Endocyte, Merck Pull Approval Applications
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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowWest Lafayette-based Endocyte Inc. (Nasdaq: ECYT) and Merck (NYSE: MRK) are withdrawing conditional marketing authorization applications from the European Medicines Agency for a potential ovarian cancer treatment. The companies suspended a late-stage trial on vintafolide earlier this month after it did not meet key goals.
May 19, 2014
News Release
Whitehouse Station, N.J. & West Lafayette, Ind. — Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Endocyte, Inc. (NASDAQ:ECYT), today announced the withdrawal of conditional marketing authorization applications (CMA) from the European Medicines Agency (EMA) for vintafolide and companion imaging components, imaging agent etarfolatide and intravenous (IV) folic acid, for the treatment of adult patients with folate receptor-positive, platinum-resistant ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD).
The Companies' decision was based on further review of interim data from the PROCEED trial. Study enrollment was suspended earlier this month based on the Data Safety Monitoring Board's (DSMB) recommendation that the study be stopped because vintafolide in combination with PLD versus PLD alone did not meet the pre-specified criteria for progression-free survival to allow continuation of the study. The DSMB did not identify any safety concerns for the patients enrolled in the PROCEED trial. The Companies will take steps to terminate the PROCEED trial and will provide investigators with instructions to conclude the trial. The study results will be presented in a future scientific congress.
“Advanced stage ovarian cancer is a difficult-to-treat disease with few options available, and we are disappointed by the outcome of this confirmatory study. We would like to thank our clinical investigators and especially the patients with platinum-resistant ovarian cancer who participated in the clinical studies for these investigational candidates,” the Companies said.
The randomized Phase 2b TARGET trial in non-small cell lung cancer (NSCLC) is ongoing. The Companies are awaiting maturation of the overall survival data later this year to help inform potential further development of the vintafolide and docetaxel combination in NSCLC.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
About Endocyte
Endocyte is a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company's SMDCs actively target receptors that are expressed or over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly potent drugs into these cells. The companion imaging agents are designed to identify patients whose disease expresses the molecular target of the therapy and who therefore may be more likely to benefit from treatment. For more information, visit http://www.endocyte.com.
Source: Endocyte Inc.