The new Patent Real World examples...

THE NEW PATIENT EXAMPLES - PART 1


ome of you, by now, are probably starting to get the impression that I think a lot about iPPS and Par.


Well sure I love to read about the science, but it gets very heavy. Other than Year 11 and 12 Chem and Bio some 37 years ago, I have absolutely no science background...But I do enjoy attempting to understand the biology...HOW does this iPPS work...WHY does it work. I long for Paul to go on about it, I love the ASX announcements that go on about it...but I know that the average person doesn't want this, gets bored, it's too dry and they want more practical stuff.

However, the other thing I love love love to read about are the practical examples of what patients experience with Pentosan...the positive stories, how it changed their lives. Doing the diary of Mr S was just so fun! I know a stack of you new guys to HC PAR haven't read this before so I'll reproduce the final update of Mr S. after this post (See below).

Tonight, come on an extended journey with me thru some new examples. These examples I have never come across and I'm betting you haven't either.

I'll spread this over two parts, the first part being published here tonight and I will endeavour to get to the second part out sometime later this week subject to my editorial staffs' availability, the copy boy being ready and the publishing staffs' deadlines working out...

Mozz Publishing house - Less this:



More this:



I have no staff, it's just me...but kinda less people to yell at yeah? ...And that Payroll Tax, so much less when it is n = 1.



Please of course, do now enjoy.


INTRO

The latest patent we picked up just a week and a bit ago was actually a steal. Most of us won't actually realise this until at least 3 years from now. I do hope we have ma lot of you still firmly on-board the good Ship Par around then.

This is what we picked up...


KL 0 -
KL 1 -
KL 2 -
KL 3 - iPPS
KL 4 - iPPS
POST KL 4 - iPPS



See those little blanks next to KL 0, 1 and 2 ?

That's what we picked up.

It's actually worth something.

It's actually worth a lot.

It's actually worth miles north of a lot.

It's measured in the Billions.




Has this Mozz guy lost it totally, what the heck is he on about?


Currently KL 0 to about 2 is served with NSAIDS.
NSAIDS give you pain relief to some extent, but NSAIDS aren't great for you, especially longer term.

Upper intestinal and kidneys can be damaged...but even bone density can be affected...the very thing they should be protecting! They are a feeble pain reliever at best. If that's all NSAIDS did, maybe I could live a little with it. Guys, NSAIDS literally aid the destruction of the ECM (Extra Cellular Matrix). I think of this as the pool of supreme nutrients the cells need. Destroy that, you destroy cells, destroy cartilage, joint, surrounding tissue joint material...and well...we can call that OA.


So why use NSAIDS, It's because there is nothing else out there!

But this patent that we recently acquired changes all that.Paul mentioned about the COX and the LOX pathways...



I'm definitely going to sink my teeth further into this one...but let's save that post for a more boring month when we are in the midst of waiting for the next milestone...




...but tonight's post is deliberately staying away from the science. I want this Mozz post to be aimed much more at the real world evidence.


It won't be me just copying and pasting some examples from the patent...I'm going to annotate them and literally show you how it relates to YOUR medicine, YOUR investment, YOUR company.

Let's go!


NOTE:
All grey text below are the words verbatim from the patent. My notes in this burgundy/brown colour.


EXAMPLE 1

JM: A fit and active 70-year-old female who had experienced symptoms of pain and joint stiffness in both hands and knees for 25 years. Radiological examination had confirmed some cartilage loss in peripheral joints as well as deterioration of disc space in cervical and lumbar spines. Physiotherapy and regular exercise (swimming and walking) and use of NSAIDs and paracetamol had provided some relief of the pain associated with the neck and lower back. However, these modalities failed to mitigate the pain in the peripheral joints, particularly in the hands.


So despite the NSAIDS and paracetamol, they failed to assist in the pain in the hands (in particular). The thing here is that its difficult to have injections in the hands. Paul R. said back in 2019, the joints where iPPS showed the best efficacy were in the hands and wrists.

Now the next line is quite important:


Hand-splints and combinations of higher doses of analgesics (codeine and paracetamol (Panadol^TM) and twice daily Celebrex^TM failed to provide lasting relief of pain and joint stiffness. Cortisone injections provided short-term relief but on the advice of her doctor they were terminated because of the known adverse side effects associated with the regular use of this class of drug.


