Update though ALS is not mentioned directly it is in their sights.
Zhittya Genesis Medicine, Inc. Announces it has Released to the Public its New White Paper on its Drug to Treat Parkinson’s Disease
“Parkinson’s Disease: Therapeutic Angiogenesis as a Disease Modifying, Breakthrough Therapy?”
Las Vegas, Nevada, January 15, 2020 – Zhittya Genesis Medicine, Inc. (Zhittya), a private company, announced that its White Paper detailing results on its breakthrough medical therapy to potentially treat and reverse Parkinson’s disease is available to all, free of charge. Zhittya is advancing upon what it believes could be a “disease modifying agent” that has the potential to slow down and possibly even reverse the inexorable decline seen in patients who suffer from this devastating disease.
Over the last five years, a new medical hypothesis has been proposed that Parkinson’s disease may be caused by vascular disruption in the areas of the brain which house the “dopamine-producing neurons”, those neurons which are the target of patients suffering from Parkinson’s disease. The concept is simply that the micro-vascularization in the brain is blocked or narrowed restricting the flow of needed blood to these neurons, resulting in the classical symptoms of Parkinson’s disease, including tremor and gait disturbances.
Just as in the heart, blockage of coronary arteries can lead to angina and heart attacks, that same process is now thought to underlie the development of Parkinson’s disease. As detailed in the White Paper, the brain’s micro-vascularization consists of billions of capillaries that are only 5 microns wide, which requires red blood cells that carry oxygen to the neurons and are approximately 7 microns wide, to twist and squeeze through those tiny and fragile vessels to deliver their supplies and to remove cellular waste products. Even a minor interference in those small capillaries can materially reduce the amount of blood getting through to the neurons.
A new medical imaging technology known as “functional MRI” is discussed in the White Paper, and this technology can measure regional blood flow in the brain. Diagnostic imaging data show diminished blood flow in the area of the brain where the dopamine-producing neurons reside (the substantia nigra region), with Parkinson’s disease patientsshowing only 50% of the blood flow compared to a healthy person. With only 50% of the blood that is needed, why would it be a surprise that those neurons do not perform up to standard?
Zhittya’s management has been developing a biological drug which in other US FDA clinical trials has demonstrated it can trigger “Therapeutics Angiogenesis” or the growth of new blood vessels in ischemic tissues. In animal studies, monkeys that were given experimental Parkinson’s disease and treated with Zhittya’s biological drug, stopped their motor skills decline and actually improved almost back to their completely normal movement abilities.
Zhittya has filed an Investigational New Drug (IND) application with the US FDA to advance its drug into a Phase I Parkinson’s disease clinical trial. Zhittya has also filed, in parallel applications to obtain approvals to start Phase I clinical trials for its Parkinson’s disease treatment in Mexico and Estonia.
Zhittya’s White Paper, “Parkinson’s Disease: Therapeutic Angiogenesis as a Disease Modifying, Breakthrough Therapy?”, is available to all, free of charge by emailing: [email protected]
Daniel C. Montano, CEO of Zhittya stated, “I believe we are truly on to something here. Over the last three years, we have continually uncovered data which enhances our belief that Therapeutic Angiogenesis might be a viable breakthrough treatment for Parkinson’s disease. If, as we believe, Parkinson’s disease is caused by micro-vascular disruption in the brain, we hope our molecule can do in the brain, what it has already demonstrated it can do in the US FDA heart trial, namely, grow new blood vessels.”
Dr. Jack Jacobs, President of Zhittya stated “millions of people around the world suffer from Parkinson’s disease. We believe we may have a breakthrough therapy for this disease, which is why we will be spending many millions of dollars to prove if we are right or wrong. In the monkey experiments that were done, our drug demonstrated a genuine disease modifying effect, by regenerating new dopamine neurons in the brain, and it is this activity that we believe led to the restoration of the animal’s motor skills. We do not know if in human clinical trials, the medical outcome will be the same, but what I do know is that we have to find out and we owe this to the millions of sufferers of this horrific disease.”
