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Snippets: Apr 15, 2009


Decode Genetics to Utilize Grace Period on Convertible Notes

Decode Genetics this week said that it would utilize a 3-day grace period for the scheduled April 15 interest payment on its outstanding 3.5 percent senior convertible notes due 2011.

The firm said that it is exercising that option "in order to provide more time for the execution of our strategic alternatives currently under consideration."

In recently announcing its fourth-quarter and fiscal 2008 financial results, Decode said that it finished the year with cash, cash equivalents, and current investments of $3.7 million, which it said was sufficient to fund operations only into its second quarter.

The company had announced in December that it was evaluating strategic alternatives for its business, including finding buyers or partners for its non-core business units, programs, and intellectual property.

The firm did not disclose the amount of the interest payment that was due today.

NCI to Fund Prognostic Biomarker Studies

In order to address what it describes as a need for more biomarker-based products aimed at predicting cancer and its advancement and predicting patient response, the National Cancer Institute has put out a new grants program to fund biomarker development.
The program, Developmental Research in Cancer Prognosis and Prediction, funds both R21 and R33 grants aimed at developing new biomarkers from initial observations into assays or test systems for use in clinical trials.

The R21 grants will award up to $275,000 over a two-year period, and the R33 program will be held to a three-year period and will have a budget that is "appropriate for the science proposed."

The goal of the R21 program is to continue development of novel prognostic and predictive biomarkers towards laboratory assays and test systems that can be used in clinical trials or in larger studies.

The R33 program aims to develop biomarkers into assays or test systems for cancer in clinical trials or other types of confirmatory clinical research studies.

"Despite strong interest in biomarkers and a growing body of knowledge, the number of clinical laboratory assays currently in routine use in oncology remains very small," NCI explained in a funding announcement. NCI said that although the R21 grants will fund "rapid appraisal of new candidate prognostic and predictive markers."

NCI said that although there is an increasing number of new molecules and new patterns of gene expression that are correlated with prognostic factors, "very few biomarkers progress beyond the stage of an initial promising result. Studies to move the development of a new diagnostic test beyond the exploratory stage require both large numbers of patient samples with associated clinical data, robust, efficient assays/techniques, and substantial statistical input," said the institute in the funding announcement.

Clinical Data Completes Cogenics Sale to Beckman Coulter

Clinical Data has completed the sale of its Cogenics division to Beckman Coulter for $17 million, the firm announced this week.

At closing, Beckman paid $15.4 million in cash, with $2.5 million held in escrow for 18 months. Clinical Data retained around $2.2 million in cash from Cogenics immediately prior to the sale, which resulted in net cash proceeds of $14.9 million.

The acquisition, which was initially announced earlier this month, includes Cogenics' operations in the US, UK, Germany, and France.

Cogenics provides genomics services, such as DNA sequencing, gene expression, clinical and non-clinical genotyping, biomanufacturing support, nucleic acid extraction, and biobanking. Its services will complement those of Beckman's Agencourt Biosciences business, which also offers genomics services and nucleic acid purification products.

Survey: Vets Supportive of Genetic Cohort Study

A large number of US military veterans may be likely to support and participate in a large cohort genetic study conducted through the Department of Veterans Affairs, according to a new survey conducted by the Genetics and Public Policy Center.

The VA has proposed establishing a database of genetic information from analyzing patients' DNA from blood samples and linking it to a variety of information in the participants' electronic health records.

According to the GPPC survey, 71 percent of respondents said that they would "definitely or probably serve as a research subject if asked," and 84 percent believed that the database would "lead to improved treatments, cures, or lives saved for veterans."

GPPC also found that 83 percent of the survey's respondents believed that such a database should "definitely" or "probably" be created.

The VA created the Genomic Medicine Program in 2006 to study the use of genetic information to improve the health of veterans. According to GPPC, the VA believes that the genetic database it has proposed "would be a powerful tool for researchers seeking links between genes, environmental factors, and health outcomes."

Privacy protection was important to nearly all the veterans surveyed, and 98 percent of them said it would be important for the VA to develop safeguards to protect their information, and three out of four said that a key to the database should be kept if the veterans' medical information were to be updated. Such a key also would allow participants to learn about the results of research using their information.

Nine out of 10 of the veterans also said they would like to know their individual research results.

NICHD Starts New PGx Program

The National Institutes of Health will support pharmacogenomics research aimed at understanding drug effects on, and targeting drugs for, children and pregnant women under a new program.

Issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Translational Research in Pediatric and Obstetric Pharmacology program will fund grants studying the special differences of drug actions and responses among children, development of new drugs targeting children and pregnant women, and multidisciplinary collaborations between basic and physician scientists to improve therapeutics for pediatrics and obstetrics.

"With recent advances in genetics, pharmacogenomics and basic developmental biology, as well as the expansion of robust technologies (such as microarray and proteomic technologies) and bioinformatics tools, both basic and clinical scientists are now better equipped to conduct drug research and development in children and pregnant women," NICHD explained in the request for applications.

These advances should be used to address a "lack of knowledge of appropriate drug dosage, efficacy, and safety for pediatric patients," which has led to "some therapeutic disasters" such as the drug chloramphenicol, which led to sudden cardiovascular collapse and death in some infants.

Theses research programs will fund studies of gene-drug interactions, drug-drug interactions, drug toxicity, and drug responses. NICHD also said it is encouraging scientists to undertake translational research programs that include genomic, epigenomic, proteomic, and systems biology approaches.

The list of possible topics researchers could explore include: identification, development, and validation of biomarkers to monitor progression and treatment responses; performance of genome-wide expression analysis to identify biomarkers for pharmacologic intervention in children and pregnant women; studies of genetic variations through genome-wide association analysis to determine whether genetic variants affect drug metabolism and disposition; genomic, proteomic, and epigenomics research associated with variability in pharmacokinetics and pharmacodynamics during pregnancy and during childhood; developing novel mathematical, statistical, and computational methods to modeling and simulating PK/PD and evaluating existing methods in children and pregnant women; and other similar research areas.

Because the nature and scope of the studies will vary, NICHD expects that the size and duration of the awards it will distribute also will vary, and the total number it awards will depend on the quality, duration, and costs of the applications it receives.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.