Navigation Links
AFFiRiS AG: Interim Analysis of Clinical Phase I Data Triggered Decision to Move Alzheimer's Vaccine Candidate AD02 into Clinical Phase II Testing
Date:11/19/2009

VIENNA, Austria, November 19 /PRNewswire/ -- AFFiRiS AG will focus its Alzheimer's vaccine program on one product candidate at an unexpectedly early stage of development: the vaccine candidate AD02 is planned to enter into Phase II clinical trial early in 2010. This decision by the company immediately follows the completion of two Phase I trials with the candidates AD01 and AD02. The company based its fast decision on the first interim analysis of the secondary endpoints at the six month time point. Furthermore, based on this analysis, the AD02 patients from the completed Phase I study will now be offered an AD02 booster vaccination.

AFFiRiS AG announced today, that Alzheimer's vaccine candidate AFFITOPE AD02 will undergo immediate tests for potential efficacy in a Phase II trial. This means that the company can focus its diversified development program for Alzheimer's vaccines earlier than initially planned. The reason for the decision is based on the interim analysis of the preceding Phase I testing.

Dr. Walter Schmidt, CEO and co-founder of the company, explains the company's surprisingly rapid decision: "Both vaccines AD01 and AD02 met the primary phase I endpoints demonstrating safety and tolerability and therefore both qualified for phase II testing. However, as a small biotech with a strong focus on optimized resourcing, we are always keen to prioritize. Based on the first interim analysis of secondary endpoints, which is confidential at this stage, we decided to focus in the first instance on AD02. The Phase II trial will start as early as possible, hopefully early next year."

Dr. Frank Mattner, CSO and co-founder, adds: "It is part of our strategy in the early phase of vaccine development to focus on more than one candidate, if possible. In this way, we diversify our risk. Based on this, we can then back in the first instance the potentially most promising candidate and put the others on hold. This is exactly what we did with our Alzheimer's vaccination program and the outcome in the Phase I trials at this stage enabled us to make this decision earlier than we expected and to offer a booster vaccination to the AD02-treated patients. Finally, we can also redirect our resources which will now be available for our other vaccination programs." AFFiRiS AG can also invest all of the EUR 10 million, paid by licensing partner GSK Biologicals as a milestone payment for the positive completion of the Phase I studies, in the other R&D programs.

The vaccine development program of AFFiRiS is based on the company's AFFITOME(R) technology, which also delivered the vaccines tested so far. Also based on this technology are six other vaccination programs being developed by AFFiRiS AG, which target, among other indications, Parkinson's disease and atherosclerosis.

About AFFiRiS AG (status November 2009):

Based on proprietary patent positions, AFFiRiS has developed tailored peptide vaccines against Alzheimer's Disease, Parkinson's and four other diseases characterized by urgent medical requirement and attractive market volumes. Alzheimer's is the current lead indication and clinical Phase I trials have just been completed on two product candidates. AFFiRiS succeeded in attracting GlaxoSmithKline Biologicals as its licensing partner in October 2008. The contract contains provisions for (milestone-dependent) payments of up to EUR 430 million. Based on the successful completion of two clinical Phase I trials, a payment of EUR 10 million was made in October. AFFiRiS currently employs 60 highly-qualified staff at its premises on the St. Marx Campus in Vienna, Austria (http://www.affiris.com).


    Contact AFFiRiS AG:
    Mag. Agnes Meyer
    Karl-Farkas-Gasse 22
    T +43-1-798-15-75-3
    mailto:agnes.meyer@affiris.com
    http://www.affiris.com

    Copy Editing & Distribution:
    PR&D - Public Relations fur
    Forschung & Bildung
    Campus Vienna Biocenter 2
    1030 Vienna
    T +43-1-505-70-44
    mailto:contact@prd.at
    http://www.prd.at

SOURCE AFFiRiS AG


'/>"/>
SOURCE AFFiRiS AG
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. AFFiRiS AG: 1st Place in Venture Capital & Private Equity Awards for MIG Fonds and AFFiRiS
2. AFFiRiS AG: Atherosclerosis Vaccine Development Receives EU Support
3. GlaxoSmithKline and AFFiRiS Sign an Exclusive Licence and Option Agreement for Therapeutic Alzheimers Disease Candidate Vaccines
4. AFFiRiS - MIG-Fonds Increases Investment by Euro 3 Million
5. Hollis-Eden Presents New Interim Data From Prostate Cancer Phase I/II Clinical Studies of Apoptone (HE3235) at AACR Molecular Targets and Cancer Therapeutics Conference
6. Hollis-Eden to Present Interim Data From Its Phase I/II Clinical Studies of Apoptone(R) (HE3235) at Molecular Targets and Cancer Therapeutics Conference
7. Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 September 2009
8. Raptor Pharmaceutical Reports Positive Interim Phase 2a Clinical Data in Non-Alcoholic Steatohepatitis (NASH)
9. Micromet Reports Interim Data from Phase 1 Study of BiTE Antibody MT110 for the Treatment of Solid Tumors
10. Bavarian Nordic A/S - Half Year Interim Report 2009
11. Arpida Reports Interim Results For Six Months to 30 June 2009
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016 Apellis Pharmaceuticals, Inc. today ... trials of its complement C3 inhibitor, APL-2. The ... ascending dose studies designed to assess the safety, ... injection in healthy adult volunteers. Forty ... a single dose (ranging from 45 to 1,440mg) ...
(Date:6/23/2016)... On Wednesday, June 22, 2016, the ... the Dow Jones Industrial Average edged 0.27% lower to finish ... 0.17%. Stock-Callers.com has initiated coverage on the following equities: Infinity ... NKTR ), Aralez Pharmaceuticals Inc. (NASDAQ: ... ). Learn more about these stocks by accessing their free ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... a new line of intelligent tools designed, tuned and optimized exclusively for Okuma ... 12–17 in Chicago. The result of a collaboration among several companies with expertise ...
(Date:6/22/2016)... Cell Applications, Inc. and StemoniX announced ... up to one billion human induced pluripotent stem ... These high-quality, consistent stem cells enable researchers to ... more time doing meaningful, relevant research. This achievement ... process that produces affordable, reliable HiPSC for life ...
Breaking Biology Technology:
(Date:6/22/2016)... , June 22, 2016  The American College of Medical ... Show Executive Magazine as one of the fastest-growing trade ... 25-27 at the Bellagio in Las Vegas ... highest percentage of growth in each of the following categories: ... companies and number of attendees. The 2015 ACMG Annual Meeting ...
(Date:6/21/2016)... , June 21, 2016 NuData Security announced ... new role of principal product architect and that ... director of customer development. Both will report directly ... officer. The moves reflect NuData,s strategic growth in ... to high customer demand and customer focus values. ...
(Date:6/15/2016)... , June 15, 2016 ... market report titled "Gesture Recognition Market by Application Market - Global ... 2016 - 2024". According to the report, the  global ... billion in 2015 and is estimated to grow ... 48.56 billion by 2024.  Increasing application ...
Breaking Biology News(10 mins):