So there are analgesics but in a lot of cases, like this one, they are useless. They have dire side effects and if they don't, you are either lucky or you haven't had to use them for the long term, which they are clearly not designed for.


More recent radiological examination of JM's hands and knees showed increased joint space narrowing in the joints of the hands, particularly at the base of the thumb and the left knee.


Some more background here, Joint Space Width (JSW) are the key longer term measure....conducted primarily by Radiographs, now it's also MRI's.


More recent radiological examination of JM's hands and knees showed increased joint space narrowing in the joints of the hands, particularly at the base of the thumb and the left knee. Pseudo gout was diagnosed and local cortisone injections were again initiated to the hand joints but the relief of pain was fleeting.


We know that PPS has the ability to address a range of associated indications, Gout being one of them. Joint Space Narrowing is applicable to knees as it is to the hips and even in the hands. Even Cortisone injections, despite the implicit destruction they can have on joints, they also failed to offer material pain relief! FInally, what was the only remaining strategy to arrest pain after these 'fleeting' pain relief?


Her hand specialist recommended surgery as the only treatment option remaining. The knee specialist recommended additional physiotherapy and maintenance of regular exercise.



Hand OA, what can be done?


These regimens just maintained for approximately 12 months but the arthritic pain associated with use of her hands for daily activities were described as being excruciating.


Mate, nothing wrong with additional physio and regular exercise...but once you are in pain....well, not only pain but 'excruciating' pain, are you really going to say no to a safe drug that may have efficacy, really kinda irrespective of the cost but especially if the bulk of it is covered by insurance?


JM then commenced a treatment protocol which required cessation of daily use of analgesics and Celebrex^TM or any corticosteroids. These medications were substituted by thrice weekly oral administration of a formulation comprising 250 mg NaPPS (obtained from Bene-PharmaChem GmbH & Co KG, Germany, as described above) and 250 mg celecoxib (commercially available generic preparation) (Pentabrex™M, a formulation of 30 NaPPS and celecoxib embodied by the invention of Proteobioactives Pty Ltd, Balgowlah, NSW, Australia).



So then, how did it go?

Within 2-3 weeks of the commencement of this treatment JM reported that her joint pain, particularly of the hands had been substantially reduced, allowing her to undertake normal household and sporting activities. JM maintained this treatment regimen on an ongoing basis for 15 months with continued beneficial effects. She did not report any adverse side effects over this period .



EXAMPLE 2


DA: A 74-year-old female diagnosed with idiopathic OA 5 years previously and prescribed 200 mg Celebrex™M daily with supplementation with analgesics such as paracetamol (Panadol^TM) when required by her doctor. The major sites of pain and stiffness were the ankles and hands but the pain emanating from these joints was not effectively attenuated by the Celebrex^TM unless its daily use was supplemented with high doses of analgesics.


How did that work out?

DA discontinued use of analgesics and Celebrex™...

Then they tried the new super drug combo:

...and initiated oral use of only a formulation of comprising 250 mg NaPPS and 200 mg celecoxib (PentabrexTM: Proteobiactives Pty Ltd) thrice weekly, which she has continued to follow for 4 months.


Did it take a long time to achieve decent results? Did it take long to obtain a change in condition?


Within 2 weeks of commencing the new treatment protocol, DA reported a positive response and reported that she did not require the use of any analgesics to support the pain relief provided by the PPS and celecoxib formulation. During the subsequent 8 months DA changed her protocol to a daily oral dose to the 350 mg Pentabrex™ formulation (175 mg celecoxib and 175 mg NaPPS) with the same clinical outcomes without any accompanying adverse side effects.


Paradigmers, within two weeks...



EXAMPLE 3


NW: An active 66-year-old female with joint pain arising from an early traumatic injury to the left knee that resulted in a torn medial meniscus and medial compartment loss of articular cartilage. NW also experienced moderate pain from the posterior compartment of her right knee that was diagnosed as arising from bursitis.


I haven't covered bursitis much in the past, another one for the Mozz Research list.


