DGAP-News: Cancer Prevention Pharmaceuticals, Inc. /
Phase III Familial Adenomatous Polyposis (FAP) Trial Now Open for
Enrollment

05.12.2013 / 12:00

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TUCSON, Ariz., 2013-12-05 12:00 CET (GLOBE NEWSWIRE) --
Cancer Prevention Pharmaceuticals, Inc., (CPP) announced today the launch of a
double-blind, randomized, Phase III trial of the efficacy and safety of
CPP-1X/sulindac (eflornithine/sulindac) compared with CPP-1X and sulindac as
single agents in 150 patients with Familial Adenomatous Polyposis. Each patient
will receive daily treatment for two years to minimize the occurrence and/or
recurrence of problematic polyps and tumors associated with this debilitating
disease. The trial is being conducted at 8 North American and 4 European
clinical trial sites. 

'The design of this trial is particularly exciting,' noted Alfred Cohen, MD and
Chief Medical Officer of CPP.  'Rather than count polyps, which has been the
past indicator of clinical success in pharmacoprevention trials in FAP, we have
designed our trial to assess meaningful clinical outcomes in these patients. 
With a successful outcome in this study, we will have real evidence of patient
benefit.' Jeff Jacob, Chief Executive Officer of CPP, added, 'The initiation of
this trial is a huge milestone for our Company and for patients with FAP.
Taking specific guidance from both the Food and Drug Administration (FDA) and
European Medicines Agency (EMA) on trial design, we and our expert advisors
believe the drug could change the treatment paradigm in FAP by delaying or
eliminating surgical interventions and/or cancer.' 

About Familial Adenomatous Polyposis (FAP)

Familial adenomatous polyposis (FAP) is an inherited disorder characterized by
cancer of the large intestine (colon) and rectum.  People with the classic type
of FAP may begin to develop multiple noncancerous (benign) growths (polyps) in
the colon as early as their teenage years.  Currently, there are no approved
pharmacologic treatments for FAP.  Unless the colon is removed - the only real
treatment option - these polyps will become malignant (cancerous).  The average
age at which an individual develops colon cancer in classic FAP is 39 years. 
Some people have a variant of the disorder, called attenuated FAP, in which
polyp growth is delayed.  The average age of colorectal cancer onset for
attenuated FAP is 55 years. 

In people with classic FAP, the number of polyp's increases with age, and over
time, hundreds to thousands of polyps carpet the colon.  Also of particular
significance are noncancerous growths called desmoid tumors.  These fibrous
tumors usually occur in the tissue covering the intestines and may be provoked
by surgery to remove the colon.  Desmoid tumors tend to recur after they are
surgically removed.  In both classic FAP and its attenuated variant, benign and
malignant tumors are sometimes found in other places in the body, including the
duodenum (a section of the small intestine), stomach, bones, skin, and other
tissues.  If left untreated, FAP leads to colorectal cancer and death. 

About Cancer Prevention Pharmaceuticals, Inc. (CPP)

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, CPP believes
there is even more potential for therapies that reduce the risk of cancer. 

In addition to this Phase III trial CPP, in collaboration with the National
Cancer Institute (NCI) and the SWOG cancer research cooperative group, is
sponsoring a large 1,340 patient Phase III trial in colon cancer survivors. CPP
is also working collaboratively with non-profit groups to support trials in
neuroblastoma--treating and preventing--with three active clinical trials.
Additional information 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 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
         Chief Executive Officer
         520-908-7774
         jjacob@canprevent.com
News Source: NASDAQ OMX


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Language:    English                                  
Company:     Cancer Prevention Pharmaceuticals, Inc.  
 
 
             United States                            
ISIN:        US9901623564                             
 
 
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