GTC Biotherapeutics (“GTC”, NASDAQ: GTCB) and OVATION Pharmaceuticals, Inc. announced that the Blood Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that ATryn is safe and efficacious for the prevention and treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgery or childbirth procedures. The FDA considers the recommendations of its Advisory Committees when making its determinations. If approved, ATryn will be the first recombinant human antithrombin available in the U.S.

“We are very pleased with the Advisory Committee’s recommendation in support of the safety and efficacy of ATryn,” said Geoffrey F. Cox, Ph.D., GTC’s Chairman and Chief Executive Officer. “ATryn is the first transgenically produced therapeutic to achieve approval in Europe and undergo review by the FDA. ATryn is also a testament to our established strength in recombinant technology, and has the potential to provide an important new treatment option for patients with hereditary antithrombin deficiency.”

In September 2008, the FDA assigned Priority Review to GTC’s Biologic License Application, or BLA, for ATryn. Priority Review is granted to applications for products that, if approved, would provide significant advances in treatment or provide a treatment where no sufficient one already exists. Under Priority Review, the FDA’s target date for action on the BLA is February 7, 2009. GTC has licensed ATryn to OVATION to develop and market it in the U.S.

“The committee’s recommendation takes us a step closer to making ATryn available to people in the U.S. with hereditary antithrombin deficiency, a rare clotting disorder associated with severe complications for which there are few treatment options,” said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. “Consistent with our overall focus on addressing unmet medical needs of small patient populations, bringing ATryn to market would give us the opportunity to make a meaningful difference in the lives of people suffering from this rare disorder.”

Antithrombin works as a natural anticoagulant in the human body by regulating thrombin, which plays an important role in controlling the formation of blood clots. ATryn was developed with the key objective to provide the purity, safety and consistency of an unlimited supply of recombinant antithrombin. Purified recombinant antithrombin has the same amino acid sequence as antithrombin derived from human plasma.

People with hereditary antithrombin deficiency are at increased risk for venous blood clots, including pulmonary embolism and deep vein thrombosis. The prevalence of hereditary antithrombin deficiency in the general population is approximately one in 2,000 to one in 3,000. Half these patients may experience a thrombosis before 25 years of age and based on one study, up to 85 percent may suffer a thromboembolic event by age 50.

About ATryn* (antithrombin [Recombinant])

ATryn is the first recombinant antithrombin product approved in the world and the first antithrombin product that has been approved through the centralized European Medicines Agency (EMEA) procedure in the European Union.

ATryn is under review by the FDA for the prevention and treatment of peripartum and perioperative thromboembolic events in patients with hereditary antithrombin deficiency.

The most common adverse events listed in the approved European labeling that may occur during ATryn treatment include dizziness, headache, bleeding, nausea, bleeding at injection site and increased bleeding during treatment. As with any intravenous protein product, allergic type hypersensitivity reactions are possible.

About GTC Biotherapeutics

GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. In addition to ATryn, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa, VIII, and IX, which are used for the treatment of hemophilia, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a monoclonal antibody to CD20 and a monoclonal antibody to CD137. GTC’s intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC’s transgenic production platform is particularly well suited to enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as proteins that are required in large volumes. Additional information is available on the GTC web site, gtc-bio.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the timing of the FDA’s review of the BLA for ATryn. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC’s most recent Annual Report on Form 10-K and its other periodic reports filed with the Securities and Exchange Commission, including the uncertainties associated with dependence upon the actions of regulatory agencies.

GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law.

About OVATION Pharmaceuticals

OVATION is a fast growing biopharmaceutical company that develops and commercializes medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients’ lives through its focus on central nervous system (CNS), hematology/oncology, and hospital-based therapies. The three new launches the company expects over the next three years will be fueled largely by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 and 2007 “Pharma Company of the Year” award from Scrip magazine for small to mid-sized enterprises. More information about the company, its products and full prescribing information may be found at ovationpharma.

* ATryn is a registered trademark of GTC Biotherapeutics

OVATION Pharmaceuticals

View drug information on Atryn.

American Water Works Company, Inc. (NYSE:AWK), the largest investor-owned U.S. water and wastewater utility company, communicated to its customers today that influenza viruses, including swine flu, are effectively removed by filtration and disinfection.

