Member Info for Saxondale

RNS says funding will be through third party or parties .
Bidding war going on for this ?

Great update !
And only 200 expected patients in Caliber trial - thats a small number for a phase III trial .
Green light for Traumakine :-)

Back in May 2018 - Faron published their final results plus plans for Traumakine - which included :

Initiation of a collaboration with Syneos Health for Traumakine - a global biopharmaceutical solutions organization with end-to-end clinical development and commercialization capabilities.

I wonder if there is still a connection ?

Big US company that fast track drugs to market ( $6.55 Billion Mcap )

Hers the summary from the European Medicines Agency in Sept 2018 regarding Farons Orphan Status

The amendment seems to have been done simply due to how the condition was classified. So rather than having orphan status for just acute lung injury , we now officially have it for ARDS .

https://www.ema.europa.eu/en/documents/orphan-designation/eu/3/07/505-public-summary-positive-opinion-acute-respiratory-distress-syndrome_en.pdf

Sorry Traumakine , not Tarumakine .

Done some digging on the current situation of Tarumakines orphan status.

Faron applied for orphan status for the medicinal product ' Interferon beta ' back in 2007 - and it was granted - as an orphan drug for ' acute lung injury '
Its listed in the Community Register of orphan medicinal products by the European Commsission :
Orphan Status - EU/3/07/505

https://ec.europa.eu/health/documents/community-register/html/o505.htm

You will see that it is listed as ' Active ' in green box with a tick .

Faron requested an amendment to the Orphan Status in June 2018
This was to change the wording from ' acute lung injury' to ' acute respiratory distress syndrome '
The European Union granted this amendment .

So from that I take it that the orphan status is still active
Once they have obtained the marketing license - the orphan status gives them 10 years exclusivity in the market .
And its quite a big market !

Too right mate - so many knock on effects of this

Not sure if anyone else picked up on another link Faron put in their Feb 6th RNS .
It was an article about using Interferons as first line of defence in global virus outbreaks.

Written in June 2019 - well before any Covid-19 dramas .

Traumakine is an Interferon IFN Beta 1a drug

Highlights
IFNs-a/ß exhibit direct antiviral effects on viral replication.
IFNs-a/ß?activate innate and adaptive immune responses.
IFNs-a/ß present as ideal broad-spectrum antivirals for acute virus infections.

The intro :

Outbreaks of severe virus infections with the potential to cause global pandemics are increasing. In many instances these outbreaks have been newly emerging (SARS coronavirus), re-emerging (Ebola virus, Zika virus) or zoonotic (avian influenza H5N1) virus infections. In the absence of a targeted vaccine or a pathogen-specific antiviral, broad-spectrum antivirals would function to limit virus spread. Given the direct antiviral effects of type I interferons (IFNs) in inhibiting the replication of both DNA and RNA viruses at different stages of their replicative cycles, and the effects of type I IFNs on activating immune cell populations to clear virus infections, IFNs-a/ß?present as ideal candidate broad-spectrum antivirals.

https://www.sciencedirect.com/science/article/pii/S1044532319300065?via%3Dihub

Dismal week for many stocks , so despite the disappointing lapse in our SP , we haven't fared too bad , considering we are still awaiting important news . Clevegen trial updates have never triggered much upsurge in the past ( apart from the FDA one ) , and I feel they are just playing around with SP until volume picks up again .
I dumped most of the other stocks today that I'd been playing with , added a bit more here and the rest in two gold stocks I have .
Just gonna sit now and watch it all play out .
Like Zen said , Gold & Faron - probably the safest places to be next week

Ah just missed reading your post Itsall !
people will start thinking we're the same person lol

At the bottom of the Traumakine part they give link to WHO Corvid-19 treatment advice - how to treat ARDS.
- Don't give patient steriods - no advantage and slows virus clearance
- Then just oxygen and ventilators

Every hospital doctor knows that there aren't enough ventilators.

I really do hope the FDA/WHO get their act together when Traumakine becomes available

https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected

What a month to relaunch a GLOBAL trial on a drug to fight the most severe symptom of Covid-19 .
Even without any Fast track/EAMS bobbins - surely this next RNS will get global attention .
71 Hospitals took part in the last trial ( Mostly Finland/France/Italy/Spain / Germany & UK )
The new study may have many more countries involved .
This is good as we get more patients dosed quicker and results back quicker saving time.
But logistics of manufacture , supply , quality control etc more involved.
Hence maybe why it has been a long time in the planning .
A third party funder is going to want the process done ASAP - time is money.

At the moment all the talk is about Testing , and containment
When it gets to treatment - the spotlights going to hit us big time I think .

This will speed up patient data results and reduce time to market .
Recruitment for this study is not going to take long thats for sure.

Maybe after the 3rd submission cycle thats it.
They can't keep making changes indefinitely.
And from what Markku said , they had agreed new protocols etc .
So maybe this is just the final paperwork coming back from quality control , so just shows everything is in order .
That's enough guessing from me , I'll just wait for the RNS .

Found this page through a google search , but can't seem to access it off their website .
Its what we already know - but first time I'd seen the page

https://www.faron.com/pipeline/partners

Couple of days ago I mentioned that Faron had sent three lots of results back to Clinical trials .gov from the Interest trial , two in 2019, and one in Feb 2020 . Anyway , the one sent on Feb 19th 2020 had a blank for a date returned by QC . Today it has a date in there of March 4th.
Somebody more knowledgeable may be able to explain why 3 sets of results have been submitted ( possibly to do with showing them the steroid interference etc ).
Anyway - that 3rd set have now been returned so maybe 3rd time lucky we are closer to getting the RNS we actually wanted.

Should help with Clevegen partnering discussions :-)

Noted in that latest presentation , that there is a slide devoted to acknowledging Sirpa Jalkanen .
35 odd years of working at the cutting edge of bio science .
She co founded Bio Tie and Faron
She was responsible for the discovery of CD73 , Clever 1 , and A0C3 , so pretty much the foundation of all Faron's products.
Recently she is making more discoveries about lymph nodes and cancer prevention.
She won the EU Prize for Women Innovators in 2016 .

So fair play for the company to give a little space to show recognition of her services.

One of her recent quotes :
"The potential in this pharmaceutical field is enormous as we target diseases which are currently without any effective treatment. Normally, drugs for unmet medical needs reach blockbuster level, selling more than one billion euros a year."

Either she is a very intelligent woman or she has been reading too many of Zens posts lol

New updated presentation on Their website .
Havent read it all - but interesting
The AC03 drug is shown in the same sector as Traumakine - for ARDS treatment - so looks to be a complementary additional drug . Double whammy !
https://www.faron.com/sites/default/files/Faron%20Carnegie%20CapMar%20Day%20March%203%202020.pdf

And the fact that hey have now signed agreements on royalties and payments etc would suggest that the drug has been tested to a stage where they know they are on to a winner , otherwise why bother .

Copper must admit I spent some time looking into it , and the words started getting too long to understand !
It seems like this inhibitor will help prevent vascular inflammation , which is basically restriction of blood flow through arteries etc , something that diabetic people can be prone to , I think .
The blurb says - Atherosclerotic cardiovascular diseases are major causes of morbidity and mortality in the diabetic population.
So by fixing the inflammation - you reduce diseases that are caused by it - which must include heart issues / strokes / renal etc .
Another ring to rule them all ?

Hopefully another cheerful Markku interview ( maybe with his inventor wife ) - will explain more :-)

The secret weapon ?
AC03 ( according to Wickepedia ) - pretty well linked to vasular & renal issues & diabetes.
Not a cough syrup then .
3rd game changer !