A new drug designed to assist in stem cell transplants will be studied in a Phase 2 clinical trial. TG-0054, created by TaiGen Biotechnology, was effective at moving stem cells from the bone marrow into the blood during the Phase 1 trial.

This drug may help patients collect enough stem cells for stem cell transplantion. Patients suffering from disorders of the blood, bone marrow, or certain cancers receive stem cells, which repopulate the depleted bone marrow with new, healthy blood cells and immune cells.

Stem cells, which are continuously renewed through cell division, have the ability to transform into a diverse range of specialized cells. These stem cells are collected from the patient or donor prior to the transplant. When the cells are collected from the patient’s own blood or marrow, it is called an autologous transplant; when a donor is involved, it is an allogeneic transplant. Typically, the stem cells are drawn from circulating blood rather than the bone marrow.

A drug like TG-0054, known as a chemokine receptor antagonist, triggers stem cells to leave the bone marrow and enter the blood stream. This means more stem cells can be collected for the transplant.

Researchers at TaiGen Biotechnology found that the number of stem cells circulating in the blood stream after one dose of TG-0054 was equal to or higher than the number required for a transplant. The number of stem cells in circulation peaked around four to six hours after the dose.

Phase 1 results indicate that TG-0554 may be able to be used alone for mobilization of stem cells. “This should greatly reduce the hospital and other associated cost for such a procedure,” said Dr. Ming-Chu Hsu, chairman and CEO of TaiGen.

The drug also mobilizes cancer cells hiding in the bone marrow. Lingering blood cancer cells in bone marrow are a major cause of relapse. Researchers suggest that the use of TG-0054, prior to chemotherapy, could eliminate residual cancer cells in the bone marrow and prolong remission.

The Phase 1 trials were safely conducted in healthy volunteers. Next, TG-0054 will enter Phase 2 trials in patients suffering from multiple myeloma, non-Hodgkin’s lymphoma, and Hodgkin’s lymphoma.

For more information, please see the TaiGen Biotechnology press release or Web site.