“In the United States, federal and state drinking water regulations require filtration and disinfection of all surface water supplies (e.g., those from lakes, reservoirs, or rivers). These regulations specify specific treatment requirements for removal and inactivation of viruses,” said Dr. Mark W. LeChevallier, director of Innovation & Environmental Stewardship for American Water. “Because influenza viruses, including swine influenza A (H1N1), are more susceptible to disinfection than most enteric viruses (like Poliovirus, Hepatitis A, or Norovirus), and the influenza viruses are slightly larger and more effectively removed by filtration, current drinking water treatment barriers provide a high degree of protection from “swine flu.” We want to reassure our customers that they do not need to be concerned about the safety of properly treated drinking water with respect to swine influenza A.”

Founded in 1886, American Water is the largest investor-owned U.S. water and wastewater utility company. With headquarters in Voorhees, N.J., the company employs more than 7,000 dedicated professionals who provide drinking water, wastewater and other related services to approximately 15 million people in 32 states and Ontario, Canada. More information can be found by visiting amwater.

Source
American Water Further information on Swine Flu

See a Map Of H1N1 Outbreaks
See our Mexico Swine Flu Blog

Medical students are reporting faults in their own professional conduct in the medical field directly related to personal distress and depression. This is commonly called “burnout.”

In an issue dedicated to professional education, a study in the September 15 JAMA states:

Professionalism is a core competency for all physicians. Professionalism includes being honest, acting with integrity, advocating for the needs of patients, reducing barriers to equitable health care, and adhering to an ethical code of conduct. Despite the widely acknowledged importance of professionalism, how personal distress (such as depression or low mental quality of life [QOL]) and professional distress (such as burnout) relate to professionalism is largely unexplored.

In Spring 2009, Liselotte N. Dyrbye, M.D., M.H.P.E., of the Mayo Clinic College of Medicine, Rochester, Minn., and colleagues conducted a study of 2,682 medical students across seven medical schools analyzing several dimensions of medical professionalism, and compared these levels to relationship with leading measures of distress: burnout, depression, quality of life, students’ personal engagement in unprofessional conduct, understanding of appropriate relationships with industry, attitudes regarding physicians’ responsibility to society. Among the outcomes, included were frequencies of self-reported cheating/dishonest behavior as defined by American Medical Association (AMA) policy.

Fifty three percent of the students studied reported straight burnout. Actual cheating on exams etcetera were quite rare, holding at less than 10%. However professional downgrades to direct patient care were reported at 43%. Students’ opinions on relationships aligned with the AMA policy held at 14%.

However, in those students that did cheat academically, more than most copied from a crib sheet or from another student during an exam, or reported a physical examination tests as normal when it was clearly tainted. Students with burnout (35%) were more likely to report engaging in one or more unprofessional behaviors than those without burnout (22%). Worn out students were also less likely to hold unselfish concern for the welfare of others regarding physicians’ responsibility to society, including personally wanting to provide care for the medically underserved.

The authors wrote:

Burnout was the only aspect of distress independently associated with report of 1 or more cheating/ dishonest clinical behaviors or with disagreeing with 1 or more altruistic attitudes regarding physicians’ responsibility to society after adjusting for demographic characteristics (sex, age, parental status, marital status, year in school, student debt load), burnout, positive depression screen, mental QOL, and physical QOL.

In final conclusions, the researches state:

In this large, multi-institutional study, self-reported cheating and dishonest clinical behaviors showed a direct association with burnout, while altruistic professional values regarding physicians’ responsibility to society showed an inverse relationship with burnout. In addition to exploring these associations further, future research should investigate whether interventions designed to reduce burnout help students cultivate professional values and behavior.

JAMA. 2010;304[11]:1173-1180

: Sy Kraft, B.A. – Journalism – California State University, Northridge (CSUN)

Taking medications to treat insomnia and anxiety increases mortality risk by 36%, according to a study conducted by Genevieve Belleville, a professor at Universite Laval’s School of Psychology. The details of this study are published in the latest edition of the Canadian Journal of Psychiatry.

