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DGAP-News: Cancer Prevention Pharmaceuticals Receives Positive Scientific Advice From EMA for CPP-1X Phase III TRIAL in FAP
ID: 452702
(firmenpresse) - Cancer Prevention Pharmaceuticals, Inc.
29.07.2011 09:00
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TUCSON, Ariz., 2011-07-29 09:00 CEST (GLOBE NEWSWIRE) --
Cancer Prevention Pharmaceuticals, Inc. (CPP) has received positive advice from
the European Medicines Agency (EMA) regarding its Phase III trial in Familial
Adenomatous Polyposis (FAP).
A request for Scientific Advice is a process offered by the EMA to provide
guidance on conduct of studies. This process is helpful to ensure that the
studies are appropriately designed to minimize the risk of major objections
being raised during the regulatory review. Scientific advice received from the
EMA represents the agreed EU regulators' position on issues relating to an
evaluation of safety, quality and efficacy.
The EMA advice included agreement on key design features such as its clinically
important endpoint, study duration, statistical analysis plan, and comparator
arms. The EMA's advice is consistent with guidance received from the FDA
earlier this year and the Company is now poised to begin a multinational study
in FAP that will be used to support registration in both European Union (EU)
and the United States.
Jeffrey Jacob, CEO of CPP said, 'This is truly a breakthrough for our Company
and the FAP Community. We have worked closely with global Key Opinion Leaders
(KOLs) and regulatory authorities in Europe and the US to create a new
registration pathway that will have both regulatory and commercial impact if
our trial is successful.'
The CPP study is a departure from previous and traditional trial designs that
focused on 'polyp counting.' Celecoxib was previously approved for FAP using
the polyp counting endpoint with only a ~28% reduction in polyp burden but
unfortunately never translated into a standard of care or proven clinical
benefit. The FAP indication was recently withdrawn from the Celecoxib label. In
a departure from these endpoints, CPP will target a delay in FAP-related events
such as surgical events, duodenal disease, cancer, and death which are now
accepted by the regulators as 'clinically meaningful.'
Mr. Jacob added, 'Both the FDA and EMA made it clear that endpoints focused
only on polyp counting will no longer be accepted for registration. In a
previous Phase II/III sporadic adenoma trial with our drug combination, our
Founders showed 92%-95% efficacy in preventing the recurrence of high risk
polyps--i.e., those at high risk of transforming into cancer. We believe, along
with many KOLs around the world, that these dramatic results may be replicated
in the FAP population--with the added benefit of delaying surgical events,
duodenal disease, cancer, and death. With agreement and guidance from the
regulatory authorities, we are now ready to move this important pivotal trial
forward.'
About Familial Adenomatous Polyposis (FAP)
Familial adenomatous polyposis (FAP) is an inherited disorder characterized by
cancer of the large intestine (colon) and rectum. It is a significant orphan
disease afflicting 1-in-10,000 people (roughly 30,000 in the United States and
40,000-50,000 in Europe). The classic type of FAP results in multiple
noncancerous (benign) growths (polyps) in the colon that can appear in children
and teenagers. Unless the colon is removed, these polyps will eventually become
malignant (cancerous). In people with classic FAP, the number of polyps
increases with age, and hundreds to thousands of polyps can develop in the
colon. FAP patients are subjected to numerous surgical and endoscopic
procedures throughout their lives and ultimately face life threatening duodenal
disease, desmoids, and cancer. FAP has been designated as an orphan disease by
the United States FDA and the European Commission.
About CPP
Cancer Prevention Pharmaceuticals, Inc. (CPP) is developing therapeutics that
reduce the risk of cancer. CPP's approach has been used with great success in
other disease categories such as cardiovascular, neurovascular and infectious
disease. Agents that target pre-disease states have helped reduce death rates
from these conditions by 50%-70% over the past 30 years. Just as these other
prevention therapies represent the largest-selling drug classes on the market
today (>$25 billion), CPP believes there is even more potential for therapies
that reduce the risk of cancer. In addition to its Phase III FAP study, CPP is
also co-sponsoring a large Phase III trial in colon cancer survivors (N-1350)
expected to begin in the second half of 2011. Additional information on CPP is
available at www.canprevent.com.
Forward Looking Statements
This press release contains forward-looking statements subject to risks and
uncertainties that could cause actual results to differ materially from those
projected. Forward-looking statements include statements about the planned
Phase III trial of the CPP-1X/sul combination therapy in FAP as well as the
company's focus, collaborative partners, and independent and partnered product
candidates. These forward-looking statements represent the company's judgment
as of the date of this release. The company disclaims, however, any intent or
obligation to update these forward-looking statements.
CONTACT: Jeffrey Jacob
CEO
520-908-7774
jjacob(at)canprevent.com
News Source: NASDAQ OMX
29.07.2011 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Cancer Prevention Pharmaceuticals, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901623564
WKN:
End of Announcement DGAP News-Service
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Datum: 29.07.2011 - 09:00 Uhr
Sprache: Deutsch
News-ID 452702
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