Phase I/II Clinical Trial in Chronic Lymphocytic Leukemia to Evaluate Combination Therapy with Biothera’s Imprime PGG

EAGAN, Minn.--(BUSINESS WIRE)-- Patients with earlier stage high-risk Chronic Lymphocytic Leukemia (CLL) recently began receiving a new combination treatment in a Phase I/II clinical trial that researchers believe could result in a more effective therapy for this disease, Biothera announced today.

The study will evaluate Biothera’s Imprime PGG® in combination with alemtuzumab (Campath®) and rituximab (Rituxan®). Imprime PGG is a developmental drug that binds to and directs neutrophils, the most abundant type of immune cell in the body, to kill cancer. Imprime PGG works synergistically with anti-tumor monoclonal antibodies, such as alemtuzumab and rituximab.

“Imprime PGG’s unique mechanism of action, which engages and directs innate immune cells to kill cancer, has been successfully demonstrated in multiple clinical and preclinical studies involving several types of cancer,” said Dan Conners, president of Biothera’s Pharmaceutical Group. “We are confident that combining Imprime PGG with Rituxan and Campath will result in similarly significant improvements in outcomes for CLL patients.”

Imprime PGG recently completed a successful Phase II clinical study in colorectal cancer patients. The drug candidate is also currently in multiple Phase II clinical trials for non-small cell lung cancer and a Phase III trial for colorectal cancer.

Study Design
Researchers will dose up to 16 patients in the Phase I open-label, dose-escalation part of the study designed to determine the maximum tolerated dose (MTD) of Imprime PGG in combination with alemtuzumab and rituximab.

In Phase II of the clinical trial, 39 CLL patients will be dosed with Imprime PGG at the dose level identified in Phase I of the study, for a total of up to 55 patients. The goal of this study is to assess the rate of complete response of subjects with high-risk, earlier-stage CLL who are treated with Imprime PGG, alemtuzumab, and rituximab. The study will also evaluate overall subject response, time to progression, time to next treatment, duration of response, and safety of the therapeutic regimen.

For more information, including patient eligibility, visit the National Institutes of Health website at clinicaltrials.gov. This study is being funded by the National Cancer Institute.

About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is cancer of the blood and bone marrow that affects more than 100,000 American with over 15,000 new diagnoses each year. CLL is a slow developing disease of lymphocytes, a type of white blood cell that help the body fight infection and disease. CLL causes lymphocytes to stop functioning properly, which can result in immune system complications and increased susceptibility to infection.

About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. Based in Eagan, Minnesota, the company is developing pharmaceuticals that engage the innate immune system to fight cancer. (www.biothera.com)



CONTACT:

Biothera, the Immune Health Company
David Walsh, 651-256-4606 (direct)
VP Communications
[email protected]

KEYWORDS:   United States  North America  Minnesota

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Oncology  Pharmaceutical  Radiology

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