Dr. Belleville arrived at these results through analysis of 12 years of data on over 14,000 Canadians in Statistics Canada’s National Population Health Survey. The data includes information on the social demographics, lifestyle, and health of Canadians age 18 to 102, surveyed every two years between 1994 and 2007.

During this period, respondents who reported having used medication to treat insomnia or anxiety at least once in the month preceding the survey had a mortality rate of 15.7%. Respondents who reported not having used such medications had a rate of 10.5%. After controlling for personal factors that might affect mortality risk, notably alcohol and tobacco consumption, physical health, physical activity level, and the presence or absence of depressive symptoms among participants, Dr. Belleville established that the consumption of sleeping pills or anxiety-relieving medications was associated with a 36% increase in the risk of death.

A number of hypotheses have been put forward to explain the link between use of these medications and increased mortality. Sleeping pills and anxiolytics affect reaction time, alertness, and coordination and are thus conducive to falls and other accidents. They may also have an inhibiting effect on the respiratory system, which could aggravate certain breathing problems during sleep. These medications are also central nervous system inhibitors that may affect judgment and thus increase the risk of suicide.

“These medications aren’t candy, and taking them is far from harmless,” commented Dr. Belleville. “Given that cognitive behavioral therapies have shown good results in treating insomnia and anxiety, doctors should systematically discuss such therapies with their patients as an option. Combining a pharmacological approach in the short term with psychological treatment is a promising strategy for reducing anxiety and promoting sleep.”

Source:
Jean-François Huppé
UniversitГ© Laval

H. Lundbeck A/S (LUN; LUN DC) announced that the Psychopharmacology Drug Advisory Committee (PDAC) appointed by the U.S. Food and Drug Administration (FDA) voted unanimously that Serdolect® (sertindole) is efficacious in the treatment of patients with schizophrenia, though they did not find the data robust enough to support an additional regulatory claim related to treatment of suicidal behaviour in schizophrenia. The majority of the committee voted against its use in a broad schizophrenia population due to safety concerns, however a majority of the committee voted that there may be subpopulations in which the therapy is beneficial with appropriate labeling and risk management tools. Lundbeck will work closely with the agency to define the appropriate indication and risk management program to support approval of Serdolect®.

The FDA is not bound by the committee’s recommendation, but usually follows its advice. The target Prescription Drug User Fee Act (PDUFA) date for the Serdolect® application is May 15, 2009. If approved, Lundbeck Inc., the company’s wholly owned U.S. subsidiary, will market the product.

“We are pleased with the Advisory Committee’s recommendation in support of the efficacy of Serdolect® in the treatment of schizophrenia and the acknowledgement of its potential safe use in the right populations with appropriate risk management measures as it is important for patients to have multiple treatment options,” said Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. “There continues to be a significant unmet medical need for a less sedating treatment for people with schizophrenia who may experience impaired cognition with other existing therapies and for a medication to treat suicidality in schizophrenia. We will continue to work closely with the FDA as the agency moves toward an action on the new drug application for Serdolect®.”

The committee reviewed comprehensive data from clinical trials. Results from short-term, double-blind, fixed-dose, placebo- and active-controlled studies demonstrated that Serdolect® was superior to placebo in treating the positive and negative symptoms associated with acute exacerbation of schizophrenia.

With nearly 10,000 patients and approximately 15,000 patient years of exposure, the Sertindole Cohort Prospective (SCoP) study showed that the all-cause mortality with Serdolect® was comparable to that with risperidone. During randomised treatment (only Serdolect® or risperidone), the all-cause mortality rate for Serdolect® was 0.63 deaths per 100 patient years, which was the same as that observed for risperidone.

The outcome of the SCoP study further confirmed that although a higher cardiovascular event rate is seen for patients treated with Serdolect®, the event rate related to arrhythmia remains very low.

About Serdolect®

Serdolect® has an inhibitory effect on central dopamine D2 and serotonin 5HT2 receptors as well as on alpha-adrenergic receptors. Serdolect® is an antipsychotic drug for the treatment of schizophrenia without sedative effect and with placebo level extrapyramidal symptoms (EPS). The safety and efficacy of Serdolect® have been studied extensively and the studies demonstrate that:

– Serdolect® reduces the positive and negative symptoms associated with acute exacerbation of schizophrenia.

