Advaxis, Inc., , the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, is pleased to announce that Cancer Research UK (CRUK), the UK philanthropy dedicated to cancer research, has agreed to fund the cost of a clinical trial to investigate the use of ADXS11-001, Advaxis’ lead human papilloma virus (HPV)-directed vaccine candidate, for the treatment of head and neck cancer.
This sponsored-clinical trial will investigate the safety and efficacy of ADXS11-001 in head and neck cancer patients who have previously failed treatment with surgery, radiotherapy and chemotherapy – alone or in combination. Advaxis will provide the vaccines with all other associated costs to be funded by CRUK.
The study is to be conducted at Aintree Hospital at the University of Liverpool, Royal Marsden Hospital in London, and Cardiff Hospital at the University of Wales. Patient enrollment is slated for the latter part 2010. At such time, enrollment officials anticipate recruiting a maximum of forty-five (45) patients.
“Both acceptance by the scientific community and interest in collaborating on live, attenuated Listeria vaccines is accelerating,” said Advaxis Executive VP of Science & Operations John Rothman. “The high caliber of collaborating clinical researchers, such as CRUK and NCI, will result in an excellent development programs. The development of new vaccines, at the pre-clinical level, is being spurred by collaborations with such noteworthy institutions as the City of Hope, the Roswell Cancer Institute and the University of Pittsburgh.”
About Head and Neck Cancer
Oropharyngeal (upper) head and neck cancer, like cervix cancer, is believed to be caused by persistent HPV infection in people whose immune systems fail to clear the virus. According to the National Cancer Institute (NCI), head and neck cancers represent approximately 3 to 5 percent of all cancers in the United States, with these types of cancers being more common in men. Historically, head and neck cancer has been associated with people over the age of 50, and the use of alcohol and tobacco (including smokeless tobacco). Recently, however, this form of cancer is increasing dramatically in younger people with no history of tobacco use.
About Cancer Research UK
Cancer Research UK is the largest single funder of cancer research in the UK and the world’s largest charity dedicated to cancer research. It funds research on all aspects of cancer, from basic cell biology to large clinical studies of entire populations. The organization funds the work of more than 4,500 scientists, doctors and nurses across the UK and runs specialized institutes dedicated to cancer research. Cancer Research UK currently funds more than 180 clinical trials. Since the early 1980’s, Cancer Research UK has taken over 100 new drugs into clinical trials with more than 100,000 patients taking part in trials since 1995. For more information, please visit: cancerresearchuk.org
About the Clinical Sites
The Aintree University Hospitals NHS Foundation Trust was established on August 1, 2006 as a public benefit corporation authorized under the National Health Service Act 2006. It is a large, complex organization providing acute healthcare to a population of 330,000 in North Merseyside and surrounding areas. The immediate catchment covers some 33 square miles, which is largely urban with significant areas of commerce including docklands. The Aintree University Hospitals NHS Foundation Trust provides acute hospital services to the residents of South Sefton, North Liverpool and Kirkby. It is also a teaching hospital for the University of Liverpool and a tertiary centre providing specialist services to a much wider population of around 1.5 million in Merseyside, Cheshire, South Lancashire and North Wales. The population served by Aintree includes some of the most socially deprived communities in the country, with high levels of illness creating a high demand for hospital-based care. For more information, please visit: aintreehospitals.nhs.uk.
The Royal Marsden NHS Foundation Trust was the first hospital in the world dedicated to the study and treatment of cancer. It was founded as the Free Cancer Hospital in 1851 by Dr. William Marsden to classify tumors, research the causes of cancer, and to find new treatments. In 1991 the Royal Marsden became the first NHS hospital to be awarded the Queen’s Award for Technology for its work on drug development. The hospital achieved the international quality standard ISO 9001 for radiotherapy in 1996 and for chemotherapy in 2003. It was recognized as one of six (6) centers of excellence in the Government’s NHS Plan and has achieved four national Charter Marks for all its services, the most recent awarded in 2005. In April 2004, the hospital became one of the country’s first NHS Foundation Trusts. This new status has provided the financial freedom and greater flexibility to focus on allowing more patients to access the hospital's expertise. For more information, please visit: royalmarsden.nhs.uk.
Cardiff Hospital (University of Wales) is part of the Cardiff and Vale NHS Trust and provides day-to-day health services to a population of around 500,000 people living in Cardiff and the Vale of Glamorgan who need hospital treatment, mental health care, care for elderly people and children as well as a growing range of community-based services, including specialist dental services, and new therapies as alternatives to hospital admission. Patients also attend from across Wales for a range of specialist services, for which the Cardiff and Vale NHS Trust is regarded as a centre of excellence, including pediatric, renal, cardiac, neurological services and bone marrow transplantation. For more information, please visit: cardiffandvale.wales.nhs.uk.
