AFFiRiS AG: Interim Analysis of Clinical Phase I Data Triggered Decision to Move Alzheimer's Vaccine Candidate AD02 into Clinical Phase II Testing

Thursday, November 19, 2009 General News
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VIENNA, Austria, November 19 AFFiRiS AG will focus itsAlzheimer's vaccine program on one product candidate at an unexpectedly earlystage of development: the vaccine candidate AD02 is planned to enter intoPhase II clinical trial early in 2010. This decision by the companyimmediately follows the completion of two Phase I trials with the candidatesAD01 and AD02. The company based its fast decision on the first interimanalysis of the secondary endpoints at the six month time point. Furthermore,based on this analysis, the AD02 patients from the completed Phase I studywill now be offered an AD02 booster vaccination.

AFFiRiS AG announced today, that Alzheimer's vaccine candidate AFFITOPEAD02 will undergo immediate tests for potential efficacy in a Phase II trial.This means that the company can focus its diversified development program forAlzheimer's vaccines earlier than initially planned. The reason for thedecision is based on the interim analysis of the preceding Phase I testing.

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

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

The vaccine development program of AFFiRiS is based on the company'sAFFITOME(R) technology, which also delivered the vaccines tested so far. Alsobased on this technology are six other vaccination programs being developedby AFFiRiS AG, which target, among other indications, Parkinson's disease andatherosclerosis.

About AFFiRiS AG (status November 2009):

Based on proprietary patent positions, AFFiRiS has developed tailoredpeptide vaccines against Alzheimer's Disease, Parkinson's and four otherdiseases characterized by urgent medical requirement and attractive marketvolumes. Alzheimer's is the current lead indication and clinical Phase Itrials have just been completed on two product candidates. AFFiRiS succeededin attracting GlaxoSmithKline Biologicals as its licensing partner in October2008. The contract contains provisions for (milestone-dependent) payments ofup to EUR 430 million. Based on the successful completion of two clinicalPhase I trials, a payment of EUR 10 million was made in October. AFFiRiScurrently employs 60 highly-qualified staff at its premises on the St. MarxCampus in Vienna, Austria ( AFFiRiS AG: Mag. Agnes Meyer Karl-Farkas-Gasse 22 T +43-1-798-15-75-3 Copy Editing & Distribution: PR&D - Public Relations fur Forschung & Bildung Campus Vienna Biocenter 2 1030 Vienna T +43-1-505-70-44


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