09 September 2007
I. WHAT'S NEW?
Please Visit Target Health's Blog
II. QUIZ - (Fill In The Blanks)
Cancer Can Be Detected By Scanning Surface Veins
III. HISTORY OF MEDICINE
How Can Medicine Not Include Evolution?
IV. PSYCHIATRY
Is There a Genetic Component to Obsessive Compulsive Disorder (OCD)?
V. RHEUMATOLOGY
STAT4 Gene and its Correlation With RA and Lupus
VI. BARIATRIC MEDICINE
Longterm Mortality Data Are Out on Gastric Bypass Surgery
VII.
REGULATORY AFFAIRS
Orphan Drug Approval For Acromegaly
VIII. TARGET HEALTH
II. QUIZ
(Fill
In The Blanks)
Cancer Can Be Detected By Scanning Surface Veins
A new technology for cancer detection that eliminates the need for drawing 1) ___ has been developed by Purdue University, cancer, chemistry, and biomedical engineering researchers, collaborating with cancer and biotechnology experts from the Mayo Clinic. By shining a 2) ___ on surface veins, such as those on the wrist and inside the cheek, the team was able to reveal and count circulating tumor cells. In addition to being less 3) ___, the new detection method is able to evaluate a much larger volume of blood than what can normally be drawn from a patient. In the 4) ___ stages of cancer, there are very few circulating tumor cells - cells that indicate the spread of cancer and initiate secondary tumor formation. By increasing the volume of blood analyzed, the sensitivity of the test is improved and allows for earlier 5) ___. If there are two cancer cells in every 50 milliliters of blood, odds are the cells would not be found in a 10-milliliter blood sample. However, the cells would be found in the 100 milliliters of blood that flow through large 6) ___ each minute. Circulating tumor cells provide a benchmark for disease progression and precise 7) ___ of their levels could lead to personalized treatment. This technique allows the quantification of the amount of circulating tumor cells, as opposed to tests that provide a 'positive' or 'negative' result. Through such precise monitoring, a physician could evaluate the response to 8) ___ and regularly adjust the dosage so that only the exact amount needed would be administered. This could reduce the time a patient is treated and the serious side effects that occur. The technique could provide doctors and patients results in a matter of minutes and save the medical industry millions of dollars in testing equipment.IV. PSYCHIATRY
Is There a Genetic Component to Obsessive Compulsive Disorder (OCD)?
There are 2.2 million American adults haunted by unwanted thoughts and repetitive behaviors associated with obsessive-compulsive disorder (OCD). According to an article published in Nature (2007;448:xiii-xiii), using genetic engineering, a team of NIH researchers have created an obsessive-compulsive disorder (OCD)-like set of behaviors in mice and reversed them with antidepressants and genetic targeting of a key brain circuit. The gene involved is SAPAP3, which is the only member of a glutamate-regulating family of proteins that is present in large amounts in the striatum. SAPAP3 is part of the machinery at the receiving end of the connections between brain cells, where the neurotransmitter binds to receptors. For the study, mice without the gene SAPAP3 were bred to make a protein that helps brain cells communicate via the glutamate chemical messenger system. Serendipitously, results showed that without this specific gene, defects were found in a brain circuit previously implicated in OCD, and much like people with a form of OCD, the mice engaged in compulsive grooming, which led to bald patches with open sores on their heads. They also exhibited anxiety-like behaviors. When the missing gene was reinserted into the circuit, both the behaviors and the defects were largely prevented. According to the authors, since this is the first study to directly link OCD-like behaviors to abnormalities in the glutamate system in a specific brain circuit, it may lead to new targets for drug development. Previous studies of OCD had implicated a circuit in which the striatum, which straddles the middle of the brain, processes decisions by the cortex, the executive hub at the front of the brain. The initial investigation was initiated to understand the function of the protein made by the SAPAP3 gene. To find out how it worked, the investigators used genetic engineering to generate SAPAP3 knockout mice. The mice seemed normal at first, but after four to six months, all developed telltale bald patches of raw flesh on their faces, caused by compulsive scratching. Videotapes confirmed that the sores were self-inflicted -- grooming behavior gone amok. In a series of behavioral tests, it was determined that the SAPAP3 knockout mice also showed anxiety-like behaviors, often associated with OCD. They were slower to venture into -- and quicker to exit -- risky environments. And like their human counterparts, the animals responded to treatment with a serotonin selective reuptake inhibitor (fluoxetine), which reduced both the excessive grooming and anxiety-like behaviors. When the striatum of seven-day-old knockout mice was injected with a probe containing the SAPAP3 gene, it protected the mice from developing the OCD and anxiety-like behaviors 4 to 6 months later and corrected the circuit dysfunction. This confirmed that the absence of the SAPAP3 gene in the striatum was indeed responsible for the OCD-like effects. According the authors, the findings suggest that anxiety-related behavior may stem from the striatum, which serves as a pivotal link between the cortex and emotion hubs. Caution: Diagnostic labels in humans may not be fully translated to mice as there is also a psychological basis for OCD.V. RHEUMATOLOGY
