(Complimentary Newsletter from Target Health Inc.)
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1 May 2006
I.
WHAT'S NEW?
Target e*CRF® Update
Presentation at Applied Clinical Trial Meeting
II. QUIZ (Fill
In The Blanks)
Laser
Fat Melt
III.
HISTORY OF MEDICINE
Arcagathus - 1st Roman Doctor
IV. CARDIOLOGY
Cardiac Troponin and Disease
V. BASIC SCIENCE
The Alcoholism Gene(s)
VI. INFECTIOUS DISEASE
Vaccine for
VII. NEUROLOGY
Antihypertensive Treatment and
Cognitive Function
VIII. FDA
FDA Approves First Treatment for Pompe
Disease
IX. Target Health Inc.
Target
e*CRF® Update
Target Health, a full
service e*CRO, is pleased to announce that it has closed on a new EDC project
with over 3,000 patients. For this large pharma
company, we are evaluating over 10,000 patients in 5 clinical programs.
Optimizing Clinical
Trials - Applied Clinical Trials Conference
Target Health will be
presenting 2 talks at the Optimization in
Clinical Trials conference, July 18-21, 2006, at the Hamilton Crowne Plaza, Washington, D.C. The first topic will be
"Building Electronic Data Capture Software" and second will
be "Evaluating EDC Vendors". We will also be presenting a demo
of our new EDC software. We can provide discounted registration upon request.
For more
information, please contact Dr.
Jules T. Mitchel.
Laser Fat Melt
Research
results, just presented at a meeting of The American Society for Laser Medicine
and Surgery, demonstrated the successful melting of 1) ___ cells with a laser.
This same laser could be used to treat patients with 2) ___
disease. Heat from an infra-red laser, was used to break down fatty 3)
___ , without harming the overlying skin. So
far, this method has only been tested on 4) ___ fat and two-inch-thick skin
samples. The fat gets melted inside the body but does not heat up the 5) ___.
The melted fat is then able to be excreted from the body. Acne and 6) ___ could be zapped away with a fat-seeking laser. The
scientists acknowledged that it would be several years before selective 7) ___
lasers can be used on humans.
Answers: 1)
fat; 2) heart; 3) tissue; 4) pig; 5) skin; 6)
cellulite; 7) photothermolysis
Arcagathus - 1st Roman Doctor
Pliny, in his Natural History, says that the first
doctor (medicus)
to come to
Cardiac Troponin
and Disease
The prevalence
and determinants of cardiac troponin T (cTnT) elevation in the general population are unknown, and
the significance of minimally increased cTnT remains
controversial. As a result, a study published in Circulation (2006;113:1958-1965), was performed to determine the prevalence
and determinants of cTnT elevation in a large,
representative sample of the general population. For the study, cTnT was measured from stored plasma samples in 3,557
subjects of the Dallas Heart Study, a population-based sample. Results showed
that cTnT elevation (> 0.01 µg/L) was correlated
with clinical variables and cardiac MRI findings. In univariable
analyses, cTnT elevation was associated with older
age, black race, male gender, coronary artery calcium by electron beam CT, a
composite marker of congestive heart failure (CHF), left ventricular
hypertrophy (LVH), diabetes mellitus (DM), and chronic kidney disease (CKD)
(P<0.001 for each). Subjects with minimally increased (0.01 to 0.029 µg/L)
and increased (> 0.03 µg/L) cTnT, had a similar
prevalence of these characteristics. In multivariable logistic regression
analysis, LVH, CHF, DM, and CKD were independently associated with cTnT elevation. According to the authors, within the
general population, cTnT elevation is rare in
subjects without CHF, LVH, CKD, or DM, suggesting that the upper limit of
normal for the immunoassay should be <0.01 µg/L. The authors added that
since even minimally increased cTnT may represent subclinical cardiac injury, this hypothesis that should be
tested in longitudinal outcome studies.
