|By PR Newswire||
|July 31, 2014 11:10 AM EDT||
NEW YORK and VIENNA, July 31, 2014 /PRNewswire/ --
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 alpha-synuclein-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 alpha-synuclein 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/presse_medien/bildmaterial_logos.php
This press release contains forward-looking statements and should not be used for investment decisions.
About AFFiRiS AG (By: May 2014)
Based on its proprietary IP positions AFFiRiS develops tailor-made drugs mainly as Peptide-based vaccines. Target diseases include Alzheimer, Parkinson, Diabetes and other indications with attractive markets and unmet medical need. Alzheimer is the lead indication. Current investors are: MIG-Fonds and Athos Service GmbH, both Munich, Germany. AFFiRiS is located at the campus of the Vienna Biocenter, Vienna Austria and employs 95 highly qualified employees. http://www.affiris.com
About The Michael J. Fox Foundation for Parkinson's Research
As the world's largest nonprofit 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 $ 450 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.
Contact AFFiRiS AG:
Mag. Julia Bock
1030 Vienna, Austria
E [email protected]
PR&D - Public Relations for Research & Education
1090 Vienna, Austria
E [email protected]
SOURCE AFFiRiS AG
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing be...
Apr. 30, 2017 01:00 PM EDT Reads: 1,060
While some vendors scramble to create and sell you a fancy solution for monitoring your spanking new Amazon Lambdas, hear how you can do it on the cheap using just built-in Java APIs yourself. By exploiting a little-known fact that Lambdas aren’t exactly single threaded, you can effectively identify hot spots in your serverless code. In his session at 20th Cloud Expo, David Martin, Principal Product Owner at CA Technologies, will give a live demonstration and code walkthrough, showing how to o...
Apr. 30, 2017 12:15 PM EDT Reads: 861
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Apr. 30, 2017 12:00 PM EDT Reads: 1,916
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, discussed the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docker c...
Apr. 30, 2017 12:00 PM EDT Reads: 1,371
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
Apr. 30, 2017 12:00 PM EDT Reads: 1,631
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Apr. 30, 2017 11:30 AM EDT Reads: 2,438
Cloud Expo, Inc. has announced today that Aruna Ravichandran, vice president of DevOps Product and Solutions Marketing at CA Technologies, has been named co-conference chair of DevOps at Cloud Expo 2017. The @DevOpsSummit at Cloud Expo New York will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and @DevOpsSummit at Cloud Expo Silicon Valley will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Apr. 30, 2017 11:30 AM EDT Reads: 2,910
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
Apr. 30, 2017 10:15 AM EDT Reads: 2,575
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Apr. 30, 2017 10:00 AM EDT Reads: 1,721
Translating agile methodology into real-world best practices within the modern software factory has driven widespread DevOps adoption, yet much work remains to expand workflows and tooling across the enterprise. As models evolve from pockets of experimentation into wholescale organizational reinvention, practitioners find themselves challenged to incorporate the culture and architecture necessary to support DevOps at scale. In his session at @DevOpsSummit at 20th Cloud Expo, Anand Akela, Senior...
Apr. 30, 2017 10:00 AM EDT Reads: 2,054
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
Apr. 30, 2017 09:45 AM EDT Reads: 1,859
SYS-CON Events announced today that Progress, a global leader in application development, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs oft...
Apr. 30, 2017 09:15 AM EDT Reads: 836
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
Apr. 30, 2017 09:15 AM EDT Reads: 1,445
As pervasive as cloud technology is -- and as persuasive as the arguments are for using it -- the cloud has its limits. Some companies will always have security concerns about storing data in the cloud and certain high-transaction applications will always be better suited for on-premises storage. Those statements were among the bottom-line takeaways delivered at Cloud Expo this week, a three day, bi-annual event focused on cloud technologies, adoption and associated challenges.
Apr. 30, 2017 09:00 AM EDT Reads: 4,302
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
Apr. 30, 2017 08:30 AM EDT Reads: 1,838