ook, there is no doubt we have quite a drug on our hands.
Sure sure we are looking for funding and someone out there is going to win the lottery, is the party(ies) that fund us fully. While it still might take some time to hit greatness and stardom, we have potentially at least a couple of years of trials to do before this thing can fly like some sorta Phoenix rising out of the Share price swamp....it's going to be darned lucrative in my books. This does not mean we can't go from zero to hero in the interim. We get funding, we get some reaction, we get even a small first deal, it's going to be all accretive.
Forget the actual lottery, we have a much more lucrative proposition that will pay lottery like dividends one day (my thoughts)
But I try and act like an insto. I'm here for the long term, bad luck, you are going to head from me for a good bit of time yet! But I love to look just a little bit ahead of the pack. There will be many new to us over the ensuing months, they will be here because of OA. I am here because of OA, but I also know there is a heck of a lot more to come after that too.
Tonight a special, yet another indication of what our molecule can do....and boy, what it can do!
Please now enjoy
WHAT IS IT?
Herpes is dermatological condition of the skin.
So what are the current remedies? The current remedies are topical and "Surprisingly do not show efficacy when used topically".1 Antivirals and general pain medications are often prescribed. It can be dangerous for newborns and Genital herpes can be transmitted sexually.
Pentosan itself has only a limited effect in herpes but it is the combination of pentosan with a few other molecules and compounds that is showing some surprising results, read on!
OUR MOLECULE'S ROLE
There is a patent1 that I came across recently that describes the usage of pentosan in combination with other substances that are anti inflammatories and/or antioxidants.
However, each on their own is found to be not as effective compared to the combination of them:
"It is still further surprising given that when either of the drugs are used separately in topical form, they are essentially inactive".
So the researchers tried a few different combinations including PPS as well as slightly different version of Pentosan eg. Zinc Pentosan Polysulphate and utilised another molecule known as Bufexamac and others.
EXAMPLES
This is where it gets interesting, the patent lists several examples of this mighty duo in practical applications, it's quite an illuminating read. Note: I have changed the example order and haven't included them all for readability.
Formidable Duo combinations?
EXAMPLE 1 - The Amazing result.
There were four patients that had herpes simplex of the lips for some 5 years. They would have tried so many creams and combos to no avail. So a combination was finally tried, this combination was specifically, sodium pentosan polysulphate (0.5%) combined with ethylene glycol monosalicylate ester (10%) in a cream base.
It's at this point we need a particular format to analyse what happened.
QUESTION - HOW LONG DID THE APPLICATION OF PPS AND THE ESTER TAKE TO RESOLVE THE HERPES OF THE LIPS FOR THE LONG SUFFERING PATIENTS AND OUT OF FIVE OF THE CASES EXAMINED, HOW MANY GOT SOME BENEFIT?
A) Oh well if they had it for 5 years plus and still couldn't get rid of it, it going to be fairly stubborn, so my initial guess would be a few months at least of daily application ...so finally after 4 months and only two of the five patients benefitted?
B) Yeah Nah, It's a Mozz Quiz, his answers start real conservative, I'm on to this trend now. My guess is 2 months and three of them were assisted by this strong and effective combo.
C) 5 and a half weeks and all but one showed some resolution??
YOUR Guess? Insert answer here ______
The answer, my fellow investors...
"All cases resolved within 2-5 days and no further outbreaks in that area of skin have occurred over the proceeding 12 months".
Can I just repeat that for you?
ALL CASES RESOLVED WITHIN 2 to 5 days. That's after waiting for 5 full years!! There been no further outbreaks for the proceeding 12 full months.
I ask you at this juncture - What do you own? How strong and efficacious is this drug?
EXAMPLE 2 - Head over heels
This amazing combo of course doesn't work on softer skin areas like lips, how about this example:Early skin carcinoma characterised by toughening of the skin on the skull of a 60 year old male, which had previously been treated with cryosurgery, were treated twice daily with a 0.5% pentosan polysulphate and 10% ethylene glycol monosalicylate ester in a cream base.
The lesions resolved and have remained clear for 12 months.
EXAMPLE 3 - The need for speed
Zinc pentosan polysulphate at a concentration of 0.5% and sodium pentosan polysulphate at a concentration of 4% was compared to 0.5% zinc pentosan polysulphate mixed with 10% triethanolamine salicylate.Five patients were treated with each formulation twice daily on the lesions. Only the group receiving the zinc pentosan polysulphate mixed with triethanolamine salicylate, showed alteration of the course of the lesions, and were essentially asymptomatic at 48 hours after start of treatment.
