Nano Design Adjustment May Help Find, Clear Some Water Contaminants

Experiments designed to test discrepancies in theoretical computational chemistry have turned up a barely two-angstrom difference that may lead to a new approach to locate and remove dangerous toxins such as perchlorate and nitrates from the environment.

The research targets toxic groundwater contaminants that contain negatively charged ions known as anions (a-NI-ens), which are historically difficult to remove. Perchlorate, a rocket fuel additive recently linked to thyroid deficiency in women, has contaminated more than 450 wells in California alone. Nitrate contamination, which results mainly from the use of nitrogen fertilizer, is a leading cause of shutdowns of wells and public water supplies in the United States.

“There is a need for improved materials that are effective at removing anions from the environment,” said Darren W. Johnson, a University of Oregon chemist and co-principal investigator of a study appearing online ahead of regular publication in the Journal of the American Chemical Society. “A current leading strategy is anion exchange, which uses a polymeric resin to exchange an anion for one that’s not a problem.” (Two other currently used methods aimed at anions are biochemical denitrification and reverse osmosis.)

In the new study, led by UO doctoral student Orion B. Berryman, researchers focused on anion-pi interaction, in which a negatively charged species is attracted to a neutral electron-deficient aromatic ring, which could be incorporated into a specifically designed receptor.

Anion-pi interactions have been the focus of recent theoretical work, in which electronic structure calculations predicted that anion binding between halides and electron-deficient aromatic rings will occur over the center of a ring. However, the lab experiments on crystalline material found that the binding occurs as much as 2 angstroms, or 0.2 nanometers from the center.

“It’s very important to consider these off-centered anion-interactions occurring through a charge-transfer interaction,” Berryman said. “We looked at solid-state structures and the geometry of the interaction involved in a simple system. In these initial studies we noted significant color changes due to this off-center binding geometry found in the crystal structures.”

Co-principal investigator Benjamin P. Hay, a chemist at the Pacific Northwest National Laboratory in Richland, Wash., where Berryman studied last fall as part of UO’s National Science Foundation-funded internship program, said the study has important ramifications in anionophore design, crystal engineering and other aspects of supramolecular chemistry. In fact, he said, the findings indicate that prior designs may be flawed, incomplete or even misleading. “We discovered an unexpected bonding motif that involves the transfer of charge from the anion to the arene — in other words, a covalent bonding motif,” Hay said. “This is the first theoretical characterization of what we have termed an off-center, weak charge-transfer interaction.”

Anions, of which notable examples include DNA, nitrate, pertechnetate, cyanide and chromate, play indispensable roles in biological and chemical processes, but they also can contribute significantly to environmental pollution that threatens aquatic life cycles and human health.

Johnson, in collaboration with UO chemist Michael M. Haley, now is seeking to design receptors that aim to the off-center location, with a goal of developing sensors for anion detection. Because Berryman’s research produced sometimes intense color changes at binding sites, such an approach could lead to developing materials that sense the presence of these toxins and remediate them.

While 0.2 nanometers seems an insignificant distance, it could mean there’s a 100 percent chance that binding cannot occur, Johnson said. “We’re finding that from a design standpoint, that 0.2 nanometers is a big difference.”

He noted that estimating or calculating the binding distances when optimizing a receptor for positively charged binding, or cation, such as the chelation of metals by EDTA (ethylenedinitrilotetraacetic acid), is done almost exactly –s (0.01 nanometers). EDTA is widely used in industrial cleaners, detergents and textile production.


Johnson and Hay are members of the Oregon Nanoscience and Microtechnologies Institute (ONAMI). Johnson also is a member of the UO Materials Science Institute. Other coauthors with them and Berryman were Vyacheslav S. Bryantsev of the Pacific Northwest National Laboratory and David P. Stay, a UO doctoral student in chemistry.

Funding included an NSF Integrative Graduate Education and Research Traineeship to Berryman. Johnson is a 2006 Cottrell Scholar of the Research Corp. and holder of an NSF Career Award. Additional support for equipment and research was supplied by the NSF to the University of Oregon and by the U.S. Department of Energy to Berryman and Hay.

Sources: Darren W. Johnson, assistant professor of chemistry and Benjamin P. Hay, Chemical Sciences Division, PNL.

Links: Johnson’s faculty Web site:;
Pacific Northwest National Laboratory: pnl/.

