Context of vulnerability provides the genetic rationale for a targeted therapy
Phoenix, AZ (PRWEB) February 17, 2009
Today, Medelis, Inc., a global oncology contract research organization, has published a free new downloadable abstract, "Context of Vulnerability: A Powerful New Paradigm for Targeted Drug Development." In this extensive interview, renowned oncology investigator Daniel D. Von Hoff, M.D., a founder of Medelis and a member the National Cancer Advisory Board, advocates for this powerful new drug development paradigm that is generating impressive results in the war on pancreatic cancer, the most deadly of all cancers.
"People say we have lost the war on cancer and it is so discouraging to the people who deliver the care every day, the people who are seeing those curves turn around," laments Dr. Von Hoff. "The fact is that the rising tide of cancer deaths hasn't just been stemmed - it's been turned around. Mortality, in terms of absolute number of deaths, has been down for two years in a row. It should have been going up like a rocket because we're all aging."
Dr. Von Hoff's team believes a new approach for targeted drug development, "context of vulnerability," is the key to developing powerful targeted therapeutics. The term, coined by TGen's Spryo Mousses, Ph.D., refers to the genetic configuration in a patient's tumor that makes it susceptible to a specific drug. "Context of vulnerability provides the genetic rationale for a targeted therapy," Dr. Von Hoff explains.
"If you let context of vulnerability guide drug development, you would put only those patients who have the appropriate susceptibility to the drug on trial," he says. "This optimizes your chance of seeing efficacy with a much smaller n. It's essentially how Herceptin® got approved with an n of 480. If they hadn't pre-selected patients for the context of vulnerability, estimates say that it would have taken about 23,000 patients to get the drug approved."
In the abstract, Dr. Von Hoff provides a detailed look at the promise and potential of this approach::
1. How to establish a patient's context of vulnerability;
2. How using context of vulnerability to guide drug development can improve your chance of seeing efficacy with a much smaller n;
3. Incorporating context of vulnerability as the oncologist's "sixth vital sign;"
4. A case study of context of vulnerability in use and how it improves patient care and new agent development;
5. The gap between known contexts of vulnerability and available therapeutics;
6. How CMOs can flip their drug development planning to leverage this approach;
7. Feedback from the FDA, national and international groups;
8. The promise and potential of this approach.
ABOUT DR. VON HOFF
A member of President Bush's National Cancer Advisory Board, Dr. Von Hoff's major interest is in the development of new anticancer agents both in the clinic and in the laboratory. His laboratory interests and contributions have been in the area of in vitro drug sensitivity testing to individualize treatment for the patient. At present, he and his colleagues are concentrating on the development of molecularly targeted therapies with a focus on pancreatic cancer.
Dr. Von Hoff currently serves as Senior Investigator and Head of Translational Research at the Translational Genomics Research Institute's (TGen) Translational Drug Development Division and Head, Pancreatic Cancer Research Program in Phoenix, Arizona. He also serves as Chief Scientific Officer for U.S. Oncology and the Scottsdale Clinical Research Institute and is a founding shareholder and chair of the medical advisory board of Medelis.
ABOUT "INSIDER ABSTRACTS"
The abstract is the fifth in Medelis' complimentary "Peer Perspectives in Oncology" Q&A series, which brings together respected researchers to discuss issues that face Chief Medical Officers today.
These free abstracts are available for download at Medelis.com.
Medelis, Inc. is an oncology contract research organization providing a total solution for biotechnology and pharmaceutical companies seeking rapid drug development and approval. Medelis' medical founders, clinical trial management physicians and advisory board members, including Dan Von Hoff, James Gourzis and Michael Gordon, are internationally-recognized oncology thought and opinion leaders who understand the future of personalized medicine and threshold of credibility trials. Offerings include strategic plans for regulatory approval from phase I through NDA and complete oncology clinical trial design, management and execution.
Medelis is privately-held and located in Phoenix, Arizona with other U.S. locations in Nashville, Boston and Reno. Medelis Europe, which also delivers complete oncology drug development services from preclinical through marketing approval, is headquartered in Port Vendres, France.