DGAP-News: WILEX AG: WILEX and IBA report on follow up meeting with the FDA on further steps in the development of REDECTANE(R)
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Research Update
WILEX AG: WILEX and IBA report on follow up meeting with the FDA on
further steps in the development of REDECTANE(R)
14.12.2011 / 08:35
---------------------------------------------------------------------
PRESS RELEASE
WILEX and IBA report on follow up meeting with the FDA on further steps in
the development of REDECTANE(R)
- FDA recommends an Advisory Committee meeting to review the regulatory
pathway as well as the timing and design of a second clinical trial
- Constitution and availability of the Advisory Committee to be confirmed
by the FDA
Munich, Germany, and Louvain-la-Neuve, Belgium, 14 December 2011. WILEX AG
(ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) and IBA (Ion Beam
Applications S.A: Reuters IBAB.BR and Bloomberg IBAB.BB) today announced
that the follow up meeting with the American Food and Drug Administration
(FDA) has taken place. The aim of the Type C Meeting was to discuss next
steps in the development process of REDECTANE(R).
The FDA and WILEX discussed the further development of REDECTANE(R)
including the timing of a second trial and the options of an outcomes based
study or a confirmatory diagnostic performance study similar to the REDECT
trial. As this product is first in class the FDA offered and WILEX accepted
the option of discussing the regulatory pathway, timing and design of a
second study with an FDA Advisory Committee. The FDA is expected to confirm
the Advisory Committee discussion after internal verification of the
logistics for the meeting.
Dr Paul Bevan, Head of R&D and member of the Executive Management Board of
WILEX AG, commented: 'We are pleased with the outcome of this meeting. The
Advisory Committees provide independent, expert advice on significant
scientific, technical, and on specific regulatory decisions, such as
product approvals, and general policy matters. We believe this recent FDA
meeting represents progress towards a common understanding of REDECTANE's
further development. '
WILEX and IBA also report today on the progress made on the CMC issues
discussed in the Pre-BLA Meeting in the second quarter 2011. WILEX's
manufacturing partner Avid Bioservices, Inc., Tustin, CA, USA, has
successfully completed the production run of the third consecutive
consistency lot for process validation of the naked antibody Girentuximab.
IBA, responsible for radioactive labelling of the antibody, is assembling
the data on the commercial production of REDECTANE(R), in particular
product characterisation and process validation. The new facility for
central manufacturing of REDECTANE(R) and the subsequent quality assurance
is completed and documentation is in preparation by IBA.
About REDECTANE and the REDECT trial
The drug candidate REDECTANE(R) (INN: 124I-Girentuximab) is the
radioactively labelled form of the antibody Girentuximab and is being
developed for the pre-surgical diagnosis of clear cell Renal Cell Cancer
(ccRCC). The labelled antibody 124I-Girentuximab targets ccRCC and
accumulates in the tumour tissue. This accumulation can be visualised by
means of positron emission tomography (PET). REDECTANE(R) may be used
before surgery to detect ccRCC in patients with renal masses. At present,
only histopathology results after surgery can determine the type of tumour
histopathology characterisation, means whetherthe tumour is benign or
malignant. As ccRCCs are associated with an aggressive phenotype their a
priori determination may help guide appropriate surgical/therapeutic
management.
In May 2010 WILEX published final data of the Phase III REDECT trial with
REDECTANE(R). REDECTANE(R) fulfilled expectations in distinguishing clear
cell from non-clear cell renal cell carcinoma. The results of the study
demonstrate that PET/CT with REDECTANE(R) lead to a significantly improved
diagnosis in comparison to CT alone. The endpoint sensitivity, the correct
diagnosis that clear cell renal cell cancer is present, was reached with
statistical significance (p value, p<=0.016) compared to CT. The study
endpoint specificity, the correct diagnosis that clear cell renal cell
cancer is not present, was confirmed with a highly statistical significance
(p<0.001). To rule out that the superiority of REDECTANE(R) resulted from
the poor performance of CT, the endpoints of REDECTANE(R) were also
compared to an arbitrary value of 75% for specificity and sensitivity as
defined in the study protocol. REDECTANE(R) achieved sensitivity of 86%
(p<=0.002) and specificity of 87% (p=0.057).
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the company has a broad portfolio of near-to-market
therapeutic and diagnostic products for the targeted treatment and specific
detection of various types of cancer. The company's therapeutic product
candidates are based on antibodies and small molecules. Through its US
subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of
research use only and in vitro diagnostic tests under the brand Oncogene
Science. These diagnostic tests could be developed as companion diagnostics
in clinical trials and for therapy monitoring. The wholly owned subsidiary
Heidelberg Pharma AG gives WILEX access to an attractive and highly
promising antibody drug conjugate technology platform and a pre-clinical
service business. The business model of WILEX covers the entire value chain
in the oncology market and comprises research, technology, development
collaboration as well as sales and marketing. WILEX's customers and
partners include leading international pharmaceutical companies. ISIN
DE0006614720 / WKN 661472 / Symbol WL6
About IBA
IBA develops and markets leading edge technologies, pharmaceuticals and
tailor-made solutions for healthcare with a focus on cancer diagnosis and
therapy. Leveraging on its scientific expertise, IBA is also active in the
field of industrial sterilization and ionization. Listed on the
pan-European stock exchange EURONEXT, IBA is included in the BelMid Index.
(IBA: Reuters IBAB.BR and Bloomberg IBAB.BB). Website:
www.iba-worldwide.com
Contact Press
WILEX AG
Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-Mail: investors(at)wilex.com
Contact IBA
Sandrine Leriche
Corporate Communication
Tel.: +32 10 47 58 90
Email: InvestorRelations(at)iba-group.com
This communication contains certain forward-looking statements relating to
the Company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will' 'should' 'future', 'potential' or similar expressions or by a
general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings or achievements
expressed or implied by such forward-looking statements. Given these
uncertainties, prospective investors and partners are cautioned not to
place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments.
End of Corporate News
---------------------------------------------------------------------
14.12.2011 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
Language: English
Company: WILEX AG
Grillparzerstr. 10
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info(at)wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
---------------------------------------------------------------------
149649 14.12.2011
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 14.12.2011 - 08:35 Uhr
Sprache: Deutsch
News-ID 96746
Anzahl Zeichen: 10978
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 310 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: WILEX AG: WILEX and IBA report on follow up meeting with the FDA on further steps in the development of REDECTANE(R)"
steht unter der journalistisch-redaktionellen Verantwortung von
WILEX AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