Contact: Jim Barlow

University of Oregon

Ancora Pharmaceuticals Awarded National Institute Of Health Grant For Continued Malaria Vaccine Research

With exciting pre-clinical results showing that its carbohydrate-based vaccine can combat cerebral malaria (CM), which causes inflammation of the brain, Ancora Pharmaceuticals has received another grant from the National Institute of Health (NIH) to research whether its vaccine candidate will also prevent severe malaria anemia (SMA).

The $530,000 Phase I SBIR grant is the third NIH grant Ancora has received. In 2005, the pharmaceutical company was awarded a $3.3 million grant from NIH to develop their current cerebral malaria vaccine candidate.

Scientific evidence indicates that severe malarial disease results from the downstream effects of a toxin generated by the malaria parasite. This toxin gives rise to the same clinical manifestations observed in both CM and SMA, leading to the possibility that Ancora’s first vaccine candidate could be successfully used for both.

Malaria afflicts up to ten percent of the global population resulting in between two and three million deaths per year. Because of global warming, the World Health Organization (WHO) has predicted that 50 percent of the population will be at risk of this disease by 2010.

This latest grant demonstrates NIH’s continued confidence in Ancora’s ability to create cost-effective vaccines utilizing carbohydrate synthesis. The company’s breakthrough method of producing synthetic carbohydrates allows for approaches to bacterial, parasitic, and viral infectious diseases previously unattainable.

Ancora Pharmaceuticals is a private venture-backed biopharmaceutical company based in Medford, Massachusetts focused on developing immune system modulation therapeutics using synthetic carbohydrates. Ancora’s automated carbohydrate synthesizer is internationally recognized as the most advanced in the world. Synthetic carbohydrate therapeutics represents an untapped opportunity within the pharmaceutical industry to develop promising vaccines against some of today’s worst infectious diseases.

Ancora Pharmaceuticals

Impact Of Sex Hormones On Erectile Function

UroToday – Dr. Varant Kupelian and associates reported at the recent American Urologic Association annual meeting the impact of sex hormones on erectile function as seen in the Massachusetts Male Aging Study.

In this prospective population-based study of men ages 40-70 years at baseline, 1519 with complete information on erectile function and hormone measurements. There was no association between total testosterone and erectile function.

After adjusting for potential confounders, no association was seen between erectile function and bioavailable testosterone or sex-hormone binding globulin. There was an increased risk of erectile dysfunction with higher luteinizing hormone levels. Consistent with other studies, there was no association between serum testosterone and erectile dysfunction.

AUA 2006 – Abstract#1328

Reviewed by UroToday Contributing Editor Joel Kaufman, MD

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LIFE Partners With Veterans For Peace To Provide Clean Drinking Water To Civilians In Iraq

Life for Relief
and Development (LIFE), an American non-profit humanitarian relief
organization based in Southfield Michigan, as part of its ongoing efforts
to alleviate human suffering, and in partnership with Veterans for Peace
(VFW), an American non-governmental organization based in St. Louis,
Missouri, completed a major rehabilitation project for a water plant in
southern Iraq, providing clean drinking water for thousands of residents.

LIFE rehabilitated and put into full production, the water treatment
plant in Hamdan Jessir, in the Abu Al-Khassib district of Basra. The
project including installing new tanks, chlorine unit filters, electric
pumps, and other equipment and accessories in a thorough overhaul of the

Although the Hamdan Jessir water treatment plant was initially designed
as a Water Treatment Unit to provide safe drinking water, it however had
been damaged and neglected as a result of conflict and many years of
sanctions, and instead simply functioned as a dilapidated pumping station,
providing low-pressure unsafe water, and contributing to the spread of
water-born diseases, which the local residents have been suffering from in
the last few years.

After the equipment was installed and activated, the connecting
underground pipes were flushed of the old contaminated water. The plant was
then put officially in full production by the local Water Directorate, and
began pumping high-pressure clean drinking water to thousands of local
inhabitants. The rehabilitation project increased both the quality and
quantity of water being supplied to the local residents.

Commenting on the cooperation with Veterans for Peace (VFP), Dr.
Mujahid Al-Fayadh, the President of LIFE said, “we are very proud of our
partnership with Veterans for Peace.” He added that “LIFE and VFW have been
working together for the last several years on many projects to help
provide clean drinking water to civilian neighborhoods in Iraq, in an
effort to help eradicate the water-born diseases.”

