Zhittya Genesis Medicine's Drug Reverses Aggregated Synuclein Accumulation in an Animal Model of Parkinson's Disease

[j2jacobs]

I posted earlier on preclinical findings that our growth factor drug (human FGF-1) can regenerate new dopamine-secreting neurons in a primate model of PD. This led to a significant improvement in motor skill functioning of the monkeys. I would now like to share data with you that FGF-1 can also decrease levels of the toxic aggregated alpha-synuclein protein, which is a hallmark of PD in humans.

In the figure below you can see brain slices through the substantia nigra region in an experimental animal model of Parkinson's disease. In the middle panel you can see the strands of aggregated synuclein which are known to be toxic to surrounding neurons. In the far right panel you can see the same area of the brain after two weeks of daily IV treatment with FGF-1 with a clearly visible decrease in synuclein tangles.

We believe we are attacking the two root causes of PD with our drug therapy, namely, by regenerating functional dopamine-secreting neurons as well as elimination of toxic aggregates of the alpha-synuclein protein.

Please follow us as we move into our clinical trials with this promising drug candidate.

[rescuema]

Looks very promising. Any observation of the increased risk for cancer with the growth factor use yet?

[j2jacobs in reply to rescuema]

So far, so good with cancer worries. In toxicity studies in animals at 100-fold higher doses than will be used in the PD study we saw no carcinogenicity. Also, we have been in humans for a coronary artery disease indication and followed serum tumor markers very carefully and saw no increases.

[rescuema in reply to j2jacobs]

Excellent!

[park_bear]

Very interesting! Thanks for taking the time to share this directly with us!

[silvestrov]

Here is a link to a more detailed explanation of FGF-1 and PD: nebula.wsimg.com/3cef08d385...

[parkie13]

If all goes well, target date for release?

[JayPwP in reply to parkie13]

I have the same question

[Despe in reply to JayPwP]

Me, too!

[j2jacobs in reply to JayPwP]

If all goes well and smoothly we could see drug approvals in 18months in Mexico and perhaps a year later in the US.

[JayPwP in reply to j2jacobs]

I am 46. By the time it reaches me I will be 60 😆😆😆

[eljimmy in reply to j2jacobs]

hi jacobs i am from mexico where does trails are going to

[j2jacobs in reply to eljimmy]

Our first clinical trial in Mexico will take place at the Zambrano Hospital in Monterrey. Thank you for your interest!

[eljimmy in reply to j2jacobs]

JACOBS THANK YOU VER YMUCH FOR YOUR ANSWER ..YESTERDAY I TRIED T O ASK FOR THE TRIALS ......... I NEED MORE INFORMATION ABOUT THE NAME OF THE DOCTOR WHO WILL BE IN FRONT OF PROJECT HERE AND THE DEPARTAMENT IN CHARGE AND DATE PLEASE ALLL INFORMATION ................I WANTT O BE THERE

[WinnieThePoo in reply to parkie13]

Still waiting for the first human trial to start...Normally at least 7 years. Is there any precedent for the proposed Mexican back door route?

[j2jacobs in reply to WinnieThePoo]

We should be starting in Mexico later this summer. We submitted the same PD application to both the US and Mexican regulatory authorities and the US said do another animal study and Mexico gave us the green light to start in PD patients.

[WinnieThePoo in reply to j2jacobs]

That sounds good. I have PD and want this to work and be available by the weekend. If you want to do a trial in Europe...But even if you start your phase 1 in August it will be March 2022 before you publish results. Then phase 2 and then phase 3, then Mexican approval then the FDA approval based on that. If covid doesn't disrupt again. I can't see my neurologist being able to prescribe for me in much less than 7 years.

How do you see it?

[Zella23]

Thanks for posting about this very promising drug therapy.

[mannp]

Unfortunately I don’t think this would work for me or others with parkinsonism. For now I will stick with high dose thiamine therapy. At least I know it helps me. This is very interesting. Is the FGF-1 human growth hormone? If not, what is it?

Thank you j2jacobs

Margie

[j2jacobs in reply to mannp]

The protein we are developing his fibroblast growth factor 1 (FGF-1) which is part of the 22 member FGF family. No structural similarities to human growth hormone.

[JayPwP]

Why not study its effects on diabetes, and bring it to market faster? Then we can all participate in your PD trial worldwide

[j2jacobs]

That is a great idea and in fact there is a San Diego company that is developing a shortened form of FGF-1 for diabetes. Unfortunately, the shortened form is good for diabetes, but lousy at growing new blood vessels, which is what we want.

[JayPwP in reply to j2jacobs]

👍👍👍

[sharoncrayn in reply to j2jacobs]

"“Over the last three years, we have continually uncovered data which strengthens our theory that Therapeutic Angiogenesis might be a viable breakthrough treatment for Parkinson’s disease,” Daniel C. Montano, ZGM’s CEO, said..."

"Critically, FGF1 is a powerful stimulator of angiogenesis — but only in tissue that has been damaged or oxygen-starved."

so is every pwp's brain OXYGEN STARVED? very few get a MRI to assess brain blood flow.

[Turnipbarrow]

Very exciting prospect! How do we get involved in clinical trial?

[PixelPaul]

Thank you for taking the time to post this, and please keep us updated!

[JAS9]

Interesting! In another topic on this forum, there's a lot of interest being generated by a new study in Australia, which uses near-infrared light to penetrate into the brain:

healthunlocked.com/cure-par...

To quote from a site that sells a product similar to the one used in the study: "The direct effect is very powerful. Red and near-infrared lights on the head result in better-functioning brain cells (neuroprotection), new brain cells being generated (neurogenesis), new blood vessels sprouting and bringing more oxygen to the cells (angiogenesis) and as well as acting to reduce inflammation. "

Very similar claims! I wonder if Zhittya is familiar with this therapy, and since it may well be years before FGF-1 is available to us, would this be a possible alternative available now?