PREVALENCE?
Yeah all very good Mozz and I'm happy for the future...seriously, what's the runway for this Simplex Herpes thing? Do any/many get it? Do we have any real scope and depth here?
Again, possibly for only the second time ever, I find myself needing to do a second Mozz Quiz® within a single post...
QUESTION - WHAT INDEED IS THE PREVALENCE OF HERPES SIMPLEX?
A) Mate, I've hardly heard of this simplex thing...surely it can't be more than 6000 patients worldwide? A fairly rare indication, yes?
B) Are you joking, a lot of ppl have it, they just don't know it or the symptoms may not be as prolific all the time, my next solid guess is 80,000
C) Bah humbug, triple B) and add 50,000 for good measure.
INSERT YOUR ANSWER HERE ________
Actually, correction, INSERT YOUR ANSWER HERE ______________________________________________________________
Well if you summed all of A, B and C together (6,000 + 80,000 + 290,000 = 376,000) and multiplied that by a nutty factor of 100, you'd still be way off.
ie 376,000 x 100 = 37.6 Million
Huh?
3.8 Billion
Don't believe me? Actually I don't believe me...
Check out Reference 2 in the Reference section to Fact Check.
Just humour me for a microsecond, Imagine we attract only 0.5% of them and they try it out? They try it on their lips, the try it on their xxx and even on their xxxx
Actually read Appendix A for an interesting experiment I might do.
CONCLUDING REMARKS
My point of looking into possible future indications is not that we should be doing this now. No. It is about impressing upon others that are new to us and impressing upon potential funders and partners that we aren't just a one trick pony, in fact we have a number of stables of horses and most of them are good enough to be run in the Melbourne Cup!
Chances of ultimately winning this race? Increases with more indications horses!
Sure it is in the future. But I don't want us to just get any ol' funding based only on OA and not be able to build in ANY value for all the extreme potential we have in the future.
In a way I am over reacting a little because even if we only arrest and address OA for the immediate future, the off labelling is going to cover a lot of indications I've highlighted in the past. It will naturally expand and patients will have more than one indication like pain in the knee AND herpes for example. Once it's shown clinically that herpes can clear up quicker and safer than anything else (well actually there is nothing at the moment) they aren't going to remain silent about it. They will tell their world and that will spread.
We have a really bright future. It has taken us a long time to get to this point and it's a fairly big pivot to be able to run a horse in the Phase 3 race. The great thing for us and the foresight of the company has allowed us to run multiple races all that the same time - the harmonisation of the FDA with the EMA, TGA and the equivalent in UK and Canada.
Once we get the go, this thing is going to be huge.
Mozz
DYOR applies, there are still risks, duly consider them.
EDITOR'S NOTES:
NOTE 1:
Please note Paradigm Bio does not own this patent. In my earlier days this would worry me, it no longer worries me. Why?
Because yes, we aren't the owners of the patent, but it is not hard to become an owner, all we have to do is buy it off them for the right price. True, we can't do this at the present moment, but once we have those Deals, once we have revenue in the multi millions, once we have a large partner with ensuing hugely numbered teams...it's going to be nothing for us to buy some of these patents outright and proceed forthwith!
NOTE 2
This will prob be the last major post before Christmas, I take this time to wish those that celebrate it, a very lovely and enjoyable Christmas. Those that don't celebrate it, enjoy the couple of days off!
I was planning on slowing down a touch over the next week or two but I did get some feedback that while many will be on vacation and travelling they will keep one eye on HC every now and again. You'll get the odd post from me for sure over the next few weeks for those that can and like to read the odd Mozz post. No probs for me, I love writing and researching all things PAR and iPPS!
Do stay safe over the festive season!
FF SECTION
(FURTHER FACTS)
APPENDIX A
How about this for an idea. Sticking somewhat with the Christmas theme of this post, last Christmas I had the good fortune to be in Europe, loved it. But I did pick myself up a tube of guess what? Yep Pentosan Topical Cream. Mate....I'm going to wait till I get the next cold sore next winter (June to Aug) , I don't often get them, maybe once in the winter season? They, luckily for me only last a few days at max and aren't at all severe so I'm not sure how this experiment will go.
But If I remember, I will dab some on and see if it accelerates the recovery time, If it's already better in say two days, I reckon that's a win. Granted it's not the duo- combo that this post is based on, but worth a try? There are references to Pentosan's 'wound repair' mechanism and efficacy, finally, improving the pool the cells find themselves in (ECM) is quite a feat to begin with.
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ook, there is no doubt we have quite a drug on our hands.
(20min delay)