Inform Genomics Announces Positive Top-Line Results in First Phase of Development for OnPART Personalized Medicine Product
Published: Oct 01, 2012
"These data from our first phase of development is highly encouraging in demonstrating OnPART's ability to predict, with a high-degree of accuracy, serious side effects from chemotherapy regimens based on patients' individual genomic profiles which may lead to actions to reduce the burden of potentially curable interventions for patients with cancer," said Dr. Ed Rubenstein, President & CEO of Inform Genomics. "We look forward to presenting the final study data at peer- reviewed major oncology meetings in the near future, as well as continuing to develop our lead platform product."
The first phase of development for OnPART(TM) was conducted as a single center study at The West Clinic in Memphis, Tennessee. The study included patients with breast, colorectal, lung and ovarian cancer who were treated with standard chemotherapy regimens including dose-dense doxorubicin, cyclophosphamide and paclitaxel for breast cancer; oxaliplatin-based regimens for colorectal cancer; and carboplatin plus paclitaxel based regimens for lung and ovarian cancer. Patients were followed for a minimum of two cycles of chemotherapy and reported symptoms of nausea and vomiting, mouth sores, diarrhea, fatigue, cognitive dysfunction and peripheral neuropathy using a validated questionnaire, the Patient Care Monitor(R). Saliva was collected with a U.S. FDA approved kit for DNA samples, which when analyzed can detect 2.5 million SNPs per patient.
"We can now identify patients at risk for these side-effects before they ever receive chemotherapy," said Dr. Lee Schwartzberg, M.D., FACP, Senior Partner and Medical Director, The West Clinic and Principal Investigator of the study. "This allows us to customize our chemotherapy regimens and side-effect control interventions in a patient-centered care paradigm. These side-effects can impair function, create inefficiencies in medical practice and are costly to patients and payers. We look forward to working with Inform Genomics to help bring this novel product to the market as quickly as possible."
OnPART(TM), Oncology Preferences And Risk of Toxicity, is Inform Genomics' lead platform personalized medicine product for treatment decisions in patients who will receive chemotherapy for breast, colorectal, lung, or ovarian cancer. Based upon response rates and survival, more than one chemotherapy regimen may be considered appropriate care for patients with these common solid tumors, yet the regimens vary widely in their side-effect profiles. OnPART(TM) is being developed to assess genomic risk for common and often debilitating therapy-related side-effects, including fatigue, nausea and vomiting, diarrhea, oral mucositis, cognitive dysfunction and peripheral neuropathy. The product includes a differentiating factor in personalized medicine, quantifying patient concerns for side-effects, using a validated, copyrighted patient questionnaire (Preference Assessment Inventory(C)). OnPART(TM) is expected to provide valuable information for patients and medical oncologists to help clarify clinical choices and is projected to be commercially available by 3Q 2014.
About Cancer Supportive Care
Most patients with cancer receive supportive care as part of their multimodal anti-cancer therapy, regardless of cancer diagnosis, stage of disease, or treatment modality. Common symptoms associated with cancer or its treatments include fatigue, nausea and vomiting, diarrhea, oral mucositis, cognitive dysfunction, and peripheral neuropathy. Some of these conditions are manageable with commercially available medications, while others are the focus of drug development programs. The development of these side-effects may interfere with ongoing anti-cancer treatment, impair patient functioning, negatively impact the patients' quality of life, and may even increase the risk of mortality. Treatment of these side-effects also results in significant costs for payers and providers.
About Inform Genomics
Inform Genomics, Inc. is a private company focused on developing novel platforms of genomic-based personalized medicine products for cancer supportive care and inflammatory diseases, including its lead platform product, OnPART(TM), designed to determine an individual's risk of side-effects associated with chemotherapy regimens based on his or her individual genomic profile. The company's business model leverages existing technology in conjunction with proprietary analytic methods for conducting genome-wide association studies. Product development programs will lead to commercial, single source laboratory tests consisting of single-nucleotide polymorphism (SNP) networks that determine the likelihood of individual patient clinical outcomes to drug therapies. The U.S. market opportunity for these differentiated products exceeds $2 billion annually. Inform Genomics is headquartered in Boston, Massachusetts. For more information, please visit www.informgenomics.com.
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