– Data suggest that Serdolect® may reduce the risk of suicide and suicide attempt in patients with schizophrenia, including those at high risk of suicide.

– Serdolect® is well tolerated and non-sedating, and has a placebo-level incidence of EPS.

– Serdolect®’s effect on the QT interval is well characterised, non-clinically and clinically, and the risk of arrhythmia is low.

– The outcome of the SCoP study, a large, simple, randomised, mortality study, confirmed that all-cause mortality for Serdolect® in patients with schizophrenia is comparable to a standard treatment (risperidone).

The efficacy, tolerability and safety of Serdolect® has through daily clinical practice been characterised in more than 40,000 patient years exposure.

Serdolect® received marketing approval for the treatment of schizophrenia from the European Commission on 20 December 2005. Serdolect® is launched in 40 countries worldwide. It is not yet approved for use in the United States.

Serdolect® derives from Lundbeck’s in-house research and the company holds the global rights.

Important Safety Information

Serdolect® (sertindole) has been shown to prolong the QT interval in a dose dependent manner. Some drugs that prolong the QT interval have been associated with the occurrence of Torsades de Pointes and with sudden unexplained death. Serdolect® is contraindicated in patients with a history of QT prolongation and in patients with clinically significant cardiovascular disease. Serdolect® should not be initiated in patients with a prolonged QT interval and should be discontinued in patients who are found to have persistent QTc measurements > 500 msec.

Serdolect® is also contraindicated in patients receiving drugs known to significantly prolong the QT interval, in patients treated with potent inhibitors of CYP3A, in patients with uncorrected hypokalemia and hypomagnesaemia and in patients with severe hepatic impairment. Increased mortality has been reported in elderly patients with dementia-related psychosis who receive anti-psychotic agents. Neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and diabetes mellitus, orthostatic hypotension, seizures and hyperprolactinemia have also been reported with Serdolect® use.

About Schizophrenia

Schizophrenia is a serious and often chronic mental disorder affecting up to one percent of the world’s population. In many patients the disorders start during late adolescence or early adulthood leading to severe changes in the patient’s way of thinking and perceiving the outside world.

During the course of the illness, periods during which the patient is in an acute psychotic condition and suffering from definite hallucinations and delusions alternate with more stable periods during which the patient experiences a significant reduction in symptoms. However, even in stable periods, many patients have difficulty in establishing social contact, completing an education programme or holding a normal job. Schizophrenia patients may have significant difficulties in performing daily activities necessary for independent living. The occurrence of suicide and suicidal behaviour is a major burden for patients, families and society. Suicide is a leading cause of premature deaths among patients with schizophrenia. Schizophrenia is also associated with increased medical morbidity like respiratory or cardiovascular diseases which all contribute to a significantly lower life expectancy.

The disorder is often disabling and produces important emotional and financial hardship for the patient and the patient’s family. Furthermore, schizophrenia causes a major economic burden to society, not only due to the direct treatment costs but also because of a reduced ability to work forcing many patients to claim disability or pensions.

About Lundbeck

H. Lundbeck A/S (LUN, LUN DC, HLUKY) is an international pharmaceutical company engaged in the research and development, production, marketing and sale of pharmaceuticals for the treatment of psychiatric and neurological disorders. In 2008, the company’s revenue was DKK 11.3 billion (approximately EUR 1.5 billion or USD 2.2 billion). The number of employees is approx 5,500 globally

Source: Lundbeck

If you want to reduce the frequency and severity of symptoms of colds you should do exercise at least five times a week and remain physically fit, US researchers report in the British Journal of Sports Medicine. They stress that not only do fit people have much fewer colds, but also when they do their symptoms are significantly milder compared to those who do not work out regularly.

Researchers from North Carolina, USA, monitored upper respiratory tract infection frequency and symptom severity over a 12-week period during autumn/winter in 2008 on 1,000 individuals aged 18 to 85. 60% of them were female and 40% were aged 19 to 39. 25% of them were over sixty years of age while 40% were middle aged.

