WHAT IS GBM?
Glioblastoma multiforme (GBM) is the most common, aggressive, and lethal adult brain cancer, and is currently largely untreatable. This terrible disease, which affects 75,000 new patients worldwide each year (and took the life of the late Senator Edward Kennedy) is almost 100% fatal within 2 years of diagnosis, and many patients do not survive beyond 6 months from diagnosis.
WHAT TREATMENT IS AVAILABLE?
At present, the only approved drug for treating newly-diagnosed GBM is a chemotherapeutic that creates DNA damage leading to cancer cell death. Unfortunately, the benefit of this drug is short-lived, because DNA damage repair mechanisms -- that are overactive in GBM cells -- undue and repair the damage created by the drug.
HOW CAN WE IMPROVE THE ODDS?
There is a pressing, unmet need for better diagnostic tests to help identify and predict which GBM patients may most benefit from alternative therapy options, including combination therapy with chemotherapeutic plus DNA damage repair inhibition, and highly targeted inhibitors in clinical trials for GBM.
PARADIGM ONCOLOGY (Danvers, MA) is a start-up cancer diagnostics company dedicated to Bringing the Promise of Personalized Medicine to GBM patients. We are developing a first-in-class and first-in-kind, GBM-specific tumor-profiling test to help inform treatment options and decision-making for GBM patients and their treating neuro-oncologists. Our predictive diagnostic test is based, in part, on a pair of novel biomarkers that we have exclusively licensed. It will be offered to patients and their physicians at the time of GBM diagnosis and prior to chemotherapy in order to provide valuable information about the molecular mechanisms of each patient's particular tumor as early as possible, to help guide subsequent patient care. Our experienced leadership team is complemented by a world-class advisory board, including some of the most respected GBM experts working at the forefront of GBM tumor biology and therapy.
James G. Cullem, J.D., B.S.
Co-Founder, Chief Executive Officer
James is a career life sciences entrepreneur and executive who brings 20+ years of diverse experience in the creation, management, and growth of early-stage companies. He brings particular expertise in the proteomics and cancer biomarker/diagnostics sectors. James formerly served as co-Founder and Chief Executive Officer of Halcyon Diagnostics, a cancer diagnostics start-up focused on tumor-profiling for refractory cancer patients. He also formerly served as Director of Corporate Development and General Counsel at Enzymatics, Inc. (genomics sector) and as Director of Intellectual Property & Licensing, and Chief Counsel, at Cell Signaling Technology, Inc. (proteomics sector). Earlier in his career, he was a bench researcher in diagnostics at both Chiron Corporation (now Novartis Diagnostics) and the J. David Gladstone Institute of Immunology & Virology. He is registered patent attorney and holds a Juris Doctorate degree from the Franklin Pierce Law Center (now part of University of New Hampshire law school) and a Bachelor of Science degree in Biochemistry from the University of California, at Davis. He is passionate about, and committed to, improving glioblastoma treatment options and patient care, having lost his mother-in-law to the disease.
Dr. Robert W. Sobol, Ph.D.
Co-Founder, Senior Scientific Advisor
Rob is a leading expert in DNA damage repair mechanism in cancer, including the base excision repair (BER) pathway, with emphasis on glioblastoma. His research focuses on the mechanisms and biomarkers of drug resistance in glioblastoma, including PARP inhibitors and alkylating chemotherapies, and novel approaches to enhance the efficacy of these drugs. Rob is an Associate Professor at the Departments of Pharmacology & Chemical Biology, and Human Genetics, University of Pittsburgh, where he is also associated with the Hillman Cancer Center. He also serves as Director of the University of Pittsburgh Cancer Institute Lentiviral Facility and Co-Director of its Vector Core Facility. Rob holds a Doctorate degree in Biochemistry from Temple University Medical School, and served as a Postdoctoral Fellow at the Laboratorie Biochemie Protines, University of Montpellier II, France. Rob also holds a Bachelor of Science degree in Chemistry from Temple University.
Our Advisory Team
Dr. Henry S. Friedman, M.D.
Dr. Friedman is an internationally renowned neuro-oncologist and leading glioblastoma expert. He co-founded and manages the world's largest brain tumor research center, The Preston Robert Tisch Brain Tumor Center at Duke University. At Duke, he is the James B. Powell, Jr., Professor of Neuro-Oncology; Professor of Pediatrics; and Assistant Professor of Pathology. Dr. Friedman has proven experience in drug development working with leaders in the pharmaceutical industry, Food and Drug Administration, National Cancer Institute and advocacy groups. He is considered one of the leading authorities on brain tumors in the world and has published extensively. He has reviewed grants for the National Institutes of Health for over 15 years in a spectrum of different study sections.
