WILEX AG reports on Oncologic Drugs Advisory Committee (ODAC) meeting and positive vote on diagnostic imaging

PDF Download back

Munich, Germany, 25 July 2012. WILEX AG (ISIN DE0006614720 / WL6 / FSE) reports that on 25 July 2012 the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed the question: 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? ODAC voted by 16 to 0 (1 abstention) in support of the imaging information being clinically useful.

Before the vote the ODAC was asked by the FDA to discuss in what clinical situations and in what patient populations an imaging test that only identifies ccRCC within the kidney in the diagnostic work-up of an indeterminate renal mass would be clinically useful or lacking in clinical utility.

After the vote the ODAC also discussed to what extent the performance characteristics of the imaging test (sensitivity/specificity/reproducibility) determined in patients undergoing resection of a kidney mass providing histopathology as standard of truth could be used to estimate how the imaging agent would perform among patients who may be managed with “active surveillance” rather than surgical resection.

As the ODAC provides FDA with independent expert advice and recommendations, the final decision is made by FDA. Based on the recommendation WILEX and FDA will discuss the further development strategy of WILEX’s diagnostic candidate REDECTANE® in a meeting which is planned for September 2012.

Katja Arnold (CIRO)
Grillparzerstrasse 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

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® in Phase III) and small molecules (MESUPRON® in Phase II, WX-554 in Phase Ib/II and WX-037 in preclinical development). In the field of diagnostics, REDECTANE® is an antibody-based, imaging in vivo 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, which are used as companion diagnostics for clinical trials and therapy monitoring. The wholly owned 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

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.

Seite gelesen: 486 | Heute: 4