The parasite that causes malaria is showing signs of resistance to the most potent drugs currently used against it. Scientists report that top-line drugs called artemisinins take nearly twice as long to knock out the parasite in people who contract malaria in western Cambodia as the drugs take in other areas—suggesting the parasite is finding ways to thwart the drugs’ effects.
Source: Science News
DENVER, Colo. — October 21, 2008 — Corgenix Medical Corporation (OTC BB: CONX) announces that new CHARISMA trial findings published in Circulation confirm that elevated urinary levels of the biomarker 11-dehydro thromboxane B2 (11dhTxB2) indicate an increased risk of heart attack, stroke and cardiac death.
The AspirinWorks® Test by Corgenix is the only FDA-cleared test that measures urinary 11dhTxB2 to accurately determine aspirin effect in apparently healthy individuals. 11dhTxB2 is a metabolite of thromboxane, the target of aspirin therapy.
The new findings, published in the October 21 issue of the American Heart Association’s peer-reviewed medical journal Circulation, directly link increased levels of this powerful biomarker to a patient’s risk of heart attack and stroke, potentially changing how millions of people worldwide are tested for aspirin effect and treated to prevent heart attacks and strokes.
The sub-study of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) trial was carried out with the pre-FDA-cleared version of the AspirinWorks Test. The test subsequently received FDA clearance in May 2007 and is available worldwide.
Cardiologist Paul A. Gurbel, M.D., Director, Sinai Center for Thrombosis Research at Sinai Hospital of Baltimore, said the study supports that measurement of urinary 11-dehydro thromboxane B2 can identify patients at risk for ischemic events and can be used as an independent risk factor for heart disease and stroke.
“Interestingly, the investigators observed a dose-dependent effect of aspirin on levels of this marker,” explained Gurbel. “These data are consistent with our (Sinai Center for Thrombosis Research) previous randomized data from the double crossover ASPECT study that evaluated the effect of three commonly used aspirin doses published last year in Circulation. We also found a reduction in 11-dehydro thromboxane B2 between 81 mg and 325 mg.
“These findings strongly support the role of urinary 11-dehydro thromboxane B2 concentrations as an independent predictor of cardiovascular risk in aspirin-treated patients,” said Gurbel. “The findings of both the ASPECT study and current investigation also raise the potential for adjusting aspirin doses to modify risk by reducing in vivo thromboxane synthesis.”
CHARISMA is a multinational, multicenter, randomized, parallel group, double-blind trial involving 15,603 patients with either clinically established cardiovascular disease or multiple risk factors. The pre-specified CHARISMA sub-study involved a total of 3,261 aspirin-treated patients from 224 sites in 12 countries.
Among the principal findings was that the upper quartile of urinary 11dhTxB2 concentration in a broad population of high-risk patients treated with usual doses of aspirin (75 to 325 mg) was independently associated with an increased risk of serious cardiovascular events. Other findings from the trial include:
1) Aspirin and statin treatment were associated with lower concentrations of 11dhTxB2.
2) Randomization to clopidogrel (vs. placebo) did not reduce urinary 11-dehydro thromboxane B2 levels nor did it reduce the hazard of cardiovascular events in patients in the highest quartile of urinary 11dhTxB2 levels.
“This is the outcome study we have all been waiting for because it demonstrates the potential value of the AspirinWorks test (11dhTxB2) for optimizing an individual’s aspirin therapy. The publication of these findings in one of the most prestigious medical journals further demonstrates the value and viability of the AspirinWorks product,” said Douglass Simpson, Corgenix’ President and Chief Executive Officer. “The ability to quickly, easily and accurately determine the effect of aspirin in patients gives the AspirinWorks test a strong and unique position in the U.S. and global cardiovascular diagnostic testing marketplace.”
For more information on AspirinWorks, visit www.aspirinworks.com. To access the full Circulation article, go to: http://circ.ahajournals.org. Physicians and laboratories interested in ordering the test can call 1-800-729-5661 x180, or e-mail: info@aspirinworks.com. The AspirinWorks Test is also available directly to consumers through HealthCheckUSA at www.healthcheckusa.com.
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders, including the world’s only non-blood-based test for aspirin effect. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience advancing products through the FDA process. More information is available at www.corgenix.com.