He is the senior editor of CNS Oncology, the Associate Editor for the Neuro-Oncology Section of Cancer and is a reviewer for over 25 academic journals. Dr. Friedman serves on the advisory board of a number of organizations including Voices Against Brain Cancer, the Tug McGraw Foundation, Pinnacle Care, the Pediatric Brain Tumor Foundation, the National Children's Cancer Society and the Association for Brain Tumor Research. He has received a number of awards for his work including the Visionary Award from the Tug McGraw Foundation and the Gary Lichtenstein Humanitarian Award from the Voices Against Brain Cancer Foundation. He is a member of the American Society of Clinical Investigation.
Dr. Darell D. Bigner, M.D., Ph.D.
is an internationally renowned neuro- pathologist and leading expert in the glioblastoma field. He is the Edwin L. Jones, Jr. and Lucille Finch Jones Cancer Research Professor; Director of the Preston Robert Tisch Brain Tumor Center at Duke, and Director of the Pediatric Brain Tumor Foundation Institute at Duke. Dr. Bigner is also Co-Leader of the Duke Cancer Institute's Neuro-Oncology Program; Vice Chairman of Basic Science and Investigative Pathology; Director of the Preuss Laboratory for Brain Tumor Research; and Chairman of the Scientific Review Board of the National Cancer Foundation, the Pediatric Brain Tumor Foundation, and the Southeastern Brain Tumor Foundation. He is considered one of the leading authorities on brain tumors in the world and has published extensively, and was the Founding Editor of the prominent journal Neuro-Oncology. His laboratory is the lead laboratory in Duke's Neuro-Oncology Program, and the goals of his laboratory are to study basic mechanisms of neoplastic transformation and mechanisms of altered growth control in malignant brain tumors and tumors that metastasize to the brain and spinal cord. Dr. Bigner has recently been awarded his third consecutive MERIT award by the National Cancer Institute (NCI), a highly selective award, presented by the National Institutes of Health, that recognizes superior researchers who have demonstrated outstanding competence and productivity in research endeavors. His MERIT award is now in its 41st year and is the longest continually funded individual research grant of the NCI's Division of Cancer Diagnosis and Treatment.
David A. Reardon, M.D.
Dr. Reardon currently serves as Clinical Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute, and is an Associate Professor of Medical Oncology at Harvard Medical School. He is an active clinical researcher with special interests in the design and implementation of clinical trials for neuro-oncology and the preclinical evaluation of promising therapeutics for central nervous system tumor patients. His work includes using innovative clinical therapeutic agents to improve the cure rates in patients with brain and spinal tumors, with particular focus on the use of novel “tumor-targeting” therapeutics, including anti-angiogenesis agents for patients with primary brain tumors, such as glioblastoma. Prior to joining the Dana-Farber Cancer Institute, Dr. Reardon served as Associate Deputy Director of The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center. In 2007, Dr. Reardon was the recipient of the R. Wayne Rundles Award for Excellence in Cancer Research, which is awarded annually to a Duke investigator whose research has made an important contribution to the detection, treatment, or prevention of cancer. He is also actively involved in clinical trials using immunotherapy, cytotoxins, and convection-enhanced delivery. Dr. Reardon has co-authored over 150 peer-reviewed manuscripts focused on neuro-oncology and 15 additional articles and book chapters, and also co-edited a recent neuro-oncology textbook.
is a diagnostic marketing expert having more than 20 years of commercial experience in the In Vitro Diagnostics space. In 1998, she launched the first companion diagnostic, HercepTest®, to identify patients with end stage breast cancer most likely to benefit from the breakthrough therapy, Herceptin. After several successful products launches in the companion diagnostic arena, Ms. Townsend, founded Market Ready Rx in 2006 to serve clients in the evolving personalized medicine space. She has held management positions at Siemens (previously Chiron Diagnostics) and Dako, leading teams in complex commercial launches requiring a coordinated launch of both the diagnostic and the pharmaceutical products. With a specialty in personalized companion diagnostics, Ms. Townsend has supported organizations in both planning go-to-market strategies and executing a successful commercial launch. At Market Ready Rx, Ms. Townsend successfully supports In Vitro Diagnostic product companies and Commercial Reference Labs in planning and implementing commercial launches of novel breakthrough diagnostics. Market Ready Rx capabilities include market strategic planning, business development and commercial launch programs for success in the diagnostic marketplace. She has previously been named Startup Woman of the Year by Women's Economic Ventures. Ms. Townsend holds a BS in Biology from Loyola Marymount University of Los Angeles, CA and a certificate in Medical Marketing from UCLA Anderson School of Business.
