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Affitech’s collaboration partner IBC Generium submits Clinical Trial Application in Russia for AT001/r84

30-12-11 kl. 30/12 2011 13:21 | Affitech 0,05 (-44,44%)

Release no. 26/2011

Copenhagen and Oslo, 2011-12-30 14:21 CET (GLOBE NEWSWIRE) --
Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today
announced that its Russian collaboration partner, IBC Generium, has submitted a
Clinical Trial Application (CTA) to the Russian Health Authority to commence a
phase 1 clinical trial with Affitech’s leading anti­body drug candidate
AT001/r84. The product candidate is a new patented 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 cancers and is a possible competitor to bevacizumab
(Avastin® – Roche). The Phase 1 clinical trial will start as soon as the
Russian CTA has been approved.


Martin Welschof, Managing Director of Affitech said:

“We are very pleased that the Clinical Trial Application regarding the first
clinical trials with AT001/r84 has been submitted as planned. We are excited
about the clinical and commercial potential of the first drug candidate in our
collaboration with IBC Generium. We look forward to testing this new human
anti-VEGF antibody candidate in human clinical trials.”


Dr Alexander Duncan, Affitech’s Chief Scientific Officer, added:

“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. The phase 1 clinical trial being initiated in cancer patients 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: [email protected]




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