About Zhittya Genesis Medicine
Zhittya’s management has been working to advance these medicines for over 21 years and expended in excess of $140 million USD to date. Zhittya’s medicine initiates a biological process in the human body referred to as “Therapeutic Angiogenesis” and this process will only occur in diseased tissues that become ischemic due to a lack of blood flow. In those areas with insufficient blood flow, the drug stimulates the growth of new blood vessels, providing nourishment and removing metabolic waste products, thereby re-establishing normal cellular functions. Heart disease, stroke, peripheral artery disease (PAD) and diabetic foot ulcers are just some of the more obvious disorders the drugs can treat, but in fact, over 75 human diseases, including neurodegenerative diseases such as Parkinson’s disease and Alzheimer’s disease, are thought to be caused by lack of blood flow to a specific tissue.
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Thank you for the encouraging update Jerry. Hopefully, sometime next year there will be some good news.
It might take a miracle but I try to keep the faith that the medical researchers and scientists are doing all they can, with their limited resources, to find an effective treatment and hopefully a cure.
It's not easy for us to stay strong but I find that reading about any progress in medical research always helps. Many thanks for kindly posting updates about this drug.
Love
Kayleigh xLeave a comment:
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Hi folks, a wee update on Zhittya. The project has relocated to Mexico where they hope to have some positive feedback in 3-4 months. They now have increased the infusion time from 3 to 6 weeks. I’m praying for good news.
Love JerryLeave a comment:
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Hi Chris, sorry mate I believe it’s infusion over 3 weeks.
Best JerryLeave a comment:
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Hi Kayleigh, good to hear from you, yeah it’s looking hopeful and it’s probably keeping us all going in a way. Haven’t been on for a while with one thing and another but I’ve packed in the Ibudilast. It just makes me feel sick so I haven’t had long enough at it to know if it’s any good. I’m feeling ok anyway and have put a bit of weight back on thanks to my brothers cooking and Ellie’s protein drinks.
Best wishes Jerry xxxLeave a comment:
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Hi Jerry
Many thanks for sharing the update. it's always good to read Jack Jacobs' messages of hope! - I am particularly encouraged by his belief that it will be "the biggest medical breakthrough in the last 100 years".
Each day this disease seems to get tougher for me to deal with but I will carry on fighting it with all the inner strength and determination I can muster. Where there's life, there's hope!
I hope you are ok Jerry. You are very kind to keep us updated with information about this drug - thank you!
Love,
Kayleigh xLast edited by Kayleigh; 15 June 2019, 20:28.Leave a comment:
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Hi folks I hope you are well in this awful place we find ourselves. I have recently received an update about the drug and if you read it you can understand the delay. I will reiterate what Dr. Jacobs and Dan say so please use this as hope and do not contact anyone regarding the trials. If its successful we will know about it so its for information only.
Love to all Jerry
Hello, this is Dr. Jack Jacobs.
I know this is an anxious time and that most of you are waiting for an UPDATE on the status of the Parkinson’s disease clinical trial.
As you know, we are attempting to develop a novel treatment for Parkinson’s disease. We are advancing a new pharmaceutical agent (human FGF-1) that has never been utilized to treat diseases in the brains of patients before. The FDA has a responsibility to request items relating to the safety of the drug for this “first in humans” utilization. Many highly complex and integrated issues must be addressed to satisfy the FDA’s safety concerns before we get the final permission to proceed with our clinical trial for Parkinson’s disease. Once we have resolved these issues, then the same safety data can be utilized to advance our clinical trials with other neurodegenerative diseases, including amyotrophic lateral sclerosis ALS, Alzheimer’s disease, multiple systems atrophy (MSA), multiple sclerosis (MS) and stroke recovery.