Statements in this press release that are not strictly historical facts are “forward looking” statements (identified by the words “believe”, “estimate”, “project”, “expect” or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.
Source: Corgenix Medical Corp.
As we approach the cold weather, you may see your kids sniffling more, having sore throats and stuffy noses.
Choosing the appropriate remedy from a wide variety of over-the-counter medications is an important choice for parents. Over the past year there has been a lot of communication about whether or not these products should be used to treat children. The rules for marketing many of these products were developed many years ago. These rules do not always require that the products be studied in children to show whether they work for children but instead allow conclusions from experience of their effectiveness in adults.
My Take is that we must now understand scientifically that children are not just little adults. Current scientific standards must be used to assure these medications are effective and safe for your children in the correct prescribed dose to treat your child’s cough and cold.
FDA has been gathering information on these products, and we have held two public meetings with stakeholders. Thus far, we have recommended that these products not be used in children under the age of two because of concerns about serious and potentially life-threatening side effects.
In the meantime, manufacturers are taking voluntary actions. Some have announced that they will change the labeling of these products to include the statement “do not use” in children under four years of age. Manufacturers are also introducing other ways to help better inform consumers and to prevent misuse – such as new child-resistant packaging and new measuring devices for use with these products.
One thing is for certain: we must not give children medication labeled only for adults. And, when deciding on the right doses for children we need to rely on modern scientific standards.
While the FDA works to gather data and revise the labeling of certain ingredients and dosing for cough and cold products for children, please consult with your doctor or pharmacist with your particular questions about the use of these medications for your child or grandchild.
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs (FDA)
The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials.
“This collaboration with the PATH-MVI supports the overall mission of the FDA and specifically the Agency’s work under our Critical Path Initiative,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “We are actively seeking ways to help organizations such as PATH develop safe and effective products that can benefit the public health both in the United States and globally.”
PATH is an international, nonprofit organization that creates sustainable, culturally relevant solutions to improve global health and well-being. PATH-MVI supports the development of malaria vaccines and is expected to spearhead the efforts to ensure their availability and accessibility in the developing world once a safe and effective vaccine becomes available.
The PATH-MVI collaborative project is expected to span about three years and is being conducted under the Cooperative Research and Development Agreement (CRADA) program, which allows federal laboratories and businesses to form partnerships that help expedite research activities. Recent scientific advances suggest that vaccines based on live, weakened (attenuated) malaria parasites may be possible in the future but assessing safety and effectiveness in the early stages of product development is challenging. Under this CRADA, PATH-MVI provides the FDA with about $1.5 million to develop tests for evaluating malaria vaccines early in their development.
To date, there are no approved vaccines to prevent malaria but several vaccines are in development. This CRADA will help develop laboratory tests to assess whether a vaccine candidate is safe enough to begin Phase I clinical trials.
Each year 350-500 million cases of malaria occur worldwide, killing an estimated one million people, most of them young children in sub-Saharan Africa. Travel between the United States and the affected areas, as well as men and women in the U.S. military who are stationed in regions at high risk for malaria, can bring the disease into the United States.
The Center’s Global Vaccine Initiative fosters the development, evaluation and availability of vaccines needed to protect against major global infectious diseases and is part of the Center’s commitment to work with others, including the World Health Organization, in advancing global public health.
The Critical Path Initiative is the FDA’s effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated and manufactured.
A landmark research study into childrens’ health, the National Childrens’ Study, will now add the St Louis area. Researchers will monitor children from Jefferson County in Missouri and Johnson, Union and Williamson counties in southern Illinois from before birth to age 21 to learn more about environmental and genetic influences on diseases.
Saint Louis University School of Public Health was awarded a $26.3 million contract from the National Institutes of Health, the Centers for Disease Control and Prevention (CDC) and the U.S. Environmental Protection Agency.
“Families in Jefferson County and southern Illinois will have an opportunity to be on the forefront of landmark research into child and maternal health,” says Terry Leet, Ph.D., lead investigator of the Jefferson, Johnson, Union and Williamson counties study sites and chairman of the department of community health at Saint Louis University School of Public Health. “Ultimately, what we find will benefit all Americans because we will gain information to help develop strategies to prevent disease, design health and safety guidelines and possibly find new treatments and cures for diseases.”
