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Amatuer17

08/07/14 10:43 PM

#64664 RE: frrol #64654

Good question - do not know
I had asked the same question few months back but did not get answer

run256

08/08/14 12:10 AM

#64668 RE: frrol #64654

Abacavir is the initial compound to obtain Prurisol, they share a similar molecular structure. As Prurisol is converted into Abacavir by the body and this compound has an FDA approval this makes the road to approval shorter.

Most common treatment for Psoriasis is MTX . The patent claim is as follows "Overall, these results suggest that prurisol is more effective than methotrexate in controlling psoriasis".

MTX is not a cure, it is used in 6 months cycles mainly and is very costly.

I hope this helps!

Ultimate01

08/08/14 12:14 AM

#64669 RE: frrol #64654

I have never been that into P because I'm here for k but I'm guessing the P patent has something to do with it. I'm sure others with a better understanding will
Chime in.

sox040713

08/08/14 2:06 AM

#64671 RE: frrol #64654

Prurisol is a prodrug (ester) of abacavir. The ester is a functional group. Different functional groups cause the proteins to fold and function differently. In the mouse model the ester form of abacavir (Prurisol) is effective against psoriasis, not abacavir itself.

Prurisol is an immune modulator that affects the proteins present in psoriasis. When the human body is distressed, the immune system is weakened. As a result, certain proteins are released repeatedly, causing psoriasis.

After Prurisol interacts with these proteins, the body breaks it down to abacavir, the active moiety of Prurisol. Bioequivalence does not mean that Prurisol and abacavir are the same compounds. It means Prurisol is able to convert to abacavir, and that is exactly what the FDA wants to see in the crossover study.

If Prurisol is the bio-equivalent of abacavir and abacavir is already administered as a pharmaceutical (for HIV) and shows possible efficacy against psoriasis, why isn't anyone doing a Phase 2/3 of abacavir for that indication? What is the advantage of Prurisol over abacavir? Anyone?

John B

08/08/14 5:58 AM

#64674 RE: frrol #64654

I see others have done a great job in answering your question. A interview with Leo was done in early 2013 by TP, that also contained very good info on Purisol:
Q&A: Cellceutix CEO Leo Ehrlich - Future Billion-Dollar Anti-Psoriasis Compound
http://seekingalpha.com/article/1113011-q-and-a-cellceutix-ceo-leo-ehrlich-future-billion-dollar-anti-psoriasis-compound

What compelled Dr. Menon to put his energy and innovative approach into Prurisol?

The idea for a psoriasis drug actually came from others and we licensed their compound. However it wasn't achieving the results we had hoped for. Cellceutix thereafter developed Prurisol. Once the patent is published, people will have a better understanding of our thought process in the development of Prurisol and how we accomplished making this new compound. At this time, we are keeping our intellectual property close to the vest until it is properly protected.

Can you provide some insight into what your strategy is for advancing Prurisol, and how it impacts the company in a broader context when taking into account all of the progress being made with Kevetrin?

Ehrlich: It's an astute observation to realize the pure value of Prurisol independent of Kevetrin when it comes to the valuation of Cellceutix. Many people overlook the value of this new drug candidate. When we saw the mice after treatment with Prurisol, there were no signs of psoriasis. Actually, it caught us a bit by surprise as Dr. Menon, our Chief Scientific Officer and co-founder, was very optimistic, but the results far surpassed anything we could have hoped for. But this is science and until you do the testing, any result is possible. There was no doubt we needed to advance this drug into human trials. A psoriasis drug with modest activity could generate $100 million in annual sales. An exceptional drug would generate many times that number. Our goal is to maximize shareholder value. That is why we are first doing a double blind Proof of Concept study. We have a high degree of expectation for this drug. It's important for our shareholders and others to understand the value of Prurisol. Should Prurisol prove itself in this trial, it will be a perfect complement to our flagship drug, Kevetrin.

What unique or compelling advantage does Prurisol offer over existing treatments or competing anti-psoriasis compounds that are also currently in clinical trials?

It is too early for us to compare Prurisol to other competing compounds in clinical trials. We do know the toxicity profile of Prurisol, but we don't know the profiles of the other drugs as they are not yet publicly available. What most impressed us about Prurisol in the animal studies was not simply that the psoriasis was visually eliminated, but that the psoriasis did not recur. There are many fine drugs out there to rid psoriatic lesions, but the results are temporary. Thereafter the individual will build resistance to the drug and it will become ineffective. Additionally, the problem with the biologic drugs is the potential for serious side effects. A new drug is urgently needed to help those suffering from psoriasis, which is a very uncomfortable and sometimes debilitating disease affecting millions of people in the U.S. alone.

What gives you confidence that the dramatic results shown so far in your lab studies will be achieved in human testing?

Of course, things can be different in humans as compared to animal research, but by utilizing mice with compromised immune systems and human xenograph models, we replicated the conditions as closely as possible in the laboratory studies. This is a recognized methodology in animal models for preclinical testing. Also, Dr. Menon's decades' of experience and understanding of the chemistry of the drug and his knowledge of the pathology of the lab studies lends a great deal of validation and confidence heading into human trials.