We understand that many of you want to learn as quickly as possible if we have a treatment for these neurodegenerative diseases. We are attempting to design the best studies to resolve complex technical issues, issues which no one has ever had to address before. The FDA, equally, is confronted with items (questions), it has never asked before, and it takes time to clarify what is the right way to obtain the needed answers. Some of our followers have gone so far as to contact the FDA on our behalf, but unfortunately, these actions only cause stress in our relationship with our regulators and could delay us even more. Please do not contact the FDA regarding our clinical trials.
Quiet Period
For a variety of reasons, we will be entering a “quiet period” were we will limit our communications to everyone, as we move forward with the additional testing being required by the FDA. We do not know if that quiet period will be 2 months or 6 months. We will continue to give presentations on data which has already been made public, but please accept that as soon as we can, we will update you with any new information we can share with you. We appreciate your understanding of our need to go quiet and look for your continued support.
Events Schedule
We had a strong response at the Orlando MoneyShow, which we attended in February 2019, and at the Las Vegas MoneyShow, which ran from May 13th-15th. At our Las Vegas presentations, we had over 700 people attending our presentations on the different drugs we are developing. Zhittya will be at the Seattle MoneyShow, June 15th-16th at the Hyatt Regency Hotel, Seattle and at the San Francisco MoneyShow, August 15th-17th at the Hilton Hotel, San Francisco Union Square. If you wish to attend those events, there is no cost. You simply have to register with the Money Show and they will send you a free ticket. On the web site for the MoneyShows, you can see the agenda for each of the shows and also the days and times when we will be giving our presentations.
Again, those dates are:
Seattle: June 15-16 at the Hyatt Regency Hotel
San Francisco: August 15-17 at the Hilton San Francisco Union Square
Additionally, Zhittya will have a presentation on our drugs at the Freedom Fest, July 17th through the 20th at the Paris Resort, Las Vegas, Nevada. If you are attending the Freedom Fest, please consider coming to our presentation. I also want to make you aware that there is a Convention Fee to attend the Freedom Fest. The Freedom Fest requires that you be a paid participate to their event to attend our presentation.
Webinar of the Presentations from the Las Vegas MoneyShow: May 13th -15th at Bally’s/Paris Hotel
Many people have asked us to come to their area and give them presentations on our medical hypothesis, clinical data and possible treatment for the medical indications we are pursuing. The MoneyShow in Las Vegas videotaped six (6) of our presentations and those presentations are available on YouTube at the links provided below for you to view and share. Some of the presentations have new content from the Updates we have been sending out, including new information on using our drug as a possible treatment for multiple sclerosis (MS). In addition, topics we have discussed in the past, but you may have missed are presented in these six videos, including a discussion on using our drug to treat “women’s small vessel heart disease”, the number one cause of death for women in the U.S.
I hope you find these presentations beneficial and please feel free to share them with others.
Presentations and Their Links:
Dr. Jack Jacobs Using Biotech to Conquer Human Diseases
Link: https://youtu.be/TIZms9V584I
Ms. Viktoriya Montano Why Does Heart Disease Kill More Women than Men
and How Can Biotech Address This?
Link: https://youtu.be/_7ACGAgcDGA
Mr. Dan Montano Investing in Biotech: Important Concepts to Succeed!
Link: https://youtu.be/6JGohtcs2U0
Dr. Jack Jacobs Angiogenesis in the Brain to Reverse Parkinson’s
Disease, Alzheimer’s Disease and More.
Link: https://youtu.be/z1pDtOdZrTA
Ms. Viktoriya Montano New Drugs for Diseases that Affect Women
Link: https://youtu.be/0yi1-Pdf6NI
Dr. Jack Jacobs New Frontiers in Healthcare: Disease Reversal Through Angiogenesis
Link: https://youtu.be/2xcF1YnY_ng
Commentary
Dan Montano here.
Our entire team suffers every day that we are delayed in advancing our hoped-for treatment for your diseases. We know that we personally do not suffer like the people with these diseases, or their caregivers. However, we have met so many of you and we have dear friends dealing with these diseases and we do care. We are trying everything we can to move these drugs along as quickly as possible and we understand time is your enemy.
