The Side-Out Foundation, which pairs volleyball enthusiasts with breast cancer researchers, is sponsoring a new clinical trial for up to 25 patients with advanced breast cancer.

TGen Drug Development (TD2) will manage this pilot study for the Side-Out Foundation at two locations: TGen Clinical Research Services (TCRS) at Scottsdale Healthcare in Scottsdale, Ariz.; and Fairfax Northern Virginia Hematology Oncology in Fairfax, Va.

The clinical trial, which began Feb. 15, 2010, follows the Bisgrove Study presented in April 2009 to the American Association for Cancer Research that showed that cancer patients could benefit from treatment based on molecular profiling of their cancer. While the Bisgrove Trial was a broader-based solid tumor cancer study, it showed the potential clinical benefit of a personalized-therapy selection strategy, based on the molecular profiling results.

This trial, currently listed on the National Cancer Institute Clinical Trial Directory, goes a step beyond molecular profiling to introduce mapping proteomic pathways within the tumor tissue so each patient can receive a highly targeted regimen designed to impede their cancer growth.

Caris Life Sciences and George Mason University’s Center for Applied Proteomics and Molecular Medicine are the two principal laboratories that will be applying their independent technical approaches to analyzing the diseased tissue.

Over the next 24 months the Side-Out Study is intended to provide real-time treatment recommendations to physicians treating patients with metastatic breast cancer.

Rick Dunetz, the head volleyball coach of a northern Virginia high school, founded the Side-Out Foundation in 2004 to recognize the struggle of his mother, who had a recurrence of breast cancer.

“Side-Out” in volleyball occurs when one team wins a point while its opponent is serving, thereby regaining serve or control of play. Likewise, in the war against breast cancer, the Side-Out Foundation supports health care professionals in their pursuit of practical solutions for women and men with this dreaded disease, enabling them to regain control of their lives and live them to the fullest.

Through its “Dig Pink®” breast cancer awareness rallies at high schools and colleges across the country last October, Side-Out exceeded its $1 million goal by nearly $500,000.

About TGen Clinical Research Services (TCRS)

TCRS is a partnership of the Translational Genomics Research Institute (TGen) and Scottsdale Healthcare. The partnership allows molecular and genomic discoveries made by TGen and others around the world to reach the patient bedside in the Virginia G. Piper Cancer Center at Scottsdale Healthcare as quickly as possible through clinical trials with agents directed at specific targets in patients’ tumors.

About the Virginia G. Piper Cancer Center at Scottsdale Healthcare

The Virginia G. Piper Cancer Center at Scottsdale Healthcare offers research, diagnosis, treatment, prevention and support in its facilities on the campus of Scottsdale Healthcare Shea Medical Center, attracting patients from across Arizona and the U.S. Groundbreaking cancer research is conducted through its Scottsdale Clinical Research Institute and TGen Clinical Research Service (TCRS), which provide targeted patient-specific therapies and support additional research activities through Scottsdale Healthcare.

About TGen Drug Development (TD2)

TD2 is a wholly owned subsidiary of the Translational Genomics Research Institute (TGen) and is a 501(c) 3 non-profit organization. TD2 provides innovative services for oncology-focused biopharmaceutical companies utilizing a dedicated team of professionals with broad experience and understanding in drug development. TD2 is uniquely positioned to support the need for improved and accelerated development of new chemical entities (NCE’s) for life-threatening diseases. TD2 utilizes a unique combination of experience gained through its contract research organization business, and an integrated suite of proprietary and non-proprietary tools, preclinical study execution, regulatory affairs assistance, clinical trial design and management, and drug development experts to successfully move therapeutics towards regulatory approval.

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 Caris Life Sciences

Caris Life Sciences is a U.S. based biosciences company specializing in the development and commercialization of clinically-validated molecular diagnostics and anatomic pathology services primarily in the fields of oncology, dermatopathology, hematopathology and gastrointestinal pathology. The company provides academic-caliber medical consults through its industry-leading team of subspecialty fellowships and expert-trained pathologists in gastrointestinal and liver pathology, dermatopathology and hematopathology. Caris Life Sciences also offers advanced molecular analyses of patient samples through prognostic testing services and genomic and proteomic profiling to assist physicians in their treatment of cancer and other complex diseases.

Fairfax Northern Virginia Hematology Oncology

For more than 30 years, Fairfax Northern Virginia Hematology Oncology (FNVHO), based in Fairfax, Va., has contributed greatly to the campaign against cancer and diseases of the blood by offering advancements in technology, treatment, early detection and clinical trials. For residents throughout Northern Virginia this means the chances of beating cancer are better than ever. Illustrating the outpatient emphasis of cancer treatment, FNVHO’s cancer care and blood disorder specialists work closely with you and your family to create an individual treatment plan that provides for your physical and emotional health, all in the familiar setting of your community.

About George Mason University’s Center for Applied Proteomics and Molecular Medicine

The Center for Applied Proteomics and Molecular Medicine in Manassas, Va., is a key element of the Life Sciences initiative in the College of Science. Proteomics the study of proteins, how they communicate and interact, and how those actions impact biology is the new frontier in molecular medicine. CAPMM Scientists, have invented the RPMA technology to provide the unprecedented ability to measure the activity level of hundreds of protein pathway biomarkers at once from a tiny needle biopsy. These biomarkers can then be used to directly tailor treatment based on the unique patient-specific information within the tumor itself. The new classes of molecular targeted inhibitors that are just now reaching the bedside act by modulating protein activity, not genes and the RPMA technology was developed by the CAPMM to synergize with these new compounds. Working with clinical investigators from health care partners and industry collaborators, their goal is to accelerate innovative laboratory discoveries into clinical research at the bedside, which holds the promise of individually tailored therapies and personalized disease management for patients, and the discovery of biomarkers for early disease detection.

About The Side-Out Foundation

The Side-Out Foundation is a 501(c)(3) non-profit organization that was established in 2004.  Inspired by one mom and embraced by the entire sport of volleyball, the mission of The Side-Out Foundation is to educate young athletes and their communities about breast cancer, both with respect to prevention and treatment, and to fund cutting edge breast cancer research.  Side-Out is focused on changing the way breast cancer is treated forever.

The term side-out refers to a situation in volleyball when one team wins a point while its opponent is serving, thereby regaining serve or control of play.  It is hoped that Side-Out will do the same for breast cancer patients, providing them with the support, education and best available treatments to regain control of their lives.