May 25, 2011
The National Institutes of Health (NIH) today announced an agreement with two non-profit organizations to accelerate the development of potential clinical therapies for rare blood cancers.
The Cooperative Research and Development Agreement (CRADA) has been established as a shared commitment to move therapies for rare blood cancers into clinical proof-of-concept studies so that promising treatments can eventually be commercialized. The agreement is among the University of Kansas Medical Center, The Leukemia & Lymphoma Society (LLS), the NIH Therapeutics for Rare and Neglected Diseases (TRND) program and the Hematology Branch within the National Heart, Lung and Blood Institute.
"The goal of this collaboration, called The Learning Collaborative (TLC) is to bridge the gap in time and resources that often exists between basic research and human testing of potential new treatments and accelerate and make more efficient the delivery of improved therapies to patients with rare blood cancers," said Christopher P. Austin, MD, director of the TRND program, currently administered by the National Human Genome Research Institute, a part of NIH. "As a result of our work, as the TLC name implies, we plan to learn more about and improve the drug development process for all diseases."
"This agreement recognizes that academic, philanthropic and patient organizations have a role - and a responsibility - to be active leaders in the drug discovery process," added Roy A. Jensen, MD, director of The University of Kansas Cancer Center. "I hope this agreement can serve as a model to other academic and patient communities."
Scott Weir, PharmD, PhD, director of the Institute for Advancing Medical Innovation (IAMI), said the partnership is another indication that the University of Kansas is defining the new role of academia in drug discovery and development.
"Through creative, high performance collaborations with industry, government, academia and disease philanthropy organizations, we've been able to rapidly advance these promising drug therapies to patients. For example, over the past two years we will have advanced six promising new cancer drug therapies to patients at the University of Kansas," Weir said. "Our focus on collaboration and bench-to-bedside translation was a key factor in the NIH choosing us for this venture."
"The establishment of collaborations like TLC is the reason the Kauffman Foundation funded the Institute for Advancing Medical Innovation," added Lesa Mitchell, vice president of innovation at the Ewing Marion Kauffman Foundation. "The TLC is exciting news for any researcher, philanthropy or pharmaceutical company seeking faster pathways to cures."
The new collaboration's first project focuses on further development of an existing small molecule drug used to treat arthritis called auranofin. Auranofin will be evaluated as a treatment for relapsed chronic lymphocytic leukemia (CLL) - one of the four major types of leukemia and one that typically affects older people. The goal is to accelerate the development of this drug and complete preclinical through clinical trial studies within two years, at which time an industry partner will be engaged.
Approximately 15,000 people in the United States receive a diagnosis of CLL each year. CLL is currently treated with various chemotherapies, but patients eventually reach a stage where they become resistant to this treatment and can die as a result. In addition, chemotherapy can be quite toxic, whereas auranofin has received regulatory approval and was demonstrated to be reasonably safe and effective in the treatment of arthritis.
"Development of new therapies for diseases like the blood cancers poses both scientific and economic challenges," said Dr. Louis J. DeGennaro, PhD, executive vice president and chief mission officer, LLS. "Partnerships are the key to addressing this significant unmet medical need and LLS is proud to add our expertise to this collaboration."
The state of Kansas is also hailing the new partnership. Kansas Lieutenant Governor Jeff Colyer , MD, said the announcement was great news for those who are have a vested interest in the University of Kansas Medical Center and for those fighting rare diseases across the state, country and world.
"Just yesterday, the Governor hosted more than 150 area leaders at a life sciences summit at KU Medical Center, where we discussed the powerful potential that exists within the corridors of academic medicine and the importance of strengthening partnerships to achieve excellence," Colyer said. "This unique collaboration is an excellent example of just such a partnership. We are very proud of this accomplishment and encouraged about its potential."