Glioblastoma multiforme (GBM) is a complex cancer, which is very difficult to treat because the tumor penetrates into the brain and is hard to physically access, and because, at the molecular level, the tumor has multiple, different cell sub- populations that respond differently to therapy (hence "multiforme" or "multiple forms"). GBM is the third leading cause of cancer death among those 20-29 years of age.
Currently, the front-line standard of care for treating GBM is (i) surgery, plus (ii) radiation therapy, and (iii) chemotherapy, which may be given together with radiation therapy. The chemotherapeutic drug, temozolomide (Temodar®) is the only currently available front-line drug to treat GBM. A second-line approved therapy, Avastin® (a targeted drug that inhibits Vascular Endothelial Growth Factor Receptor (VEGFR)), which is a key enzyme involved in angiogenesis (new blood supply formation crucial to tumor growth), is available for recurrent GBM, but does not offer lasting benefit as tumors rapidly develop resistance to this drug.
It is known that many GBM patients do not have a lasting response to the front- line chemotherapeutic treatment because the DNA damage that the drug causes in cancer cells (leading to cell death) is undone and repaired by DNA damage repair mechanisms that over-activated in those cancer cells. A new and promising class of cancer drugs that work by inhibiting those DNA repair mechanisms are currently in clinical trials, and include the well-known PARP inhibitors.
PARADIGM ONCOLOGY 's planned diagnostic test includes patent-pending biomarkers that provide valuable information about whether a particular GBM patient is likely to respond to combination therapy of the chemotherapeutic plus a PARP inhibitor. Our test also provides valuable information about which molecular mechanisms are driving a particular GBM patient's tumor, in order to potentially match the patient to the specific clinical trials of drugs targeting those molecular mechanisms.
For more information, please visit these Wikipedia articles:
To learn more about GBM patient stories and support, see:
The power of "personalized medicine" lies in understanding the molecular mechanisms of a particular patient's tumor, and then tailoring that patient's therapy to drugs most likely to be effective against those mechanisms. PARADIGM ONCOLOGY is committed to Bringing the Promise of Personalized Medicine to Glioblastoma Patients.
February 19, 2013 -- Third renowned neuro-oncologist joins Paradigm Oncology's scientific advisory board. World renowned neuro-oncologist and leading glioblastoma (GBM) expert, Dr. David A Reardon, M.D., Clinical Director of the prestigious Center for Neuro-Oncology at The Dana Farber Cancer Institute, has joined Paradigm Oncology's scientific advisory board.
Feburary 13, 2013 -- Oncology diagnostics commercialization veteran joins Paradigm Oncology advisory team. Martha C. Townsend, a respected expert in the promotion, marketing, and launch of predictive diagnostic tests in the oncology field, has joined Paradigm Oncology's business advisory board. Ms. Townsend is well known for her involvement, while at DAKO, with the commercial launch of HercepTest®.
December 5, 2012 -- Paradigm Oncology files federal grant application to support its test development.
Paradigm Oncology has filed a small business STTR Phase I grant application, with the National Cancer Institute (NCI), to support and advance the development of its first-in-kind glioblastoma (GBM)-specific tumor-profiling diagnostic test to help personalize therapy options for GBM patients.
January 1, 2012 -- World-renown neuro-oncologists join Paradigm Oncology's scientific advisory board.
Leading glioblastoma (GBM) experts and world-renown neuro-oncologists Dr. Henry S. Friedman, M.D., and Dr. Darell D. Bigner, M.D., Ph.D., co-Directors of the prestigious Preston Robert Tisch Brain Tumor Center at Duke University, have joined Paradigm Oncology's scientific advisory board. Dr. Friedman will serve as its Chairman.
If you are a patient, family member, physician, or patient advocate interested in learning more about PARADIGM ONCOLOGY , please email us at: firstname.lastname@example.org
Thank you to all of our generous donors, via indiegogo
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