Information was gathered on how often they did aerobic exercises. The participants were also asked to rate their levels of fitness with a 10 point validated scoring system. Other data was collected, including participants’ diet, lifestyle, and recent stressful occurrences – factors which can have an impact on an individual’s immune system response, the authors explained.

Cold symptoms were present for an average of 13 days during the winter and 8 days during the autumn (fall). The researchers reveal married older men seem to catch colds less often.

However, after factoring out the most significant factors linked to upper respiratory tract infections (colds) the scientists found that an individual’s level of fitness as well as exercise frequency had the biggest impact in reducing occurrences and severity of colds.

Those who were physically fit and did exercise at least five times each week had a 43% to 46% lower frequency of colds compared to people who only did exercise once a week at the most.

The fittest participants had a 41% lower symptoms severity, while regular exercisers’ severity of symptoms was reduced by 31%, the authors wrote.

The average American adult has two to four colds each year. US children have an average of between 6 and 10 colds annually. The economic toll of colds on the American economy is estimated to be approximately $40 billion annually.

The researchers say that exercise sessions trigger a temporary increase in immune system cells that circulate within the body. Although immune system cell levels soon return to normal after exercise, they probably improve the body’s surveillance of pathogens – harmful bacteria, viruses and other organisms. Improved pathogen surveillance leads to fewer and less severe infections.

The authors concluded:

Perceived physical fitness and frequency of aerobic exercise are important correlates of reduced days with URTI (upper respiratory tract infection) and severity of symptoms during the winter and fall common cold seasons.
What is Aerobic Exercise
Aerobic exercise improves our body’s oxygen consumption – aerobic means with oxygen. Aerobic refers to the body’s use of oxygen in its energy-generating process (metabolic process). Aerobic exercises are generally done with a moderate level of intensity for long periods, when compared to other forms of exercise. Typically, a bout of aerobic exercise involves warming up, exertion for at least 20 minutes, and then a cool down. This type of exercise involves mainly the large muscle groups.

The term aerobic exercise was first used in the 1960s by Col. Pauline Potts, an exercise physiologist and Dr. Kenneth Cooper. They were both in the US Air Force. Dr. Cooper wondered why some physically strong individuals were poor at long-distance endurance sports. He used a bicycle ergometer to measure participants’ ability to use oxygen. In 1968 he published a book titled “Aerobics”, which included scientific programs using aerobic exercises. It became a bestseller. All current aerobic programs include Dr. Cooper’s data as a baseline.

“Upper respiratory tract infection is reduced in physically fit and active adults”
David C Nieman, Dru A Henson, Melanie D Austin, Wei Sha
Br J Sports Med doi:10.1136/bjsm.2010.077875

Runners clutching bottles of energy drink are a common sight, and it has long been known that sugary drinks and sweets can significantly improve athletes’ performance in endurance events. The question is how?

Clearly, ‘sports’ drinks and tablets contain calories. But this alone is not enough to explain the boost, and the benefits are felt even if the drink is spat out rather than swallowed. Nor does the sugary taste solve the riddle, as artificial sweeteners do not boost performance even when they are indistinguishable from real sugars.

Writing in the latest issue of The Journal of Physiology, Ed Chambers and colleagues not only show that sugary drinks can significantly boost performance in an endurance event without being ingested, but so can a tasteless carbohydrate and they do so in unexpected ways.

The researchers prepared drinks that contained either glucose (a sugar), maltodextrin (a tasteless carbohydrate) or neither, then carefully laced them with artificial sweeteners until they tasted identical. They asked endurance-trained athletes to complete a challenging time-trial, during which they rinsed their mouths with one of the three concoctions.

The results were striking. Athletes given the glucose or maltodextrin drinks outperformed those on ‘disguised’ water by 2 – 3% and sustained a higher average power output and pulse rate, even though didn’t feel they were working any harder. The authors conclude that as-yet unidentified receptors in the mouth independent from the usual ‘sweet’ taste buds must be responsible. “Much of the benefit from carbohydrate in sports drinks is provided by signalling directly from mouth to brain rather than providing energy for the working muscles,” explained Dr Chambers.

The team then used a neuro-imaging technique known as fMRI to monitor the athletes’ brain activity shortly after giving them one of the three compounds. They found that both glucose and maltodextrin triggered specific areas of the brain associated with reward or pleasure, while the artificial sweetener did not. This acts to reduce the athletes’ perception of their workload, suggest the authors, and hence enables them to sustain a higher average output.

