SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Translational Drug Development (TD2)—an oncology-specialty CRO that guides medicines through the preclinical, regulatory and clinical trial processes—managed a pilot clinical trial concluded in 2016 that examined the effectiveness of metastatic breast cancer (MBC) treatment based on Multi-Omic Profiling (MOP) compared to empiric treatment selection. The study was sponsored by The Side-Out Foundation, a nonprofit that funds cutting-edge breast cancer research. Results of the study will be presented at the upcoming annual American Society of Clinical Oncology (ASCO) meeting on June 2, 2018.
“Multi-Omic Profiling gives physicians the ability to personalize treatments for patients,” said Stephen Gately, Ph.D., Chief Executive Officer of TD2. “It can reveal a comprehensive list of actionable drug targets within complex diseases like metastatic breast cancers. We are proud to have partnered with The Side-Out Foundation over the past decade to support these cutting-edge trials and look forward to future trials as they continue their work in this exciting field.”
For the study, biopsies were collected from the metastatic lesions of 32 MBC patients. Each sample underwent genomic and proteomic profiling, including exome sequencing, RNA-Seq, IHC and quantitative phosphoprotein-based protein pathway activation mapping by Reverse Phase Protein Array (RPPA). Whole tissue lysates were used for each method except RPPA, which relied on samples obtained from microdissected tumor epithelia. To determine if MOP provided clinical benefits—meaning the cancer was controlled for a longer time—over empiric treatment and warranted further investigation, the team examined the patient’s progression-free survival on MOP compared to their prior treatment.
“While Multi-Omic Profiling comes with its own set of challenges, both scientific and logistical, the possibilities this approach opens up to the field of oncology research are promising for patients as new options become available,” said Bryant Dunetz, Chief Operating Officer of The Side-Out Foundation. “It’s our hope that we can offer inspiration to cancer patients through our studies.”
The study builds upon previous trials TD2 has conducted in partnership with The Side-Out Foundation: The results of a breast cancer pilot study initiated in 2009 revealed that cancer patients do better when molecular profiling guides their treatment, while a second study initiated in 2012 showed success in pinpointing individualized treatment for women with MBC.
TD2 is currently running a third trial for The Side-Out Foundation to extend its recent findings regarding the role MOP plays in the treatment of MBC.
About Translational Drug Development (TD2)
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, the rapid identification of clinically significant endpoints and the application of this approach even in the earliest stages of preclinical development. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.
About The Side-Out Foundation
The Side-Out Foundation is a 501(c)(3) nonprofit 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.