Zhittya Regenerative Medicine

[Jer788]

Dear all, I have been put in touch with the CEO of this company who is very excited about his trials on Parkinson's disease which he believes can be directly related to ALS. Trials are starting in the US early 2019 with a drug called FGF-1. This drug stimulates nerve growth and blood flow to the brain and ALS is high on his list. He has emailed me personally and his enthusiasm is infectious. Sign up for the updates on ALS as far too much to put here.

https://sites.google.com/view/pdzhittya

There's hope folks x

[Guest]

Hello
Good luck and report on the progress of the medication. Is it a tablet or infusion etc?
Chris

[Kayleigh]

Thank you for alerting us to the trial of a new drug for Parkinson's disease. Hopefully, it will be successful!

Although the CEO thinks the drug can be directly related to ALS, I wonder if separate trials on ALS would have to take place before it could be considered for ALS patients?

Best wishes

Kayleigh

[Terry]

Thanks for the info, jerry,

Fingers crossed.

Love Terry

[Jer788]

Kayleigh, FYI >

Update #12-as of December 17, 2018 from Zhittya

Preface

Hello friends, supporters and potential participants in our upcoming clinical trials.

In this month’s Newsletter, we will update you on our upcoming speaking engagements and presentations, as well as the status of the clinical trials.

First, we are putting the final touches on our application to the FDA to begin treating subjects with Parkinson’s disease. We are working to finalize the patient consent form and the IRB (Institutional Review Board) forms with the clinical research organization who will supervise our trial. We then will be ready to file the entire application (over 1000 pages) with the FDA and our target date is still by the end of this month. By law, the FDA must respond to us within 30 days, so in January 2019 we should know the response and we pray we will be able to start the study. We will keep you all closely informed. We are also working hard to complete the next two IND applications that we will be filing with the FDA for patients with amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease.

Let’s move on to our schedule of upcoming events and presentations. Our recent November 16th presentation at the Las Vegas Country Club was a resounding success and we thank all the participants who attended and contributed to what was an engaging and high-energy event. The audience also got to hear from our neurologist, Dr. Simon Farrow, who will be the Principal Investigator for our upcoming clinical trials. As he emphatically stated at the luncheon presentation: “Let’s get these trials started!”

You can subscribe to the newsletters by contacting Dan Montano <[email protected]>

Regards Jerry

Thank you for alerting us to the trial of a new drug for Parkinson's disease. Hopefully, it will be successful!

Although the CEO thinks the drug can be directly related to ALS, I wonder if separate trials on ALS would have to take place before it could be considered for ALS patients?

Best wishes

Kayleigh

[Kayleigh]

Hi Jerry,

Many thanks for the update about the clinical trial. It was so kind and thoughtful of you to provide the information that answered my question about whether separate trials would take place for ALS patients. It is wonderful that there plans for trials to include ALS and Alzheimer's. Thank you for sharing this good news with us!

I hope all is going well for your Christmas celebrations.

Very best wishes to you and your wife.

Kayleigh

[Guest]

Oh exciting news just as a thinking point Parkinson's and Huntingdon's can both come under MND so not a huge jump to trial on ALS

[Guest]

Hi
I understand that there is a trial for a drug to treat Parkinson's which could help with MND , but the two illnesses are not related . I asked my neurologist when I was first diagnosed because my dad had Parkinson's and wondered if it was genetically linked to MND

He said it was definitely not

Let's hope they do find a drug soon that considerably can help MND

Love Chris

[nunhead_man]

Dear Chris

I asked my neurologist when I was first diagnosed because my dad had Parkinson's and wondered if it was genetically linked to MND - He said it was definitely not

The fact that there is no genetic link does not mean that there is not a similar process going on where the motor neurones are affected.

My understanding is that the damage to motor neurones in Parkinson's is in some ways similar to the damage in motor neurone disease.

So if the drug for Parkinson's can support motor neurones in the spine and brain then it may be of some use?

With warm wishes for a peaceful, productive and positive 2019

Andy

[Kayleigh]

I would presume (maybe too optimistically?) that the Zhittya scientists would not recommend carrying out the drug trials on ALS if there was zero chance of it being effective.

Maybe I have too much of a 'blue- sky' view about this, but hopefully this drug will give us at least a glimmer of hope on the horizon.

