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WILEX AG: WILEX signs antibody license agreement with Telix Pharmaceuticals Limited - Seite 2
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About REDECTANE(R) and the Phase III REDECT Study
REDECTANE(R) (INN: 124I-Girentuximab) is a radiolabeled form of the
monoclonal antibody Girentuximab, which binds to the Carbonic Anhydrase-9
(CAIX) antigen, expressed on the surface of cancer cells of the clear-cell
phenotype. Accumulation of this antibody in tumor tissue can be visualized
by means of molecular imaging using Positron Emission Tomography (PET).
Additional anatomical information provided by computer tomography (CT) can
be used to localize the accumulation of the antibody. REDECTANE(R) has the
potential to fundamentally change therapy planning for renal cancer
patients, including the avoidance of unnecessary surgery. Furthermore,
REDECTANE(R) may also prove suitable for the diagnosis, staging and
treatment response assessment in other kinds of cancers, such as lung and
ovarian cancer.
The Phase III REDECT trial demonstrated that REDECTANE(R) can differentiate
between clear cell and non-clear cell renal cell cancer and that PET/CT
molecular imaging with REDECTANE(R) was superior to CT alone. In order to
obtain market authorization from the US Food and Drug Administration (FDA),
REDECTANE(R) requires a second Phase III confirmatory study. WILEX has been
granted a special protocol assessment (SPA) from the FDA for the planned
confirmatory study (REDECT 2).
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About WILEX
WILEX AG is a biopharmaceutical company based in Munich, Germany, that
serves as a parent and holding company. The Company's research and
development work is conducted by its subsidiary Heidelberg Pharma GmbH in
Ladenburg. Heidelberg Pharma is the first company to develop the toxin
Amanitin into cancer therapies using its proprietary Antibody Targeted
Amanitin Conjugate (ATAC) technology and to advance the biological mode of
action of the toxin as a novel therapeutic principle. This proprietary
technology platform is being applied to develop the company's own
therapeutic ATACs as well as in third-party collaborations to create a
variety of ATAC candidates. The proprietary lead candidate is a BCMA ATAC
for multiple myeloma. WILEX's clinical assets MESUPRON(R) and REDECTANE(R)
have been partnered, while RENCAREX(R) is available for out-licensing and
further development. WILEX is listed on the Frankfurt Stock Exchange: ISIN
DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at