ARCA Submits Genetically Targeted Beta Blocker for FDA Approval
The US Food and Drug Administration this week accepted ARCA Biopharma’s new drug application for its lead product candidate, bucindolol, an investigational, genetically targeted beta-blocker and mild vasodilator for chronic heart failure.
“If approved by the FDA, bucindolol could become the first genetically targeted cardiovascular therapy,” ARCA said in a statement.
ARCA and Laboratory Corporation of America are working together to develop a companion genetic test for bucindolol. LabCorp has said it will consult the FDA “on the appropriate regulatory path for the test” and ideally, attempt to launch the test and the drug simultaneously.
According to results from a prospectively defined genetic sub-study of the Beta Blocker Evaluation of Survival Trial, a large Phase III clinical trial funded and conducted by the National Institutes of Health and the Veterans Affairs Cooperative, bucindolol significantly reduces hospitalizations and deaths in heart failure patients with a certain, common genetic variation compared to placebo.
The data from this sub-study was presented last week by Christopher O'Connor, director of the Heart Center at Duke University Medical Center, at the Heart Failure Society of America annual meeting in Toronto.
The genetic subset of patients who are most likely to benefit from bucindolol comprise approximately 50 percent of the US heart failure population, according to ARCA.
"By seeking regulatory approval for bucindolol, we are taking a major step forward in our quest to bring the benefits of personalized medicine to cardiovascular disease," Richard Brewer, ARCA Biopharma CEO, said in a statement.
BD to Use Luminex xMAP Platform for Early-Stage Cancer Tests
Luminex and Becton Dickinson’s Diagnostics-TriPath division have struck a development and supply agreement for biomarker-based cancer tests, Luminex said this week.
BD Diagnostics-TriPath will use Luminex’s multiplexing xMAP Technology, which allows multiple, simultaneous tests to be conducted using one sample, to develop diagnostic tests for certain cancers that BD will market.
Luminex said that BD plans to expand its cancer test program to include “a broad menu” of new diagnostic tests for solid tumor cancers using Luminex’s xMAP Technology.
"We believe providing biomarker testing in a multiplex format would allow detection of cancer at an earlier stage,” which could lead to better patient outcomes, BD Diagnostics-TriPath VP and GM Wayne Brinster said in a statement.
This week at the UBS Global Life Sciences Conference in New York, Luminex CEO Patrick Balthrop said he views the agreement with BD, a leader in the flow cytometry market, as a validation of the flow-cytometry-based xMAP platform.
Balthrop did not disclose the specific cancers that would be targeted in the collaboration, but said that they would be those that are “most difficult to diagnose.”
Dana-Farber to Evaluate Monogram's HERmark Assay for Metastatic Breast Cancer
Monogram Biosciences said this week that the Dana-Farber Cancer Institute has agreed to evaluate its HERmark breast cancer assay in metastatic breast cancer.
The goal of the project is to test HERmark cutoff values and determine whether the assay is better than conventional methods for identifying metastatic breast cancer patients who are susceptible to Genentech’s Herceptin (trastuzumab) treatment.
The researchers will use HERmark, an assay that measures total HER2 protein and HER2 homodimer levels, to analyze roughly 600 tissue samples from breast cancer patients — half of whom are believed to be eligible for Herceptin treatment based on HER2 immunohistochemistry and/or fluorescence in situ hybridization tests. The researchers will then compare the HERmark measurements with IHC and FISH results and with Herceptin treatment response.
Monogram believes that the HERmark assay could lead to a reclassification of as many of 15 to 20 percent of patients currently classified as HER2-negative and that it may also uncover HER2-positive patients with varying Herceptin treatment response.
“Results from prior studies in metastatic breast cancer have suggested that HERmark can identify subsets of patients with different responses to Herceptin even though they had all been previously assessed as ‘HER2-positive’ by IHC and/or FISH, tested centrally,” Michael Bates, Monogram’s vice president of clinical research, said in a statement.
Bates noted that the researchers also plan to measure HER3 expression levels in breast cancer tumors and determine whether they relate to clinical outcomes. And, he said, the tissue obtained for the study may facilitate testing of newer assays currently in advanced development at Monogram — for instance, tests that gauge HER1 or p95 expression and tests for HER2 heterodimers.
Proteomics Dx Startup PPM Gets $2.3M from NHLBI for Cardio Health Test
Predictive Physiology & Medicine, a diagnostic startup based in Bloomington, Ind., will use a $2.3 million grant from the National Heart, Lung, and Blood Institute to develop a proteomics-based test aimed at assessing cardiovascular health, the company said this week.
PPM said it is developing a test that will analyze 500 molecules in a single blood sample to detect conditions such as heart disease, diabetes, and hypertension “earlier than other tests.”
According to the abstract for the NHLBI grant, the company's assessment method is a comparative proteomics approach that uses ion mobility spectrometry and mass spectrometry combined with a “three-minute” analytical step.
“Very short experimental timescales are required to analyze the large number of individuals necessary to obtain statistically relevant healthy and disease profiles,” the company said in the abstract. “To accomplish this, PPM has selected a highly innovative approach in combining targeted proteomics with IMS-MS techniques. Here PPM will target low-abundance proteins using extensive abundant protein depletion as well as the immunoaffinity selection of the apolipoprotein family of proteins.”
PPM added that this approach “is distinguished from other immunoaffinity selection approaches in that a high level of sample complexity is retained after sample workup.”
The company, which currently employs 15 people, began developing the test in 2006.
The NHLBI funding will give the company “the resources we need to follow cardiovascular patients over time and track their progress," PPM’s CCO Brian Kleber, said in a statement.
“The information we capture will give us a better understanding of cardiovascular health. It also allows us to discover if and how individuals act on the knowledge provided by our assessment — what steps they take to improve health and the success of their actions,” Kleber continued.
PPM said it secured the NHLBI funding with help from the Indiana Economic Development Corporation’s Small Business Innovation and Small Business Technology Transfer Program.
The company said it plans to launch the test, called the PPM Cardiovascular Health and Wellness Report, in test markets before the end of the year.
PPM plans to start selling the service though wellness centers, sports medicine centers, executive health programs, and in other medical facilities in 2009.
Diamond Healthcare, AssureRx Team on Personalized Medicine Program for Behavioral Health
AssureRx and Diamond Healthcare will collaborate on a personalized medicine platform for use by physicians treating patients with behavioral health conditions, AssureRx said last week.
Through the alliance, AssureRx will gain access to the managerial and clinical expertise and industry relationships of Diamond Healthcare, which provides behavioral health management and consulting services, to help develop its first commercial product for the behavioral health market.
Cincinnati-based AssureRx is developing products based on pharmacogenetics to help guide physicians in making treatment decisions. The platform is based on technology licensed from the Mayo Clinic and the Cincinnati Children’s Hospital.
As part of the alliance with Diamond, George White, president of Diamond Healthcare, has joined AssureRx’s board of directors.