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Novel personalized treatment approach targets folate receptors on cancer cells
Vintafolide is a proprietary, injectable, conjugate consisting of folate (vitamin B9) linked to a potent vinca alkaloid anti-cancer agent, desacetylvinblastine hydrazide (DAVLBH). Folate is essential for cell division, and cancer cells generally consume higher levels of folate than normal cells to fuel their rapid rate of growth and division. In order to satisfy the demand for folate, some cancer cell types — including ovarian — express high concentrations of folate receptors on their surface. Vintafolide is designed to exploit this characteristic by selectively targeting the folate receptor to deliver the anti-cancer agent DAVLBH intracellular to the tumor.
"The acceptance of the EMA filing for vintafolide is an important
milestone for Merck and Endocyte," said
The MAA filings are supported by four clinical studies: a Phase I study in solid tumors, two single-agent, single-arm Phase II studies in ovarian cancer and non-small cell lung cancer, and the PRECEDENT trial, a randomized Phase IIb study in patients with platinum-resistant ovarian cancer. The application is being submitted for conditional approval on the basis that the results from the Phase II studies fulfill an unmet medical need.
Vintafolide is currently being evaluated in a Phase III randomized,
double-blind clinical trial for platinum-resistant ovarian cancer
(PROCEED trial). The PROCEED trial is evaluating vintafolide in
combination with PLD compared to PLD plus placebo for the treatment of
folate-receptor positive platinum-resistant ovarian cancer. This trial
also employs the companion diagnostic imaging agent etarfolatide, which
is a molecular imaging agent that is being developed as a non-invasive
method to identify tumors that over-express folate receptors. The
primary endpoint of the trial is progression-free survival 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. Overall survival is a secondary endpoint. The
trial anticipates recruiting patients at approximately 150 sites in
"We are pleased with the acceptance of the applications in
As part of an exclusive license agreement with
About Folate-Receptor Positive Platinum-Resistant Ovarian Cancer
In 2012, it is estimated that there will be 22,280 new cases of ovarian
cancer in
About Merck
Today's Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside
About
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. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that the expected synergies from the merger of Merck and
Schering-Plough will not be realized, or will not be realized within the
expected time period; the impact of pharmaceutical industry regulation
and health care legislation; the risk that the businesses will not be
integrated successfully; disruption from the merger making it more
difficult to maintain business and operational relationships; Merck's
ability to accurately predict future market conditions; dependence on
the effectiveness of Merck's patents and other protections for
innovative products; the risk of new and changing regulation and health
policies in
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 2010 Annual Report on Form 10-K and the company's other
filings with the
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 partnership.
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 PLD, 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
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