Copenhagen and Oslo, 17th April, 2012, 2012-04-17 18:01 CEST (GLOBE NEWSWIRE) -- Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today announced that the Russian Health Authority has approved the CTA submitted by Affitechs collaboration partner IBC Generium and that phase 1 clinical trial with Affitech’s leading antibody drug candidate AT001/r84 will commence in May, 2012. The product candidate is a new patented fully human monoclonal antibody to human vascular endothelial growth factor (VEGF), and is being developed as a potential treatment of cancer. The anti-VEGF antibody will be evaluated in patients with various metastatic cancers and is a possible competitor to bevacizumab (Avastin® – Roche).
Dr Alexander Duncan, Affitech’s Chief Scientific Officer, said:
“AT001/r84 is a novel antibody which in disease models has proven to be a potent and effective blocker of tumor vascularization and growth and we believe it to have significant potential in the treatment of a number of different human cancers. We are very pleased that the Clinical Trial Application regarding the first clinical trials with AT001/r84 has been approved so that the initial clinical trials with this new human anti-VEGF antibody candidate can shortly start.”
The phase 1 clinical trials in Russia will be conducted to international standards and the data generated will be useful both for IBC Generium to design further trials in Russia, and for Affitech or other potential partners for international development of the product outside Russia.
About Affitech
Affitech A/S is a publicly traded (NASDAQ OMX Copenhagen) human therapeutic antibody company based in Copenhagen, Denmark with R&D facilities in Oslo, Norway. The Company utilizes a range of proprietary antibody technologies for the discovery of fully human antibodies for application in oncology, inflammation and other disease areas. CBAS™ (Cell Based Antibody Selection) is Affitech’s premier discovery engine for the isolation of lead antibodies to cell surface molecules. Affitech co-develops its two lead antibody drug programs AT001/r84 and AT008/CCR4 with Russian partner IBC Generium. The Company’s initial focus is on rapid and cost effective development by partnering clinical trials in emerging markets. Further information is available at www.affitech.com.
About AT001/r84
AT001/r84 is a novel, proprietary therapeutic antibody to vascular endothelial growth factor (VEGF) which is being developed for the treatment of certain human cancers. An anti-VEGF antibody is on the Russian list of highly needed innovative new drugs for the Russian market.
Disclaimer
This announcement may contain forward-looking statements including statements about Affitech’s expectations of the progression of its pipeline including the timing for commencement and completion of clinical trials and with respect to cash burn guidance. Such statements are based on Management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Affitech cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to transact viable and profitable commercial deals, the risk of non-approval of patents not yet granted, and difficulties of obtaining relevant governmental approvals for new products. No expressed or implied representations or warranties are given concerning Affitech A/S or the accuracy or completeness of the information provided herein, and no claims shall be made by the recipient of this news release by virtue of the information contained herein.
Contact:
Randi Krogsgaard, Director IR & Corporate Communications
Tel # +45 2320 1001, e-mail: ir@affitech.com