We are now entering a period of time where we have to be very careful with what we say and do. We cannot share with you our discussions with regulators, our actions to resolved these items, or even predict the outcomes or the timing of those items. I can state, however, that we see nothing we believe we can not address, overcome and then move forward.
The animal toxicity trial the FDA wants us to provide them will cost just under $1 million dollars. It will take months to conclude. This animal trial is critical to us to advance to the next step. We need to confirm every aspect of that trial with the FDA, so the animal trial we conduct has everything they want and exactly in the way they want it. We do not want to spend months and a million dollars to learn we did not address with a complex blood test a possible X, Y or Z toxicity in the animals.
We are very busy advancing many items simultaneously that we cannot share with you at this time. Please be patient with us during this brief “quiet period.” I am confident that when we get to the other side you will be pleased with us and understand the need for us to be quiet now.
I want to thank the thousands of you who pray for us and our efforts. We are working feverishly to advance what I believe is the biggest medical breakthrough of the last 100 years. Just as penicillin and other anti-microbial drugs enhanced the human battle against tuberculosis, syphilis, pneumonia, cholera and more, turning these incurable death sentences to treatable diseases, and thereby extended human life expectance from 35 years in 1918 to now 77 years, I hope our work changes today’s incurable diseases, such as diabetes, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, ALS and more into treatable disease and thereby add another 20 to 30 years of quality life to each of us. Since I turn 71 in July, I believe 20 or 30 additional health years is a good thing! As a California “baby boomer” I can not express my displeasure that our songs of “Forever Young” seem not to be coming to pass.
Ladies and gentlemen, we are making great progress and we need and want your support, but please leave us now to carry on the next steps of our journey to see if we are right or wrong.
Dan Montano
Attachments area
Preview YouTube video Using Biotech to Conquer Human Diseases | Jack Jacobs
Using Biotech to Conquer Human Diseases | Jack Jacobs
Preview YouTube video Why Does Heart Disease Kill More Women than Men and How Biotech Can Address This?
Why Does Heart Disease Kill More Women than Men and How Biotech Can Address This?
Preview YouTube video Investing in Biotech Important Concepts to Succeed | Daniel Montano
Investing in Biotech Important Concepts to Succeed | Daniel Montano
Preview YouTube video Angiogenesis in the Brain to Reverse Parkinson's Disease, Alzheimer's Disease and More
Angiogenesis in the Brain to Reverse Parkinson's Disease, Alzheimer's Disease and More
Preview YouTube video New Drugs for Diseases That Affect Women | Viktoriya Montano
New Drugs for Diseases That Affect Women | Viktoriya Montano
Preview YouTube video New Frontiers in Healthcare: Disease Reversal Through Angiogenesis | Jack Jacobs
New Frontiers in Healthcare: Disease Reversal Through Angiogenesis | Jack Jacobs
Sent from my iPadLeave a comment:
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Latest update folks. There is hope but as you read below it is too much for some myself included at times. I suppose we just have to keep on fighting as long as you can bear it xxxx
Zhittya Genesis Medicine, Inc.
March 11, 2019 Update
Number 2019-3
Dear Friends:
Hello, this is Dr. Jack Jacobs.
UPDATE on the Status of the Parkinson’s Disease Clinical Trial
As I reported to you in our last month’s update, our clinical trial for Parkinson’s disease is on hold at the FDA, pending the completion of an additional animal toxicity study which will take several months to complete. It is not uncommon, especially when you are attempting a novel treatment for a disease, for the FDA to request additional items relating to the safety of the drug.
The good news is that we now know what the FDA will require for this additional study and we have identified an animal toxicology lab in California that can immediately begin the study. The data from this study will also satisfy what the FDA wants for our clinical trials with other neurodegenerative diseases, including amyotrophic lateral sclerosis ALS, Alzheimer’s disease, multiple systems atrophy (MSA) and multiple sclerosis (MS). We will proceed on this animal study as fast as is humanly possible and will keep you informed of its progress.
