Osiris Therapeutics Inc. said yesterday that it has begun human testing of a treatment to help regenerate bone marrow and blood cells for cancer patients undergoing chemotherapy and bone marrow transplants.
The company said its experimental treatment, Allogen, will be tested at seven U.S. and European cancer centers.
In this Phase I trial, Osiris will test the product for safety, specifically to ensure that patients' bodies do not reject the cell treatment.
Allogen is the company's second cell product to reach clinical trials.
In September, the Baltimore-based company launched testing of Stromagen, which is designed to stimulate blood-cell production in breast cancer patients who are undergoing high-dose chemotherapy.
Chemotherapy often destroys precursor blood cells, known as stem cells, which give rise to all types of blood cells.
It can also affect bone marrow's natural ability to produce blood cells. Meanwhile, cancer patients receiving bone marrow transplants often encounter problems with rejection or other complications.
Osiris said Allogen was shown in laboratory studies to improve the likelihood that bone marrow transplants would not result in rejection or immune system complications.
The company said Allogen will be given to patients by infusion, and will be made from the stem cells of relatives who have matching cells.
Doctors will obtain blood stem cells and stem cells that give rise to bone marrow tissue from the donor and then ship them to the company's headquarters in Baltimore.
The privately held company has developed a proprietary system for culturing and increasing cell counts by 3,000-fold.
The resulting product will then be shipped and stored frozen. It will be thawed before being given to the patient.
Osiris said Allogen would initially be tested on cancer patients with leukemias and lymphomas, specifically non-Hodgkin's lymphoma.
In the United States, about 30,000 cases of leukemia are diagnosed each year, and about 22,000 people die from the disease. Non-Hodgkin's lymphoma is diagnosed in about 57,000 people annually, and kills 27,000 each year.
"Our goal is to bring adult stem cells into routine use for cancer and various stromal disorders," said Dr. Annemarie B. Moseley, senior vice president for clinical and regulatory affairs at Osiris.
She said the Allogen clinical trial was "an important step in determining the clinical potential of donor-derived adult stem cells."
Osiris executives have said it is too early to estimate how much any of its products might cost if approved by regulators.