Biothera's Phase II clinical trials in lung cancer attain stage 1 endpoint

Biothera announced today that its second Phase II non-small cell lung cancer trial, evaluating Imprime PGG® in combination with bevacizumab (Avastin®) and two chemotherapeutic agents, has achieved its stage 1 endpoint and has begun enrolling patients for stage 2 of the study.

“As we have seen in our other clinical trials, Imprime PGG can significantly improve patient outcomes.”

Imprime PGG is Biothera's developmental drug that binds to and directs neutrophils, one of the most abundant types of immune cells in the body, to kill cancer. Imprime PGG works synergistically with anti-tumor monoclonal antibodies to target cancer cells through a novel mechanism researchers believe could be used to treat most types of cancer.

The open label, randomized controlled, Phase II trial is being conducted at eight medical centers in the U.S. and six in Germany. Study details are available at the U.S. Institute of Health's website, clinicaltrials.gov (ID number: NCT00874107). The trial will enroll up to 90 patients and enrollment is scheduled to complete in the second half of 2011.

Biothera's first Phase II trial in non-small cell lung cancer patients (clinicaltrials.gov ID# NCT00874848) combines Imprime PGG and cetuximab (Erbitux®) and two chemotherapeutic agents. The study has five U.S. sites and six sites in Germany. The 90-patient, open label, randomized controlled trial presently has 67 patients enrolled and is expected to complete enrollment in the near future.

"The initial results of both our non-small lung cancer trials are very promising and further demonstrate Imprime PGG's unique mechanism of action and synergy with monoclonal antibody therapies," said Dan Conners, president of Biothera's Pharmaceutical Group. "As we have seen in our other clinical trials, Imprime PGG can significantly improve patient outcomes."

Imprime PGG recently completed multiple Phase II clinical studies in colorectal cancer patients. Enrollment for a Phase III colorectal cancer study is expected to begin soon. Imprime PGG is also part of a new combination treatment being evaluated in a Phase I/II clinical trial in patients with earlier stage high-risk chronic lymphocytic leukemia.

Source: Biothera