Tag Archives: td2

134127959

TGen-TD2-Scottsdale Healthcare study benefits patients

The Side-Out Foundation’s breast cancer pilot study, led by the Translational Genomics Research Institute (TGen), Translational Drug Development (TD2) and Scottsdale Healthcare, has shown that cancer patients do better when their treatment is guided by molecular profiling.

Specifically, 52 percent of patients with advanced breast cancer received clinical benefit – meaning their disease was controlled for a longer time – when their cancer was treated based on addressing the abnormal proteins in their tumor, according to the study conducted at the Virginia G. Piper Cancer Center Clinical Trials, a partnership of Scottsdale Healthcare and TGen.

Each patient’s treatment was “personalized,” meaning that the therapy they received was based on their individual tumor biology.

“This study demonstrates the feasibility of personalized cancer treatment, and shows that this approach merits further investigation in future studies,” said Gayle Jameson, Nurse Practitioner at Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and the study’s Principal Investigator.

“The success of this pilot study will lead to a larger study and hopefully greater clinical benefit for more patients with advanced breast cancer,” said Jameson, who presented the results of the study in June at the 2013 American Society of Clinical Oncology (ASCO) in Chicago.

Due to the overwhelmingly positive results, a new study incorporating additional technology for tumor analysis, Side-Out II, will open at the Virginia G. Piper Cancer Center Clinical Trials in the near future for patients with advanced breast cancer.

“The success of our pilot proof-of-concept study has established a firm launching pad for the upcoming Side-Out II study, which involves a more in-depth investigation of tumor biology with an expanded repertoire of tests to direct personalized treatment,” said Dr. Jasgit Sachdev, M.D., a breast cancer specialist and Associate Professor at the Virginia G. Piper Cancer Center Clinical Trials.

“By showing the significant advantages of molecular profiling, this pilot study has enabled us to move forward with a project that should strengthen the evidence for using this approach in routine clinical care.”

The recent pilot study built on previous studies by Scottsdale Healthcare and TGen that showed the value of guiding treatment based on molecular profiling, in which each patient’s tumor was analyzed for protein abnormalities that may “drive” the cancer’s growth. The results pointed investigators toward specific genetic changes that might be addressed by specific medications.

Beyond molecular profiling, the pilot study also included mapping proteomic pathways within the tumor tissue so each patient could receive a highly targeted regimen designed to impede their cancer growth.

All of the patients in the recent study had advanced breast cancer that had progressed following multiple previous chemotherapy treatments. Of the 25 patients, 13 received clinical benefit as a result of molecular profiling. For all 25 patients, the therapy selected based on their tumor analysis was different than what they would have received in their next planned treatment, if they had not participated in the study.

The Virginia G. Piper Cancer Center at Scottsdale Healthcare was the lead site in the 2-½ year pilot study. In addition, patients in the study were treated at Virginia Cancer Specialists, US Oncology, in Fairfax, Vir.; and at Evergreen Hematology & Oncology in Spokane, Wash.

Translational Drug Development (TD2), a TGen company, managed the pilot clinical trial, and will also oversee the follow-on study, Side-Out II.

“This was an exciting study for TD2,” said Linda Vocila, BSN, RN, Director of Clinical Operations at TD2 and co-author of the study. “It demonstrates that close collaboration between physicians and scientists leads to greater clinical benefit for patients with cancer.”

Two labs analyzed tissue: the Center for Applied Proteomics and Molecular Medicine (CAPMM) at George Mason University in Manassas, Vir.; and Caris Life Sciences in Phoenix.

The Side-Out Foundation of Fairfax, Vir., sponsored the study.

To participate in a clinical trial at the Virginia G. Piper Cancer Center, please contact Patient Care Coordinator Joyce Schaffer at 480-323-1339 or joschaffer@shc.org.

forma therapeutics

FORMA Therapeutics Teams With TGen Drug Development

FORMA Therapeutics and TGen Drug Development (TD2) announced an agreement to jointly develop transformative cancer therapies, leveraging the synergistic capabilities of both organizations.

“TD2 brings preclinical and clinical development capabilities to FORMA, filling the missing piece in our strategy to become a fully-integrated research and development organization, leading the creation of breakthrough medicines for cancer patients”

TD2 is a subsidiary of the Phoenix-based Translational Genomics Research Institute (TGen), a world-renowned biomedical research institute.

FORMA and TD2 also announced that Daniel D. Von Hoff, M.D., F.A.C.P., TGen’s Distinguished Professor and Physician-in-Chief, and Stephen Gately, Ph.D., President and Chief Scientific Officer at TD2, will serve as clinical advisors to FORMA.

FORMA Therapeutics targets essential cancer pathways to create transformative, small molecule cancer therapies. Its focus on early identification of potent tool compounds helps facilitate target validation, enabling the creation of a robust pipeline of new therapies in areas such as tumor metabolism, protein-protein interactions and epigenetics.

TD2’s mission is to facilitate innovative drug development and move new, targeted compounds to patients as quickly as possible. TD2 applies cutting-edge preclinical tools, streamlined and efficient regulatory processes and unique, targeted clinical trial designs and strategies. The combination of cutting-edge science, clinical development expertise and access to patients will accelerate the development of new agents for patients.

“I am excited about the potential of this relationship between FORMA and TD2,” said Dr. Von Hoff. “It will accelerate the creation of new molecules that could be placed in research programs, such as our US Oncology Research Phase I program, further accelerating development and getting the right treatment to the right patient as soon as possible.”

“TD2 brings preclinical and clinical development capabilities to FORMA, filling the missing piece in our strategy to become a fully-integrated research and development organization, leading the creation of breakthrough medicines for cancer patients,” said Steven Tregay, Ph.D., Chief Executive Officer of FORMA. “We welcome Drs. Von Hoff and Gately as advisors and their unprecedented experience and networks in oncology drug development.”

“FORMA’s pioneering approach to oncology small molecule drug discovery has been prolific in tackling intractable targets and establishing industry partnerships,” said Dr. Von Hoff. “We look forward to bringing the experience of our team to the FORMA team to guide its discovery programs and develop these important new drugs for patients.”

TD2 has helped transition more than 40 companies from discovery to clinical development over the past five years, and TD2 has collective experience in performing clinical studies on more than 400 new anti-cancer agents

“Our oncology discovery programs span more than 30 drug targets per year, and we need a partner to help direct the right drugs to the right patient groups,” said Kenneth Bair, Ph.D., Chief Scientific Officer and Head of Research and Development of FORMA Therapeutics. “The TD2 team provides unique access to genetically selected patient populations that will help us both discover and test personalized therapeutics.”

For more information on FORMA Therapeutics and TGen Drug Development, visit FORMA Therapeutics’s website at formatherapeutics.com and visit TGen Drug Development’s website td2.org.