Merry Christmas and very best wishes for the New Year.

Kayleigh

[Guest]

Hi Andy
Thanks for your reply yes I do understand the link and the possibility of a drug for Parkinson's working for MND . I don't know a lot about Parkinson's because my dad was diagnosed before we had ( Dr google) but it is about the lack of Dopamine in the brain !

It was just in reply to broken nails comment about Parkinson's coming under MND that confused me . I am sorry that I didn't address it as such

Anyway all the best to you and family for Christmas and for the new year

Love Chris

[Doug Carpenter]

I think one needs to be cautious in extrapolating treatments between diseases.

At one level, MND, Parkinson’s Disease and Dementia have common characteristics. They are incurable, progressive, neurodegenerative diseases, often associated with aging, that affect the central nervous system, mainly motor neurones. Although the causes are poorly understood, there are thought to be inherited and environmental elements. Within the patient populations there are wide differences in the types and rates of progression of symptoms.

There are broad similarities too at a cellular level. Put very simply, mis-folded proteins end up in the wrong places, causing cell death. This may be linked to RNA transcription errors and failures in cellular “recycling” processes.

But there are also important differences. MND affects both upper and lower motor neurones, the latter being away from the brain. Whereas Parkinson’s disease is associated with a specific region of the mid-brain, the substantia nigra. And the Lewy bodies associated with Parkinson’s and Alzheimer’s – one of over a hundred different forms of dementia – are confined to the brain. Moreover, the proteins that accumulate in Parkinson’s and Alzheimer’s are different.

However, it is possible that, in the next twenty years, some researcher has a eureka moment and identifies a fundamental mechanism in one disease that is relevant to others. There is a saying amongst scientists that we all unknowingly have the last piece of somebody else’s jigsaw!

Doug

[Kayleigh]

Thank you for a very clear and interesting explanation Doug.
Best wishes and Merry Christmas.
Kayleigh x

[Guest]

Hi Doug
Thanks for that explanation . I understand that they have very similar characteristics but you have explained it well .

I hope that one day someone might come up with a treatment that makes a significant difference

Love Chris

[Jer788]

Zhittya January Update

Dear all, January update.


Zhittya Genesis Medicine, Inc.

January 17, 2019 Update

Number 2019-1

Dear Friends:

The year 2018 was a very productive one for Zhittya. We made outstanding progress in many areas. We found hundreds of scientific papers supporting our hypothesis that vascular disruption and micro-vessel disease in the brain is a major contributor to neurodegenerative diseases, such as Parkinson’s disease, ALS, Alzheimer’s disease, multiple systems atrophy and many more.

In 2019, we now have to prove (or disprove) our hypothesis through US FDA-authorized clinical trials. We have very ambitious plans! As of today, we plan upon filing eleven (11) Investigational New Drug (INDs) with the FDA during 2019. The rough order in which those applications will be submitted is: (1) Parkinson’s disease, (2) amyotrophic lateral sclerosis (ALS), (3) Alzheimer’s disease, (4) multiple sclerosis (MS), (5) stroke recovery, (6) vascular dementia, (7) multiple systems atrophy (MSA), (8) post-traumatic stress disorder (PTSD), (9) traumatic brain injury (TBI), (10) chronic traumatic encephalopathy (CTE) and (11) chronic depression.

Filing eleven IND applications to the FDA may seem like an overly tall order for 2019, but please keep in mind that we believe the root problem in all of these diseases is the same, namely, vascular disruption in the brain. We believe if the blood supply is disrupted in areas of the brain that control memory and executive functioning, then Alzheimer’s disease or vascular dementia result. If vascular dysfunction occurs with the dopamine-producing cells in the substantia nigra region of the brain, then Parkinson’s disease results. The same with ALS and motor neurons in the brain and spinal cord.

In 1918, the life expectancy of a US male was 35 years. Diseases, including tuberculous, cholera, diphtheria, pneumonia and many other bacterial infections were the major causes of death in 1918. No one realized that penicillin (and subsequently, additional antibiotic drugs) would treat all of these bacterial infections and extend life expectancy to 73 years now and transform what people died from in the US in 2018.