Their findings support the emerging ‘central governor hypothesis’ the theory that it is not the muscles, heart or lungs that ultimately limit performance, but the brain itself, based on the information it receives from the body. Stimulating the brain in certain ways such as swilling sugary drinks can boost output, perhaps giving athletes that all-important edge over their rivals.

Source: Wiley – Blackwell

A signaling system in the brain previously shown to regulate sleep is also responsible for inducing lethargy during illness, according to research conducted at Oregon Health & Science University Doernbecher Children’s Hospital.

This research is particularly meaningful because it implies that a new class of drugs developed to treat sleep disorders can reverse the inactivity and exhaustion brought on by acute illness. Although the sleep drugs were initially designed to treat narcolepsy, they have the potential to restore energy and motivation in patients with acute and chronic disease, the researchers report. Their findings are published in the The Journal of Neuroscience.

“We all know what it means to feel ‘bad’ when we’re acutely ill. In particular, patients with chronic diseases experience a compromise in motivated behaviors. They don’t feel like getting up and doing anything. Yet the brain mechanisms behind this common experience have remained obscure,” said Daniel L. Marks, M.D., Ph.D., principal investigator and associate professor of pediatrics in the PapГ© Family Pediatric Research Institute at OHSU Doernbecher Children’s Hospital.

“Our lab has found that the neurotransmitter system thought to be primarily involved in the induction of sleep is actually extremely important in maintaining motivation and movement during acute and chronic illness,” Marks explained.

Research has shown that in response to illness, animals divert all their energy to fight infection. Lethargy, fever and loss of appetite are symptoms of the body’s highly organized strategy to sacrifice biological and physiological priorities to provide the greatest chance of survival.

Although previous studies have identified the neurotransmitter system in the brain responsible for inducing fever and loss of appetite in response to disease, the mechanism for suppressing physical activity and motivation, and the means to treat it, has been unclear – until now.

To determine the cause of illness-induced lethargy, Marks and colleagues studied the brains of rats, the neuroactivity of which closely mimics human brains. They determined that acute and chronic inflammation-induced lethargy is brought about by a specific population of inflammation-sensitive neurons located near the neurotransmitter system that controls physical activity and arousal, known as the orexin system. When the researchers injected the rats with orexin, they were able to restore orexin signaling and, thus, restore motivated behaviors and movement.

This research demonstrates that orexin replacement is a viable therapeutic avenue for sickness-induced lethargy, the researchers explain. Because chronic disruption of this crucial neurotransmitter system leads to profound sleep disturbance and loss of motivated behaviors, they propose that drugs that mimic orexin would be useful in chronically ill patients to improve quality of life and independent living.

“There is a very exciting opportunity to quickly translate these findings into clinical practice,” Marks said. “Because the role of orexin in sleep disorders like narcolepsy has been known for several years, the drug development efforts aimed at restoring orexin signaling are at an advanced state and nearly ready for clinical application.”

The study, “Inflammation-induced lethargy is mediated by suppression of orexin neuron activity,” was funded by the National Institutes of Health.

Other members of the research team include: Aaron Grossberg, XinXia Zhu, Pete Levasseur, and Theodore Braun, all of Oregon Health & Science University; and Gina Marie Leinninger and Martin Myers, of the University of Michigan

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, presented promising clinical data for CMX001 in a late-breaker poster session at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Wendy Painter, M.D., Chief Medical Officer of Chimerix, presented pharmacokinetic and preliminary safety data pertaining to renal function from 46 patients enrolled in Investigator-held Emergency Investigational New Drug applications (EINDs). The majority of patients participating in the EIND program had received stem cell or bone marrow transplant procedures, and presented with severe renal impairment attributed to prior administration of the antiviral drug Vistide® (cidofovir). Data from the EIND patient case studies demonstrate that following the administration of CMX001, renal function improved or remained unchanged in the majority of patients. Further, moderate-to-severe renal impairment in both pediatric and adult patients, did not alter systemic exposure to CMX001. CMX001 exposure was also not affected by hemodialysis.

