April 19--A Tucson company has moved a step closer to launching its first
cancer-prevention drug with a late-stage clinical trial.
Tucson-based Cancer Prevention Pharmaceuticals Inc. announced the launch of a
three-year, Phase III colon-cancer-prevention trial in collaboration with the
National Cancer Institute and SWOG (formerly the Southwest Oncology Group), an
NCI-supported clinical-trials group.
The Phase III clinical trial -- typically the final trial phase before
regulatory approval -- will test the company's preventive drug (known as
CPP-1X/sul, or eflornithine/sulindac) in 1,340 colon-cancer survivors -- each of
whom will receive daily treatment for three years to prevent the recurrence of
cancer or high-risk polyps.
In an earlier trial, people who had had adenomas -- benign tumors -- removed
from their colon and then took daily eflornithine and sulindac for three years
lowered their risk of developing another tumor to less than a third of the
three-year risk for those who did not take the drugs, Cancer Pharmaceuticals
said. And they lowered their chances of developing a high-risk adenoma during
that time by 90 percent.
The new trial is being conducted under Cancer Pharmaceuticals' investigational
new drug application, funded mostly by the NCI, and primarily managed by SWOG.
It will take place at more than 200 sites around the nation, including the
University of Arizona and the Mayo Clinic.
"This is a huge milestone for all of us," said Jeff Jacob, CEO of Cancer
Prevention Pharmaceuticals, noting that the company has been working for three
years with the NCI and federal regulators to launch the trial.
The company inherited data from earlier Phase I and II trials, Jacob noted.
Eugene W. Gerner, University of Arizona professor emeritus and Arizona Cancer
Center member, is a co-founder and chief scientific officer of the company.
"It takes many people 12 years to get to this point, so we feel lucky," Jacob
Working closely with the U.S. Food and Drug Administration and the NCI, the
Tucson company has paved one of the first regulatory paths for cancer-prevention
therapies, he said.
"It's not the first (preventive cancer drug), but it's one of the first," Jacob
said, citing one breast-cancer drug, Tamoxifen, that is used for prevention of
breast cancer in high-risk patients.
The company is also considering supplementing the new trial with a parallel
study in Europe or Asia.
Contact Assistant Business Editor David Wichner at dwichner@ azstarnet.com or
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