Boston, MA, Dec. 6, 2012 (GLOBE NEWSWIRE) -- Inform Genomics, Inc., a private company focused on developing novel platforms of genomic-based personalized medicine products for cancer supportive care, presented results that demonstrate the ability of its lead platform product, OnPART™ to predict, with a high-degree of accuracy, serious side effects from chemotherapy regimens based on patients l genomic profiles. The first phase of development for OnPART™ enrolled 384 patients' including 78 patients with breast cancer who received dose dense doxorubicin plus cyclophosphamide and paclitaxel. These results are the subject of a poster presentation at the CTRC-AACR San Antonio Breast Cancer Symposium taking place December 4th to 8th, 2012.
"We can now identify patients at risk for 6 common side-effects before they ever receive chemotherapy," said Dr. Lee Schwartzberg, MD, 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."
The recently completed first phase of development for OnPART™ 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 that were treated with standard chemotherapy regimens including dose-dense doxorubicin, cyclophosphamide and paclitaxel for breast cancer; 5-fluoururacil and oxaliplatin based regimens for colorectal cancer; and carboplatin plus paclitaxel based regimens for lung and ovarian cancer. Patients were followed for a minimum of three cycles of chemotherapy and reported symptoms of 6 side effects including: oral mucositis, nausea and vomiting, diarrhea, fatigue, cognitive dysfunction and peripheral neuropathy using a validated questionnaire, the Patient Care Monitor®. Saliva was collected with an FDA approved kit for DNA collection, which when analyzed, can detect 2.5 million single nucleotide polymorphisms (SNPs) per patient.
Using algorithms based on Bayesian methodological programming, predictive networks were discovered for each of 6 chemotherapy-induced side effects with accuracies greater than 90%. Side effect rates, the accuracies of each SNP network, and the areas under the receiver operating characteristic (aROC) curves are shown in the table below for the 78 patients with breast cancer who received dose dense doxorubin plus cyclophosphamide and paclitaxel.
| Measurement | Oral Mucositis | Nausea & Vomiting | Diarrhea | Fatigue | Cognitive Dysfunction | Peripheral Neuropathy |
| Side Effect Rate (%) | 49 | 50 | 15 | 59 | 22 | 13 |
| Accuracy (%) |
97.4 | 93.5 | 98.7 | 93.5 | 100 | 98.7 |
| aROC | 0.997 | 0.924 | 0.997 | 0.994 | 1.00 | 1.00 |
"These data are highly encouraging, showing a high-degree of accuracy in predicting serious chemotherapy-related side effects based on patients' genomic profiles. This approach may offer clinicians an opportunity to take actions to reduce the side effect burden of potentially curative interventions for patients with breast cancer," said Dr. Ed Rubenstein, president & CEO of Inform Genomics. "We look forward to presenting our study results in patients with colorectal cancer at the ASCO GI Symposium in San Francisco, January 28-31st 2013."
About OnPART™
OnPART™, 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™ is being developed to assess genomic risk for 6 common and often debilitating therapy-related side-effects, including oral mucositis, nausea and vomiting, diarrhea, fatigue, 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©). OnPART™ is expected to provide valuable information for patients and medical oncologists to help clarify clinical choices and is projected to be commercially available in 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 side effects associated with cancer or its treatments include oral mucositis, nausea and vomiting, diarrhea, fatigue, cognitive dysfunction, and peripheral neuropathy. Some of these conditions are manageable with commercially available medications, while others are the focus of current drug development programs. These side effects are costly for payers, create inefficiencies' for oncology practices, 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.
About The West Clinic
The West Clinic is the Mid-South's premier provider of cancer care. Over the past 33 years, West Clinic has built a team second to none in breadth of expertise, dedication to excellence, and compassionate care. Our multidisciplinary physician group is comprised of 33 specialists in Medical Oncology, Hematology, Gynecologic Oncology, Breast Surgery, Endocrinology, Diagnostic and Interventional Radiology, Pain and Palliative Care, and other advanced medical care. With eight locations in Memphis, West Tennessee, North Mississippi, and East Arkansas, patients across the Mid-South have greater access to the highest quality care available.
In 2012, The West Clinic formed a novel partnership with Methodist Healthcare and the University of Tennessee Health Science Center (UTHSC) to transform cancer care in the Mid-South. The partnership takes advantage of the strengths and cultures of all three partners leading to the development of a fully integrated cancer program which will expand collaborative efforts in cancer research and education with a vision toward personalized precision cancer care.
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. Our proprietary methodologies, including the utilization of Bayesian Network analysis, have discovered biologically valid, single nucleotide polymorphism (SNP) networks that are highly predictive of moderate-to-severe side effects of common chemotherapy regimens. We have completed the first phase of development for our products. The development programs are expected to lead to commercial, single source laboratory developed tests consisting of SNP networks that determine the likelihood of individual patient clinical outcomes. The U.S. market opportunity for these differentiated products exceeds $1B annually. We expect to begin product sales in 2014.