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The Michael J. Fox Foundation Awards AFFiRiS AG $1.5 Million for the Clinical Development of the First Parkinson's Disease Vaccine


10/12/2011 10:15:51 AM

NEW YORK, USA AND VIENNA, AUSTRIA, October 12, 2011 - The Michael J. Fox Foundation (MJFF) today announced that it has awarded $1.5 million to AFFiRiS AG, a Vienna, Austria-based biotech company, for a clinical study of AFFITOPE® PD01, a first-of-its-kind Parkinson´s disease (PD) vaccine. AFFITOPE® PD01 targets and helps remove the alpha-synuclein protein, whose clumping is the pathological hallmark of PD. Principal investigator Achim Schneeberger, MD, chief medical officer at AFFiRiS AG, will head the Phase I study of the vaccine candidate.

"Our Foundation´s top priority is the development of a disease-modifying treatment for PD, the most significant unmet need of Parkinson´s patients," said Todd Sherer, PhD, CEO of MJFF. "PD01 represents the first time a vaccine approach to Parkinson´s disease has been studied in the clinic, and while it is still in the early stages of testing, its potential to stop the progression of the disease itself could lead to a breakthrough in how we treat PD."

"MJFF´s ongoing support is critical to the development of AFFITOPE® PD01," said Dr. Schneeberger. "Through MJFF´s Edmond J. Safra Core Program for PD Research, we have been able to bring an initial pre-clinical study of PD01 into the clinic. This latest award takes our partnership to the next level, while enhancing the Foundation´s presence in Austria and in Europe on the whole, further solidifying MJFF as a worldwide leader in PD research and treatment."

Pre-clinical studies show that the PD01 vaccine stimulates the body´s immune system to produce antibodies that bind to the protein alpha-synuclein, clearing it from the brain and slowing disease progression. Alpha-synuclein is the major component in the Lewy bodies that are found in the brains of people with Parkinson´s. It is a high-priority target for MJFF, largely because there is compelling evidence that it may play a role in both idiopathic and rarer genetic cases of PD.

AFFiRiS´s PD vaccine approach builds on the company´s experience developing an Alzheimer´s disease (AD) vaccine. Two of its AD vaccine candidates have already passed Phase I safety and tolerability testing and one of these, AFFITOPE AD02, has moved forward into Phase II testing. A third potential AD vaccine, AD03, is in the first stage of clinical testing.

"Both the AD and PD AFFITOPE® vaccine families are delivered by the proprietary AFFITOME® technology," explained Markus Mandler, PhD, head of the neurodegeneration team at AFFiRiS. "Its safety has been validated during Phase I testing of our AD vaccines. More importantly, early efficacy signals in the AD02 vaccine support our development strategy, which proposes the early testing of several members of a vaccine family in humans, the most relevant setting. We are able to do this given the compelling safety profile of these vaccines. We call this concept clinical maturation."

With this award, MJFF expands its research presence in Austria, with total awards of more than $2.5 million to Austrian research teams to date. In Innsbruck, a research team led by Werner Poewe, MD, is working to identify Parkinson´s biomarkers (including alpha-synuclein biomarkers) as one of 21 clinical sites of the Parkinson's Progression Markers Initiative (PPMI), a landmark international study sponsored by MJFF. Biomarkers are concrete ways to demonstrate that a candidate therapy is, or is not, impacting disease course in PD patients, as opposed to simply alleviating disease symptoms. With biomarkers in hand, it will be possible to establish definitive endpoints for clinical trials of disease-modifying Parkinson´s treatments such as PD01.

About The Michael J. Fox Foundation for Parkinson´s Research As the world´s largest private funder of Parkinson´s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson´s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson´s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $264 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson´s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson´s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson´s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. Now through December 31, 2012, all new and increased giving to The Michael J. Fox Foundation, as well as gifts from donors who have not given since 2009 or earlier, will be matched on a dollar-for-dollar basis with the $50-million Brin Wojcicki Challenge, launched by Sergey Brin and Anne Wojcicki.

For more information, visit: www.michaeljfox.org; www.facebook.com/michaeljfoxfoundation.

About AFFiRiS AG

On the basis of the company´s own patent positions AFFiRiS develops tailor-made peptide vaccines for Alzheimer´s disease, Atherosclerosis, Parkinson´s disease, Hypertension and several other conditions with unmet medical need and attractive market sizes. Alzheimer´s is the current lead indication. For the Alzheimer´s vaccine program, a license and option agreement with GlaxoSmithKline was closed in October 2008, triggering an upfront payment of EUR 22.5 million. The contract envisages (milestone-dependent) payments of up to EUR 430 million. A first milestone payment of EUR 10 million was made in October 2009 followed by EUR 3.5 million as announced recently. AFFiRiS currently employs 82 highly-qualified staff at the Campus Vienna Biocenter in Vienna, Austria (www.affiris.com).

Contacts:

The Michael J. Fox Foundation

Nate Herpich

+1 212 509-0995 295

nherpich@michaeljfox.org

Halsin Partners

Mike Sinclair

+44 20 7318 2955

msinclair@halsin.com

AFFiRis AG

Julia Bock

+43 1 798 15 75 - 303

julia.bock@affiris.com

PR&D - Public Relations für Forschung und Bildung Jacqueline Bogdanovic

+43 1 505 70 44

contact@prd.at

Katja Korehnke

+49 30 243 456 25

kk@korehnke-kommunikation.de

Jacqueline Bogdanovic, Bakk.

PR-Assistentin

PR&D - Public Relations für Forschung & Bildung

T +43 1 505 70 44

F +43 1 505 50 83

E bogdanovic@prd.at

Mariannengasse 8

1090 Vienna, Austria

http://www.prd.at


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