Parkinson's Disease Tulip


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Old 07-31-2014, 11:38 AM #11
Tupelo3 Tupelo3 is offline
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Originally Posted by soccertese View Post
i assume MJFF will do a webinar to put things in perspective?
I would imagine so. Todd Sherer was on the podium and gave part of the presentation. I would anticipate a summary on their website soon.
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Old 07-31-2014, 11:47 AM #12
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Originally Posted by Tupelo3 View Post
Badboy, thanks for posting the link. I'll be at the presentation and I'm very interested in seeing the early results. The vaccine still has a long way to go, but it could be a breakthrough development if it works.
Did you attend?
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Old 07-31-2014, 11:51 AM #13
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Originally Posted by Tupelo3 View Post
Presentation should be available for rebroadcast shortly (including slides). If not, I have copies and can PM to anyone who wants them.
Please PM me. I have to leave home soon. Thank you.
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Old 07-31-2014, 05:29 PM #14
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webcast here: http://totalwebcasting.com/view/?id=affiris
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Old 07-31-2014, 05:30 PM #15
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PRESS RELEASES

First Clinical Data of Therapeutic Parkinson’s Disease Vaccine Encourages Continued Development
AFFiRiS AG presents Phase I data on a first-of-its-kind treatment with support from The Michael J. Fox Foundation

(NEW YORK, USA, VIENNA, Austria) July 31, 2014 — AFFiRiS AG announced today at a press conference in New York results of AFF008, a Phase I clinical trial of PD01A, a vaccine against Parkinson´s disease. PD01A is the first therapy against the protein alpha-synuclein, a promising Parkinson’s drug target, to enter clinical testing.

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) supported the study with a $1.5 million grant, and presented at the press conference on the impact a disease-modifying therapy would have for patients. The Foundation will support a follow-up study testing a boost vaccination, the next step toward a Phase II trial.

"A treatment that could slow or stop Parkinson’s progression would be a game changer for the five million worldwide living with this disease and the many more who will become at risk as our population ages," said MJFF CEO Todd Sherer, PhD. "The AFF008 trial is one of the most promising efforts toward that goal, and we’re proud to support this work of AFFiRiS AG.“ In this study, two different doses of PD01A were safe and well tolerated, meeting the primary endpoint of the trial. Secondary endpoints of the study included the induction of an alphasynuclein- specific antibody response. A hallmark pathology of Parkinson’s disease is aggregates of protein — chiefly alpha-synuclein — called Lewy bodies that accummulate in brain cells, leading to cell degeneration and cell death. Researchers hypothesize that reducing alpha-synuclein accumulation will be neuroprotective; AFFiRiS is using active immunotherapy to test that theory and develop a disease-modifying treatment.

PD01A was applied at two different doses (15 μg and 75 μg) to 12 patients per group. All received four vaccinations in monthly intervals, and all completed the study. Eight patients on best medical care, including standard symptomatic medication, served as a control group. Each patient was regularly seen and evaluated during a 12-month period.

Fifty percent of the vaccinated patients generated alpha-synuclein-specific antibodies as measured in serum samples. Additionally, vaccine-induced antibodies were detectable in cerebrospinal fluid. This induction of antibodies against alpha-synuclein is strong preliminary evidence in support of the principle of AFFiRiS' proprietary therapeutic vaccine.

Furthermore, analysis of clinical endpoints revealed a trend, consistent over all parameters, towards functional stabilization of the vaccinated groups as compared to non-vaccinated control patients. The pharmacodynamic profile of PD01A and its clinical effects will be the
basis of later phase studies, should development continue.

"The safety and tolerability observed in this study, especially in a protein such as alphasynuclein where we do not yet know its normal function, are encouraging," said Walter Schmidt, PhD, Co-founder and CEO of AFFiRiS AG. "We are grateful for the continued support of The Michael J. Fox Foundation as we progress in clinical development."

The next study will take place in Vienna, Austria and focus on assessing the immunological and clinical effects of a boost vaccination. Recruitment is expected to begin September.


A recording of the press conference will be made available at
http://totalwebcasting.com/view/?id=affiris

Photographs from the press conference are available for download immediately after the event at
http://imgur.com/a/EwZUK

Further pictures are available at:
http://www.affiris.com/html/de/press...rial_logos.php
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Old 07-31-2014, 07:50 PM #16
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Default MJFF blog post on the matter...

https://www.michaeljfox.org/foundati...s_subsrc=email

Debi
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Old 07-31-2014, 08:08 PM #17
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Quote:
Originally Posted by Debi Brooks View Post
Thanks Debi. Sure hope you can get a phase II study conducted in the US....
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