) provided an update on pending EU conditional marketing
authorization applications (MAA) for vintafolide, etarfolatide
and intravenous (IV) folic acid. The Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) recently confirmed questions to be addressed by Endocyte
regarding these applications.
The company's management expects the questions to be addressed
in the first quarter of 2014. Following a successful response,
the committee is expected to give its opinion in a meeting in the
Endocyte had submitted an MAA seeking approval for vintafolide
for platinum-resistant ovarian cancer in 2012. The company is
also seeking EU approval for a folate-targeted molecular imaging
agent, etarfolatide. These applications are supported by four
clinical studies: a phase I study in solid tumors, two single
agent and single-arm phase II studies in ovarian cancer and
non-small cell lung cancer (NSCLC) and phase II PRECEDENT
The applications for conditional marketing authorization were
accepted by the EMA in Nov 2012, for vintafolide for the
treatment of platinum-resistant ovarian cancer and etarfolatide
and folic acid for patient selection.
We note that Endocyte and
Merck & Co. Inc.
) had entered into a partnership in Apr 2012, wherein Endocyte
granted Merck an exclusive license to develop, manufacture and
commercialize vintafolide outside the U.S.
Endocyte expects interim results from phase III PROCEED study
in the second quarter of 2014. Endocyte completed enrollment in
the phase IIb TARGET study of vintafolide in NSCLC patients.
Top-line data from the study is expected in the first quarter of
Endocyte and Merck will initiate a phase II randomized trial
on vintafolide in folate receptor-positive triple negative breast
cancer in the first half of 2014.
For its folate-targeted tubulysin therapeutic, EC1456, an
investigational new drug application was accepted by the U.S.
Food and Drug Administration (FDA) in Sep 2013. Endocyte dosed
its first patient in a phase I study evaluating EC1456, for the
treatment of advanced solid tumors in Dec 2013.
We expect investor focus on updates on the two candidates -
vintafolide and etarfolatide. Endocyte carries a Zacks Rank #1
(Strong Buy). Other players in the pharma industry sharing the
Zacks Rank #1 include
Lannett Co. Inc.
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