It was bound to happen. Cynapsus Therapeutics announced today that it is being bought out by Sunovion Pharmaceuticals for $40.50 per share. This morning Cynapsus woke up to $18.36 per share and celebrated the end of that day at $39.70. UP $21.34. Very well deserved. Let's get this drug I am on out to the masses.
I feel so incredibly blessed to be only 1 of 106 on this last leg of the trial. And, of course, I have a story to share from last night. My husband, Lee and I took in an AC/DC concert here in Fort Lauderdale with friends. The concert (with Axl Rose in for Bon Scott doing an A-M-A-Z-I-N-G job, by the way) was soooo much fun. Until three-quarters of the way in. That's when for some bizarre reason, the pounding from the instruments through the speakers made a change in my body and wore my Carb-Levo off in an instant (no kidding). There was no "wear off". It was one minute on and the next off in full tremor. Normally I would have made a beeline for the bathroom and cried out the rest of the concert. It was took early to take more Sinimet so I would have been rocking and rolling (no pun intended, trust me) for another 2 hours until the next dose. Instead I popped a sublingual APL-130277 under my tongue and within 10-15 minutes I was completely still like it never happened. I am still dumbfounded that this miracle drug has entered my life and taken PD on and shut it down.
To everyone around me it looked like I was dancing. To me, my heart was palpitating as I realized I was have a PD attack in a crowd of thousands. Speechless. That's what I am. Grateful beyond words. And humbled by the work of hundreds of researchers who are doing this for me.... and for you.
Thank you Cynapsus. And as always, a very special THANK YOU to the Michael J. Fox Foundation, who without I would be incapacitated at 52 years old. Instead I am very alive, very vibrant, very active, very viable and still enjoying the fruits of a (somewhat) normal life.
2,786 days walking with Parkinsons and counting.
7 years, 7 months, and 17 days.
Ironically that it adds up to the number 22, which is my birthdate and my lucky number
More importantly, it is "MASTER NUMBER" in Kabbalah numerology.
One of the most revered numbers.
The month of August which started my personal cycle to start to skyrocket started out on August 1, 2016 adding up to CHAI. The number 8. Ana, you are right - as usual. You can't get any better than that.
Today is a very good day.
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.
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............
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!!
Can't lie. I am nervous the night before the start of my drug trial.
I sit in awe and gratitude. I can't register what has happened today. It seems like the whole day is just a dream. I wasn't planning for this. It just happened. Today tremors. Tomorrow on my way to the stillness I seek. I will never forget today as long as I live.
Today I enrolled as 1 of only 100 people in the US for the Final CTH-301 PHASE 3 SAFETY STUDY. The Efficacy Study is closed. That is the double blind placebo study. They are now on to the Open Label version. I will be getting the drug; no placebo. And I start the testing tomorrow and the drug next week. For those that want to check out the study I am joining, click here: http://www.cynapsus.ca/product-p…/apl-130277-clinical-trials
The drug APOKYN has been used for PD for this purpose since 2004 but its only been available in injection delivery. This drug is sublingual (under the tongue). I will take it with each of the 5 doses of dopamine I take a day. It will reduce the "OFF" period from 2 hours in the morning and 45 minutes for all other doses down to several to 15 minutes. Wow!
I think I will go buy myself a lottery ticket tonight. Hey, wait - I have won the lottery!!! Who would have thought 5 years ago when I started to tremor that only 5 years later there would be a way to stop it.
My dream in all of my writings is to return to the peace and stillness I once took for granted.
I might just get that wish. And sooner than I was expecting.
Dream boldly, friends. Never, ever, ever, ever, ever, ever give up. Ever.
Hi everyone. I am so excited to report that I have volunteered for CTH-300: A Phase 3 Study to Examine the Efficacy, Safety and Tolerability of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease. 3rd phase is the final phase before being approved to go to market and this one is tailor made for me. (I am joining the final Safety study)
They were searching for PDers that take a min of 4 doses of dopamine a day (I take 5) and that experience at least 2 hours of OFF time each morning. That's me!!!! I chatted with the study doctor's office in Boca yesterday and will be tested on July 26th. The drug is a sublingual (under the tongue) strip that I use with my regular medicine regiment. It cuts the wait time from OFF to ON from 2 hours (or 45 mins for each of the other 4 doses I take) down to 15 mins!!!! So I should hopefully cut the time I am annoyed each day to only 1 hour 15 mins total. That's down from about 8 hours a year ago....and another positive step toward my dream come true.
I am happily biding my time waiting for the drugs that slow or stop the progression to hit the market. They are only around the corner!!!! Yay. Thank God for Michael J Fox.
PS: the drug company is so positive they went public with an IPO on June 30th ❤️❤️❤️
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