Eagan, Minnesota-based immune health company Biothera Inc. announced Wednesday that it has begun dosing patients for its phase 3 clinical trial to evaluate a new drug to treat late-stage colorectal cancer.
Biothera has developed the Imprime PGG drug that it is testing in combination with another drug — cetuximab (Erbitux), which is approved to treat late-stage colorectal cancer among other cancers.
“Late-stage colorectal cancer patients who can neither tolerate nor benefit from chemotherapy represent a large unmet clinical need,” said Dan Conners, president of Biothera’s Pharmaceutical Group, in a statement. “Based on previous trials, we are confident that the combination of Imprime PGG and cetuximab will prove effective in treating this disease and further extending the survival and quality of life in these patients.”
The goal of the trial is overall survival, while a secondary goal is to see whether the combined treatment can affect progression-free survival, tumor response to the treatment and improvement in the quality of life. If those endpoints are fulfilled, then the U.S. Food and Drug Administration can approve the Imprime drug faster.
The study will enroll up to 795 patients and be conducted in more than 50 locations globally, including the U.S., Europe and South America.
Biothera was incorporated more than five years ago and was formerly known as Biopolymer Engineering Inc. In a regulatory filing from April 2010, the company said it raised $3.5 million of the $25 million it was seeking. Richard Mueller is the CEO of Biothera, as well as the president of its healthcare group. That division makes patented food-grade immune health ingredients for functional food, beverage, nutritional supplement, cosmetic and animal nutrition products worldwide.
