Published: March 14, 2011
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)
Biothera, the Immune Health Company
David Walsh, 651-256-4606
(direct)
VP Communications
dwalsh@biothera.com
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