Patient advocacy group, research community and pharmaceutical companies join forces for new breakthroughs in treatment; clinical trials to begin in 2010
For more than a decade, there have been no new therapies that have improved survival rates for patients with advanced melanoma. Today, at the 6th International Melanoma Congress for the Society for Melanoma Research, the Melanoma Research Foundation (MRF) announced a novel collaboration between the research community and pharmaceutical companies that will pool knowledge and resources to generate new breakthroughs in treatment.
"As a community, we have hit a wall. We are fed up with melanoma patients having so few treatment options to battle their disease. It's time to change course, get creative and accelerate the development of new therapies," said Randy Lomax, chairman of the MRF.
The MRF's research Consortium will bring together 10 major academic centers specializing in melanoma research, and the major pharmaceutical companies with individual therapies that have shown promise in melanoma. This initiative will break down traditional barriers that hinder collaborations between companies and the research community, and will advance the Consortium's common goal for developing new treatments.
"We are not aware of any other disease state that has used a model like this to fuel new research," said Tim Turnham, executive director of the MRF. The Consortium's structure and work will be groundbreaking because of both its collaborative framework and research approach. Research will be geared toward combining multiple investigative drugs, rather than combining approved drugs, or an approved drug with an investigational drug.
"Melanoma is a disease with two faces. It is curable and easy to treat in its early stage, but advanced melanoma is resistant to the therapies that work for other cancers," said Keith Flaherty, M.D., member of the MRF's Scientific Advisory Committee and lead physician for the Consortium. Nearly 69,000 people are expected to be diagnosed in the United States with the disease in 2009, resulting in an estimated 8,650 deaths. The vast majority of melanomas are caught early, when the cancer is easy to treat and cure. However, in its most advanced stages few treatment options exist, and this year, one person will die from this disease every hour.
The Consortium provides a collaborative infrastructure that allows researchers to partner together to conduct laboratory research and clinical trials, and to share data and information. It also creates open avenues of communication between researchers and partner pharmaceutical companies. Expanded access and an increased flow of information will allow researchers to systematically explore various combinations of therapeutic agents -- including those currently being tested in stage II and III clinical trials only as stand-alone therapies -- that would not otherwise be possible.
"For too long we have focused on the discovery of the single drug that will knock the table down by taking out one of four legs," says Dr. Flaherty. "In melanoma, we now have the tools to target enough legs to radically change the treatment of this disease."
For decades, the melanoma research community has focused on single-agent approaches. Interleukin-2 (IL-2) was the last drug approved to treat advanced melanoma, but 85% of patients derive no benefit from this drug. The Consortium approach to research will address the growing recognition that melanoma patients will need combination therapies to meaningfully increase survival. Melanoma's complex molecular make-up means that combinations of treatments may more effectively address the underpinnings of the disease.
"This novel approach opens up many exciting new research avenues and combining pathways may result in a durable solution for patients that does not exist at this point," said Lomax.
The Consortium's approach addresses why some trials have been hamstrung in the past. Academic institutions often do not have the capacity to test investigative drugs without support from pharmaceutical companies, and pharmaceutical companies have not been able to test combination therapies of investigational drugs without support from research and academic institutions. "The Consortium breaks down the barriers to collaboration, and facilitates clinical trials that are otherwise not viable," said Turnham.
The Consortium is coordinated by the Melanoma Research Foundation (MRF), which is committed to accelerating medical research by bringing together the leaders in drug development, laboratory and clinical research for finding effective treatments and eventually a cure for melanoma. The MRF believes this initiative will foster the development of effective treatment options for patients with advanced melanoma. Clinical trials are set to begin in 2010.
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