Endocyte Begins Phase II Clinical Trial Of Ec145 For Treatment Of Women With Ovarian Cancer

February 20, 2009 at 2:00 pm Leave a comment


Endocyte Inc. has announced the initiation of a randomized Phase II
clinical study of the company’s investigational drug EC145 in women with
platinum-resistant ovarian cancer. The phase II trial, also called the
“PRECEDENT study,” will evaluate the efficacy and safety of EC145 when
administered in combination with pegylated liposomal doxorubicin (PLD).
PLD is widely used as a standard therapy for women with
platinum-resistant ovarian cancer. The efficacy and safety of the
combination of EC145/PLD will be compared to treatment with PLD without
EC145.



Ovarian cancer is the fifth most common cancer among women in the United
States and the leading cause of death due to cancer of the female
reproductive system. The PRECEDENT study will enroll 122 subjects and
involve more than 50 clinical centers in the U.S., Canada, and Europe.
Trial details can be found at http://www.endocyte.com and
http://www.clinicaltrials.gov.



EC145 links a very potent anticancer drug to the vitamin folate, which
is required for cell division. Rapidly dividing cancer cells
over-express folate receptors to capture enough folate to support cell
division. By combining a chemotherapy drug with folate, EC145 targets
cancer cells while avoiding normal cells. This targeted approach is
designed to provide treatment with more potent drugs with lower toxicity.



In addition to EC145, patients in the PRECEDENT trial will also be
treated with a new molecular imaging agent called EC20 developed by
Endocyte. By targeting folate receptors, EC20 imaging agent allows
clinicians to identify tumors that over-express the folate receptor.
Using EC20, doctors may be able to identify, in advance, those patients
who will benefit from EC145 therapy.





According to Dr. Wendel Naumann of the Blumenthal Cancer Center,
Carolinas Medical Center and principal investigator for the PRECEDENT
study, “Patients with advanced, platinum resistant, ovarian cancer are
in need of therapy that does not result in significant toxicity. The
earlier clinical studies of EC145 were encouraging because they
indicated that clinicians could use EC20 to identify women whose tumors
expressed the molecular target of EC145. Therapy with EC145 might
benefit these patients without causing significant additional toxicity.”



“The start of the PRECEDENT study is another important validation of
Endocyte’s promising DGS technology platform,” said Dr. Richard
Messmann, Endocyte’s vice president for medical affairs. “This also
represents an important milestone in Endocyte’s efforts to develop a
range of new drugs and predictive medicine tools to treat cancer and
other serious diseases in the years ahead.”



About Endocyte



Endocyte is a privately-held biotechnology company with headquarters in
the Purdue Research Park of West Lafayette, IN. Based on the
applications of Endocyte’s advanced proprietary Drug Guidance System
(DGS), the Company is working to develop new drugs and diagnostic agents
to treat many types of cancer and other serious diseases. The DGS
platform makes it possible to use highly-potent drugs on extended and
frequent dosing schedules and in combination with other drugs to
maximize efficacy. The technology improves drug targeting and reduces
the risk of side effects by combining drugs with ligands that are able
to identify and attach to receptors found on tumor and other disease
cells. Endocyte is currently conducting three separate Phase 2 clinical
trials for its lead compound, EC145, together with EC20, a companion
molecular imaging agent, for the treatment of ovarian cancer and
non-small cell lung cancer. Other clinical-stage products in the
Endocyte pipeline include: EC0225, a combination of two potent
anticancer drugs; BMS493, a potent drug being developed in partnership
with Bristol-Myers Squibb; EC17, a targeted immunotherapy agent; and
EC0489, a targeted cancer drug. The Company also has multiple product
candidates in preclinical stage development.



This press release contains “forward-looking statements” as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management’s current expectations and involve
significant risks and uncertainties that may cause results to differ
materially from those set forth in the statements. We undertake no
obligation to publicly update any forward-looking statement, whether as
a result of new information, future events, or otherwise



*To the Purdue Research Park*, http://www.purdueresearchpark.com



Endocyte Inc.

[Via http://www.medicalnewstoday.com]

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