We believe our drug is a “disease modifying agent” and that it addresses the root cause of these neurodegenerative diseases. If we are correct, our treatment should improve all of these neurodegenerative diseases. In each case, the INDs which we will submit to the FDA will be 90% the same. The only major difference is how we will measure improvements for each of the diseases. For example, with Parkinson’s disease, we will utilize a neurological examination developed by the US Movement Disorder Society that emphasizes motor skills; for an ALS patient, we will use an exam that rates difficulties with breathing, speech and swallowing; Alzheimer’s disease patients will be subjected to validated tests of their cognitive skills.

I am 70 years old and have enjoyed a wonderful life. I have advised presidents and prime ministers. I have danced inside the White House and danced in the streets of Nice, France. I was born very poor in East LA, made myself some fortunes and lost some fortunes. But, never in the past have I anticipated or have been as excited about a year as I am about this upcoming year of 2019. To quote my father, “it is time to put up or shut up!”

Dr. Jacobs, and his entire team at Zhittya, believe that in 2019 we will clarify if our hypothesis on neurodegenerative disease is correct and if our molecule can treat these devastating disorders. Dr. Jacobs and his team will be entirely focused on getting these clinical trials up and going in 2019.

As soon as we finalize the “inclusion and exclusion criteria” with the FDA, we will email each one of you these criteria to see if you are eligible to participate in our clinical trials.

The first place we will post the FDA-authorized inclusion and exclusion criteria will be on Zhittya’s YouTube channel. For those of you who are not subscribed on Zhittya’s YouTube channel you can go to:

https://www.youtube.com/channel/UCJxXe8QTf5PoqpZARgL3frw

and subscribe by hitting the red button that says “Subscribe”. If you are already subscribed it should show a gray button that says “Subscribed” with a check mark. To subscribe is free, and there is the added benefit that once you are subscribed, you will automatically receive a notice from YouTube whenever we post new information on the channel.

When people notify us that they meet the inclusion and exclusion criteria we will inform them of the screening process. The Principal Investigator and the clinic in Las Vegas have assured us that they will screen people as fast as possible to enroll the first cohort of study patients. We want to start dosing patients as quickly as we can, since time and delays are not friends for Parkinson’s disease or ALS sufferers.

IMPORTANT REALITY

We understand from many of you that your primary objective is to be in the clinical trials. We respectfully disagree, as we do not believe your primary objective should just be to participate in the clinical trials. We believe your primary objective is to eventually be treated and, hopefully, cured of your disease. Even if you are not in the clinical trials, but we prove our drug is safe and enhances the lives of the recipients, then your life could be made better in the future.

We have over 5,000 people who have registered with us to be in the clinical trials. Obviously, not everyone can be in those trials. Those people who will be chosen for the first clinical trials will be the best candidates to prove the drug is safe and maybe has hints of success in treating the diseases. I call these first patients who will volunteer to be in the trials “pathfinders.”

In the military, “pathfinders” are those brave souls who go into harm’s way before the invasion force arrives. In Normandy, 1944, the pathfinders were brave paratroopers who jumped in before the invasion began to prepare the landing zones for the paratroopers who would follow. In the Pacific, Navy seals or frogmen went onto the beaches before the Marines landed to prepare the way for them. These brave souls went into hostile territories to prepare the way for the first invasion forces and they were alone, except for God!

We ask you to think about these volunteers for our clinical trials over the next few months. I ask you to pray for their courage and their recovery. If they prove that the molecule is safe and benefits the recipient, we are all better off.

I believe over the next 9 to 12 months you will be like a person sitting on a sandy beach in December 1905, watching some people push their experiment down a ramp at Kitty Hawk, North Carolina. One of two things will happen in that experiment and in ours, the plane will crash, or the plane will fly. Please pray for the pilots of this experiment, your pathfinders.

If the plane flies, your life and the lives of potentially millions of people will benefit. If our molecule does what we believe it will do, the world of neurodegenerative disease and perhaps even the fears of aging will diminish.

We believe 2019 will be a Happy Year.

Daniel C. Montano, CEO Zhittya Genesis Medicine Inc.








January 2019 Events Schedule:

The following events are scheduled. We are in discussions for additional presentations and those will be listed as they become finalized.

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Tuesday, February 5, 2019

St. Simons Island, Georgia

Two presentations will be given at the Centered for Life, located at 2487 Demere Rd., #500, Saint Simons Island, Georgia.

