Inform Genomics Selects US Oncology Research As The Site Management Organization (SMO) For Pivotal Multicenter Study Of Onpart
Boston, MA, May 29, 2015 (GLOBE NEWSWIRE) -- Inform Genomics, Inc., a privately held company that utilizes a proprietary analytic platform to discover and develop genomic-based, precision medicine products, today announced the selection of US Oncology Research, supported by McKesson Specialty Health and The US Oncology Network, as its site management organization (SMO) for the multicenter pivotal study of OnPART™ (Oncology Preferences And Risk of Toxicity). Inform Genomics anticipates enrolling up to 10,000 patients in approximately 130 sites in the United States beginning in the fourth quarter of this year.
"US Oncology Research's SMO services offer efficient access to a large number of sites and patients through a single point of access, greatly enhancing our ability to meet enrollment goals," said Carl de Moor PhD, Inform Genomics Chief Technology Officer. "They are demonstrable leaders in oncology research, with a strong commitment to advancing care for cancer patients."
Ed Rubenstein, MD, President and CEO of Inform Genomics, concluded, "Through our relationship with the US Oncology Research team, we are gaining access to a wealth of expertise and capabilities in implementation of oncology trials. We look forward to working together to advance OnPART™ towards market availability."
OnPART™ has completed its first phase of development and has demonstrated it can predict side-effect risk with a high degree of precision and accuracy. In addition, it has shown biologic validity for each of the predictive networks. In this next phase of development, Inform Genomics will enroll patients with breast, colorectal, lung and ovarian cancer that are undergoing treatment with standard chemotherapy regimens.
About Inform Genomics
Inform Genomics, Inc. is a privately held company that utilizes a proprietary analytic platform to develop genomic-based, precision medicine products that are designed to predict, with a high degree of accuracy, clinically important outcomes that assist physicians and their patients in making individualized medical decisions.
The Company's lead development program is in oncology supportive care, with two product candidates currently in development: Oncology Preferences And Risk of Toxicity (OnPART™) and Hematopoietic Stem Cell Transplant (HSCT)/Mucositis™
About the Product Candidates
OnPART™ is designed to accurately predict, in advance of chemotherapy, the risk for six clinically significant and costly chemotherapy-related side effects including moderate to severe: nausea and vomiting, diarrhea, peripheral neuropathy, oral mucositis, cognitive dysfunction, and fatigue. It not only incorporates genomic risk for side effects but also offers a unique feature that quantifies a patient's willingness to tolerate these side effects using a Preference Assessment Inventory tool.
HSCT/Mucositis™ is designed to help identify which patients are at high risk of developing oral mucositis (ie, debilitating mouth sores), a common side effect resulting from high-dose chemotherapy conditioning regimens used prior to stem cell transplantation. Understanding who is at risk for oral mucositis in advance of these conditioning regimens will help physicians plan primary prevention strategies (eg, use of palifermin or dose modification) thus reducing the patient, clinical, and economic burden of this serious side effect.
For more information, please visit www.informgenomics.com.
About US Oncology Research
Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves nearly 60 research sites and approximately 160 locations managing about 225 active trials at any given time. Physicians in the research network have enrolled more than 60,000 patients in more than 1,400 trials since inception in 1992 and have played a role in more than 50 FDA-approved cancer therapies, nearly one-third of all cancer therapies approved by the FDA to date. For more information call (800) 482-6700 or visit www.usoncology.com/oncologists.
CONTACT: Inform Genomics Ed Rubenstein, MD, President and CEO erubenstein@informgenomics.com 101 Federal Street Suite 1900 Boston, MA 02110
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