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Events Schedule
From such a strong response at the Orlando MoneyShow we attended in February 2019, Zhittya has committed to participate in additional MoneyShows around the country. In case you may want to meet us at one of these events, here are the dates of the upcoming MoneyShows we will be attending:
Las Vegas: May 13-15 at Bally’s/Paris Hotel
Seattle: June 15-16 at the Hyatt Regency Hotel
San Francisco: August 15-17 at the Hilton San Francisco Union Square
Toronto: September 20-21 at the Metro Toronto Convention Centre
Philadelphia: September 26-28 at the Sheraton Philadelphia Downtown
Dallas: October 13-14 at the Hyatt Regency Dallas
Las Vegas MoneyShow: May 13-15 at Bally’s/Paris Hotel
As below, we have the schedule of the presentations we will be making at the Las Vegas MoneyShow in May 2019. Please come join us at this meeting where we will also have an exhibition booth. There is no cost to attend this meeting and please email us at [email protected] if you would like to receive registration materials.
Schedule of our Presentations and Titles
Monday, May 13th
8:30 am Dr. Jack Jacobs Using Biotech to Conquer Human Diseases
9:45 am Vika Montano Why Does Heart Disease Kill More Women than Men
and How Can Biotech Address This?
10:45 am Dan Montano Investing in Biotech: Important Concepts to Succeed!
11:45 am Dr. Jack Jacobs Angiogenesis in the Brain to Reverse Parkinson’s
Disease, Alzheimer’s Disease and More
Money Show:
Tuesday, May 14th
3:15 pm Vika Montano: New Drugs for Diseases that Affect Women
Wednesday, May 15th
10:00 am Dan Montano: Biotech Investing
11:45 am Dr. Jack Jacobs: New Frontiers in Healthcare: Disease Reversal Through Angiogenesis
Report on February Event in San Diego
On February 21st we travelled to beautiful La Jolla, California to deliver a presentation to the local Parkinson’s disease support groups in the San Diego area. Our host for this meeting was Dr. David R. Higgins, Parkinson’s Patient Advocate & Coordinator, UCSD Parkinson’s Support Group Network. The setting was spectacular with approximately 75 people attending the talk delivered in a stunning auditorium on the campus of the University of California, San Diego overlooking the Pacific Ocean.
A number of the attendees were medical professionals which resulted in some excellent questions. We thank all of the attendees for your interest.
Commentary
Dan Montano here.
Our entire team suffers every day that we are delayed in advancing our hoped-for treatment for your disease. We know that we personally do not suffer like the people with these diseases or their caregivers. However, we have met so many of you and we have dear friends dealing with these diseases and we do care. We are trying everything we can to move these drugs along as quickly as possible and we understand time is your enemy.
As I have shared with many of you, each month after sending out our Updates, we receive back 3-10 replies with a statement such as: “please remove my wife from your list, she is no longer with us.” “Please remove my father from your list” and more. One reply arrived last month that touched me so much that I made a call to the widow in New Zealand and ask her permission to share her email with you all. She granted my request and I have copied it below (with her last name removed).
__________________________________________________ ________
Dear Dan,
Unfortunately, my husband took his own life on 16th October 2018 as he no longer wanted to live with his Parkinson. He was only diagnosed in November 2016. He developed the severe depression side of it. The Parkinson medication didn’t help him and the drugs for depression made him feel worse. He didn’t have the shaking either.
He was a fit healthy man of 67years who played, squash, tennis, golf & skied. He was very competitive. He never smoked and only had the occasional beer.
He worked full time on our Kiwifruit Orchard which was very successful.
I wish you well with your trials and hope you find a cure soon.
He has left a wife, 3 adult children and 2 grandchildren who he adored behind.