Life for Relief & Development

Vaccine For H1N1 Flu Virus In Swine Developed By Iowa State University Researcher

The H1N1 virus has now been found in a Canadian swine herd, and an Iowa State University researcher has developed an H1N1 flu vaccine for pigs.

“Now that H1N1 virus is in pigs, we’re seeking funding to conduct a proof-of-concept study to demonstrate how rapidly we can produce an effective and safe vaccine for pigs,” said Dr. Hank Harris, professor in animal science and veterinary diagnostic and production animal medicine.

Harris’ start-up company at the ISU Research Park, Harrisvaccines, Inc., uses a technology that is much faster for producing vaccines than traditional methods.

The technique, called RNA Backbone, was developed for human use by a North Carolina company called Alphavax. Harrisvaccines has adapted it for pigs.

The technique uses electric current to combine the RNA Backbone material with the relevant genetic information from the active flu virus through a process called electro-poration.

Harris notes that his new vaccines using the Backbone method are currently in the pipeline for approval and may have approval from the United States Department of Agriculture by 2011.

Recently, Harris’ new, faster method of producing vaccines was put to use during an outbreak of the disease Porcine Reproductive Respiratory Syndrome virus. Harris’ Backbone method allowed vaccines to be ready within two months of the outbreak. That research was supported by the United States Department of Agriculture’s Small Business Innovation Research Program.

Traditional production methods require five to six months for human vaccines and 11 to 12 months for swine vaccines.

“Right now, to make human or animal vaccines, you have to get the live virus and grow it in eggs or cell culture and then inactivate it,” said Harris. “We don’t have to do that.”

“That’s what’s really neat about this technology, you don’t really need the live virus,” he said. “We just need the genes from the original virus which can be made synthetically.”

Harris needs only the virus’ genetic information, which is easily available. The new H1N1 virus, for instance, has already been genetically mapped and is already available on the Web and in the public domain.

Hank Harris

Iowa State University

High-Risk Elderly Patients Benefit From Minimally-Invasive Aortic Valve Bypass

An uncommonly used surgical procedure that bypasses a narrowed aortic valve, rather than replacing it, effectively restores blood flow from the heart to the rest of the body and gives high-risk patients a safe alternative to conventional valve surgery. That is the finding of a study conducted at the University of Maryland Medical Center in Baltimore. The researchers conclude that the procedure, called aortic valve bypass, is an important treatment option for high-risk elderly patients with a narrowed aortic valve, a condition called aortic stenosis.

The bypass procedure can be performed in a minimally invasive way without stopping the heart. Many of the patients in the study had previously been considered too frail to benefit from surgery. The study will appear in the September 30, 2008 print issue of Circulation and is now online.

“Because of the possible risks associated with aortic valve replacement in the elderly, almost 60 percent of patients with symptoms related to aortic stenosis are never referred to surgery,” says the study’s principal investigator, James S. Gammie, M.D., associate professor of surgery at the University of Maryland School of Medicine and cardiac surgeon at the University of Maryland Medical Center.

Survival for these patients without surgery is poor; only 20 percent are alive three years after diagnosis. “But our research and five years of experience with the bypass procedure suggests there is a group of patients, typically considered inoperable because they are at the upper level of the risk spectrum, who could benefit from aortic valve bypass,” says Dr. Gammie.

The aortic valve controls the flow of blood from the heart’s main pumping chamber, the left ventricle, to the aorta, the artery that supplies blood to the rest of the body. In aortic stenosis, calcium deposits narrow the valve and impair the heart’s ability to pump blood. Aortic stenosis is the most common heart valve disease of the elderly in the United States. More than 50,000 people in the United States require surgery for aortic stenosis each year.

During conventional valve replacement, the surgeon opens the chest, stops the heart for about 90 minutes, opens the aorta just above the aortic valve, cuts out the old valve and sews in a new one. While valve replacement has benefited millions of patients with good outcomes, in elderly patients, particularly those with other health conditions, the death rate can exceed 10 percent.

The bypass procedure

In order to bypass the narrowed aortic valve, surgeons at the University of Maryland Medical Center have refined a procedure, originally called an apicoaortic conduit, which was developed in the 1970s and initially used for children. During the procedure, most of the blood flow from the heart is diverted through a tube containing a standard replacement valve that is placed near the apex of the left ventricle, the pointed tip at the bottom of the heart, to the aorta, the main blood vessel at the back of the chest.