STAT4 Gene and its Correlation With RA and Lupus
Both rheumatoid arthritis (RA) and systemic lupus erythematosus (lupus) are considered autoimmune diseases, or diseases in which the body's immune system attacks healthy tissue. In RA, the immune system attacks the linings of the joints and sometimes other organs. In lupus, the immune system attacks the internal organs, joints and skin. If not well controlled, both diseases can lead to significant disability. According to an article published in the New England Journal of Medicine (2007;357:13-22), a genetic variation has been identified that increases the risk of RA and lupus. For the study, variants within 13 candidate genes located in a region of chromosome 2, which they had previously linked with RA, were tested for association with disease in large collections of RA and lupus patients and controls. Among the variants were several disease-associated single nucleotide polymorphisms (SNPs) -- small differences in DNA sequence that represent the most common genetic variations between individuals -- in a large segment of the STAT4 gene. The STAT4 gene encodes a protein that plays an important role in the regulation and activation of certain cells of the immune system. According to the authors, it may be too early to predict the impact of identifying the STAT4 gene as a susceptibility locus for RA. It may also be too early to predict whether the presence of the variant and others will serve as a predictor of disease, disease outcome or response to therapy. Results showed that one variant form of the STAT4 gene was present at a significantly higher frequency in RA patient samples as compared with controls. The scientists replicated that result in two independent collections of RA cases and controls. Results again showed that the same variant of the STAT4 gene was even more strongly linked with lupus in three independent collections of patients and controls. Frequency data on the genetic profiles of the patients and controls suggest that individuals who carry two copies of the disease-risk variant form of the STAT4 gene have a 60% increased risk for RA and more than double the risk for lupus compared with people who carry no copies of the variant form. The research also suggests a shared disease pathway for RA and lupus.VI. BARIATRIC MEDICINE
Longterm Mortality Data Are Out on Gastric Bypass Surgery
Although gastric bypass surgery accounts for 80% of bariatric surgery in theVII. REGULATORY AFFAIRS
TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.Orphan Drug Approval For Acromegaly
The FDA approved Somatuline Depot (lanreotide acetate injection) for the treatment of acromegaly. Acromegaly is a rare and potentially life threatening disease in adults and affects approximately 15,000 people in the United States and Canada. It is most commonly found in middle-aged adults. Patients with acromegaly have reduction in life expectancy of 5 to 10 years. Acromegaly is caused by abnormal secretion of growth hormone (GH), commonly from a benign tumor located in the pituitary gland. Excessive GH secretion, working through insulin-like growth factor, can cause enlargement of the hands, feet, facial bones, and enlargement of internal organs such as the heart and liver. If untreated, patients with acromegaly often have a shortened life span because of heart and respiratory diseases, diabetes mellitus, and colon cancer. FDA approved Somatuline Depot for the long-term treatment of patients with acromegaly who have had inadequate response to or cannot be treated with surgery and/or radiation therapy. This new treatment lowers the levels of certain hormones in the body, including GH and insulin-like growth factor. The safety and effectiveness of Somatuline Depot (administered through injection) was determined in two pivotal clinical trials involving a total of 400 patients. Common side effects include diarrhea, gallstones, skin reactions such as itching, slow heart rate, and change in blood sugar levels. Patients with diabetes who receive treatment with Somatuline Depot may need to have their diabetes medication adjusted. FDA designated Somatuline Depot orphan status because the drug treats a rare disease and meets other criteria. Orphan products are developed to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan product. Somatuline Depot will be marketed by Tercica, Inc. in Brisbane, CA.VIII. TARGET HEALTH
TARGET HEALTH INC. (www.targethealth.com)is a full service eCRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND, IDE, NDA, PMA and 510(k) submissions, execution of Clinical Trials, Project Management, Biostatistics and Data Management, Web Trials, utilizing Target e*CRF®, our proprietary Internet-based Clinical Trial System, and Medical Writing. TARGET HEALTH's Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.TARGET
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