Merck and Endocyte Announce Independent DSMB Recommends Vintafolide PROCEED Phase 3 Trial Be Stopped for Futility Following Interim Analysis


May 2, 2014 7:00 am ET

WHITEHOUSE STATION, N.J. & WEST LAFAYETTE, Ind.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
Endocyte, Inc. (NASDAQ:ECYT), today announced that the Data Safety
Monitoring Board (DSMB) of the PROCEED trial has completed a
pre-specified, interim futility analysis and the DSMB recommended that
the trial be stopped because vintafolide did not demonstrate efficacy on
the pre-specified outcome of Progression-Free Survival (PFS) in patients
with platinum-resistant ovarian cancer. The DSMB did not identify any
safety concerns for the patients enrolled in the trial. Based on the
DSMB recommendation and while further review of the data is conducted,
the Companies have taken steps to notify investigators that screening
and randomization of participants in the trial will be suspended.

PROCEED is a Phase 3 randomized, double-blind clinical trial, evaluating
vintafolide in combination with pegylated liposomal doxorubicin (PLD)
compared to PLD plus placebo for the treatment of folate
receptor-positive, platinum-resistant ovarian cancer. The primary
endpoint of the trial was PFS as measured by RECIST v 1.1 (Response
Evaluation Criteria In Solid Tumor) criteria in patients with all target
tumor lesions positive as assessed by etarfolatide imaging agent.

About Merck

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well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
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operate in more than 140 countries to deliver innovative health
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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

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. There can be no
guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2013 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (

Endocyte Forward-Looking Statement

Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the company’s
expectations for seeking regulatory approval and commercial launch of
its products, including any conditional marketing authorization from the
EMA, initiation of future clinical trials, and expectations for the
receipt of milestones, royalties or other profits from the company’s
partnership with Merck. Actual results or developments may differ
materially from those projected or implied in these forward-looking
statements. Factors that may cause such a difference include risks that
the company may experience delays in the completion of its clinical
trials (whether caused by competition, adverse events, patient
enrollment rates, unavailability of clinical trial materials, regulatory
issues or other factors); risks that data from its clinical trials may
not be indicative of subsequent clinical trial results; risks related to
the safety and efficacy of the company’s product candidates, the goals
of its development activities, estimates of the potential markets for
its product candidates, estimates of the capacity of manufacturing and
other facilities required to support its product candidates, projected
cash needs, and expected financial results. More information about the
risks and uncertainties faced by Endocyte, Inc. is contained in the
company’s periodic reports filed with the Securities and Exchange
Commission. Endocyte, Inc. disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.

Ian McConnell, +1 908-423-3046
Claire Mulhearn, +1 908-423-7425
Carol Ferguson, +1 908-423-4465
Justin Holko, +1 908-423-5088
Martina Schwarzkopf, +1 212-845-4292
Tony Russo, +1 212-845-4251
Stephanie Ascher, +1 212-362-1200

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