The first presentation will be given at 12 noon and a second presentation at 7 pm (EST). If you RSVP, please tell us which time you prefer. The two presentations will be the same, just at different times for people to choose the presentation that is most convenient for them.

This event is hosted by the Centered for Life organization. The presentation will focus on Zhittya’s hypothesis on the cause of neurodegenerative diseases, including Parkinson’s disease, ALS (Lou Gehrig’s disease), Alzheimer’s disease, multiple sclerosis, stroke recovery and more. Zhittya will also discuss its novel biological drug to treat these diseases and the design of the proposed FDA-authorized clinical trials to test its drug.

To RSVP for this event email: [email protected]

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Wednesday, February 6, 2019

New Port Richey, Florida at 1:00 PM

A presentation is being hosted by the New Port Richey Parkinson’s Disease Support Group and the Family Fitness Centers of Pasco. The presentation will be at the Timber Greens Country Club, 6333 Timber Greens Blvd., New Port Richey, Florida.

Similar to the talk at St. Simons Island, the presentation will focus on Zhittya’s hypothesis on the cause of neurodegenerative diseases, the biological actions of Zhittya’s novel drug to treat these diseases and the design of the proposed FDA-authorized clinical trials to test its drug.

Seating is limited so RSVP for this event email: [email protected]

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Thursday, February 7th – Sunday, February 10th 2019

MoneyShow Orlando, Florida

The annual MoneyShow Orlando will be held at the Omni Orlando Resort at Champions Gate, Orlando, FL. This event is expecting around 4,500 investor attendees.

Zhittya will have an exhibition booth (#503) at this conference from Thursday, February 7, 6:30 PM through Saturday February 9, 6:00 PM.

*NOTE: CHANGE of booth number to #503. The MoneyShow people have informed us, that due to extremely high interest levels from attendees, that they wanted to change our exhibition booth to “center and forward” in an effort to deal with the larger crowds of people they now expect to visit our booth.

Dr. Jacobs and Dan Montano will be available at the exhibit booth to meet and answer questions from attendees.

*NOTE: CHANGE OF DATE FOR VIP BREAKFAST PRESENTATION FROM SATURDAY, FEBRUARY 9th TO FRIDAY, FEBRUARY 8th AT 7 am

The VIP breakfast presentation at the Orlando MoneyShow has received such an overwhelming response that we needed to get a larger room for people interested in attending it. The VIP Breakfast Presentation has now been moved from its originally scheduled Saturday date forward one day to Friday morning, February 8th at 7 am.

For those of you who have already confirmed and RSVP to us for tickets, please reconfirm that you will still be able to attend the breakfast on Friday morning. We have people who we know are flying to the meeting from Boston, Germany and Kuwait and I hope the change of date of our breakfast conference is not a problem for you. If it is, perhaps we can try and figure out how to accommodate you. Maybe we can have a breakfast meeting and presentation Saturday morning with Dr. Jacobs at the hotel? Please see below for more information on this breakfast meeting.

Friday, February 8th at 7:00 am

MoneyShow’s VIP Breakfast for its Alumni members (hosted by WUND Healing Biopharmaceuticals and Zhittya)

Presentation is entitled: “Parkinson’s Disease, Alzheimer’s Disease, Multiple Sclerosis: Can Angiogenesis Cure These Diseases?”

At this breakfast conference, Dr. Jacobs and Dan Montano will present an over- view of Zhittya’s drug development efforts.

In addition, Mr. John Laub, CEO of WUND Healing Biopharmaceuticals (WUND), will discuss his company’s business responsibilities, which include the sale and distribution of Zhittya’s portfolio of drugs, including the drug being developed for the treatment of Parkinson’s disease and other neurodegenerative diseases.

Tickets for the breakfast event are free, but you must make a reservation and obtain an Admittance Ticket. The MoneyShow is keeping many tickets for their VIP Investor Members and Zhittya is holding a limited amount of tickets for our guests to the event. As of December 31, 2018, the analytics of our Google campaign for Parkinson’s disease indicates that in the first 11 months of last year we have had in excess of over 235,000 users to our Zhittya sites on Parkinson’s disease. The analytics also indicate that around 22% of those people come from Florida, the Carolinas, Georgia and Alabama, all states within easy driving distance to Orlando. We recognize that a small percentage of those people are investor- types interested in attending the MoneyShow, however, if you are interested in attending the breakfast presentation, please RSVP and request an Admittance Ticket from us as soon as possible. Of the tickets Zhittya is holding for its invitees, most have been taken already, and we are still a month away from the event.

