National Cancer Institute Stops Gene-based Clinical Trials – Part 2

Last week we discussed the National Cancer Institute’s suspension of three ongoing clinical trails using genomic platforms to select therapies for cancer patients. This week, we seek to answer the question: What went wrong?

The simple answer is that cancer isn’t simple.

Cancer dynamics are not linear. Cancer biology does not conform to the dictates of molecular biologists. Once again, we are forced to confront the realization that genotype does not equal phenotype.

In a nutshell, cancer cells utilize cross talk and redundancy to circumvent therapies. They back up, zig-zag and move in reverse, regardless of what the sign posts say. Using genomic signatures to predict response is like saying that Dr. Seuss and Shakespeare are truly the same because they use the same words. The building blocks of human biology are carefully construed into the complexities that we recognize as human beings. However appealing gene profiling may appear to those engaged in this field (such as Response Genetics, Caris, the group from Duke and many others) it will be years, perhaps decades, before these profiles can approximate the vagaries of human cancer.

Functional analyses like the EVA-PCD platform, which measure biological signals rather than DNA indicators, will continue to provide clinically validated information and play an important role in cancer drug selection. The data that support functional analyses is demonstrably greater and more compelling than any data currently generated from DNA analyses.

About Dr. Robert A. Nagourney
Dr. Nagourney received his undergraduate degree in chemistry from Boston University and his doctor of medicine at McGill University in Montreal, where he was a University Scholar. After a residency in internal medicine at the University of California, Irvine, he went on to complete fellowship training in medical oncology at Georgetown University, as well as in hematology at the Scripps Institute in La Jolla. During his fellowship at Georgetown University, Dr. Nagourney confronted aggressive malignancies for which the standard therapies remained mostly ineffective. No matter what he did, all of his patients died. While he found this “standard of care” to be unacceptable, it inspired him to return to the laboratory where he eventually developed “personalized cancer therapy.” In 1986, Dr. Nagourney, along with colleague Larry Weisenthal, MD, PhD, received a Phase I grant from a federally funded program and launched Oncotech, Inc. They began conducting experiments to prove that human tumors resistant to chemotherapeutics could be re-sensitized by pre-incubation with calcium channel blockers, glutathione depletors and protein kinase C inhibitors. The original research was a success. Oncotech grew with financial backing from investors who ultimately changed the direction of the company’s research. The changes proved untenable to Dr. Nagourney and in 1991, he left the company he co-founded. He then returned to the laboratory, and developed the Ex-vivo Analysis - Programmed Cell Death ® (EVA-PCD) test to identify the treatments that would induce programmed cell death, or “apoptosis.” He soon took a position as Director of Experimental Therapeutics at the Cancer Institute of Long Beach Memorial Medical Center. His primary research project during this time was chronic lymphocytic leukemia. He remained in this position until the basic research program funding was cut, at which time he founded Rational Therapeutics in 1995. It is here where the EVA-PCD test is used to identity the drug, combinations of drugs or targeted therapies that will kill a patient's tumor - thus providing patients with truly personalized cancer treatment plans. With the desire to change how cancer care is delivered, he became Medical Director of the Todd Cancer Institute at Long Beach Memorial in 2003. In 2008, he returned to Rational Therapeutics full time to rededicate his time and expertise to expand the research opportunities available through the laboratory. He is a frequently invited lecturer for numerous professional organizations and universities, and has served as a reviewer and on the editorial boards of several journals including Clinical Cancer Research, British Journal of Cancer, Gynecologic Oncology, Cancer Research and the Journal of Medicinal Food.

One Response to National Cancer Institute Stops Gene-based Clinical Trials – Part 2

  1. [A comment posting by a Mike on the Medical News Today on Article Opinions in relation to Dr. Anil Potti Resigns From Duke University Amid Study Reliability Concerns.]

    I have never been in a lab either. However, my sister was one of the first patients admitted to this study. She received a phone call from one of the Doctors in the program three nights ago apologizing for the news about Dr. Potti. The next day, we found out that the issue started last July. She never received an official notification from Duke, even though she has continued to be seen and treated there since July. I find it hard to believe that Dr. Potti credentials were not checked regardless of what the Duke President says. My sister and I both worked at Duke University for quite a while. Our Father retired from Duke University.

    No one in my family could ever afford to attend Duke University, but, we did contribute to the well being of the faculty , staff and students. My sister is devastated because of this mess. I believe that if any of you had a family member or friend go through this, you might look at it differently.

    Technically, I do not care about peer reviews, papers published, lab protocols, face value acceptance of resumes, or, passing the buck.

    What I do expect is that an institution such as Duke needs to step up. I have seen a ton of inter-net stories and after the fact comments concerning this issue with Doctor Potti, Duke University, Eli Lilly, Glaxosmithkline, (Dr. Potti received thousands of dollars numerous times to speak at functions held by these pharmaceutical companies on this genome project) in the last few days. The fingers are pointing everywhere.

    Yes, this could eventually affect the University, the Potti backers, the Federal grant money applied to the project, reputations of both the University and it’s administration. I know from personal experience that 99.9% of the general employees and mid-management staff do a great job. Most of them care deeply about providing the best service possible to the public, students and faculty of the University.

    The sad part is that no one has reached out to the patients that are ultimately the most affected people of all. I do not have great assets or influence. I will however do everything in my power to ensure that ultimately someone at Duke is held responsible, and, that all of the patients that were boondoggled by this idiot are not forgotten.

    My sister was under the impression until a few days ago that she was fortunate to be included in this study, that her cancer was being aggressively treated based on the hype that the University and it’s staff had given her. She has been in this program since the beginning. My sister has been fighting cancer for about six years total, had surgeries, chemo and everything else prescribed to her based on erroneous data. Cancer is a terrible disease and fighting it is hard enough. Add to that the emotional ups and downs that go with it, she did not need this to add to her struggle.

    Although I was not educated at Duke, I did receive education on the treatment of people. Duke University, this is totally unsatisfactory.

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