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Thread: Zhittya Regenerative Medicine

  1. #21
    Forum Member Terry's Avatar
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    Hi Jerry,

    You can't come back, when we have all just saved up enough money to come out there.

    Two more months should get you over the cold period.

    Have you a house here and whereabouts in England?

    Best try to sort out a few things now for here.

    Love Terry

  2. #22
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    Hi Kayleigh, yes you are right. I donít know how bad I could have been if Iíd tried nothing. Obviously the family and lifestyle weather etc are big pluses but I also thought here there seems to be more going on treatment/trial wise compared to the UK but that is also connected to legislation. My good friend is coming out tomorrow to stay for 10 days so will discuss with him and my wife about the next step.
    Best wishes Jerry 😘

  3. #23
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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 ��

  4. #24
    Forum Member Terry's Avatar
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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 Terry

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    I will try my friend xxxt

  6. #26
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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 Parkinsonís Disease IND

    As you know, we submitted our Investigational New Drug (IND) application to treat patients with Parkinsonís 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 Parkinsonís 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 Parkinsonís disease submission, the start of the other clinical trials for ALS, Alzheimerís 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.

    __________________________________________________ __
    San Diego Presentation *IMPORTANT: TIME HAS CHANGED

    Date: Thursday, February 21, 2019

    New Time: 2:00 Ė 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: vika@zhittyamedicine.com

    At this presentation we will discuss our latest data and also update the audience on the status of the Parkinsonís 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. Simonís 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 Parkinsonís 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 Ballyís/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.

    image.png
    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 Parkinsonís 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 Parkinsonís disease clinical trial. When we have the final ďinclusion and exclusion criteriaĒ 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 peopleís 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 Jacobs

  7. #27
    Forum Member Kayleigh's Avatar
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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 x

  8. #28
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    Hi Kayleigh, there’s certainly hope there. Xxx Jerry

  9. #29
    Forum Member Kayleigh's Avatar
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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 xx

  10. #30
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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.

    __________________________________________________ __

    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 Vika@zhittyamedicine.com 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

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