The Mozz things to do lost isn't getting any smaller any time soon! Got lots to research and write about...lots!



These symptoms were partially managed over a number of years with the use of a variety of NSAIDs.

Imagine, she has been on NSAIDS for a "number of years".


Within the previous 2 years NW was prescribed Celebrex™. However, the pain and joint stiffness were not satisfactorily resolved by this drug and symptoms were exacerbated by exercises such as heavy gardening, walking and playing golf.


I'm hearing this over and over again, how ineffective NSAIDs and pain killers are.


NW commenced treatment with a formulation comprising two 250 mg PentabrexTM HPMC capsules each containing(125 mg Celebrex and 125 mg NaPPS) taken orally thrice weekly, and reported therapeutic benefits with respect to amelioration of joint pain, improved joint function and wellbeing after 2 -3 weeks of commencing this treatment protocol. NW maintained this regimen on an ongoing basis for a further 12 months. The protocol was then changed to oral daily dose of a single 250 mg Pentabrex™ (containing 125 mg Celebrex and 125 mg NaPPS). Using this new regimen symptomatic relief was maintained as before. During the period of these treatments NW did not observe any adverse side effects while using the daily 250 mg Pentabrex™M formulation or thrice weekly 500mg Pentabrex™ formulation.


Again, main point here, less combo needed to be prescribed after time and NO adverse effects.


This is called layering of revenue for us Paradigmers. Paradigm of Australia will literally fill in this disease pathogenesis gap. But isn't this the most important gap? Stem it here at this early stage and if nothing else, at least you will delay the inevitable?

EXAMPLE 4


PG: An active 77 year old male with a history of sport induced post-traumatic osteoarthritis (PTOA) exacerbated by mild bilateral genu valgum leading to medial compartment cartilage loss and bone edema.


A lot of OA cases are caused by malalignment of the bones. In this case 'genu valgum' refers to the condition known as "knock-knees" whereby the knees angle inwards but the ankles are apart when the person stands with their feet together. Speaking of PTOA, there are some 200,000 ACL tears in the USA alone every year². Do you think that's a lot? What about Meniscus tears? Same? A few more? Try 1,000,000 a year³. This is our market size potential. What drugs are currently prescribed for these tears? Hello?




PG had been a regular user of complementary medicines of putative therapeutic benefits together with regular use of Celebrex™M. However, the symptoms of joint pain exacerbated by physical activity remained unresolved and he commenced treatment with a Pentabrex™M formulation comprising 250 mg NaPPS and 250 mg celecoxib (500 mg Pentabrex™M, Proteobiactives Pty Ltd) taken orally on an ongoing thrice weekly basis. PG reported amelioration of arthritic symptoms, and reduction in daily use of hypertension medications while maintaining acceptable blood pressure. During the subsequent 12 months PG changed his protocol to a daily oral dose of the 350 mg Pentabrex TM formulation (containing 175 mg Celecoxib and 175 mg NaPPS). This formulation provided the same positive clinical outcomes as initially experienced, again without any accompanying adverse side effects.






Here ends Part 1.

In Part 2 later this week we will take a look at even more examples and I'll include an even more comprehensive example set to get a sense of what really is the power of PPS at a much lower bioavailability than the SubQ version. Getting efficacy here in pill format is one thing, imagine the resultant stories in the future for our drug when we tackle KL Grades 3 plus out in the real world, the SAS and Controlled studies we have seen to date is but a glimpse of what we may indeed one day observe...










REFERENCE:

1] https://patentimages.storage.googleapis.com/82/dd/bd/824e58151aec70/WO2019157560A1.pdf
2] https://www.uptodate.com/contents/anterior-cruciate-ligament-injury#:~:text=The%20anterior%20cruciate%20ligament%20(ACL,alone%20%5B1%2D3%5D.
3] https://moveu.com/blogs/news/the-most-accurate-meniscus-tear-tests-youll-ever-need#:~:text=No%20one%20wants%20to%20hear,does%20one%20know%20the%20difference?

No advice intended. Must Do Your Own Research. Do not rely on merely one poster, no matter how enthusiastic/pessimistic they may sound.