Saint Louis University School of Public Health was awarded a $26.8 million contract last year to monitor the health of children from St. Louis City and Macoupin County in Illinois, and the research team will enroll participants from those areas in 2010.
Dr. Leet, who was recently appointed to serve on the executive steering committee of the National Children’s Study, is lead investigator of both sets of study sites. This appointment acknowledges his national expertise in maternal and child health.
The four Missouri and Illinois sites form the region’s Gateway Study Center. Partnering institutions are Saint Louis University School of Medicine; Southern Illinois University Edwardsville School of Nursing; Southern Illinois University School of Medicine; Washington University School of Medicine; Southern Illinois University Carbondale’s Center for Rural Health and Social Service Development; and Battelle Memorial Institute.
Factors affecting a child’s health before it is born will be followed, and information about diet and exposure to chemicals and other substances in the environment and emotional stress.will be obtained from pregnant women or women likely to become pregnant.
“Recruiting mothers before conception, or in very early pregnancy, means we can measure environmental influences when the fetus is first forming. We have limited knowledge currently but we know that early exposures can have lifelong effects on metabolism and risk of chronic disease in adulthood,” said Louise Flick, DrPH, co-principal investigator and professor of nursing from Southern Illinois University Edwardsville School of Nursing.
Once the child is born, researchers will collect air, water and environmental samples from where children spend most of their time. They will analyze fingernail, hair, blood and urine samples and screen for birth defects, injury susceptibility, physical and mental disorders, asthma, diabetes and obesity, among other conditions.
“Our research will give scientists access to a vault of information that could ensure a healthier future for generations to come,” Leet says. “What we find could have huge implications for the health of our children and their children’s children.” “Large population-based studies are best suited by institutions with overlapping, yet distinct skills,” said Allison King, M.D., assistant professor of pediatrics and of occupational therapy at Washington University School of Medicine in St. Louis and co-principal investigator of the study. “We are lucky enough to have several strong institutions in the area that complement each other.”
The National Children’s Study will be conducted in 105 locations across the country. During the last two years, Congress has appropriated a total of $179.9 million to support the project.
A revolutionary new technique, which involves jump-starting the growth of nerve fibers to compensate for brain cells destroyed by the stroke, may be capable of restoring functions to a stroke patient weeks, and even months after the attack, according to a recent report.
“In the best-case scenario, this would open up the window of time that people could recover and go back to normal functional status,” said Gwendolyn Kartje, MD, Ph.D., a professor in the department of cell biology, neurobiology and anatomy and department of neurology at Loyola University Chicago Stritch School of Medicine.
The experimental approach is described by Kartje and colleagues in the journal Topics in Stroke Rehabilitation. Called anti-nogo-A immunotherapy, anti-nogo has dramatically improved functions in lab animals that have experienced strokes. Anti-nogo is also the subject of an ongoing clinical trial in Europe and Canada to test the technique in patients with spinal chord injuries.
Most strokes are caused by clots that block blood flow to one part of the brain, killing brain cells within hours. The drug TPA can minimize damage by dissolving the clot. But TPA is safe and effective only when given within about three hours of the onset of symptoms. Most patients don’t receive treatment within that brief window. Patients typically arrive at the hospital too late, or hospitals do not begin administering TPA soon enough.
Nogo-A is a protein that inhibits the growth of nerve fibers called axons, and checks uncontrolled nerve growth causing excessive sensitivity to pain, or involuntary movements.In anti nogo immunotherapy, an antibody disables the nogo protein.
The left side of the brain controls movements on the right side of the body, and vice versa. Thus, a stroke on the left side of the brain can cause paralysis on the right side of the body. In such a patient, anti-nogo would, it’s hoped, spur the growth of axons from the healthy right side of the brain. These axons would then grow into the right side of the body and restore functions lost by the stroke.
Rats that have undergone strokes in old age have been tested with anti nogo. After anti nogo function in the front paw of the affected side was almost completely restored in some rats. The Novartis company is sponsoring a phase 1 clinical trial of anti-nogo for patients paralyzed by spinal cord injuries, and a clinical trial for stroke [patients could begin by 2012, according to Kartje, who believes anti-nogo has great potential for stroke patients.
Anti nogo “offers the potential for stroke patients to recover, return to nearly normal functional status, and stay out of nursing homes,” Kartje said. “Theoretically, there’s no reason why this should not happen.”
