DGAP-News: WILEX AG and the FDA agree on the further development of REDECTANE(R)
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Miscellaneous
WILEX AG and the FDA agree on the further development of REDECTANE(R)
05.10.2012 / 17:36
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PRESS RELEASE
WILEX AG and the FDA agree on the further development of REDECTANE(R)
- FDA follows positive ODAC recommendation regarding the clinical
usefulness of a clear cell renal cell carcinoma (ccRCC) imaging test
- Confirmatory diagnostic performance trial accepted by the FDA instead
of an outcomes-based study
Munich, Germany, 5 October 2012. WILEX AG (ISIN DE0006614720 / WL6 / FSE)
today announced that the Company has received the FDA's (Food and Drug
Administration) minutes of the Type C meeting held in September 2012. The
FDA accepted the positive vote of the Oncologic Drugs Advisory Committee
(ODAC) regarding the clinical usefulness of an imaging test which
identifies ccRCC within the kidney of patients with an indeterminate renal
mass. In its meeting in July 2012, ODAC voted by 16 to 0 (1 abstention) in
support of the imaging information being clinically useful.
Furthermore the Company and the Agency agreed to conduct a second
diagnostic performance trial instead of an outcomes-based study (i.e. a
trial that studies patient outcomes such as survival) that the FDA had
previously required. The FDA does however require a second trial to confirm
the diagnostic performance and safety of REDECTANE(R). WILEX assumes that
approval can be expected after successful conclusion of this second trial.
The concept and the design of the new trial were discussed with the FDA.
WILEX is currently developing the protocol for this Phase III trial (REDECT
2) for submission to the FDA under a Special Protocol Assessment (SPA).
Details on the study design will be announced after approval of the study
protocol.
Dr Paul Bevan, Head of Research and Development and member of the Executive
Management Board of WILEX AG, said: 'Supported by the ODAC recommendation,
we have now agreed with the FDA on the further development of REDECTANE(R).
Eliminating the need for an outcomes-based study - which in our opinion was
not a feasible option - will enable us to move forward with our strategy as
the regulatory pathway for marketing approval of this innovative imaging
agent is now clear. We are delighted with the result.'
About REDECTANE(R) and the REDECT trial
The drug candidate REDECTANE(R) (INN: Iodine (124I) Girentuximab) is the
radioactively labelled form of the antibody Girentuximab and is being
developed for the diagnosis of clear cell Renal Cell Cancer (ccRCC). The
labelled antibody 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 during diagnostic work up to detect ccRCC
in patients with renal masses. At present, only histopathology results
after surgery can determine whether the tumour is benign or malignant. As
ccRCCs are associated with an aggressive phenotype their identification may
help guide appropriate 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) leads to a significantly improved
diagnosis in comparison to CTalone. 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).
The FDA suggested in the second quarter of 2011 that WILEX AG and the
marketing partner IBA Pharma SPRL, Louvain-la-Neuve, Belgium, (IBA)
consider conducting an outcomes-based study to obtain additional evidence
of the product's clinical usefulness. However, WILEX, IBA and external
medical advisors were of the opinion that such a trial could only be
conducted as a Phase IV trial after market approval. Thus, in the fourth
quarter of 2011, a Type C meeting took place at the FDA, in which the
further development of REDECTANE(R) was outlined, including the scheduling
of a second trial and the options to conduct an 'outcomes-based study' or a
'confirmatory' study similar to the REDECT trial to confirm the candidate's
diagnostic performance. The FDA suggested resolving the question of
clinical usefulness and the resulting regulatory pathway with an FDA
Advisory Committee.
The following question was discussed in the Oncologic Drugs Advisory
Committee meeting on 25 July 2012: 'Would an imaging test provide useful
clinical information if it identified only clear cell renal cell carcinoma
(ccRCC) within the kidney of patients with an indeterminate renal mass?'
The Advisory Committee voted by 16 to 0 (1 abstention) in support of the
imaging information being clinically useful. As the ODAC provides the FDA
with independent expert advice and recommendations, the final decision is
made by FDA.
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the Company has a broad portfolio of diagnostic and
therapeutic products for the specific detection and targeted treatment of
various types of cancer. WILEX's therapeutic product candidates are based
on antibodies (RENCAREX(R) in Phase III) and small molecules (MESUPRON(R)
two Phase IIa trials completed, WX-554 in Phase Ib/II and WX-037 in
preclinical development). In the field of diagnostics, REDECTANE(R) is an
antibody-based, imaging diagnostic agent that is currently in a Phase III
programme. WILEX's US subsidiary WILEX Inc. in Cambridge, MA, markets a
portfolio of research use only tests and in vitro diagnostic agents under
the brand Oncogene Science. The subsidiary Heidelberg Pharma GmbH offers an
attractive and highly promising antibody drug conjugate technology platform
and preclinical contract research services. The business model of WILEX
comprises research, technology, product development and commercialisation.
WILEX's customers and partners include leading international pharmaceutical
companies.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
Contact WILEX
Katja Arnold (CIRO)
Corporate Communications
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors(at)wilex.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
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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
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