Norwood to commence phase II cancer vaccine trial

Melbourne immune therapy developer Norwood Immunology (AIM:NIM) has signed an agreement for a phase II collaboration with the University of Texas MD Anderson Cancer Centre of Houston to determine whether its investigational melanoma cancer vaccine generates an enhanced immune response.

"The strategy is to treat the cancer patient with Lupron, which will stimulate the immune system and in turn will make it much more responsive to the cancer vaccine," said senior VP of corporate development, Bernie Romanin. "The technology is applicable to a number of diseases that affect the immune system and in this instance it is the use of a cancer vaccine to treat a specific melanoma cancer -- but generally speaking an enhanced immune system has the possibility of making adult vaccines work more effectively."

The phase II clinical trial in 100 patients will be conducted under the supervision of Dr Patrick Hwu, professor and chair of Melanoma Medical Oncology at the MD Anderson Cancer Centre, which is reportedly one of the top three cancer centres in the world. The trial protocol has been accepted by the US FDA and is expected to commence in November 2005.

According to Romanin there are many reasons why cancer vaccines traditionally give poor anti-tumour responses. One major problem is the compromised immune system in adults, resulting from age-induced degeneration of the thymus. The thymus is important because it produces the T cells required for virtually all immune responses. Norwood's strategy is to increase thymic activity and the output and function of T cells by temporary sex steroid inhibition using the GnRH analog, Lupron Depot.

The trial will compare the tumour-specific immune responses to melanoma peptide vaccines, gp100 and MAGE-3 in the presence or absence of Lupron Depot in patients with stage IIb and stage III melanoma or stage IV melanoma where the metastatic lesion(s) has been surgically removed. When fully enrolled, the study aims to analyse results from 100 vaccinated patients, half of whom will received Lupron Depot.

The trial is to be funded by Norwood Immunology with support from its US licence partner, TAP Pharmaceutical Products, who market Lupron Depot in the US, as well as grants applied for by Hwu.