The surgeons work through an incision between two ribs on the left side of the chest. During the first cases, a large incision was needed. However, the procedure was modified this year, so that only a small, three-inch opening between the ribs is required. “We are excited because for the first time we can surgically treat a narrowed aortic valve through a minimally-invasive approach with the heart beating, compared to the traditional breastbone-splitting approach,” says Dr. Gammie.

Study details

Between 2003 and 2007, the surgeons treated 31 high-risk aortic stenosis patients with aortic valve bypass surgery. Many of the patients also had other conditions ranging from chronic obstructive pulmonary disease to kidney disease, or had a history of heart attack or diabetes. The average age was 81, and nearly half had been refused conventional surgery. Early in the series, four of the 31 patients did not survive the procedure, yet there were no deaths among the most recent 16 consecutive patients.

The procedure was as effective as conventional aortic valve replacement surgery at relieving the obstruction of blood leaving the heart. Stroke and kidney problems were uncommon. Because the impaired aortic valve was left in place, some blood flow continued through that valve. But postsurgical blood flow measurements indicated that in most patients, approximately 70 percent of cardiac output flowed through the new bypass.

The study results suggest that continued improvements in technology and surgical technique may warrant extending aortic valve bypass surgery to moderate-risk patients with aortic stenosis. In addition to the 31 patients who received an aortic valve bypass, the University of Maryland Medical Center performed 438 other aortic valve procedures during the same time period.


Gammie JS, Krowsoski LS, Brown JM, Odonkor PN, Young CA, Santos MJ, Gottdiener JS, Griffith BP. Aortic Valve Bypass Surgery: Mid-term Clinical Outcomes in a High-Risk Aortic Stenosis Population. Circulation. Published online ahead of print, September 15, 2008.

Source: Bill Seiler

University of Maryland Medical Center

2 Cases Of Rapid Development Of Drug-Resistant 2009 H1N1 Influenza Reported

Two people with compromised immune systems who became ill with 2009 H1N1 influenza developed drug-resistant strains of virus after less than two weeks on therapy, report doctors from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Doctors who treat prolonged influenza infection should be aware that even a short course of antiviral treatment may lead to drug-resistant virus, say the authors, and clinicians should consider this possibility as they develop initial treatment strategies for their patients who have impaired immune function.

Both patients in the new report developed resistance to the key influenza drug oseltamivir (Tamiflu), and one also demonstrated clinical resistance to another antiviral agent, now in experimental testing, intravenous peramivir, note senior authors Matthew J. Memoli, M.D., and Jeffery K. Taubenberger, M.D., Ph.D. This is the first reported case of clinically significant peramivir-resistant 2009 H1N1 illness, say the scientists. The report is scheduled to appear in print on May 1 in Clinical Infectious Diseases and is now online.

The people in the current case report had immune limitations due to blood stem cell transplants that occurred several years previously. Both recovered from their influenza infections.

“While the emergence of drug-resistant influenza virus is not in itself surprising, these cases demonstrate that resistant strains can emerge after only a brief period of drug therapy,” says NIAID Director Anthony S. Fauci, M.D. “We have a limited number of drugs available for treating influenza and these findings provide additional urgency to efforts to develop antivirals that attack influenza virus in novel ways.”

The 2009 H1N1 influenza virus is susceptible to just one of the two available classes of anti-influenza drugs, the neuraminidase inhibitors. Besides oseltamivir, other neuraminidase inhibitors are zanamivir (Relenza), which is inhaled, and the intravenously administered investigational drug peramivir. As the H1N1 influenza pandemic unfolded, laboratory tests of virus strains isolated from patients showed that some strains contained a genetic mutation (the H275Y mutation) that makes the virus less susceptible to some neuraminidase inhibitors.

The two people in the current case study had pre-existing medical conditions that impaired their immune system function before contracting 2009 H1N1 flu. Strains of 2009 H1N1 influenza containing the H275Y mutation had been reported previously in people with diminished immune function, but in previous cases the mutation arose after more than 24 days of continuous therapy. In the newly described cases, the mutation appeared after 14 days in one individual and after nine days in the second.

“Although the recommended length of treatment with oseltamivir is five days, it is common for physicians to continue giving this first-line drug longer if the patient does not improve,” says Dr. Memoli.

