Today I woke up another year older and a whole lot less shaky!
Today I began my participation in the Phase 3 Safety Trial for APL-130277 and I received a birthday present that blows the imagination. You have to watch this!!!!
P.S.: You have my permission to share this video, especially if you know anyone with PD.
I promise you. There is no one with more precious, loving and loyal friends and family than me. I have an overflowing blessing cup that never ceases to amaze me. My heart is so full. My life would not be the same without each and every one of you. Thank you for being a part or my journey.
WE ARE GETTING EXCITED!!
Lee: "What do you want for your birthday?"
Me: "My new medicine tomorrow"
Me: "Are you coming with me?"
Lee: "Wouldn't miss it!"
Me: "Me neither. What a great start to my new year."
I can't believe in about 24 hours it will finally be in my hands. Have to admit I never thought medicine would be my ultimate choice for a birthday gift, but in my new reality it is. To be 1 of 100 in the US who gets this present humbles me. I wish every PD traveler could have it. Right away. In the meantime I will let it right my ship and bring me some much welcomed relief. I plan to add a little fanfare flourish to the occasion. ITS MY 52nd BIRTHDAY. Bring it on!!!!
The older you get the longer your birthday celebration becomes and you find yourself enjoying an entire Birthday Week. I most definitely take advantage of that little benefit. Welcome everyone to my Birthday Weekend.
I am especially excited because my birthday is Monday. August 22nd. I turn 52 at precisely 2:55pm. At 10:30am, I will be picking up my new medicine to start the drug trial. ON MY BIRTHDAY!!!! I would say there is NO better present than that in the world world.... aside from a cure. In that absence, this is most assuredly the next best thing.
A shipping delay by the pharmaceutical company added to my work commitments coincidentally pushed my start date to August 22nd. I truly think it's all in the timing!!
LET THE CELEBRATION BEGIN............
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Reposted from the FoxFeed Blog
Under-the-Tongue Film Strip for "Off" Rescue Moves Closer to Market
Posted by Maggie McGuire Kuhl,
August 16, 2016
Clinical trial news update: Cynapsus Therapeutics Inc. recently announcedresults from the Phase II trial of their listerine-like strip "off" rescue therapy to restore motor function when the effects of levodopa begin to drop. The therapy is now in Phase III testing, and Cynapsus anticipates filing for a new drug application (a formal proposal from the company to the FDA asking for drug approval) in the first half of 2017; the FDA must review all safety and efficacy data in the application before it decides on approval, which can take up to 10 months.
MJFF promoted recruitment of these trials through Fox Trial Finder and is funding a sub-study within the Phase III trial, in which data will be collected from a subset of participants through the use of wearable devices and MJFF's Fox Insight smartphone application (developed in partnership with Intel). Read more below about this therapy and MJFF's support of its development:
The development of a user-friendly "off" rescue therapy recently reached two monumental milestones that will propel it closer to pharmacy shelves.
Cynapsus Therapeutics Inc. is testing a thin-film, under-the-tongue strip (similar to those offered by Listerine for fresh breath) to quickly restore motor function when the effects of levodopa wane. ThePhase I study — funded by The Michael J. Fox Foundation — reported positive results, and the company secured $25 million from investors to support further development.
The thin-film strip is a reformulation of an available drug, apomorphine, that is injected for rescue from "off" episodes. People with Parkinson's disease can go from "on" to "off" when the concentration of levodopa (the primary PD drug) in the bloodstream drops, causing a reemergence of motor symptoms. As patients take levodopa over the long-term, the drug can wear off before the next allotted dosage. Taking more levodopa upon "off" is undesirable since too much of the drug can cause debilitating side effects.
Apomorphine is the only available drug for "off" rescue, but the need for injection discourages use. It also may cause side effects of nausea and vomiting. The under-the-tongue formulation, called APL-130277, may be easier to use and offer longer relief than the injected apomorphine. Initial studies show fewer side effects, as well.
