Boston, MA, June 1, 2015 (GLOBE NEWSWIRE) -- Inform Genomics, Inc., a privately held company that utilizes a proprietary analytic platform to develop genomic-based, precision medicine products, today announced the selection of ICON as its contract research organization (CRO) for the pivotal multicenter study of its Hematopoietic Stem Cell Transplant (HSCT)/Mucositis™ product candidate. Inform Genomics anticipates enrolling up to 1,000 patients in approximately 30 sites in the United States beginning in the fourth quarter of this year.
“We completed an extensive review process of CROs with experience conducting studies in patients undergoing stem cell transplant,” said Carl de Moor, PhD, Inform Genomics Chief Technology Officer. “ICON has a long history of successfully conducting studies with the type of sites and patients critical for this program. The ICON team impressed us with their expertise.”
Ed Rubenstein, MD, President and CEO of Inform Genomics, continued, “The selection of ICON moves us one step closer to bringing our HSCT/Mucositis™ product candidate to market, where it may benefit patients, physicians in bone marrow transplant centers, and payers alike.”
“Being able to identify patients at increased risk for mucositis and adjust their treatment plan to avoid this devastating complication would be an important advance in the field of stem cell transplantation,” said Sergio Giralt, MD, Chief of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center, and the Principal Investigator of the multicenter study.
In the first phase of development, the HSCT/Mucositis™ product candidate demonstrated that it could accurately predict a patient’s risk for developing oral mucositis.
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: HSCT/Mucositis™ and Oncology Preferences And Risk of Toxicity (OnPART™).
About the Product Candidates
HSCT/Mucositis™ is designed to help identify which patients are at high risk for developing oral mucositis (i.e., 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 (e.g., use of palifermin or dose modification), thus reducing the patient, clinical, and economic burden of this serious side effect.
OnPART™ is designed to accurately predict, in advance of chemotherapy, the risk for six clinically significant and costly chemotherapy-related side effects--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 (Preference Assessment Inventory© tool) that quantifies a patient’s willingness to tolerate these side effects.
For more information, please visit www.informgenomics.com.
About ICON
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology, and medical device industries. The company specializes in the strategic development, management, and analysis of programs that support clinical development--from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 81 locations in 38 countries and has approximately 11,200 employees. Further information is available at www.iconplc.com.
CONTACT: Inform Genomics Ed Rubenstein, MD, President and CEO erubenstein@informgenomics.com 101 Federal Street Suite 1900 Boston, MA 02110
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