Zhittya Regenerative Medicine

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  • Jer788
    Forum Member
    • Sep 2018
    • 121

    #31
    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 iPad

    Comment

    • Kayleigh
      Forum Member
      • Nov 2018
      • 1227

      #32
      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 x
      Last edited by Kayleigh; 15 June 2019, 20:28.

      Comment

      • Jer788
        Forum Member
        • Sep 2018
        • 121

        #33
        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 xxx

        Comment

        • Jer788
          Forum Member
          • Sep 2018
          • 121

          #34
          Hi Chris, sorry mate I believe it’s infusion over 3 weeks.
          Best Jerry

          Comment

          • Jer788
            Forum Member
            • Sep 2018
            • 121

            #35
            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 Jerry

            Comment

            • Kayleigh
              Forum Member
              • Nov 2018
              • 1227

              #36
              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 x

              Comment

              • Jer788
                Forum Member
                • Sep 2018
                • 121

                #37
                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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