The development of Monepantel Tablets is now drawing closer.
This week the Monepantel Formulation should be winging its way from Syngene International in Delhi to Catalent Pharmaceuticals in New Jersey USA.
The credentials and history of these Companies should deliver a high sense of security that the development phase of Monepantel (MPL) is drawing to a close.
Shareholders may recall the Beagle test carried out 2019 where the newly formulated MPL which has been micronised which lead to an increase of 10 times the original efficacy and allowed greater absorbency.
The Topline from the Beagle Trial was " Beagles took the pills freely from Clinicians hand and from the floor. The Beagles took the pills consecutively for several days , this action demonstrated the Pills have NO POOR Taste and no adverse Ill effects intestinally.
As Dogs have 10,000 to 100,000 times the smelling ability of a Human and a Taste memory far superior to a Human e.g a Dog will only be sick from eating something once the memory then lasts a lifetime.
For me personally this delivered enough solid data "that is, if a Beagle cannot detect a poor taste or have Palatability issues then a Human should have absolutely no issues" also for those who have dogs , you don't want to be wrestling an unwell Dog to force medication into them , The Human Patient remember has the ability to understand that the medication is beneficial and in the case of Lymphoma the outcome is extremely poor so Humans will take medication that has poor taste and adverse effects.
The following Phase II K9 trial cemented the Palatability issue had been overcome with Vets and Dog owners both administering MPL Tablets over a 3 month period with no reported adverse effects or Palatability issues.
What also was confirmed was a weight to dose regime that supplied sufficient MPL into the blood system to deliver a high enough active ingredient to have a positive effect on Lymphoma and benefit the patient..
As a stand alone K9 Lymphoma Treatment the value of this treatment is circa $300 m USD.
Aratana sold their Lymphoma Treatment Tanovea to Elanco for $245M USD and Tanovea is best used as a combination drug in some cases in conjunction with Chemotherapy.. MPL has been shown to negate the use of Chemo but may well be a great companion drug to prednisone.
A stand alone Manager for this technology has been selected and is currently working closely with 2 Vet Majors to deliver a commercial outcome.
Human Cancer The work carried out over a 6 year period utilising the K9 organism/animal has delivered crucial data that allows PAA to progress to Humans with a high degree of confidence.
The results from the early Phase I Human Trial were "astounding" taking into account the Trial Patients had all failed standard of care, there was nothing left in the medical arsenal to assist these Cancer Patients. Yet MPL delivered a reduction in Tumors and healing of lesions...Patients also gained QOL, Quality of Life a general better feeling of well being.
The Human Oncology positive trial results were over shadowed by the poor Palatability and Taste issues surrounding a liquid capsule. This will be the first milestone recognised by the first Trial Patient in the up coming MND Trial.
The Company has gained ANZCTR regulatory approval to continue with a Phase II Human Oncology Trial programmed to take place in Q4.
MND Motor Neuron Disease.MND Australia has approached Pharmaust to carry out a significant trial of the effects of MPL on MND.
The Trial is fully funded and due to commence in May 2022 , roughly only 2 months away.
MND is uncommon but not rare. Recent statistics estimate there areover 2,000 people in Australia currently diagnosed with MND and every day 2 Australians are diagnosed with MND.
There is no cure for motor neurone disease and no treatment will significantly alter its course. Medications may be prescribed to control involuntary muscle twitching, muscle cramps and excess saliva. However,treatment essentially focuses on retaining function and quality of life and providing comfort.
We eagerly await the commencement of this Trial not only to try and benefit MND sufferers but to also gain further information on exactly how MPL assists the Human Body.COVID / SARs MPL has demonstrated through 3 Independent Research Facilities that MPL has a significant positive effect on SARs and the subsequent Covid genres .
Firstly WEHI
The results from trialing MPL on Covid 19 were Remarkable on two fronts.
The first was the speed at which MPL reduced the Viral load , The mechanism of action begun instantly.
The second was the thoroughness and effectiveness of reducing the viral load , 50% in the first 24 hours and 95% viral load reduction in 72 hours.
This was muted at 99% but from what it seemed to placate the ASX was reduced for announcement to 95%.
The Trial results were so positive that WEHI ran the Trial again and the initial results were replicated.
The company continued on with an additional trial with Biolabs 360
In experiments conducted at 360biolabs, MPL and MPLS inhibited virus burden by up to 99%
and 75%, respectively. The data for MPL were quite notably similar to the 100% inhibition
demonstrated for remdesivir used as a positive control, although at differing concentrations of
drug. Anti-viral activity by mTOR inhibitor rapamycin was not demonstrated at the
concentrations tested by 360biolabs.
The Company then progressed to the prestigious Leiden University in Holland.
Findings from Leiden.
i) significantly protect cells in vitro against SARS-CoV2-induced cell death,
ii) significantly inhibit completion of the SARS-CoV2 life cycle, by blocking transmission of virus to
neighbouring cells,
iii) may act later in the SARS-CoV2 virus life cycle than well characterised drugs ie Remdesivir.
The potentially distinct mechanism by which MPL and MPLS inhibit viral replication may offer the opportunity to
generate “combination cocktails” with other anti-virals to simultaneously block multiple points of the virus life cycle
to strengthen anti-viral activity.
Human Covid / Sars Trial is due to commence June upon the completed recruitment of MND trial patients.
An Oral Treatment for the swift reduction of Covid / Sars symptoms with no known adverse effects would be in the Billions as stated by Pfizer and Merck over the past months..Human Phase II OncologyScheduled for late 2022 , Benefiting from data gained during the proposed MND and Covid trials Pharmaust hope to finalise a dosing regime for the effective control of Lymphoma, although MPL has been trialed on multiple cancers including Ovarian and Pharmaust own over 50 patents for MPL in the Cancer domain..
The benefits of a non Chemo based MTOR Pathway drug with no adverse effects and the possibility of in home care and administration or treatment again leaves the high Millions in value and joins the Block Buster ranks of global treatment drugs in the Billions...
The Company has not been valued in the past 6 years and momentous break through' s have been achieved during that period. Primarily the Covid arm of Treatments as well as additional data supplied by the ONJF that MPL has demonstrated beneficial action for the potential Treatment of Leukemia and HVTL-1 Viral Infection.
Additional Intellectual Property has been awarded to PAA and Big Pharmas clock on alternative patents is running down..
Pharmaust is now due a significant rerate as the wider investment market become aware of the years of Trialing that has delivered Positive Results compounded on Positive Results, in fact for a small Perth Biotech the past 2 years have only delivered Positive Results to all Trials carried out by the company and associated Research Institutes..
Messaging has increased over the past 3 months with a strategy to educate and engage not only the current SH base but to demonstrate Pharmaust is well worth having in your portfolio...
This is the High Risk end of the Street , High Risk High Rewards,,, for me volumes of Risk have now been removed and its time for the company to emerge as one of Australia most Valuable Biotechs...
MPL is not a same same drug, this is no generic treatment with a different label, there are only two commercial MTOR Pathway drugs currently on the market and between them they revenue their owners $2.4B ,, and it would seem MPL will be the third but with out demonstrating any toxicity issues the currents are impaired by.
Yes I am a Trader , I constantly Trade Biotechs , every day of every week , I rotate across 23 ASX Biotechs but here I have graduated to Investor..
I'm not here for 20% ,, This is Blue Sky Technology and the market is uncluttered... as they say the proof is in the pudding and I can see the dessert trolley is heading this way.... best of luck to all holders NZT
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