The Phase I study in control volunteers tested how much of the drug from the strip reached the bloodstream and how fast it did so, compared to the established already available injectable. Cynapsus found similar results: the 10mg strip correlates to the profile of the 2mg injection, and the 15mg strip to the 3mg.
Since this study was in control volunteers, they do not know for certain how fast the strip can relieve motor symptoms. However, they do know the level of the drug in the blood that is usually the "on/off" threshold. The strip took 10 minutes to reach that threshold, compared to about six minutes with the injection.
Accounting for the time to fill a syringe and self-inject versus place a strip under the tongue, though, may offset that difference. Furthermore, the effects of the strip on motor symptoms may last longer than the apomorphine from injection.
"Patients can defer taking another dose of levodopa perhaps even longer than they would have scheduled, and we know fewer levodopa is a good thing in the long run," said Albert Agro, PhD, chief medical officer at Cynapsus.
A separate study from Cynapsus of a 25mg dose of APL-130277 showed faster time to reach the "on/off" threshold and longer efficacy.
Their next step is to test these doses in people with Parkinson's. The study is still being planned. When sites start recruiting, the details will be listed on Fox Trial Finder.
The $25 million follow-on investment for this study is a testament to the MJFF de-risking model, supporting early-stage research to make these projects more attractive to larger funders.
"We look forward to initiating the efficacy program in patients suffering from Parkinson's disease with debilitating motor complications," Dr. Agro said.
Said Anthony Giovinazzo, CEO of Cynapsus, "Our partnership with The Michael J. Fox Foundation is very important to us as not only does it provide credibility, but they have the means to help us accelerate our recruitment."
Register with Fox Trial Finder today to be matched with clinical studies recruiting in your area.
I am pleased to report that this visit was everything we wanted it to be.
Everything went perfectly except the dose is still too low. I need one more appointment on Friday morning to go to 20mg which should be on the money.
Monday I did not come fully "ON" before having to take the rest of my meds.
Today I came fully "ON" at about 25 mins.
They suspect that on 20mg I should be "ON" in 10 mins which is perfect. Down from 120 MINUTES!! Holy cow.
Again I didn't sleep last night because I have to be off all meds to do the testing so I am going home to sleep it off. I have been up for 31 straight hours and counting.
I feel GREAT!!! This is a rescue-type of drug so it zooms me from OFF to ON. Not so fast that it is uncomfortable, but fast enough that I can feel everything calming down and coming to. It is the coolest feeling ever!!!!!
This is going to dramatically change my schedule and our lives. This is God's perfect timing for all the excitement and growth we have coming up. As soon as it zoomed me to life (in about 2 mins) I started tearing up. What an amazing relief. I wish I could adequately share the experience.
Thanks again for all your prayers, support and love. IT WORKED!!
Tonight I find myself wide awake in the middle of the night, once again. Later this morning I go in for my second level dosing of the drug I am receiving in a clinical trial for my Early Onset Parkinsons Disease (I am 51). Monday I was given 10mgs; today will be 15. Monday's dose only did about 80% of the job of bringing me to an "ON" state within the 15 minutes allotted, so up in dose I go. They call it "titrating." Unfortunately, each new dose level requires me to be off my meds so they can test the effectiveness. As you know by now, my brain which is controlled by Parkinsons medications has long since lost the ability to cross over from conscious to unconscious without them.....so I sit in the dark, in peaceful serenity while the world around me sleeps. The only sound is a soft rain rhythmically falling outside the window. And I count the hours until daylight knowing its going to be another long day tomorrow.
This night, however, I am pleasantly surprised when a friend, Amanda, joins me. Amanda lives in Ohio and we met through a online hobby site we frequent. She's awake with me and we are chatting at 1:45am Eastern time. We stumbled on the topic of The Giving Keys and I find out that she has one. She gives me hers. Engraved on it is the word "HOPE". I cannot believe it. Her timing is impeccable.
