Human Genome Sciences, Inc. (HGSI) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for LymphoRad, a radio iodinated form of B Lymphocyte Stimulator (BLyS).

Upon receiving clearance from the FDA, Human Genome Sciences plans to initiate Phase 1 clinical trials. LymphoRad has the potential to treat a broad range of B-cell tumors, including multiple myeloma, large B-cell lymphomas, follicular B-cell lymphomas, chronic lymphocytic leukemia, and Burkitt's lymphoma. Preclinical studies show that LymphoRad binds to receptors found only on B cells and B-cell tumors, delivering low doses of radiation that cause cell death. Such studies of multiple myeloma and non-Hodgkin's lymphomas also show that treatment with LymphoRad results in inhibition of tumor growth and prolonged survival.

Craig Rosen, Ph.D., Executive Vice President, R&D, said, "LymphoRad has the potential to target a narrow range of cells in the body, leaving others untouched. LymphoRad derives its targeting potential from its ability to bind specific receptors found only on B-cell tumors and on normal B cells ranging from naive B cells through mature plasma B cells. The distribution of LymphoRad receptors differs from that of CD20, the target of three other drugs, Rituxan, Bexxar, and Zevalin, which may also be used to treat some B-cell tumors. The LymphoRad receptors are present on multiple myelomas, whereas the receptors for Bexxar, Zevalin, and Rituxan are generally not, suggesting that LymphoRad may provide a novel treatment option for people with such disease. Additionally, pre-B cells needed to replenish the normal B-cell population lack the LymphoRad receptor, but carry CD20, suggesting that pre-B cells might escape killing by LymphoRad, thus mitigating drug-related side effects."

David Stump, M.D., Senior Vice President, Drug Development, said, "I look forward to the prospect of initiating clinical trials of LymphoRad. In contrast to many anticancer drugs now in use that kill a broad range of normal healthy cells as well as cancer cells, LymphoRad has the potential to be much more specific. B-cell tumors are known to be susceptible to the lethal effects of radiation. LymphoRad is designed to bring such radiation to the tumor cells and spare most normal cells. Our initial focus will be on patients with multiple myeloma, as current treatments for this disease are few. The need for new treatments for B-cell tumors is great. For example, the Multiple Myeloma Research Foundation estimates that over 14,000 new cases of multiple myeloma are diagnosed each year in the United States. It is estimated that a total of approximately 30,000 people in the U.S., Europe and Japan are afflicted with multiple myeloma. Multiple myeloma is the second most prevalent blood cancer and is approximately twice as prevalent in men as in women. Multiple myeloma is also among the ten leading causes of death in African Americans."

William A. Haseltine, Ph.D., Chairman and CEO, said, "LymphoRad is yet another drug to emerge from our genomic discovery efforts. It is the eighth drug for which we have filed an IND application, and the fifth drug for our cancer franchise. The other drugs in development for cancer include repifermin for the treatment of cancer therapy-induced mucositis, mirostipen for the protection of blood-forming tissues in patients undergoing chemotherapy, Albuferon an improved form of interferon alpha for the treatment of certain types of cancer, and Albuleukin an improved form of interleukin-2 for the treatment of solid tumors. Cancer treatment continues to be one of the principal areas of our drug discovery and development efforts. We are proud of our ability to discover breakthrough products that are based on novel mechanisms of action and that meet significant medical needs, and to bring them to clinical trials promptly."

LymphoRad will be manufactured in accordance with the FDA's Good Manufacturing Practice (GMP) guidelines. The targeting protein, BLyS, will be manufactured at Human Genome Sciences in Rockville, Md. LymphoRad will be manufactured at a GMP manufacturing facility under construction at MDS Nordion in Ottawa, Canada. MDS Nordion will use a process it developed for Human Genome Sciences that covalently binds the radioactive isotope iodine131 to the BLyS protein.

Claudette David, Vice President, Therapeutic Products, MDS Nordion, said, "MDS Nordion is pleased to have been selected by Human Genome Sciences for the clinical manufacturing of LymphoRad. Their decision further demonstrates MDS Nordion's leadership position and expertise in the development and manufacturing of GMP radiotherapeutics for clinical and commercial supply."