UPDATE on phase 3 clinical trial progress from Zhittya Genesis Medicine

[PDWarrior1900]

I know some of you are very skeptical about this company (I have some doubts but I'm crossing my fingers).

I just got a very lengthy update email from Zhittya Genesis Medicine about progress with their PD clinical phase 3 trial progress. I copied the entire email to a PDF and uploaded it for you to download and read.

https://drive.google.com/file/d/1KxiGTtzRdSuXPxFHMA5cTIPftIaqB6zy/view?usp=sharing

HERE IS A KEY PART IN THAT UPDATE:

"Defer or delay disease progression: When one is developing a drug for an unmet medical need such as Parkinson's disease, to be able to stop or reverse the disease is the hoped for outcome. However, another beneficial outcome, although not a cure, would be to significantly defer or delay disease progression. Below is a figure from a peer-reviewed publication looking at the 5-year progression of 316 Parkinson's disease subjects."

(there is a graph inserted here that you will find in the PDF when you download it.)

"The PD Questionnaire motor skills scores (Part III) were followed over five years in both medicated (blue line) and unmedicated (red line) patients. The higher the score, the worse on motor skill testing. Not to be unduly morbid, but clearly the trends in both medicated and unmedicated patients (from a different company, different drug) is in only one direction, and that is a steady worsening of motor scores.

"Another thing I came across was how the FDA looks at these scores in the approval of new Parkinson's drugs. In a US clinical trial sponsored by Roche, the primary endpoint they were trying to reach was a "meaningful progression" on MDS-UPDRS, Part III scores over a 1-year period (the Roche trial failed). "Meaningful" was defined as a decline in Part III scores over a 1-year period by more than 5 points. We certainly are hitting that "meaningful" definition in most of our patients so far, but obviously we need data at longer time points."

"So, in summary, please be patient with us and your perceived progress after treatment. Initial improvement may be followed by a plateau period or even a perceived worsening of symptoms. The key is to see how things look after a 9-12 month period to assess improvements or a delay in disease progression. During this time frame, we can also form ideas on new dosing regimens and how often we may need to retreat patients. We are just beginning this journey, and we appreciate all the efforts our experimental "lab rats" have made for us."

[MBAnderson]

It sounds like you are considering participating in their trial?

[PDWarrior1900 in reply to MBAnderson]

Nope. It's out of the country for participation. I'm far more likely to participate in the AnnnovisBio.com phase 3 clinical trial. They have over 40 USA clinical sites -- and 2 of them are not far from where I live. I've exchanged emails several times with the prez of that company and she is very forthcoming. I've also exchanged emails with the volunteer recruiter at the university which is one of the phase 3 trial sites.

[WinnieThePoo]

Phase 3?

😂

[Farooqji in reply to WinnieThePoo]

Why laughing

[WinnieThePoo in reply to Farooqji]

It was months ago, but they are a joke. Where is this phase 3 trial?

[Farooqji in reply to WinnieThePoo]

As per my information recruitment for phase 3 has been completed

[WinnieThePoo in reply to Farooqji]

I can find this oneclinicaltrials.gov/ct2/show...

But no listed phase 3

[Farooqji in reply to WinnieThePoo]

Sorry, I was confusing it with ANNOVIS BIO

[Bolt_Upright]

So one thing they wrote was "We certainly are hitting that "meaningful" definition in most of our patients so far".

I don't know how they can say this. Watching their videos, watching their before and after tests from different sized chairs and walkways. It looks like they are doing their testing at a resort patio. It really did not look like they were even keeping track of specific tests results.

Maybe I'm being too hard on them. Here is the video I am referring to: youtu.be/C2oUmhO_wjg?t=1368(Not working as expected?)

[PDWarrior1900 in reply to Bolt_Upright]

well my objection is that the "results videos" are far too short -- obviously edited severely .... that's the same concern I have with Dr Constantini's B1 regime testimonial videos... I studied those videos very carefully --- NOT impressive at all... even made me SUSPICIOUS

[Isthistheone in reply to PDWarrior1900]

Hey BOLT, I've noticed your enthusiasm in keeping us informed on many PD topics of interest. As you

[amykp]

You have to pay to participate. That sure makes it sound like a scam to me.