The Giving Keys is a "pay-it-forward" company that does beautiful work in the Los Angeles area. Their mission is to empower those transitioning out of homelessness. On their website they implore you to: "EMBRACE YOUR WORD (ON THE KEY), THEN PAY IT FORWARD TO A PERSON YOU FEEL NEEDS THE MESSAGE MORE THAN YOU. WRITE US THE STORY OF WHY YOU GAVE IT AWAY AT WWW.THEGIVINGKEYS.COM".
So begins the story of my Giving Key, passed to me from Amanda..... a picture of it I posted below.
The Giving Keys are brass and come in colors of gold, silver, and copper. They also have more expensive precious metal versions. You can choose a necklace, bracelet, earrings, or charms. You can layer them. They engrave the word BELIEVE, BRAVE, BREATHE, COURAGE, CREATE, DREAM, FAITH, FEARLESS, HOPE, INSPIRE, LET GO, LOVE, OR STRENGTH - your choice on each piece. You can also customize your own, which I will do when I order mine online. It will say "BEAT PD". You get up to 8 letters/spaces. I will will wear mine lovingly and will be sure to, in time, pass it on to another PD traveler I meet on my journey who is going through the same thing as me and who needs encouragement, hope, and love.
I encourage you to go to The Giving Keys and buy one or more today. They make beautiful gifts for you and your loved ones. And you will help support those that need us most.
Thank you so much Amanda. I will never forget tonight. It is with love and a continuous HOPE for the Cure that I wish all of you.....
See my story online at The Giving Keys website: www.thegivingkeys.com/blogs/news/hope-for-the-cure. I am so proud to support their efforts. Please keep them in mind for your gift giving. You will never forget the experience. Thank you.
I am waiting to give an update until I am fully on the drug so not to jinx it, but I wanted to share with you the most beautiful support note I received from a personal angel, who without I would not be where I am today, in so many ways.
This angel was at the right place at the exact right moment minding his own business in a grocery store when my mother overheard a conversation he was having with someone about Parkinsons. My brave mom waited for them to finish and then approached him to find out how he knew so much about PD. At that time he worked with the South Palm Beach Chapter of the National Parkinsons Foundation. She could hardly believe it. I still lived in WI at the time and was only just suspecting PD a week ago, then BAM; he appears in Publix. My life hasn't been the same ever since.
Last night, he wrote me (and is so graciously allowing me to share with you):
"Love you and your courage. You too, Lee. We know what one day at a time means. Stay calm and all will work out. Think about all the people who are waiting for the results and their hope for a better life. You are helping over 4 million people, let the meds do what they were meant to do. 15 minutes off all meds? What a great first day. Remember that and you are a rock star as you like to say. History kid, history. Now you know why I love you so much. You define hero."
"Lisa it's much easier to see when you're not in the box. I don't have PD, but I went through it with my dad. I'm in the brain Bank study, and every trial that I can possibly be without Parkinson's. It's always helping all the people that come after us, and my way of thanking my dad for all he's done. What you're doing is helping every other person on this planet that has PD. You said that is only a hundred people in the study, you truly are blazing a path for every other person. You said that you know the meds work in about 15 minutes, that's amazing. Think about how amazing that is, and keep your eyes on the prize. When you're back on your meds and you're having an off think of how much hopefully the meds can help. Always realize that today was day 1. Now we all know what stress does to PD. So even with all the stress, the lack of sleep, and the fear that comes with not knowing, it worked. Absolutely amazing. Keep your eyes on the prize and it should get easier day by day. Anytime you want call me I will always be there for you. I don't know why God placed me in front of your mom but it was for a reason. Keep up the fight kid. I love you."
I LOVE YOU TOO, Stuart Perlin
Do you need support?
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"Lisa Vullo is One Face of Early Onset Parkinson's Disease. Come along on her journey from symptoms to diagnosis; through treatments and therapies. There are highs and lows, miracles and heart notes, and the determination to never, ever, ever, ever give up on the power of HOPE."