Both people in the current report received oseltamivir for extended periods but they continued to shed virus in their nasal secretions throughout treatment. When one patient’s condition worsened despite 24 days of oseltamivir treatment, doctors administered peramivir for 10 days. The drug did not reduce viral shedding and the patient remained ill, demonstrating what the authors described as clinically significant resistance to peramivir. Next, doctors administered the only other available flu drug, zanamivir, for 10 days. The person then fully recovered.

“Additional, larger studies are needed to further refine our findings,” says Dr. Memoli. “But these cases of rapid appearance of drug-resistant 2009 H1N1 influenza in immune-compromised patients are worrisome and should prompt clinicians to reconsider how they use available flu drugs.”

The mutation that allows 2009 H1N1 to resist oseltamivir also significantly reduces the virus’s susceptibility to peramivir. If a relatively short course of oseltamivir causes a mutant flu strain to emerge in a particular patient, that person may not respond to peramivir. Zanamivir might be a good choice if a patient does not respond within a few days to oseltamivir, Dr. Memoli says. However, because zanamivir must be inhaled, patients who are very ill and whose breathing is mechanically supported cannot be given zanamivir.

“As clinicians, we should carefully consider our treatment options and use all the drugs available to us wisely. This is especially important in a patient with prolonged infection or when an antiviral drug fails to cure the patient after the recommended course of treatment,” says Dr. Memoli.

NIAID scientist Rachel J. Hrabal contributed to this study along with Arash Hassantoufighi and Maryna C. Eichelberger, Ph.D., of the FDA.

Anne A. Oplinger

NIH/National Institute of Allergy and Infectious Diseases

View drug information on Relenza; Tamiflu capsule.

Urologist Dr. J. Francois Eid, MD Warns Against The Dangers Of Online Herbal Remedies For Erectile Dysfunction (ED)

News reports coming out of the UK and Australia show evidence of prescription ingredients in many “natural” herb remedies sold on the Internet to treat erectile dysfunction (ED). These popular online supplements, which claim to consist only of homeopathic ingredients, are often improperly labeled and may actually contain dangerous ingredients. Dr. J. Francois Eid, director and founder of Advanced Urological Care in New York City, is concerned about this practice, especially since, in his experience, men with erectile dysfunction choose to suffer in silence rather than seek medical help for their condition.

The Medicines and Healthcare products Regulatory Agency (MHRA), the governing body for medication sales in the United Kingdom, tested 138 unlicensed ED treatments and found random, uncontrolled quantities of prescription ingredients in almost two-thirds of them. “Erectile dysfunction is a condition that is easily treatable in a variety of safe ways under the careful watch of a physician,” said Dr. Eid, who has successfully treated ED patients over the last 22 years of practice. “However, since many men are embarrassed by ED, they look for help elsewhere and expose themselves to serious problems such as heart attack, stroke and severe hypertension.”

Even more troubling is the fact that many of these “natural” products falsely claimed to be approved by the Food and Drug Administration. In actuality, more than one-third of the supplements that claim to treat ED or enhance sexual performance contain sildenafil, the active ingredient in Viagra, or vardenafil, the active ingredient in Levitra. Advertisements for Viagra, Levitra and other drugs for ED warn of the dangers of taking these drugs if you are also on prescription medications that contain nitrates. Nitrates are prescribed for conditions such as angina or coronary artery disease in patients that also may suffer from ED.

The combination of nitrates with the active ingredients in ED medications could potentially lower blood pressure to an unsafe level. Under a physician’s care, blood pressure levels are carefully monitored. However, an online consumer of these supplements, not approved by a doctor, will be unaware of the Viagra- or Levitra-type of ingredients in these supplements, which could either present a serious problem or exacerbate a pre-existing condition.

Conversely, according to Bloomberg News, Pfizer’s Viagra patent was partially rejected after it was discovered that the active ingredient [sildenafil citrate] was too similar to a Chinese herb known as Horny Goat Weed. An appeals board upheld the decision that “an element, or claim, of the patent for a method of treating male erectile dysfunction didn’t cover a new invention.” The patent claim was part of an infringement suit Pfizer filed in 2002 against Eli Lilly over its rival Cialis drug. The decision on that part of the patent will now go into appeals.

