written by reader Non Opioid drug going to be a game changer in Osteoarthritis?

By edski, May 8, 2020

I’ve been a member of Stock Gumshoe a long time. I think that it is one of the best newsletters for investing out there. Why? Because Travis and his magic Thinkolator bring you what is probably the correct answer to those many stock pitches. But there is more that you don’t get from any other newsletter, and that is people like yourself, having their say as to what any given stock or area of investment has going for it or NOT going for it. It brings new ideas into your way of thinking about your possible choices, and every so often someone offers up a lead or an idea of something that they have found and they wish to share it with like minded people. After receiving some ideas in the past, I want to offer up something that, I believe…. has not been pitched to an American audience….yet!

I am introducing an Australian Company to you today, one that has not gotten much attention from newsletters or Investment Bankers in the US. There are many reasons as to why it has not been covered as yet, but that is about to change. The drug is called Zilosul, and it is repurposing the drug Pentosan Polysulphate Sodium (PPS).

PPS has been used on horses, dogs and cats for decades all around the world for joint pain. This new INJECTABLE form for humans (see bene below) is patented by Paradigm, and is nearly impossible to copy. Even Johnson and Johnson gave up on trying to copy it years ago

In recent years there has been a trend towards the prescription of weak and strong opioids for the treatment of moderate to severe pain in people with hip or knee OA who have not responded to other analgesic medications or NSAIDs. The problems arising from the prescription of opioids for chronic conditions are particularly pronounced in the United States. Almost 30% of patients with arthritis were treated with prescription opioids in 2013 (5). This trend coincides with strong concerns about their safety. In 2016 17,087 prescription opioid deaths were reported (6), and in 2017, the US Department of Health and Human Services officially declared the opioid β€œcrisis” a national public health emergency.

Pentosan Polysulphate Sodium (PPS) is NOT an Opioid Drug! One of the biggest challenges in managing OA pain!

This company is about to start it’s double blind phase three trials under the FDA guidance. It has been around for 50 years in different parts of the world, but is being re-introduced as a new drug because this one is inject-able as opposed to pill form. As an inject-able drug, it has been tried and used on hundreds of individuals in Australia. Where clinical trial participation is not possible, Regulatory Agencies may grant permission to provide a licensed physician with an unapproved product for an individual patient. This is called Expanded or Compassionate Access, and the results have been amazing. I will not write everything down here, but I will supply you with enough information to do your own research.

Company: Paradigm Biopharmaceuticals Limited. Australian Stock Exchange, ASX:PAR
https://paradigmbiopharma.com/

In the latest trial given the OK by the FDA,There has been a secretive group of 10 ex-NFL players with Osteoarthritis of the knee done with iPPS and we are awaiting the results any time now. Footballers and regular folks in Australia have been given new lives after being treated over the years, and their results have been received by the FDA as well.
https://www.thesentiment.com.au/retired-nfl-players-endorse-zilosul-paradigms-osteoarthritis-drug-trials/

The company making the drug for Paradigm:

https://www.bene-arzneimittel.de/en/business-partners/company/company-history

Company History

ALSO, on March 5 this year……..
Recent FDA announcement for PPS catagorized as an Orphan Drug
EAP treatment completed and Orphan Status achieved for MPS-I

Release Date: 30/04/20 10:24
Summary: EAP treatment completed and Orphan Status achieved for MPS-I
Price Sensitive: Yes
Download Document 255.32KB

What is MPS? The mucopolysaccharidoses (MPS) are a family of Orphan Diseases. The cumulative rate for all types of MPS is around 3.5 in 100,000 live births and generally the patients present in one of three ways: 1. As a dysmorphic syndrome (MPS IH, MPS II, MPS VI) often with early onset middle ear disease, deafness, or upper airways obstruction; 2. With learning difficulties, behavioural disturbance and dementia and mild somatic abnormalities (MPS III); 3. As a severe bone dysplasia (MPS IV).

Mucopolysaccharidosis type I (MPS-I) is a rare inborn metabolic disorder caused by a genetic defect in the catabolism of two glycosaminoglycans (GAGs): heparan sulfate and dermatan sulfate. Disorders in the catabolism of these GAGs interfere with cellular function, resulting in abnormal bone development, growth retardation, cardiac and respiratory problems, and sometimes cognitive impairment2 .

MPS VI is recognized as an orphan designation, and classified as a rare autosomal recessive, inherited lysosomal storage disorder caused by a deficiency of N- acetylgalactosamine 4– sulfatase, leading to accumulation of glycosaminoglycans (GAGs) in the lysosomes and physical manifestations.

OK……might take a year or so, (do to FDA double blind testing) and maybe another up and down price per share, but this trades on the ASX (Australian Stock Exchange) under PAR. Australian dollar is about .66 cents per US dollar, so a big difference, but it will probably cost you more to go thru a foreign exchange IF you are interested. IT is listed in the Pink Sheets as PBIGF, but I would not use that vehicle because of it’s low volume (so far). Better to buy directly thru the ASX for quicker order results. AS I have been putting this together, it has had a great run up the last three days. It has also had some pretty good drops over time, so I am not promising very large returns, just sending out what I think is a great possibility for a rising star in the Bio sector. I want to share as others here have before me. DO NOT TAKE THIS AS ABSOLUTE INVESTMENT INFORMATION. DO YOUR OWN RESEARCH. I HAVE BEEN MOSTLY WRONG IN MY INVESTING LIFE, BUT THE BEAUTY OF SHARING INFORMATION WITH OTHERS IS THAT IT OFFERS A POSSIBILITY FOR ACTUALLY WORKING FOR ALL.

For more information by ASX stockholders, visit Hot Copper. One of the nicest, most business like group of investors I have had the pleasure of talking with.
PARADIGM BIOPHARMACEUTICALS LIMITED.. PAR(ASX) – ASX Share Price & News | HotCopper Forum

PARADIGM BIOPHARMACEUTICALS LIMITED.. PAR(ASX) – ASX Share Price & News …
HotCopper has news, discussion, prices and market data on PARADIGM BIOPHARMACEUTICALS LIMITED… Join the HotCop…

I hope that I have given you enough information to peak your interest. You MUST do your own Due Diligence and Research. I am promising you nothing but an opportunity to find what I think is a great invest over time.

Please review and tell me what you think about PARADIGM. Good, Bad, Foolhardy, whatever, but I will not sit by and watch this to answer questions that can be found by doing general research. Thank you all very much and good investing!

Ed

This is a discussion topic or guest posting submitted by a Stock Gumshoe reader. The content has not been edited or reviewed by Stock Gumshoe, and any opinions expressed are those of the author alone.

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