10 June 2007
I. WHAT'S NEW?
Target e*CRF® (EDC) Regulatory Submissions (16) and Approvals (13)
II. QUIZ - (Fill In The Blanks)
Cancer Wonder Drug
III. HISTORY OF MEDICINE
Medicine in Chaucer’s England
IV. INFECTIOUS DISEASE
New Mechanism To Fight Infections
V. ONCOLOGY
Biomarkers Predict Outcomes in Head and Neck Cancer
VI. NEUROLOGY
Early Diagnosis of Type 2 Diabetes and Stroke Risk
VII.
REGULATORY AFFAIRS
FDA Approves 7-Day Glucose Monitoring Device
VIII. TARGET HEALTH
I.
WHAT'S NEW
II. QUIZ
(Fill
In The Blanks)
Cancer Wonder Drug
ST1 571, or Imatinib, also known as 1) ___ is a cancer pill, approved by the FDA in 2001, that is being used to treat CML, 2) ___ ___ ___and may be effective in treating certain types of brain, specifically glioblastoma, as well as stomach cancers, especially gastrointestinal stromal tumors (GIST), a rare cancer of the digestive system's connective tissue. STI-571 is a part of a growing group of molecularly targeted treatments in which drugs are designed to treat diseases with specific 3) ___ changes. It blocks a signal that the abnormal 4) ___ sends out, preventing the abnormal growth and production of other cancerous cells. In GIST, imatinib blocks a different abnormal enzyme found on the tumor cells. The drug has turned one of the commonest forms of leukemia from a deadly disease to a manageable chronic illness. Trials have shown that around 90% of patients with CML who take Gleevec are alive and well after 5) ___ years. Gleevec is also showing good progress with related cancers. Although it does not cure the cancer, it keeps it under control. This one-a-day cancer pill is hailed a life-saver. It is recommended for those for whom a 6 ___ ___ transplant - the normal radical treatment for CML - is not an option. Patients will have to take the drug for 7) ___ and although it takes some weeks normally before real benefits can be measured, it means that the leukaemia becomes manageable. Imatinib is being investigated for its effectiveness against other kinds of cancer, as well, including acute lymphocytic leukemia and hypereosinophilic syndrome (HES). 8) ___, the maker of imatinib, has a Patient Assistance Program, (PAP) to help patients who may be eligible for financial assistance in covering the cost of the drug.IV. INFECTIOUS DISEASE
New Mechanism To Fight Infections
To survive during colonization or infection of the human body, microorganisms must circumvent mechanisms of innate host defense. Antimicrobial peptides (AMPs) represent a key component of innate host defense, especially in phagocytes and on epithelial surfaces. AMPs are defense molecules sent by the body to kill bacteria. AMPs are made by virtually all groups of organisms, including amphibians, insects, several invertebrates and mammals, including humans. Bacteria are divided into two types, gram-positive and gram-negative, with the primary difference being the nature of the bacterial cell wall. Little is known about how gram-positive bacteria, such as those that can lead to food poisoning, skin disorders and toxic shock, avoid being killed by AMPs. According to an article published in the Proceedings of the National Academy of Science (2007;104:9469-9474), a survival mechanism for gram-positive bacteria has been discovered. For the investigation, the gram-positive bacterium Staphylococcus epidermidis was studied in its response to a specific human AMP, human beta defensin 3. S. epidermidis is one of several hard-to-treat infectious agents that can be transmitted to patients in hospitals via contaminated medical implants. Other well-known types of gram-positive bacteria include agents that cause anthrax, strep throat, flesh-eating disease and various types of food poisoning. By exploring the genome-wide gene regulatory response to human beta-defensin 3 in S. epidermidis, an antimicrobial peptide sensor system was discovered that controls major specific resistance mechanisms of Gram-positive bacteria. This sensory system contains a classical two-component signal transducer and an unusual third protein, all of which are indispensable for signal transduction and antimicrobial peptide resistance. Studies show that all three components of aps must be present for the system to function and effectively protect bacteria from AMPs. According to the authors, the study may also provide a promising target for antimicrobial drug development In gram-negative bacteria, such as those that cause plague and salmonellosis. In these organisms the gene regulation system PhoP/PhoQ protects invading bacteria. The authors added that once there is a better understanding of these systems, new drugs could be developed that are more effective at protecting people from infection.V. ONCOLOGY
Biomarkers Predict Outcomes in Head and Neck Cancer
It is estimated that more than 34,000 Americans will be diagnosed with cancer of the oral cavity and pharynx (the middle part of the throat that includes the soft palate, tonsils, and tongue) in 2007, and that 7,550 will die from it. Alcohol and tobacco use are the most important risk factors for head and neck cancers, with tobacco use accounting for 85% of the cases. Just last month, it was reported that STD transmission of human papillomavirus is strongly associated with throat cancer, especially in cancers arising from the tonsils and base of the tongue. Because surgical treatment can severely impair a patient's quality of life by damaging voice, speech, and swallowing, in many cases physicians and their patients are now opting for a combination of chemotherapy and radiation as a first line of treatment. However, there is no way to predict which patients will respond well to this treatment or whether a tumor will return later. According to a study published in Clinical Cancer Research (2007 13: 3182-3190), a blood test that detects proteins commonly released by a growing tumor could one day become a useful tool for monitoring the effectiveness of chemotherapy and radiation treatment