Kind Regards
Jackie
For those of you who know me, you know I am a fighter. Our team is passionate to try and stop the nightmare of these diseases. A major part of our frustration is that we believe we may have a treatment to end this scourge which has befallen so many millions of people.
We have to prove to the US FDA that our treatment is safe and is effective in reversing the course of these diseases. We are advancing as fast as we can, but that brings no relief to our frustration that you are suffering.
I seek your forgiveness for our delays.
We do not know what more there is to do to make it go faster, but I still feel so helpless.
I honor Jackie’s husband and I pray his passing has meaning to you. Could we have done more to make him aware that relief was potentially coming? If we had made him more aware that a treatment might only be months away, could it have provided that additional ounce of hope to change the weight of his decision? I pray for each of you that you will have the strength to hold on until we can prove if our drugs are viable.
Please keep fighting. DO NOT GIVE UP!
Jackie, I am sorry that a good man, a good husband, a good father and grandfather gave up. I believe he gave up because the monster that is Parkinson’s disease is without mercy and no one has ever recovered. I do not know if I could fight the depression of daily pain, the daily struggle to walk, talk and conduct the most basic bodily functions. I do not know if I would be strong enough to endure if I am told by everyone that no one has ever overcome this monster and that my pain will only grow worse. I do not know if I would have the courage to fight the battle that he and so many others reading this letter fight every day. I do not know if I am tough enough to keep up the fight that each of you is fighting every day. What I do know is please keep up the “FIGHT!”
I do not know if we will succeed or if our drug will treat these diseases. What I know is we should find out soon (6 to 12 months).
I ask each of you to consider this question: Are you giving hope to others that maybe this nightmare may end? If we are right about the cause and if our drug does in humans what it did in the monkeys, maybe this nightmare will end for Parkinson’s disease, ALS, Alzheimer’s disease, MS and more. I wish I could have reached Jackie’s husband and given him hope to fight longer. Maybe, if we had shown him more hope, he would have struggled longer to see if we succeed. Each of us knows people struggling with the depression of their hopelessness in their fight with Parkinson’s disease, ALS, MSA, MS, Alzheimer’s diseases and more. Give them some hope!
I am blessed that God has given me an abundance of hope. Every time disaster has destroyed me, I rebuild because I have boundless hope. I have a great life, great health and no pain. Would I be so brave if I had Parkinson’s disease, ALS or another neurodegenerative disease? If I was not in control of my body or my mind, and suffering daily pain, would I also surrender to depression?
There is nothing any of you can do to bring back Jackie’s husband. What you can do is give hope to others and maybe that ounce of additional hope you give them makes them fight to see if there is a treatment for this monster. Maybe you can help save one additional life?
Please do not lose your hope or your faith that this monster can be beaten.
May God bless you all and give you the strength to endure.
With Love-Dan Montano
Reply
ForwardLeave a comment:
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Thanks Jerry. Anything positive to read about always cheers me up! Hope things are going ok for my forum brother in Thailand xxLeave a comment:
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Hi Jerry,
Thanks for the very interesting update. Despite the FDA wanting further information before trials can proceed, it is good to know that Jack Jacobs and his team are still very enthusiastic about the potential benefits of the drug. I like his enthusiasm and positive attitude - it gives me a glimmer of hope
Sending love and hugs to everyone in this brave forum family,
Kayleigh xLeave a comment:
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Zhittya Update
Dear all, this months update,
image.png
Zhittya Genesis Medicine, Inc.
February 14, 2019 Update
Number 2019-2
Dear Friends:
Hello, this is Dr. Jack Jacobs.
UPDATE on the Status of the Parkinson’s Disease IND
As you know, we submitted our Investigational New Drug (IND) application to treat patients with Parkinson’s disease to the FDA around Christmas time. Since then, we have had many email and telephone exchanges with them regarding our submission.
