News Release

Side-Out Foundation teams with leading medical professionals to battle breast cancer

Dig Pink Volleyball Breast Cancer Awareness Campaign aims to raise $1 million

Business Announcement

Scottsdale Healthcare

Fairfax, VA. (Oct. 22, 2009) -- The Side-Out Foundation and its Dig Pink® Volleyball Breast Cancer Awareness campaign will launch a first of its kind clinical trial this month to examine the effects of individualized treatment on patients with metastatic breast cancer. Individualized treatment, known as targeted therapy, provides doctors a better way to tailor cancer treatment and offers the hope of more precisely targeting the cancerous cells, which would reduce side effects and improve quality of life.

The trial protocol will bring together the diverse skills and unique experience of community oncologists, nurses and researchers in the field molecular medicine. Clinical trials will occur at TGen Clinical Research Services (TCRS) at Scottsdale Healthcare and Fairfax Northern Virginia Hematology – Oncology. TGen Drug Development Services (TD2) will manage the trial for the Side-Out Foundation. The two major contributing laboratories are CARIS Diagnostics, and George Mason University's Center for Applied Proteomics and Molecular Medicine.

This pilot study follows on the heels of the Bisgrove Trial, which indicated cancer patients can survive longer under treatments based on their individual genetic profiles. Results were reported in April 2009 by TCRS at Scottsdale Healthcare in connection with Caris Dx.

While the Bisgrove Trial was a broader-based solid tumor cancer study, the results of this study indicated the potential clinical benefit of a molecular-based personalized therapy selection strategy for patients with recurrent and/or metastatic disease. Intended to provide real time treatment recommendations to physicians, this metastatic breast cancer trial will be conducted over the next 24 months.

Researchers will utilize these advanced molecular profiling technologies, focusing on tailoring therapy for each patient based on the individual genomic and proteomic molecular portrait within the metastatic lesion itself. The patient would then be treated with a single agent based on the aggregate information provided by the genomic and proteomic molecular profiling analyses.

High schools and colleges across the country will host volleyball matches to "pink-out" the stands this October, Breast Cancer Awareness month, in support of this new research.

The Side-Out Foundation is continuing that momentum by attracting more than 1,000 additional high schools and colleges to compete in similar volleyball tournaments in order to raise $1,000,000 in support of breast cancer research and the social and physiological aspects of the disease .

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The Side-Out Foundation Participating Organization Include:

Scottsdale Healthcare Virginia G. Piper Cancer Center, Scottsdale, Ariz.

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.

Located in the Debi and Jerry Bisgrove Research Pavilion of Scottsdale Healthcare's Virginia G. Piper Cancer Center, 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. For more information, visit www.shc.org.

TGen Drug Development Services (TD2)

TGen Drug Development Services (TD2), a wholly owned subsidiary of the Translational Genomics Research Institute (TGen), 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. TD2 is dedicated to reducing the risks and uncertainty inherent in the drug development process. www.td2.org

About Caris Diagnostics (Caris Dx)

Caris Dx 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 Dx 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. Currently, Caris Dx receives and analyzes biopsies for more than 2,700 patients per day, referred by more than 2,500 physicians nationally. Formed in 1996, the company is headquartered in Irving, Texas and operates four laboratories: Irving, Texas; Phoenix, Arizona (2 sites) and 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. For more information, visit: www.tgen.org

Fairfax Northern Virginia Hematology - Oncology, Fairfax, VA

For more than thirty years, Fairfax Northern Virginia Hematology Oncology (FNVHO) 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. www.fnvho.com

George Mason University's Center for Applied Proteomics and Molecular Medicine, Manassas, VA

The Center for Applied Proteomics and Molecular Medicine 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.

The Side-Out Foundation

The Side-Out Foundation (Side-Out) was established in 2004 by a group of individuals drawn together by their love of volleyball, but who also share a similar passion to be a part of the war against breast cancer. Side-Out's mission is to raise money for the war against breast cancer through the sport of volleyball. www.side-out.org

For media inquiries, contact:

Bryant Dunetz
COO The Side-Out Foundation
703-615-8740
bryant.dunetz@side-out.org


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