WILEX’s partner Link Health submits IND application for clinical Phase I with the uPA inhibitor MESUPRON® in China
- Phase I dose escalation study in solid tumour patients
- WILEX AG will receive remaining amount of EUR 500 k milestone payment
- Phase II programme is planned
Munich, Germany, 13 January 2016 – The WILEX AG (ISIN DE000A11QVV0 / WL6 / FSE) today announced that its partner Link Health Co., Guangzhou, China, submitted an IND application (Investigational New Drug application) to the CFDA (China Food and Drug Administration) to conduct a Phase I dose escalation study with the cancer compound MESUPRON®.
The open-label, dose-escalation study will investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of MESUPRON® in Chinese patients with solid tumours. After this dose escalation study to confirm the biologically effective dose, two Phase II studies in cancer patients are planned.
WILEX AG will receive the remaining amount of the agreed milestone payments totalling EUR 500 k. A partial amount was already paid in the second quarter 2015 after the transfer of a number of MESUPRON® patents, which were needed by Link Health to apply for grants under a national subsidy programme.
Information on MESUPRON® and the uPA-programme
WILEX has developed with MESUPRON® (INN: Upamostat) a drug candidate to inhibit the Urokinase Plasminogen Activator (uPA) system. The uPA system has been shown to play a key role in tumour cell invasion and metastasis, as well as in primary tumour growth, of various solid tumours. In the Company’s view, the uPA inhibitor MESUPRON® of WILEX can be considered as a promising new non-cytotoxic approach in cancer therapy to prolong progression free survival and to specifically block tumour metastasis in solid cancers. Data from two Phase IIa trials (proof of concept) in locally advanced pancreatic cancer (2010) and metastatic breast cancer (2012) indications show the safety and activity of the drug candidate in combination with chemotherapeutic agents. In 2014, the rights to the development and commercialisation of MESUPRON® were out-licensed to Link Health Co., Guangzhou, China, for the region comprising China, Hong Kong, Taiwan and Macau.
WILEX AG is a biopharmaceutical company which discontinued all clinical development activities at its Munich site and now exercises a holding function as the Group parent. Research and development focus on the operations of its subsidiary Heidelberg Pharma GmbH in Ladenburg, which primarily advances the development of the innovative platform technology for antibody drug conjugates (ADC technology) and provides pre-clinical drug discovery and development services. WILEX has the diagnostic and therapeutic drug candidates REDECTANE® and RENCAREX®, which are available for out-licensing and further development in Phase III for external partners. WILEX is listed at the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at http://www.wilex.com/.
About Link Health Group Link Health Group is a high-quality pharmaceutical company focused on licensing, registration, clinical study and regulatory consulting services in the Greater China area. Link Health aim at unveiling and promoting innovative drugs, which are made to address crucial medical needs. Based on eight years’ experience in the pharmaceutical industry, Link Health created a strong team to provide solutions for regulatory, (pre)clinical research, licensing, partnering and communications (IND, NDA applications) with the CFDA (China Food and Drug Administration), among others.
Link Health Group has expertise in the licensing and co-development of INDs or devices at clinical stage. Operating from the Chinese market, Link Health Group specialises in linking businesses from different markets to the mutual benefit of each other. The professional teams target and screen the best innovations in medical industry with the aim of creating market value in China with local partners. More information can be found at: www.healthinlink.com
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