in people with advanced throat cancer. For the study, starting immediately before treatment and continuing every three months for 12 months, 30 patients were tested for five proteins that, in previous studies, had been found to occur at heightened levels in head and neck cancer patients. These include two cytokines -- Interleukin (IL)-6 and IL-8, and three growth factors -- growth-related oncogene (GRO)-1, vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF). These cytokines and growth factors play an important role in the body's inflammatory response and in the growth of cells and new blood vessels. Results showed that patients whose blood levels of these cytokines and growth factors dropped and remained low following treatment were more likely to continue in remission. In contrast, patients who experienced large increases in protein levels were more likely to exhibit a return of the cancer or to die from it. For example, large increases in IL-6, VEGF, and HGF concentrations over time yielded a 3.8-fold, 3.0-fold, and 2.9-fold higher risk of dying of throat cancer, respectively. Patients with an increase in three or more factors were at highest risk for dying of throat cancer-more than twice as likely as patients with an increase in two or fewer factors. Finally, patients with the sharpest rises in protein levels had lower chances for survival, with patients who had a history of smoking experiencing the largest spikes. Because the production of these growth factors and cytokines is controlled by the same "master switch" -- a regulator protein known as nuclear factor kappa B (NF-kappaB), the authors suggest that this protein may represent a new target for drug therapy. In addition, because IL-6, IL-8, VEGF, and HGF have been detected in the blood of patients with breast, cervical, ovarian, and other cancers, they suggest that this technique may have broader application in the monitoring of other forms of cancer.
VI. NEUROLOGY
Early Diagnosis of Type 2 Diabetes and Stroke Risk
Cardiovascular risk factors are suboptimally treated in diabetes, possibly because of the impression that there is a long delay between diagnosis and the development of macrovascular complications such as stroke. As a result, a study, published in the journal Stroke (2007;38:1739-1743), was performed to determine the incidence of stroke in people newly treated for type 2 diabetes. For the study, subjects entered a type 2 diabetes cohort on receipt of their first prescription for an oral antidiabetic medication. Age-standardized incidence rates for stroke were compared between the diabetes cohort and the general population. For the analysis, there were 12,272 subjects in the diabetes cohort, with a mean age of 64 years; 55% were male. During a mean 5-year follow-up, 9.1% of the diabetes cohort had a stroke. The age-standardized incidence rate for stroke was 642 per 100,000 person-years in subjects with diabetes, compared with 313 per 100,000 person-years in the general population (rate ratio=2.1). The relative short-term risk for stroke in the diabetes cohort compared with the general population ranged from 1.8 in persons >75 years to 5.6 in the 30- to 44-year age group. According to the authors the risk of stroke is high within 5 years of treatment for type 2 diabetes and is more than double the rate for the general population. The authors add that this observation further supports the need for aggressive early cardiovascular risk factor management in type 2 diabetes.VII. 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.
FDA Approves 7-Day Glucose Monitoring Device
Diabetes is caused by the body’s inability to produce or use insulin, a hormone that unlocks the cells of the body, allowing glucose (sugar) to enter and fuel them. An estimated 20.8 million people in the United States (7% of the population) have diabetes. Most have type 2 diabetes, a condition in which the body does not properly use insulin. An estimated 5-10% of people with diabetes have type 1 diabetes, which results from the body's failure to produce insulin. People with type 1 diabetes must take insulin every day. Diabetes can lead to wide fluctuations in blood sugar levels. Over time, abnormally high levels of glucose can damage the small and large blood vessels, leading to diabetic blindness, kidney disease, amputations of limbs, stroke, and heart disease. While there is no known cure, studies have shown that patients who regularly monitor and regulate their blood glucose levels have lower incidences of complications associated with the disease. The FDA approved a device that measures glucose levels continuously for up to seven days in people with diabetes. While a standard fingerstick test records a person’s glucose level as a snapshot in time, the STS-7 Continuous Glucose Monitoring System (STS-7 System) measures glucose levels every five minutes throughout a seven-day period. This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick measurements alone. However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed. The STS-7 System, manufactured by DexCom Inc. of San Diego, Calif., uses a disposable sensor placed just below the skin in the abdomen to measure the level of glucose in the fluid found in the body’s tissues (interstitial fluid). Sensor placement causes minimal discomfort and can easily be done by patients themselves. The sensor must be replaced weekly. An alarm can be programmed to sound if a patient’s glucose level reaches pre-set lows or pre-set highs. FDA’s approval of the STS-7 System was based on results of a study conducted by DexCom of 72 patients with diabetes at five clinical sites in the United States. The study demonstrated that the STS-7 System was safe and effective for detecting trends and tracking patterns in glucose levels in adults.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 (PADT) assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.
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