[PDWarrior1900 in reply to amykp]

read that here ... but i don't see that in his email or their website... if you'd be so kind, please post that link here that says it costs to participate in the trial - thanks

[WinnieThePoo in reply to PDWarrior1900]

OK. A confession. I have been interested in this, and on Zhittyas mailing list for some while. I still think they might get lucky, in that they picked up this drug from Merck's cutting room floor, and have been looking for an illness for it to help. There is increasing evidence of a vascular element to PD, and one monkey did well on it. They might get lucky - and find it is an effective therapy for PD. Having failed to get intravenous trials off the ground in Mexico, their serendipity then revealed the intranasal option in the Carribean, and they have started administering the stuff to humans (I deliberately avoided saying they had commenced clinical trials). The exciting part is they are getting on with it.

But the more they blunder into this latest round of their snake oil style fund raising mission , the more comically hopeless they look. Instead of focussing on PD - and getting some properly controlled trial data, they are rushing for it to "Just work" for every CNS or Brain ailment since Noah put down his lathe and chisels. And if you read between the lines, the human test preliminary responses, aside from having no placebo control, damn with faint praise. Looks like its probably safe, but not doing anything. Certainly not the dramatic unambiguous significant symptom relief hoped for. Of course, in itself , that's not an issue - it should take time for results to manifest. Indeed - the worst thing about the video's and spurious benefits claimed, is that IF the bloody stuff works, it shouldn't have worked yet, and so any very rapid reported symptomatic response to initial treatment, is almost by definition a placebo effect.

Regarding paying to participate, they have a 2 tier approach. If you are accepted as a subject for their "clinical trial" (their description of this activity they are pursuing, not mine) then there is no charge - although I think you are expected to get to the "trial" site and pay your own accommodation costs for 2 weeks. I don't think there are too many places, if any available on this

If instead you want to join the more widely available "Medical Research Studies" then in addition to paying transport , board and lodging, (all usually paid by the trial sponsor in conventional trials) there is a $25,000 - $75,000 patient funding contribution required

But what that amounts to is a "hope" ticket for people wanting to jump the queue and just conclude that it works, and they want it as soon as possible.

[PDWarrior1900 in reply to WinnieThePoo]

thanks for the detailed info

[WinnieThePoo in reply to PDWarrior1900]

A further thought has just occurred to me. Of course, in addition to their ambition to get rich beyond their wildest dreams by getting fgf-1 properly authorised and sold to millions paid for by their respective health care services or insurance...

They have found a way to make money from PWP by selling unlicensed untested products at full retail in the guise of medical trial participation. This exploits the weakness we all have legitimately, namely our frustration at the time it takes to authorise new therapies when we have a condition which progresses daily. But the point of that testing is to be sure it is safe and it works. And although all of us, me included, are tempted to try to queue jump, it disregards the evidence that historically most of these exciting new therapies have failed. Our frustration that after 50 years Sinemet is still the gold standard therapy, reflects the fact that the hundreds of fgf-1 we read about and wanted today during the last 50 years All failed to deliver when tested

[PDWarrior1900 in reply to WinnieThePoo]

you're right... and FIFTY fricken years... same damn "remedy" --- I could go "political" on this... but then this site would ban me... again ... LOL

[amykp]

If you go here crossbordermed.com/diseases... and click on you'll see this TO PARTICIPATE IN CLINICAL TRIALS CLICK HERE

THEN, when you go to fill out the form, near the end:

We will be screening patients for both Clinical Trials (sponsored by Zhittya Genesis Medicine, to take place in the USA, estimated to begin 2025) and Medical Research Studies (Patient funded, Multiple locations, estimated to begin June of 2022). Which program would you like to participate in? Mark all that apply.

Then, from a long reddit conversation (here: reddit.com/r/Scams/comments... )

My BIL and wife are taking out a loan of 60k to participate. I work with pharma and review trial protocols quite often and never have I seen a trial that requires such a huge amount of money up front just to participate.