So should men go with the prescription drugs or the supplements? “The take-away message is that many men may not realize that some medicines or supplement may actually cause or worsen ED,” said Dr. Eid. “Only your physician can determine the best course of medication and mitigate these side effects successfully.” A world-renowned surgeon and a foremost specialist in urological prosthetic reconstruction, Eid believes that, with so many approved treatment options for ED, there is no reason for men to take unnecessary risks with ED. “Many advances in this area have resulted in performance guarantees of at least 20 years, allowing men to have full control of their durability, rigidity and reliability,” said Dr. Eid.

ED is not a problem that will just correct itself, which is why Dr. Eid advises anyone suffering from the condition to not take matters into their own hands and, instead, consult with their doctor. Eid initially treats ED by suggesting exercise, diet, avoiding tobacco and alcohol, before prescribing medications or more comprehensive treatments, such as pumps or implants (IPP). Eid believes in the efficacy of IPP’s, since he has performed more internal penile implant surgeries than anyone in the world, over 300 per year. Eid developed the “No-Touch” penile prosthesis surgery, which boasts an infection rate of less than one percent. His practice, Advanced Urological Care, is dedicated to erectile dysfunction treatment and urinary incontinence treatment.

“ED is very under-reported because many men choose to suffer in silence, but this can wreak havoc not only on your health but on your relationships and self-esteem,” says Dr. Eid. In many instances, investigating one problem might uncover another underlying health concern, such as cardiovascular disease, which is important especially when dealing with ED. This is why medical intervention is so important. “The first step in any difficult situation is acknowledging there is a problem and then deciding to take care of it, the right way,” concluded Eid.

Advanced Urological Care

View drug information on Cialis; Levitra; Viagra.

Orthofix International Launches Three New Sports Medicine Products

Orthofix International (NASDAQ: OFIX) (the Company) announced today that its sports medicine division, Breg, has introduced three new products, including a soft knee brace with an integrated hinge for added stability, a hip pad to be used with its cold therapy devices for post surgery pain management, and a wrist immobilization accessory for its T-Scope Elbow brace.

The Company also introduced the OrthoFind app, one of the first iPhone applications for the orthopedics market, designed to assist health care providers in choosing products for their patients directly from their mobile phones.

Lateral Stabilizer with Hinge provides comfort with stability

The newest product in Breg’s line of soft knee braces is the Lateral Stabilizer with Hinge. The brace is designed to enhance knee stability and provide pain relief for patients suffering from a range of conditions affecting the kneecap, and to also be eligible for coverage under patients’ health care insurance. Available in Airmesh® breathable fabric and neoprene, the low profile brace is intended to maximize the patient’s comfort while providing minimal interference. The U.S. market for soft knee braces and immobilizers is projected to be approximately $345.1 million in 2010.

Hip Pad Brings Pain Management to Joint Replacement Patients

The Polar Care® Kodiak® Intelli-Flo Hip Pad provides cold therapy pain management during post-operative care and rehabilitation for patients recovering from hip surgery. Ergonomically designed for comfort and coverage of the hip, the Intelli-Flo Hip Pad’s unique flow channel directs water circulation throughout the pad, with additional circulation at the incision site. An estimated 625,000 total or partial hip replacements will be performed in the U.S. in 2010.

T-Scope Elbow Neutral Hand Accessory for Wrist Immobilization

Breg’s Neutral Hand Accessory extends the functionality of its T-Scope Elbow brace. Designed to provide the patient with comfort and control while restricting wrist motion, the new device is intended for patients with elbow injuries, including tendon and ligament ailments such as tennis elbow. The U.S. market for upper extremity supports is expected to reach approximately $53.7 million in 2010.

OrthoFind Mobile Application

Developed for the Apple iPhone and iTouch devices, the OrthoFind app provides mobile access to Breg’s catalog of bracing and cold therapy products. The app includes product descriptions, indications, Medicare coding and ordering information. It also offers the latest news on orthopedic procedures and surgeries, provides frequently asked questions about the industry, and lets users join and interact with the OrthoFind community. Products are searchable by anatomy, category or keyword. It is estimated that 80 percent of physicians will be using smart phones by 2012.

Orthofix International, N.V.

