Biothera, the immune health company, has initiated a Phase I/II clinical trial to evaluate the effects of its drug compound Imprime PGG™ in combination with G-CSF for mobilization of bone marrow stem cells into the peripheral blood in normal human subjects.
Stem cells are necessary to maintain a healthy immune system. Aggressive chemotherapy used in treating cancer also destroys stem cells.
A common procedure to help patients reconstitute their immune systems involves harvesting stem cells prior to chemotherapy and reintroducing them following treatment.
G-CSF is typically used to enhance the movement of stem cells into the peripheral circulation where they can be harvested. However, the effectiveness of G-CSF is limited in many patients.
The objective of the Phase I/II study is to determine whether the combination of Imprime PGG plus G-CSF is better than G-CSF alone for enhancing the stem cell mobilization.
Subject selection for the Phase I/II trial is underway and treatment should be completed before the end of 2006.
The Phase I/II study will enroll 56 subjects and will be performed in the United States.
“Our preclinical research has demonstrated that the combination of Imprime PGG and G-CSF enhances the mobilization of stem cells beyond that induced by G-CSF alone and also enhances stem cell mobilization in animals that respond poorly to G-CSF alone,” said Daniel Conners, chairman of Biothera.
“We are hopeful that the combination therapy will result in effective stem cell harvesting and, ultimately, help cancer patients recover quickly from life-threatening myeloablative effects of chemotherapy.”
In preparation for the clinical trial, Biothera filed and received approval from the U.S. Food and Drug Administration for an Investigational New Drug (IND) application for the stem cell mobilization indication.
The IND enables Biothera to initiate a clinical trial program using Imprime PGG in combination with G-CSF to evaluate effects on stem cell mobilization.
Results from the clinical trial will enable Biothera to proceed to a Phase II trial in cancer patients.
In the cancer study, stem cells mobilized by Imprime PGG plus G-CSF will be harvested, reintroduced into patients following their chemotherapy and reconstitution of their immune system monitored.
Under a separate IND, approved in 2005, Biothera is also developing Imprime PGG as an adjunct to monoclonal antibodies for the treatment of cancer.
The company has completed two Phase I clinical trials with Imprime PGG for this indication.