vivo experiments.  Tumors will be measured over time, and again the goal is to find out if these compounds in combination will have a synergistic effect on these cancers.

Question:  Sounds promising, what happens if it works?

If this works, it will certainly attract the attention of the other pharmaceutical company involved in this study that has just sold their  infant formula business to Nestle for about 12 billion dollars.The bottom line is that Kevetrin represents a completely new class of chemotherapy and that is something that is very rare.  Our laboratory testing has produced extraordinary data that continues to be expanded upon to further delineate the Mechanism of Action and explain why it has worked on every, single type of cancer we have tried it on.

Question:  Kevetrin certainly seems to have amazing potential.  I’d like to move on with you telling us a bit more about Prurisol.  What’s the current status?

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.  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 thatMIT 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 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 struck 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 HCV drug while it was still in trials.  Just last week, Human Genome Sciences rejected a $2.6 billion takeover bid from GlaxoSmithKline, whomanalysts 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 never do.  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 so closely.  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.  Thank you to our loyal shareholders for all of their continued support.