IRVING, Texas and PHOENIX, April 20, 2009 (GLOBE NEWSWIRE) -- Clinical study results released today at the 100th Annual Meeting of the American Association for Cancer Research (AACR) in Denver, CO, indicated that the molecular profiling of patients through the Caris Diagnostics' (Caris Dx) Target Now(tm) molecular profiling analysis identifies individual genetic profiles that often drive more informed and effective personalized treatment options. The findings provide early validation for the application of therapy selection through molecular profiling, resulting in improved patient care and enhanced outcomes.
The research trial was funded through the Scottsdale Healthcare Foundation with a grant from the The Stardust Foundation and led by Dr. Daniel Von Hoff M.D., Senior Investigator and Chief Scientific Officer of TGen Clinical Research Services (TCRS) at Scottsdale Healthcare and consultant for the Tissue Banking and Analysis Center (TBAC), a research subsidiary of Caris Dx. TCRS is a partnership between TGen and Scottsdale Healthcare that is administered by the Scottsdale Clinical Research Institute (SCRI) at Scottsdale Healthcare Shea Medical Center.
Von Hoff and his clinical colleagues utilized Target Now(tm) to profile patients with late-stage cancer. All patients in the study had previously experienced growth of their tumors while undergoing anywhere from two to thirteen previous cancer treatments, including standard guideline chemotherapies.
David D. Halbert, Chairman and CEO of Caris Dx, commented, "We were honored to work with Scottsdale Healthcare and TGen in this important clinical trial, and pleased that Target Now played an instrumental role in identifying the biological markers that drove more targeted therapeutic options and improved outcomes. The collaborative effort highlights the very real potential of personalized medicine, as the targeted treatment options derived from Target Now's molecular data resulted in a number of patients experiencing significant periods of time when there was no progression of their disease and, in some cases, diminished tumor size.
"Going forward, we are committing extraordinary resources to biomarker development and evaluation. As this database grows over time so, too, will Target Now's ability to yield molecular and genetic data that growing numbers of physicians and patients can utilize to select more efficacious, targeted treatment options that improve outcomes and lower payer costs."
Dr. Von Hoff added, "This clinical trial provided early evidence of the clinical value of personalized medicine, as the type of drugs, dosages, their delivery and other treatment aspects were based on each patient's individual medical needs. By identifying the unique molecular markers that drive therapy options in the trial, Target Now played a key role in the trial's success and I am optimistic about its applicability going forward as levels of evidence continue to evolve."
Clinical Trial Results and Target Now Overview
Patients in this study experienced varying levels of improvement. Specifically, among patients with breast cancer, the period of progression-free survival increased for 44 percent of patients; for colorectal the improvement was seen for 38 percent of patients; for ovarian the improvement was seen in 20 percent of patients; and for miscellaneous cancers the improvement was seen in 16 percent of patients.
These results are just the first in a series of studies in further support of Target Now, a commercially available oncology testing service, offered exclusively through Caris Dx. Target Now utilizes cutting-edge molecular profiling techniques, including DNA microarray, immunohistochemical (IHC) analysis, fluorescent in-situ hybridization (FISH) and DNA sequencing to provide individualized molecular information about a patient's tumor as an aid to the treating oncologist.
Dr. David Loesch, M.D., Director of Oncology, Clinical Trials & Services for Caris Dx, commented, "These clinical trial results are exciting, because they prove how useful this molecular information is in helping physicians select potential treatment regimens for cancer patients with resistant cancer. Target Now is designed with one goal in mind: to get more information into the oncologists' hands so they can continue to provide the best management for their patients."
The engine behind the Target Now program is a robust evidence-based literature review process driven by a Caris Biomarker Review Team. The systematic and dynamic nature of the process ensures that only the most relevant and appropriate biomarkers are introduced into Target Now and appropriately analyzed, while continuously evolving Target Now with the latest biomarker research. In essence, the selection of tests is customized to each patient's specific needs and clinical situation.
Furthermore, Caris Dx is in the process of developing a Target Now patient registry. The registry captures the experiences and results of molecularly targeted therapy in the community and makes it available to treating oncologists so that future therapy strategies can be improved. Caris anticipates this patient registry will also serve as a vehicle for their physicians to data-mine and develop prospective clinically relevant research publications and posters.
The Target Now testing service is available exclusively from Caris Dx at www.carisdx.com or www.targetnow.com.
About Caris Diagnostics
Caris Diagnostics (Caris Dx) is a leading provider of the highest quality diagnostic, translational development and pharmaceutical services encompassing anatomic pathology and proprietary molecular testing. Caris Diagnostics provides world-class pathology services to physicians who treat patients in the community setting. The company provides academic-caliber medical consults through its industry-leading team of subspecialty fellowship and expert-trained pathologists in gastrointestinal and liver pathology, dermatopathology and hematopathology. Caris Diagnostics provides the highest levels of service to its customers and their patients through its state-of-the-art laboratories; proprietary, advanced clinical and technology solutions; and rigorous quality assurance programs. The company also offers advanced molecular analyses of patient samples through prognostic testing services and genomic and proteomic profiling to provide critical information to physicians treating cancer and other complex diseases. In addition, Caris MPI supports pharmaceutical companies and other researchers in their clinical trials for targeted therapeutics with custom genomic and proteomic analyses, analyte preservation, tissue procurement and comprehensive reporting services. The company has strategic relationships with the International Genomics Consortium, US Oncology, the Translational Genomics Research Institute, and the Biodesign Institute of Arizona State University. More than 2,000 physicians nationally use Caris Diagnostics. Formed in 1996, the company is headquartered in Irving, Texas and operates four laboratories: Irving, Texas; Phoenix, Arizona (2 sites); Newton, Massachusetts. Additional information is available at www.carisdx.com.
About TGen
The Translational Genomics Research Institute (TGen) is a non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process.
About Scottsdale Healthcare
Scottsdale Healthcare is the not-for-profit parent organization of the Scottsdale Healthcare Shea, Scottsdale Healthcare Osborn and Scottsdale Healthcare Thompson Peak hospitals, Virginia G. Piper Cancer Center, Scottsdale Clinical Research Institute, TGen Clinical Research Services at Scottsdale Healthcare and Scottsdale Healthcare Foundation. Scottsdale Healthcare is a primary clinical research site for TGen. TCRS at Scottsdale Healthcare is housed in the Virginia G. Piper Cancer Center at Scottsdale Healthcare, located at the Scottsdale Healthcare Shea Medical Campus. For additional information, visit www.shc.org.
About Scottsdale Clinical Research Institute (SCRI)
SCRI, established in 2005, provides infrastructure and support for the clinical research at Scottsdale Healthcare. Start-up funding for SCRI was provided by a lead gift of $4.5 million from the Virginia G. Piper Charitable Trust in 2005. An additional $5 million was provided by the Stardust Foundation to support this multi-site molecular profiling study of targeted therapies for treatment refractory cancers coordinated by SCRI. A defining feature of SCRI is a focus on genomics and personalized medicine as well as clinical and translational research. The basic science arm of SCRI is provided by a partnership with the Translational Genomics Research Institute (TGen). Innovations from TGen's laboratory are taken to the bedside at SHC by our joint clinical research program, TGen Clinical Research Services (TCRS) at Scottsdale Healthcare. Additional research collaborations include the University of Arizona, Arizona State University, other local health care delivery systems and participation in the Arizona NIH Clinical and Translational Science Award (CTSA) program initiative. Areas of study at SCRI include Cancer, Cardiovascular, Trauma, Metabolic and Nanomedicine.