The Alcoholism
Gene(s)
According to an
article published in the Proceedings of the National Academy of Sciences (2006
103:6368-6373),new genes have been identified that may
contribute to excessive alcohol consumption. The new study, conducted with
strains of animals that have either a high or low innate preference for
alcohol, provides clues about the molecular mechanisms that underlie the tendency
to drink heavily. For the study, mice were used that had been selectively bred
to have either a high or low preference for alcohol. This model of disease has
been a mainstay of alcohol research for many years, allowing investigators to
study diverse behavioral and physiological characteristics of alcohol
dependence. The current study used microarray
techniques to study gene expression in the brains of these animals. Microarrays are powerful tools that are used for
comprehensive analyses of gene activity. When a gene is activated, cellular
machinery transcribes certain parts of the gene's DNA into messenger RNA
(mRNA), which is the body's template for creating proteins. The complete set of
transcribed mRNA in a tissue is termed the "transcriptome.
The study examined brain transcriptomes of nine
strains of mice, each differing in their voluntary alcohol consumption. By
measuring total gene expression in brains of each of the mouse models, it was
possible to explore which transcripts were consistently changed in different
genetic models of high and low alcohol intake. By doing this, the
transcriptional signatures of genetic predisposition to high and low alcohol
consumption could be defined. The research team employed novel statistical
techniques to identify nearly 4,000 differentially expressed genes between the
high and low alcohol drinking mouse strains and to narrow the focus to 75
primary candidate genes. In addition, a comparison of the mouse data with human
genetic studies revealed that genes with significant expression differences
reside in chromosomal regions that previously were shown to be associated with
human alcoholism. According to the authors, numerous pathways, as well as genes
whose functions are currently unknown, may contribute to the genetic
predisposition to drink high amounts of alcohol. The authors added that the
results will provide the ability to focus on targets never previously
implicated in excessive drinking. For example, genetic studies have shown that
chromosome 9 contains genes that may regulate alcohol consumption in mice and
the current analysis may allow the narrowing of the focus from thousands of
genes in that region to twenty.
Vaccine for
Effective countermeasures
are urgently needed to prevent and treat infections caused by highly pathogenic
and biological threat agents such as
Antihypertensive Treatment and Cognitive Function
The effectiveness of
treating older persons for hypertension remains controversial. Although clinical
trials suggest no short-term harm, and even some benefits, there are little
data on the effect on cognitive function of long-term antihypertensive
treatment. As a result, a study published in the journal Stroke (2006;37:1165), evaluated the risk of dementia and cognitive
decline associated with duration of antihypertensive treatment. For the study,
data were derived from the Honolulu Asia Aging Study. This study has followed
Japanese American men since 1965. Subjects included in this analysis were hypertensive
from midlife and dementia-free in 1991 (mean age 76.7 years). In 1991, 1994 and
1997, global cognitive function was assessed with the Cognitive Abilities
Screening Instrument (CASI) and dementia by a standardized examination using
international criteria. The sample was grouped by treatment duration
(never-treated hypertensives (NTH), <5 years, 5 to
12 years, >12 years). Normotensive subjects up to
1991 were included in the analysis as a control group. Results showed that for
each additional year of treatment, there was a reduction in the risk of
incident dementia (hazard ratio [HR]=0.94). The risk
for dementia in subjects with >12 years of treatment was lower compared to
NTH (HR for dementia = 0.40 and for Alzheimer disease HR=0.35. Nondemented subjects with 5 to 12 years of treatment had
lower yearly CASI decline compared to NTH. It was concluded that in
hypertensive men, the duration of the antihypertensive treatment is associated
with a reduced risk for dementia and cognitive decline.
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.
FDA Approves First Treatment for Pompe Disease
FDA has approved a biologics
license application (BLA) for Myozyme (alglucosidase alfa, rhGAA), the first treatment for patients with Pompe disease, a rare but severely
debilitating disease. Pompe disease, which affects
one in 40,000-300,000 individuals, drastically reduces a person's muscle and
respiratory function. Pompe disease is an inherited
disease caused by the deficiency or lack of the enzyme acid alpha-glucosidase, which is essential for normal muscle
development and function. The disease, which usually results in death from
respiratory failure, is rapidly fatal in newborn babies. Myozyme
had been granted FDA Orphan Drug designation and was approved under a priority
review. Orphan products are developed to treat rare diseases or conditions that
affect fewer than 200,000 people in the
For more information
about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel
or Dr. Glen Park.
TARGET HEALTH INC. (www.targethealth.com)
is a full service e*CRO with fulltime 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 (PADT) assists companies in strategic
planning from Discovery to Market Launch. Let us help you on your next project.
TARGET HEALTH INC.
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24th Floor
New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105
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Dr. Jules T. Mitchel,
President
Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved