Biothera Initiates Phase I/II Clinical Trial for Stem Cell Mobilization.EAGAN, Minn. -- Biothera, the immune health company, has initiated a Phase I/II clinical trial to evaluate the effects of its lead drug compound Imprime PGG PGG Purple, Green, and Gold (Mardi Gras beads colors) PGG Project Galactic Guide PGG Patrol Gunboat (Missile) PGG Pendleton Grain Growers, Inc. (Pendleton, OR, USA) [TM] in combination with G-CSF G-CSF granulocyte colony-stimulating factor. G-CSF granulocyte-colony stimulating factor. G-CSF Granulocyte colony-stimulating factor Molecular therapeutics A biological response modifier, the recombinant DNA form of for mobilization of bone marrow stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young into the peripheral blood peripheral blood Cardiology Blood circulating in the system/body in normal human subjects. Stem cells are necessary to maintain a healthy immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . Aggressive chemotherapy used in treating cancer also destroys stem cells. A common procedure to help patients reconstitute re·con·sti·tute tr.v. re·con·sti·tut·ed, re·con·sti·tut·ing, re·con·sti·tutes 1. To provide with a new structure: The parks commission has been reconstituted. 2. 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 stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . "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 more effective stem cell harvesting and, ultimately, help cancer patients recover more 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. About Biothera, the Immune Health Company Biothera is a biotechnology company dedicated to improving immune health. The company's primary focus is developing pharmaceuticals that engage the immune system to fight cancer. In addition, compounds are also in development to facilitate immune system recovery after damage from chemotherapy or acute radiation exposure. Biothera also manufactures and markets food-grade ingredients that support healthy immune function Immune function The state in which the body recognizes foreign materials and is able to neutralize them before they can do any harm. Mentioned in: Herbalism, Traditional Chinese, Stress Reduction to the nutritional supplement, functional food, cosmetic and animal nutrition markets. Website: www.biotherapharma.com. |
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