17.10.2012 - The dreams of Wilex CEO Olaf Wilhelm to bring a drug to the market are destroyed. The company's most advanced compound has failed in Phase III.
On Tuesday evening, the Munich-based antibody developer reported results of a comprehensive Phase III study testing an anti-CA-IX antibody in the adjuvant treatment of renal cancer after surgery. The analysis showed no improvement in median disease free survival (approximately 72 months) following treatment with Rencarex compared with placebo. The Independent Data Monitoring Committee has recommended to terminate the Phase III ARISER trial which was started as long ago as in June 2004.
Originally, the company planned to announce the results in 2008. However, the number of adverse events did not come in as planned. Professor Seppo Pyrhoenen, Chairman of the ARISER IDMC, said: "I have over 30 years experience in treating patients with kidney cancer and applaud this study for being well balanced, controlled and very well conducted. This is probably the most comprehensive study in the adjuvant setting conducted in the past 20 years."
Wilex is also conducting Phase II trials with Mesupron in pancreatic and breast cancer and developing a diagnostic based on a radioactively labelled version of Rencarex in Phase III. At the Frankfurt stock exchange, Wilex shares fell more than 60%. The biggest shareholder is SAP founder Dietmar Hopp.
26.08.2016 Adocia said it would discontinue its diabetic foot ulcer programme after its lead product BioChaperone PDGF disappointed in Phase III. The French company will turn the focus on its earlier-stage products.
24.08.2016 Pharma major Pfizer is putting the cherry on top of its multi-billion-dollar takeover of Medivation with the acquisition of AstraZeneca’s antibiotics for a cool US$1.5bn. With the divestment, AZ aims to further sharpen its focus.
23.08.2016 Cambridge University-allied investor Cambridge Innovation Capital has raised £75m (€87m) to reinvest in technology and healthcare companies. Among the backers were Woodford Investment and Winton Ventures.
19.08.2016 Together with partner Johnson & Johnson, Danish biotech Genmab is now one step closer to FDA approval with its combination treatment for multiple myeloma after its submission of a supplemental Biologics License Application. In July, Genmab was granted a Breakthrough Therapy Designation (BTD) for its blood cancer therapy.
17.08.2016 Philip Hammond, the UK’S chancellor has announced the government will guarantee funding for EU-backed "structural and investment fund" projects whose timelines extend beyond the UK’s departure from the EU, provided the projects are signed prior to this year's Autumn Statement on the UK budget. The decision ensures continued funding for farmers, companies and institutions involved in the EU’s Horizon 2020 project. The move could cost the UK government up to £6bn (€6.9bn).
15.08.2016 Back in April, the American FDA gave the green light for the colorectal cancer-screening test Epi procolon. Now Berlin-based diagnostics specialist Epigenomics is considering a secondary listing in the US. A draft of the required registration document was confidentially submitted to the US Securities and Exchange Commission (SEC).
09.08.2016 Hungarian Gedeon Richter and Irish Allergan are staying on course in the face of dissappointing Phase III results for depression drug cariprazine. The partners will now begin another Phase III study needed for approval.
08.08.2016 Araclon Biotech’s Alzheimer’s vaccine ABvac40 is going forward into Phase II after showing a good safety profile in Phase I. The promising trial results were presented at the Alzheimer’s Association International Conference.
FILTRODISC™ BIO SD is a filtration system which removes particles (e.g. cells, bacteria, yeast), impurities (e.g. HCP, DNA) and other turbid matter from process liquids (e.g. fermentation broths). more