ATLANTA — 2014 年 3 月 21 日 —Pharmacokinetic (PK) data supporting the dose and schedule regimens of Biothera’s phase 3 cancer immunotherapy Imprime PGG® are being presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting in Atlanta this week.
The results are based on population pharmacokinetic data generated from four clinical trials that included two phase 1 safety studies in healthy volunteers, a phase 1b/2 study in colorectal cancer patients receiving cetuximab with or without irinotecan, and a phase 2 study in non-small cell lung cancer patients receiving cetuximab with carboplatin and paclitaxel. Key findings included:
- Clearance of Imprime PGG in cancer patients treated with monoclonal antibodies with or without chemotherapy was similar to that in healthy volunteers.
- The effective half-life of Imprime PGG ranged from 19.5 to 27.3 h. Based on modeling and simulations, negligible or minimal accumulation of Imprime PGG was observed with weekly dosing in cancer patients, supporting a weekly dose regimen.
- Exposure to Imprime PGG was similar in patients who were positive or negative for a biomarker correlated with response to Imprime PGG in patients with non-small cell lung cancer.
“These results indicate that there were no apparent drug-drug interactions or concerns about clearance or accumulation following administration of Imprime PGG,” said Myra Patchen, Ph.D., Biothera chief scientific officer. “The PK data support the dose and schedule regimen for Imprime PGG in our clinical studies.”
Certara contributed to the findings through population PK modeling of Imprime PGG to support the dosing rationale and assess potential drug-drug interactions with cetuximab, with and without irinotecan.
“Certara is delighted to partner with Biothera on this important project,” said JF Marier, Ph.D., lead author, and vice president and lead scientist for Certara. “This is an excellent example of how population PK modeling can be used to support dosing of cancer patients in clinical studies.”
Biothera’s PK data is the subject of two presentations:
- JF Marier, AL Menard, M Beliveau, MA Gargano, R Walsh, and ML Patchen. Modeling and Simulations of β-Glucan After Administration of PGG-Glucan Alone or in Combination with Cetuximab, with and without Irinotecan, in Colorectal Cancer Patients.
- JF Marier, C Jomphe, M Beliveau, JR Lowe, P Mattson, R Walsh, and ML Patchen. Pharmacokinetic Analysis of β-Glucan Following Administration of Imprime PGG, a Novel β-Glucan Immunomodulator Being Developed for the Treatment of Non-Small Cell Lung Cancer.
About Imprime PGG®
Imprime PGG is a novel cancer immunotherapy that engages and directs the innate immune system to kill cancer cells. This targeted mechanism is synergistic with all anti-tumor monoclonal antibodies tested to date, demonstrating significant therapeutic potential in a wide range of cancer indications. In phase 2 clinical trials, Imprime PGG has demonstrated marked improvements in response rates in multiple clinical trials for non-small cell lung cancer (NSCLC), colorectal cancer and chronic lymphocytic leukemia. Imprime PGG is currently being investigated in a phase 3 clinical trial for advanced colorectal cancer and a second phase 2 study for NSCLC.
About Biothera, the Immune Health Company
Biothera is a U.S. biotechnology company dedicated to improving immune health. The company is a pioneer in the field of cancer immunotherapy and the leader in innate immune modulation.
Certara is the leading technology-enabled drug development consultancy. Headquartered in St Louis, MO, with offices in the UK, Canada, and Japan, Certara has more than 225 employees worldwide. The company delivers model-based drug development and discovery solutions including molecular modeling, physiologically-based predictions of pharmacokinetics from in vitro and physiochemical data, and modeling of pharmacokinetic and pharmacodynamic data from preclinical and clinical studies.
Biothera, the Immune Health Company
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