Source: Loyola University Health System
We as patients often assume that a prescription for health involves taking medicines. The drugs that FDA approves are essential for treating disease, but perhaps the most important prescription to prevent many diseases is the food we eat.
Our food not only needs to be safe to protect our health – but also nutritious, in order to promote our health. The FDA’s core mission is to do both, and the Center for Food Safety and Applied Nutrition and other components of FDA, like our Division of Personalized Nutrition and Medicine at NCTR, are hard at work in researching and developing new frontiers in the field of nutrition.
Proper nutrition is an old concept so why do we still have problems with our diet? The answer is complex. But – just like prescriptions for medicine – nutrition must become more personalized because people are different. When I was growing up I could not understand why my brother could eat so much more than I did, and yet he was so much thinner. He obviously metabolized food differently. Because of advancements in science, technology and medicine, we now know that our genes and how they function make us all unique, and we need to factor that understanding into recognizing that our nutritional needs are unique.
In the past, public health recommendations looked like a “one size fits all” approach to nutrition, breaking food down into groups that every school child could easily identify—and we made very good, but very broad recommendations about what we should eat—like fruits and vegetables.
But today we are breaking new frontiers in nutrition and eating behavior. One example is we are beginning to understand the benefits of nutrition at the genetic level. For example, we have identified 50 genes associated with how the human body processes meat and the changes in genes metabolizing starch.
In the future, we will understand your individual needs for such things as vitamins. And if you know your genetic make up and how your body metabolizes different food groups, you will be able to learn how specific nutritional choices you make will affect your health.
As researchers unravel the science, FDA will speed the pathway and apply cutting-edge discoveries in nutrition as quickly as possible, whether it’s in the field of dietary supplements, micronutrients, or our approach to the food label we put on the items you purchase. I hope you will visit the website for FDA’s Center for Food Safety and Applied Nutrition on a regular basis, as well as the USDA web site: MyPyramid.gov, to get the latest on how food can be your prescription for health.
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
Cancer cells can bypass the immune system by pretending to be harmless. But researchers at the University of North Carolina at Chapel Hill’s Eshelman School of Pharmacy, led by Moo J. Cho, Ph.D., an associate professor of molecular pharmaceutics, are creating a way to expose these cancer cells and alert the immune system to recognize and attack the tumor.
“It’s like planting a big red flag on the tumor to attract the attention of the body’s immune system, which normally ignores cancerous cells,” Cho said. “It’s a great idea. We just don’t know how to do it yet.”
The Natinal Cancer Institute has awarded Dr. Cho, a member of UNC’s Lineberger Comprehensive Cancer Center. The goal of the research is to develop a unique way to intravenously administer a nucleic acid derived from bacteria and deliver it to a tumor. While it is possible to inject some tumors directly, many are relatively inaccessible and can be better reached through the body’s own pathways, Cho said.
The bacteria’s nucleic acid would normally be excreted very rapidly from the body when delivered via IV. Cho plans to add a molecule to the nucleic acid that will allow it to latch on to a class of proteins called IgG immunoglobulin that occur naturally in the body.
“We will ask the IgG antibodies to carry the bacteria-derived nucleic acid as a guest throughout the body,” Cho said. “This will allow the nucleic acid to circulate for days, which is different from how antibodies have been used in classical targeted delivery.”
Cho believes that eventually enough nucleic acid will be carried to the tumor to attract the attention of nearby immune cells, which recognize the nucleic acids as an invading pathogen, triggering an anti-tumor immune response. This approach differs from the classical method of actively targeting a tumor based on specific markers.
“Rapidly growing solid tumors are surrounded by imperfect, almost chaotic, blood flow,” Cho said. “The tissue is very leaky. Because of this unusual permeability, the antibody-nucleic acid complex should become lodged in the tumor periphery. This should mimic a local infection, which the body will work to eliminate.”
Infecting a tumor so that the body can see it and kill it is one element of immunotherapy, a cancer-treatment option that has been used since the late nineteenth century but has fallen out of favor since the development of radiation therapy and chemotherapy. Radiation and chemotherapy are well understood and relatively predictable, but they can kill healthy cells as well as cancerous ones, suppress the immune system, and come with unpleasant and often dangerous side effects.
