Ortho Biotech Oncology Research & Development, a unit of Centocor Research & Development, Inc., announced that it has entered into a five-year Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), with Steven A. Rosenberg, M.D., Ph.D., chief, Surgery Branch, serving as the NCI principal investigator, to research and develop novel cell therapy technologies as potential treatments for a variety of cancers. These adoptive immunotherapy technologies are designed to work by helping the immune system fight cancer. Standard cancer treatments still have not progressed much beyond surgery, radiation and chemotherapy, which are effective at killing tumour cells but also can harm or kill healthy tissues. Adoptive immunotherapies have the potential to spare healthy tissue because they are designed to directly find and destroy cancerous tumour cells using a patient's own immune system T cells.

Dr. Rosenberg has been a pioneer in the field of adoptive immunotherapy of cancer for decades. His group developed Tumour Infiltrating Lymphocytes (TILs), T cells obtained from a patient's tumour, expanded and then re-administered to actively seek and destroy cancer cells. Remarkable responses to this therapy have been observed in patients with malignant melanoma, a type of skin cancer that ranks sixth among U.S. men and seventh in U.S. women for the most commonly diagnosed cancer, according to the NCI. In recent years, Dr. Rosenberg's team pioneered a new technology in which T cells obtained from a patient's blood are genetically engineered to express receptors that give them specific immunity against cancer cells and then re-administered.

Researchers at Ortho Biotech Oncology Research & Development independently developed a different and proprietary adoptive immunotherapeutic approach that uses tumour antigens and other materials to stimulate T cells from a patient's blood to become Cytotoxic T Lymphocytes (CTLs), which recognize and attack tumour cells. Early clinical results show that this technology holds promise in melanoma patients and also has the potential to work in other types of cancers.

Under the CRADA, Dr. Rosenberg's lab will conduct a clinical trial in melanoma patients using Ortho Biotech Oncology Research & Development's proprietary technology. It is hoped that the technology will be effective in other types of cancer, as well. The other part of the CRADA will focus on a collaborative effort on a T-Cell Receptor (TCR) research programme.

"This public-private partnership represents an extraordinary opportunity to bring together complementary and substantial expertise and resources from two groups with the common goal of advancing a highly promising new modality of therapy for patients with cancer," says Jay P Siegel, chief biotechnology officer of Johnson & Johnson's Pharmaceuticals and Medical Devices & Diagnostics businesses.

"Dr. Rosenberg and NCI have extensive experience in the development of immunotherapies for melanoma and other cancers, as well as a strong track record in conducting early phase clinical studies. We look forward to collaborating with NCI to optimize technologies and to begin testing of our immunotherapy technology in melanoma patients by the end of 2009, with the possibility of additional studies for other types of cancer and other technologies in years to come," adds William N Hait, senior vice president and worldwide head of oncology research and development, who with Dr Siegel will direct the Ortho Biotech Oncology Research & Development team under the collaboration.

Skin cancer is the most common form of cancer in the United States, and Melanoma, its most deadly form, accounts for 4 percent of all diagnosed skin cancers, according to NCI. Melanoma, which usually begins in cutaneous melanocytes -- the cells that produce the pigment melanin -- is more likely to spread to other body parts, known as metastatic melanoma. In 2008 in the United States, an estimated 68,000 people were diagnosed with melanoma and 8,420 people died. The percentage of people in the United States who develop melanoma has more than doubled in the last 30 years. When detected early, melanoma can be successfully treated with surgery; however, more advanced disease has limited treatment options, with a poor prognosis. Treatment of patients with melanoma in the United States costs about $1.5 billion annually, NCI reports.

Ortho Biotech Oncology Research & Development, a unit of Centocor Research & Development, Inc., is a research and development organization dedicated to oncology, haematology and supportive care. It partners closely with Centocor Ortho Biotech, Inc. and Janssen-Cilag companies worldwide to bring oncology treatments and supportive medicines to patients around the world.