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Avalon Pharmaceutical, Agendia, Asuragen, FDA, Cepheid, Affymetrix

Avalon IDs Patient Stratification Biomarkers For Cancer Drug AVN944
Avalon Pharmaceutical said this week that it has identified several biomarkers that may help identify patients most likely to benefit from its investigational cancer drug AVN944.
The company used its AvalonRx technology to identify gene signatures that may be useful for patient stratification, Avalon said in a release. Data from the Phase I study was presented at the American Association for Cancer Research Annual Meeting being held this week in Los Angeles.
"We can now validate these gene signatures for utility in patient stratification in our upcoming Phase II trials, as well as for their use as prognostic signatures. If this approach works, it could significantly accelerate the development of AVN944 and enhance its utility as a marketed product,” the company said in statement.
AVN944, an inhibitor of inosine monophosphate dehydrogenase 1 and 2, is highly up-regulated and required for the production of guanine nucleotides in many malignancies, including hematologic cancers. The drug has been studied in repeat-dose and dose escalation trials in patients with advanced hematologic cancers including AML, CLL, Multiple Myeloma and lymphomas.

Agendia Licenses Asuragen’s Sample-Preservation Product for Use with MammaPrint
Asuragen has granted global rights to Agendia for use of its RNARetain tissue preservation solution for human diagnostic applications.
Under the non-exclusive agreement announced this week, Agendia will use RNARetain to store and ship tumor samples for its MammaPrint diagnostic, which predicts the risk of the recurrence of breast cancer.
RNARetain, also known as RNAlater, is used to preserve nucleic acid profiles in solid tissues.
Agendia performs the MammaPrint analysis in its own lab using samples that physicians prepare and ship to its Amsterdam headquarters. According to the company’s website, MammaPrint analysis cannot be performed on formalin-fixed paraffin embedded tumor tissue “as this fixation procedure causes the RNA to degrade.”
Agendia received 510(k) clearance from the US Food and Drug Administration for MammaPrint earlier this year. It was the first assay the agency approved as an in vitro diagnostic multivariate assay since it released a draft guidance concerning the use of such devices last year [see PGx Reporter 02-07-07].

Newly Sequenced Macaque Genome May Hint at Human Mental Disorders
Researchers have sequenced the genome of the rhesus macaque, the third primate genome to be sequenced.
In findings detailed in a special issue of the journal Science dedicated to the macaque project, researchers said the rhesus macaque, also known as Macaca mulatta, is 97.5 percent similar to humans.
That makes it valuable both for its proximity to humans — for which researchers found a link to a mental disorder — and for its relative distance with the chimpanzee, which shares 99 percent of its genes with humans.
The macaque genome, which can be found here, is approximately 2.87 Gb long and includes around 14.9 Gb of raw sequence. There are around 24 million bases in the scaffold sequence, the authors said.
Comparative research into the changes that have taken place in the time since the macaque, an old-world monkey, diverged from humans and chimps 25 million years ago could offer researchers insights into disease research in particular, according to the scientists.
Richard Gibbs, director of the Baylor College of Medicine’s Human Genome Sequencing Center and leader of the project, said the macaque genome “helps illuminate what makes humans different from other apes.”
This information “allows us to learn what has been added or deleted in primate evolution from the rhesus macague to the chimpanzee to the human,” Gibbs added.
The project was performed by more than 100 researchers working with $20 million in funding from the National Human Genome Research Institute. The Genome Sequencing Center at Washington University and the J. Craig Venter Institute contributed significantly to the sequencing project.
According to the study, researchers identified around 200 genes that “show evidence of positive selection during evolution, making them potential candidates for determining the differences among primate species.”
The study said those genes are involved in hair formation, immune response, membrane proteins, and sperm-egg fusion.
Other findings with potential medical implications are examples of normal macaque proteins that looked like diseased human proteins, including one diseased protein involved in mental retardation and brain damage.

FDA Clears Cepheid's PCR-based Drug-Resistant S. aureus Test
The US Food and Drug Administration has cleared a Cepheid test designed to swiftly detect nosocomial and antibiotic-resistant strain of Staphylococcus, the company said this week.
Cepheid said its Xpert MRSA test, which operates on the company’s GeneXpert system, identifies methicillin-resistant S. aureus in “just over one hour,” and can be administered 24 hours a day without the need to submit samples to a lab.  
Cepheid said MRSA infections are the “leading cause” of nosocomial, or hospital-acquired infections, and that they kill as many as 100,000 patients a year in the US.
The company said it is currently “engaged with a broad cross-section of health care organizations” about plans to try using MRSA surveillance systems. These organizations are considering testing only “high risk” cases, or testing “all patient admissions,” the company added.
Last month, the FDA cleared the company’s PCR-based Xpert EV meningitis test.

Affymetrix to Fund European Cancer Studies Using Microarrays
Affymetrix is launching a program to fund microarray-related cancer research at European research centers, the company said this week.
Under the Collaborations in Cancer Research Program, Affymetrix said it will financially support “selected research projects” that use a variety of microarray-based applications and that are aimed at developing new understanding and discoveries in 10 types of cancer.
The research is being performed at a number of academic and state-run research facilities throughout Europe.
The company said these programs use microarray applications, including copy number analysis, gene expression, chromatin immunoprecipitation, and splicing pattern analysis.
Affy also said it will help researchers “obtain tools and training,” and said it will “provide forums where investigators can exchange knowledge and share best practices.”
Researchers in the programs are studying leukemia and cancers of the breast, lung, prostate, thyroid, skin, and other organs.
Affy said results of these studies will be presented at a meeting it will sponsor later this year. The company also plans to expand the program in 2007 to include research facilities in Japan and North America.
A partial list of CCRP participants can be found here.
The company did not say how much financial support it will offer these programs.

Filed under

The Scan

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.

Duke University Team Develops Programmable RNA Tool for Cell Editing

Researchers have developed an RNA-based editing tool that can target specific cells, as they describe in Nature.

Novel Gene Editing Approach for Treating Cystic Fibrosis

Researchers in Science Advances report on their development of a non-nuclease-based gene editing approach they hope to apply to treat cystic fibrosis.

Study Tracks Responses in Patients Pursuing Polygenic Risk Score Profiling

Using interviews, researchers in the European Journal of Human Genetics qualitatively assess individuals' motivations for, and experiences with, direct-to-consumer polygenic risk score testing.