The overall summary of our discussions is that we will need to provide them with additional information to proceed with our clinical trial for Parkinson’s disease. In several weeks we will receive, in writing, what specific additional data they are looking for, but from my discussions with the FDA, I suspect they will ask for an additional animal toxicity study which will take several months to complete.
From my past experience with the FDA, this is not an unusual request, especially when you are doing something no one has ever done before. We are the first company to propose to use a potent angiogenic (growth of new blood vessels) molecule to attempt to treat a degenerative brain disorder. With this type of cutting-edge pharmaceutical development, it is not uncommon for the FDA to request additional items relating to the safety of the drug.
Until we satisfy what the FDA wants with our Parkinson’s disease submission, the start of the other clinical trials for ALS, Alzheimer’s disease, multiple systems atrophy (MSA) and multiple sclerosis (MS) will also be delayed. We are ready to obtain whatever additional data they want as fast as is humanly possible and it is my hope the delay will be only a few months.
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San Diego Presentation *IMPORTANT: TIME HAS CHANGED
Date: Thursday, February 21, 2019
New Time: 2:00 – 4:00 PM
Location: Sanford Consortium for Regenerative Medicine, 2880 Torrey Pines Scenic Drive, La Jolla, CA 92037
The response for this presentation has been higher than expected, so we needed to secure a different meeting room that can accommodate 155 people.
We anticipate an excellent turnout, so if you are interested in attending, please RSVP for a seat to: [email protected]
At this presentation we will discuss our latest data and also update the audience on the status of the Parkinson’s disease clinical trial.
Report on February Events in Georgia and Florida
From February 2nd through the 10th we were in Georgia and Florida giving presentations.
At St. Simon’s Island, we had over 70 people attend. We thank those who traveled all the way from Ohio, New York, Pennsylvania, Virginia and elsewhere to hear the two presentations. Your willingness to travel far distances means a lot to us and confirms your commitment to us and what we are trying to accomplish. We thank Dr. Neil Schulenburg and the Centered for Life for their hosting of the event.
In New Port Richey, we had around 150 people. We thank Joe Fabrizio and the New Port Richey Parkinson’s Disease Support Group and the Family Fitness Centers of Pasco. The setting was outstanding and I believe it was our largest turnout to date for the medical presentation. A number of the attendees were medical professionals which resulted in some excellent questions. We thank all of the attendees for your interest.
MoneyShow in Orlando
Wow! Between the VIP breakfast for accredited investors, the afternoon medical presentation and the exhibition booth, I believe we met between 700 and 1,000 new people. We had over 400 interest cards filled out by attendees, so the MoneyShow was a great success for us.
It seems that many of the attendees at the event had never heard of our medical work, so our presentations were full and our exhibition booth was swamped with people wanting to know more. Seems people over the age of 55 really want us to succeed with our drugs, with the hope that we can potentially save their lives and those of their loved ones.
From such a strong response, Zhittya has committed to participate in additional MoneyShows around the country. In case you may want to meet us at one of these events, here are the dates of the upcoming MoneyShows we will be attending:
Las Vegas: May 13-15 at Bally’s/Paris Hotel
Seattle: June 15-16 at the Hyatt Regency Hotel
San Francisco: August 15-17 at the Hilton San Francisco Union Square Toronto: September 20-21 at the Metro Toronto Convention Centre Philadelphia: September 26-28 at the Sheraton Philadelphia Downtown Dallas: October 13-14 at the Hyatt Regency Dallas.
We hope this will provide you with an opportunity to meet with us face to face to answer any questions you may have and to learn more about the status of the clinical trials.
Commentary
I want to spend some time and go over the reasons why we are reaching out to you and our unique approach in trying to recruit patients for our clinical trials. Many of you have reported to us that your physicians have told you that our method to identify and recruit possible patients for our clinical trials is highly untraditional, and we agree, it is!
