Norwood Immunology begins phase II of cancer trial

The first of 80 patients have been enrolled in Norwood Immunology's (AIM:NIM) phase II clinical trial using its thymus-rejuvenating technology in cancer patients receiving self-derived (autologous) bone marrow transplants.

Norwood Immunology is a subsidiary of Norwood Abbey (ASX:NAL) and its technology is based on the use of Lupron Depot, an FDA approved GnRH (gonadotropin releasing hormone) analogue drug which suppresses the production of sex-hormones that cause the thymus to atrophy. This causes the organ to regrow and resume production of new T cells, enabling patients to better respond to disease.

Norwood Immunology COO Suzanne Lipe said data from the double blind, placebo-controlled study would show that Lupron enhances patients' immune response to vaccines, resulting in much quicker immune system recovery. Although Norwood Immunology recruited the first of 100 post-surgical melanoma patients into another phase II clinical trial late last year, that trial was not double-blinded, said Lipe.

In the double-blinded study, 40 patients undergoing chemotherapy and autologous bone marrow transplant (also known as haematopoietic stem cell transplant) will be treated with Lupron, and 40 will receive a placebo. It is usual for adult patients, in this case those being treated for Hodgkin's disease, non-Hodgkin's lymphoma or multiple myeloma, to have a poor immune recovery after chemotherapy.

Lipe said the trial would test T cell response and other immune cells in the blood to various vaccines, the first being keyhole limpet haemocyanin (KLH) -- an antigen derived from a prehistoric lizard and therefore one that the general population would not have been exposed to -- as well three common antigens, hepatitis A, tetanus and pneumocosis.

Males aged 18-60 and females aged 18-50 will receive nine months of Lupron or the placebo and be studied for about 13 months. The trial is being conducted in the US at the Houston-based University of Texas MD Anderson Cancer Centre, which enrolled the first patient, as well as the Dana-Farber Cancer Institute, Harvard Medical School and University of Minnesota Medical Centre.

The study has been funded by an NIH grant with Norwood Immunology and its US licensing partner, TAP Pharmaceutical Products, providing additional funds and in-kind resources. TAP is the FDA Investigational New Drug holder for this drug.