Integrated Safety Data From Two Phase 2 Cancer Studies Demonstrates Biothera’s Investigational Cancer Immunotherapy Is Well Tolerated

CHICAGO--(BUSINESS WIRE)--A new, combined analysis of patient-level data from two randomized studies in non-small cell lung cancer provides further evidence that Biothera’s investigational immunotherapy Imprime PGG is safe and well tolerated, with adverse events generally consistent with complications of the disease and toxicities attributable to the cytotoxic drugs or monoclonal antibody therapies. Biothera presented the data yesterday at the American Society of Clinical Oncology’s annual meeting (abstract #3071).

“This analysis provides the single largest safety dataset to date from randomized clinical trials with Imprime PGG, including nearly 180 patients with both squamous and non-squamous cell non-small cell lung cancer”

In two recent, identically designed phase 2 trials in patients with stage IV non-small lung cancer, Imprime PGG in combination with carboplatin/paclitaxel (CP) chemotherapy and bevacizumab or cetuximab increased objective response rates in comparison with CP and bevacizumab or cetuximab alone.

“This analysis provides the single largest safety dataset to date from randomized clinical trials with Imprime PGG, including nearly 180 patients with both squamous and non-squamous cell non-small cell lung cancer,” said Ada Braun, M.D., Ph.D., Biothera’s Chief Medical Officer. “Imprime PGG was safe and generally well tolerated across the two studies. Adverse events reported with T-cell modulators were not observed at increased frequency with Imprime PGG.”

In the two studies, 118 patients were treated with Imprime PGG, frontline carboplatin/paclitaxel chemotherapy and bevacizumab or cetuximab. Fifty-nine (59) patients received the chemotherapy and monoclonal antibody treatment alone.

Overall, adverse events occurred in 99.2% of patients treated with Imprime PGG and 100.0% of patients in the control group. Severe (CTCAE grade 3 or 4) events occurred in 85.6% vs. 76.3% and serious events in 51.7% vs. 42.4% of patients. The most common adverse events in either arm of the study included fatigue (Imprime PGG 53.4% vs. control 59.3%), nausea (55.1 % vs. 47.5 %), alopecia (42.4% vs. 45.8%) and neutropenia (40.7% vs. control 42.4%). The most common severe events included neutropenia (35.6% vs. 37.3%), leukopenia (10.2% vs. 16.9%) and thrombocytopenia (11% vs. 11.9%). Severe infections occurred at a lower incidence with Imprime PGG compared to control (6.8% vs. 11.9%).

About Biothera

Biothera is a privately held biotechnology company developing Imprime PGG, a late clinical stage immunotherapeutic drug candidate that modulates key immune cells to recognize and kill cancer. Proof of concept has been established from randomized and single-arm Phase 2 studies in non-small cell lung cancer, colorectal cancer, and chronic lymphocytic leukemia. Studies are ongoing in metastatic colorectal cancer and non-Hodgkin lymphoma. In addition, new research shows that Imprime PGG elicits cross talk that bridges innate and adaptive immunity that may result in coordinated immune response to cancer.

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