“You can use a sledgehammer to kill a fly,” Cho said. “But I prefer to try a lighter touch.”
A recent study presented at the American Society for Therapeutic Radiology and Oncology meeting, claims that accelerated partial breast irradiation (APBI) using a newer type of irradiation therapy called balloon brachytherapy reduces radiation therapy from six or seven weeks to one, and is as effective in keeping breast cancer from coming back as the standard external beam radiation treatment.
“Not only does it make radiation treatment much more convenient, it may actually increase the rate of breast conservation, since some women choose mastectomy because they live too far from a radiation center and cannot afford the time and expense of six to seven weeks of living or traveling to the center,” Peter Beitsch, M.D., lead author of the study and a surgical oncologist at Medical City Dallas Hospital in Dallas, said. “Also, there are many women who for a host of reasons don’t receive the necessary postoperative radiation and the shortened course should hopefully allow more women to receive the therapy that they need.”
Many women have a lumpectomy followed by radiation therapy, which enables them to keep their breast after treatment, a process that can last some six or seven weeks. Brachytherapy treats only the area surrounding the tumor, instead of the whole breast. After removal of the tumor, a small balloon is inserted into the cavity. The balloon is attached to a catheter which delivers high doses of radiation via tiny radioactive seeds into the lumpectomy cavity.
The American Society of Breast Surgeons (ASBS) MammoSite RTS Registry Trial evaluated data from more than 1,400 women with early stage breast cancer who were treated with balloon brachytherapy using the MammoSite Radiation Therapy System, one type of breast brachytherapy. In this study, 400 women were followed for nearly four years and results show that women with early-stage breast cancer who are treated with APBI using this type of balloon brachytherapy had the same chance of the cancer returning as those who had the standard radiation treatment.
The study was presented September 22, 2008, at the American Society for Therapeutic Radiology and Oncology’s 50th Annual Meeting in Boston, MA.
Source: American Society for Therapeutic Radiology and Oncology (ASTRO), September, 2008
According to Temple University pediatric dentist Mark Helpin it’s the frequency of eating candy, not the amount, that increases the risk of cavities. So when her daughters go trick or treating, Megan Chiplock lets them eat as much as they want.
“We let them go at it, gorge themselves, and maybe for a few days after if they want a piece here and there,” she says. “But they really get their fill on Halloween night, and [then] it’s sort of out of their system.” “The frequency of eating candy, and other refined carbohydrates, and their stickiness, are big factors in creating the risk of caries (cavities),” adds. Mark Helpin.
The pH balance in the mouth can be changed by eating carbohydrates. The resulting increase in acidity can increase the risk of cavities, and each time someone eats candy it can take an hour for the acid environment in the mouth to dissipate.
“So, if I eat a piece of candy now, the pH in my mouth will become acidic, and it will take 30-60 minutes for it to become normal,” said Helpin. “If I keep eating candy throughout the day, there is acid in my mouth for a much longer period of time. The longer teeth are in an acid environment, the greater the risk they will become decayed.”
There are several ways that parents can allow kids to enjoy the holiday, and still minimize the risk, says Helpin, the acting chair of Pediatric Dentistry at Temple’s Maurice H. Kornberg School of Dentistry. “Parents can let kids eat a bunch [of candy] now and a bunch later. But don’t let them have one piece now, then an hour later let them have another piece,” he said, adding that candy can also be dispensed as a dessert or snack. Treats as dessert at mealtimes? Good idea, says Helpin, because the production of saliva increases and that helps wash away oral acidity. Brushing teeth immediately after eating candy is recommended by Helpin, or at least rinsing out the mouth with water 3 or 4 times after eating, again to reduce acidity in the mouth.
Helpin warns that substituting small bags of chips or pretzels for candy doesn’t solve the cavity problem, either. “Chips and pretzels are also carbohydrates and they also will create an acid environment that can create cavities,” he says. “These treats and snacks get stuck on your teeth, and that’s the stickiness factor,” he said.
At trick or treat time, Helpin avoids sticky candies in favor of sugar-free varieties. Ultimately, “it’s not realistic to think you can tell your child you can’t have candy, cookies, cakes, or other treats,” says Helpin. “Those are the things most people enjoy—and we want our kids to enjoy life.”