Our new approach stems from a bad experience I had in the past when I was supervising the FDA-authorized clinical trial where patients with severe coronary artery disease were being treated with FGF-1. This was the trial in which it was demonstrated that FGF-1 could grow new blood vessels in the heart and was featured in an ABC Nightly News story at this link: https://www.youtube.com/watch?v=IPtv_0LWK4k
The problem was that before the ABC News piece aired, it was very difficult to recruit patients into the study. It took over two years just to line up the academic institutions to perform the study and to get their Institutional Review Boards (IRBs) to approve the clinical trial design. After that, at the approximately 10 Centers that were in the study, less than one patient per month was being treated from all the Centers! Some of the biggest, most famous university hospitals which participated in the clinical trial never did one patient in three years.
I believe the traditional way to recruit patients into clinical trials is not effective. Delays that were seen in the heart trial resulted in millions of dollars being wasted and extended the clinical trials into the financial crisis of 2008-2011, which effectively killed the development of that drug. I believe if the trials had proceeded faster and the drug had been approved that 200,000 to 2,000,000 people per year would have suffered less from their severe coronary artery disease and lived longer. I think we would have had a much better shot at approval with the heart drug if we had learned how to recruit patients faster and more effectively.
To reinforce this point I have reproduced below a chart that appeared in the January 2019 issue of Scientific American. The article in which this chart appeared was discussing the difficulty of obtaining volunteers for cancer clinical trials. It is amazing that the top reason (by far) that patients gave for not joining trials is that they were not aware of the trial (as highlighted in yellow on the left side of the chart). Equally astounding is that again, by far, the top reason for a trial stopping prematurely is insufficient recruitment of patients into the trial.
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This is why we are making such an effort to reach out to you directly and not waiting on your neurologist or a busy university neurologist to get the word out about our clinical trials. We want as many people as possible to be aware of our clinical trials and that insufficient patient recruitment will not torpedo our studies.
We believe the person that cares most about your health is you! We want well- informed, motivated people ready to go the moment the FDA says we can start.
For the first Parkinson’s disease clinical trial, budget estimates indicate we will spend $100,000 for each patient we enroll into the trial. For this sum, we definitely want to enroll patients who will comply with the requirements of the clinical trial. For example, we will be doing motor and balance testing throughout the trial and anything that interferes with this testing could adversely affect the outcome of our study. For this reason, at every session where this motor testing will be performed, we will conduct alcohol and drugs of abuse screening, to confirm that our patients are not self-medicating and thereby risking the outcome for everyone in the trial. Millions of people are depending upon us to succeed and improve their lives.
We have over 5,000 people who have registered for consideration to be in our Parkinson’s disease clinical trial. When we have the final “inclusion and exclusion criteria” maybe only 20% of those patients will qualify. Maybe we are one person short of filling up the clinical trial and that final person is in Siberia. Those of you who know Dan Montano, know that Dan will go get that person in Siberia and bring them back so we can move forward.
Given what I know now, I wish in the past that we had reached out directly to heart patients, instead of following the traditional way. I believe millions of people’s lives would be better had we done that. We do not want to make the same mistake with your lives. As soon as we have the inclusion and exclusion criteria from the FDA, we will post them on our YouTube channel. You can subscribe to the YouTube channel by going here: https://www.youtube.com/channel/UCJx...5PoqpZARgL3frw
Thank you for your interest and support in what we are doing. We are moving as fast as we can, this I can promise you.
God bless you, Jack JacobsLeave a comment:
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Hi Jerry;
I'm in Suffolk. London sounds good and great if your brother wants you there with him. A extra set of hands never goes a miss.
Maybe see if he, you and the Mnda can sort out a specialist and a team for you for when you arrive.
Love TerryLeave a comment:
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Hi Terry ������ great out here if you’re healthy not so great if you’re not. Yeah I have a home in the North East but my brother wants me to move in with him in Central London. He works from home and very proactive so will go there most likely. He even has a pub 100 yards away so as long as I’m still swallowing and can raise my right arm I should be ok.
Where are you based btw ?
Keep in touch Jerry ��Leave a comment:
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