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    Posted June 12, 2014 by

    Paradigm Oncology Founder James Cullem Previews New Drugs in Development for Glioblastoma Multiforme Patients

    Glioblastoma multiforme (GBM), according to biotech entrepreneur James Cullem, is a the most common form of primary adult brain cancer, which affects the lives of hundreds of thousands of people around the world. Essentially incurable and hard to treatable, this disease has been noted for its aggressive characteristics and terminal nature.

    James Cullem points out that the late Senator Edward Kennedy is among the most high-profile cases of glioblastoma. Below, James Cullem describes the efforts of his startup company, Paradigm Oncology, to bring the promise of personalized medicine to to this devastating disease by developing and commercializing a first-in-kind predictive diagnostic to aid neuro-oncologists in determining potential therapy options for GBM patients on a patient-by-patient basis.

    Q: At this stage, what are the possible treatments for glioblastoma?

    James Cullem: The only approved, front-line drug at this stage for treating new cases of glioblastoma is a chemotherapeutic (Temozolomide/Temodar®) designed to cause the death of GBM cancer cells. This drug is given to essentially all new GBM patients as part of the Standard of Care for this disease, despite the fact that it is largely ineffective in the vast majority of patients.

    Q: How does this chemotherapeutic agent act in the human body?

    James Cullem: It is an alkylating chemotherapeutic that creates damage in the DNA of GBM cancer cells. Unfortunately, DNA damage repair mechanisms active in the glioblastoma multiforme cells undo most if not all of this damage, which is why the drug does not create lasting benefit in most GBM patients.

    Q: How can Paradigm Oncology serve as a powerful force in the treatment of this horrible disease?

    James Cullem: The promise of personalized medicine -- namely, giving the right drug to the right patient at the right time, based on that patient’s specific tumor biology -- has not yet come to GBM patients. Accordingly, the Standard of Care for this aggressive disease remains largely unimproved over the past 15 years. There are currently a number of more modern “targeted” inhibitors in clinical trials for GBM. These drugs will only be effective in GBM tumors that are being driven by the enzyme target of those drugs. Accordingly, there is a tremendous need for new, “predictive” diagnostic tests designed to identify such tumor-drivers, in order to enable the move towards more highly-targeted, patient-specific alternative therapy options (including access to promising drugs undergoing clinical trials).

    Q: Where is Paradigm Oncology currently based?

    James Cullem: Paradigm Oncology is currently a virtual start-up, based on the edges of the Boston, Massachusetts life sciences hub.

    Q: Are current company efforts confined to the state of Massachusetts?

    James Cullem: Since our goal is to present a cutting edge, predictive diagnostic test to GBM patients globally, we collaborate with researchers and physicians from around the world.

    Q: I understand this is an important issue for you...

    James Cullem: Yes, unfortunately it is. My mother-in-law passed away about a decade ago after a brave, but sadly short, fight against glioblastoma. From that time until the present, I have been motivated to be a part of improving the diagnosis and treatment of this terrible cancer.

    Q: What specific projects are currently in the works at your company?

    James Cullem: Paradigm Oncology is in the process of developing a tumor-profiling test specific to glioblastoma multiforme. Our work (and company) is based on the important research of our Co-Founder, Dr. Robert W. Sobol, Jr., Ph.D., at the University of Pittsburgh, who is one of the foremost researchers in DNA damage repair mechanisms in GBM. We are currently seeking to establish pilot projects with a number of companies that are developing PARP inhibitors, a promising targeted therapy to which our test is highly relevant.

    Q: When would the proposed test be administered to patients?

    James Cullem: Since our diagnostic test is intended to help guide potential therapy options, it would be performed right after the diagnosis of the disease and the standard surgery to remove the tumor, and before the first round of chemotherapy.

    Q: What valuable information is the test expected to offer?

    James Cullem: The purpose and value of the test is to help predict which GBM patients are likely to respond to various therapy options (including PARP inhibitors, currently in clinical trials) and to avoid simply defaulting to the current chemotherapy treatment, which is often ineffective. Thus, the proposed test would help personalize treatment options for these patients and help inform treatment alternatives for their treating neuro-oncologists.

    Q: Besides yourself, what other industry experts have proven crucial in advancing the company’s important cause?

    James Cullem: In addition to our Co-Founder and expert, Dr. Robert Sobol, we have assembled an Advisory Team that consisting of some of the most highly regarded experts in the fields of neurobiology and glioblastoma. This team includes Drs. Darell Bigner, M.D., Ph.D. and Henry Friedman, M.D. (both of the Tisch Brain Tumor Center at Duke University) and Dr. David Reardon, M.D. (of the Center for Neuro-Oncology at the Dana Farber Cancer Institute).

    A serial biotechnology entrepreneur and executive, James Cullem has brought his vision, leadership, and passion for personalized medicine to a number of startups and early stage companies. Please visit aboutjamescullem.com for more information about James Cullem.
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