GENFIT: Potential For Combination Of GFT505 With Statins

GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and neurodegenerative diseases, announces the absence of a safety risk due to pharmacokinetic drug-drug interaction when GFT505 is co-administered with a statin (GFT505-1095 clinical study). These results prepare the launch of Phase IIb and Phase III trials in patients already treated with a statin (on-top of statin trials). Furthermore, GENFIT is now evaluating the opportunity to develop a combination therapy associating GFT505 with a generic statin in the same pill.

Certain fibrates are associated with an increased risk of serious muscular side-effects when they are co-administered with a statin. Indeed, these drugs significantly increase the plasma concentration of certain statins (including simvastatin) and/or their active metabolites. This pharmacokinetic drug-drug interaction increases the risk of muscular side-effects associated with hypolipidemic agents.

To assess the safety of use of GFT505 in co-administration of a therapeutic dose of GFT505 (80 mg/d) with a usual dose of simvastatin (20 mg/d), the study GFT505-1095 was conducted in two parallel groups of healthy volunteers.

In the first group, a repeated daily administration of GFT505 for 14 days did not increase the plasma exposure of simvastatin and its active metabolite. On the contrary, a modest but statistically significant decrease in this plasma exposure was observed.

In the second group, a repeated daily administration of simvastatin for 14 days did not affect the plasma exposure of GFT505 and its active metabolite GFT1007.

No adverse side-effect was observed when either drug was administered for 14 days. As expected, simvastatin treatment resulted in a reduction in the plasma levels of LDL-cholesterol, and GFT505 treatment resulted in a reduction in plasma triglyceride levels. Moreover, no adverse reaction was observed when GFT505 and simvastatin were co-administered at the end of the 14-day treatment periods.

Dr. RГ©my Hanf, Vice-President of Product Development, stated: “These new data are of vital importance, since GFT505 targets the residual cardiovascular risk that persists in patients treated with statins. These patients make up a substantial proportion of the target pre-diabetic and diabetic population. In sharp contrast to the demonstrated pharmacokinetic interaction of certain fibrates with statins, GFT505 could potentially be prescribed to the entire pre-diabetic and diabetic population, irrespective of whether patients are already under statin treatment or not.”

Jean-FranГ§ois Mouney, CEO of GENFIT, added: “We were awaiting the results of this clinical study with impatience, since the information it provides substantially increases the intrinsic value of GFT505. The absence of a pharmacokinetic interaction between GFT505 and statins provides GFT505 with an undeniable competitive advantage that is of critical importance for the pharmaceutical groups with which we are discussing.”

About the clinical trial GFT505-1095

This is an open label randomized phase I study in two parallel groups of healthy volunteers to evaluate the potential pharmacokinetic interaction between GFT505 80 mg and simvastatin 20 mg. In group 1, fourteen volunteers were treated from D2 to D15 with GFT505 80 mg/d. Simvastatin (20 mg) was administered alone at D0 and co-administered with GF505 (80 mg) at D16 for pharmacokinetic analysis of native simvastatin and beta-hydroxyacid simvastatin (active metabolite). In group 2, fourteen healthy volunteers were treated from D2 to D15 with simvastatin 20 mg/d. GFT505 (80 mg) was administered alone at D0 and co-administered with simvastatin (20 mg) at D16 for pharmacokinetic analysis of native GFT505 and GFT1007 (active metabolite).

About the treatment of prediabetes and diabetes

The worldwide obesity epidemic forecasts a parallel increase in the prevalence of type II diabetes and associated complications. According to the WHO, this “epidemic disease” could affect up to 300 million people by 2025 whereas they were only 30 million in 1985. Thus, the prevention and treatment of micro and macro-vascular diseases associated with prediabetes and diabetes are considered to be worldwide public health issues by both academic societies (IAS, ADA, EASD) and health organizations (WHO, FDA, EMEA). Prediabetic and diabetic patients suffer from overlapping disorders (high blood pressure, dyslipidemia, insulin resistance, inflammation…) which increase the risk of developing type II diabetes as well as related micro and macro-vascular diseases: myocardial infarction, stroke, retinopathy, kidney disease, diabetic foot or arteritis… Current diagnostic tools and treatments do not sufficiently cover this global medical need. At present, even treated patients remain at high risk of developing vascular diseases. In particular, atherogenic dyslipidemia (characterized by low plasma concentration of good cholesterol (HDL-C) and high level of triglycerides), the pro-inflammatory and oxidative states and alteration of glucose metabolism are promising therapeutic targets for the medical management of prediabetic and diabetic populations.