If you wish to obtain tickets for the breakfast presentation please email:

Vika Montano at: [email protected]

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IMPORTANT: new additional presentation by Zhittya at the Orlando MoneyShow, is scheduled for Friday, February 8th at 4:30 PM

The response for the breakfast meeting presentation at the MoneyShow has been very strong and we have been asked to give a second presentation in the afternoon. The second presentation will be for those unable to get into the breakfast presentation and is entitled:

“New Frontiers in Medicine-Novel BioPharmaceuticals to Potentially Reverse Neurodegenerative Diseases.”

This talk will cover similar ground as the breakfast presentation where Zhittya will discuss its novel biological drug and its drug development programs for neurodegenerative diseases, including Parkinson’s disease, ALS, Alzheimer’s disease, multiple sclerosis and more. There is no cost to attend this presentation. You simply have to register with us and RSVP.

RSVP: Vika Montano at: [email protected]

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We encourage you to visit us at the MoneyShow Orlando. Attendance is free if you register with the MoneyShow as an investor. If you want to register and attend this Florida conference, please email us and we will send you the necessary information.

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Thursday, February 21, 2019, San Diego, California from 12:30 - 2:30 PM

Location: Sanford Consortium for Regenerative Medicine, 2880 Torrey Pines Scenic Drive, La Jolla, CA 92037

We will be presenting to a number of Parkinson’s disease support groups in the San Diego area who have offered us this opportunity. We hope by that date in February that we will have more specifics about our clinical trials for Parkinson’s disease and ALS, depending on what new information is received in January/early February 2019. We hope to give you more specifics in the February 2019 Update.

We anticipate an excellent turnout so if you are interested in attending, please RSVP for a seat to: [email protected]

Now a word from Dr. Jacobs:

Hello, Dr. Jacobs here. As Dan mentioned above, we are now moving from the easy part of thinking how our drug may work in these diseases, to actually proving the drug is safe and effective in complex and exacting clinic trials. The “pathfinders” in these clinical trials will be subjected to multiple intravenous infusions of our drug for a 3-month period, and pricked and prodded for an additional 3 months to see if the drug is safe and effective through testing by our neurologist Principal Investigator.

Dan has mentioned the posting of the inclusion and exclusion criteria that will occur once we get clearance from the FDA on these criteria. Having worked with the FDA in the past on this issue (in the clinical trials dealing with FGF-1 for severe coronary artery disease), I know they are “sensitive” regarding certain hypothetical side effects of our drug. In the past, they have asked us to exclude anyone with a history of cancer (with the exception of skin cancer) or any patients that have any retinal disorders of the eyes. Even though we have seen no evidence of cancer or eye problems in any of our animal toxicity testing, where up to 100-fold higher levels of FGF-1 than will be used in the human studies were examined, I suspect the same exclusion criteria will be true with our upcoming clinical trials.

From my own past research experience with FGF-1, I know that high serum levels of cholesterol or heavy tobacco use can interfere with the drug’s biological activity, and so those issues will likely make it into the exclusion criteria and disqualify certain patients from participating. The good news is that the FDA will allow those patients into a subsequent trial if they stop smoking or get their cholesterol levels down with medications, so all is not lost.

There will be a fairly detailed screening procedure done before a person can enroll in the trial. This will include physical and neurological exams, extensive clinical laboratory testing, heart EKGs and a number of questionnaires to determine the subject’s mental status. Because of this, we have developed a short pre-screening form, approved by our institutional review board (IRB) that can be taken before a patient submits to the much longer formal screening process at the clinical trial study site(s). This form can be filled out (with input from the patient’s primary care provider or neurologist) and e-mailed to us, so patients living at a distance from the clinical trial site(s) will not be disadvantaged.

Well, that is about all for now. We commit to keeping you informed as soon as we learn any information from the FDA. We know living with these diseases is very difficult and that hope can sometimes be a commodity in short supply. I, personally, appreciate your overwhelming support as we move into this next crucial phase of clinical testing.

Thank you!

Dr. Jack Jacobs, Chief Science Officer, Zhittya Genesis Medicine Inc.