“CMX001 was well tolerated in patients with severe viral infections with no evidence of nephrotoxicity, which has been a significant dose-limiting factor for several existing therapies,” stated Dr. Painter. “The data also show that the pharmacokinetics of CMX001 are unchanged in patients with renal impairment, a major complication for severely ill patients. We are gratified by the growing body of evidence supporting CMX001′s broad-spectrum antiviral activity and excellent tolerability profile.”

To date, Chimerix has treated nearly 100 patients under investigator-held EINDs or foreign equivalent at leading medical centers in the US, Canada and Europe for the treatment of a wide-range of life-threatening infections caused by double-stranded DNA viruses for which there are either no FDA-approved treatments or where patients have failed the available treatment.

These data were presented at the 50th ICAAC during the late-breaker “Pharmacokinetics and Pharmacodynamics of HIV and Antiviral Agents” session at 9:30 am ET in a presentation titled “Compromised Renal Function Does Not Affect the Pharmacokinetics of CMX001 in Patients with Severe Double-Stranded DNA Virus Infections” (Abstract #A1-2017a). Hosted by the American Society for Microbiology (ASM), the 50th ICAAC provides physicians, researchers, and other medical professionals from around the world an opportunity to deliberate on global solutions for infectious disease.

About CMX001

CMX001 combines Chimerix’s PIM (Phospholipid Intramembrane Microfluidization) Conjugate Technology with cidofovir, an approved antiviral agent requiring intravenous administration, with the aim of creating a well-tolerated oral antiviral agent with potent broad-spectrum activity. CMX001 is initially being developed for both commercial and medical preparedness uses. A Phase 2 clinical trial is underway to assess the safety, tolerability and ability of CMX001 to prevent or control cytomegalovirus (CMV) infection in stem cell transplant recipients. In addition, Chimerix is conducting a multi-dose Phase 1 clinical trial of CMX001 in transplant recipients with BK viruria, which like CMV can cause serious complications in immunocompromised patients. In clinical testing to date, CMX001 has shown oral bioavailability in humans and has demonstrated a positive safety profile.

Source: Chimerix, Inc

View drug information on Vistide.

Sun. Sand. Surf. And no smoking. California’s attitude toward smoking may be the best recipe for success when trying to quit. New research shows that social pressure plays a key role in getting smokers to quit.

By analyzing the smoking patterns of Asian immigrants from countries where smoking is socially acceptable, researchers at the University of California, San Diego School of Medicine have shown that smokers are far more likely to try to quit when living where smoking is not socially acceptable. And the more these smokers try to quit, the more they succeed.

“People say they don’t want to conform but in reality, the desire to conform is strong,” said principal investigator Shu-Hong Zhu, Ph.D., of the Cancer Prevention and Control Program at Moores UCSD Cancer Center, and Department of Family and Preventive Medicine at UCSD School of Medicine. “For a study like this, you have to create a different social norm and then allow people to experience it, so immigrants are an ideal group to study.”

Using data from three previous tobacco studies conducted in California, Zhu’s team looked at smokers who are recent immigrants to California from China and Korea, where smoking is still widely accepted. They found that the California immigrants have a smoking cessation rate much higher than their counterparts in their native countries, where about two thirds of all men smoke, and smoking is a common and expected social interaction.

California provides a radically different setting. The most recent data from the Centers for Disease Control (CDC) shows that only about 14 percent of California’s adults smoke. With a strong state tobacco control program in place since 1989, most Californians see smoking as socially unacceptable. Smoking has been banned in restaurants and bars statewide for nearly a decade, and more than half the Californians who have ever smoked have now successfully quit, one of the highest quit rates in the nation.

The Numbers

In their study, published in Nicotine and Tobacco Research (November 2007: Volume 9, Supplement 3) researchers note that more than half of all Chinese and Korean immigrants in California who ever smoked have quit. Chinese immigrant smokers in California stop smoking at roughly seven times the rate of their counterparts in China. In Korea, a recent, aggressive tobacco control campaign is starting to boost the quit rate, but Korean immigrants in California still stop smoking at more than three times the rate of their counterparts in Korea.

Anti-smoking Campaigns Work

The researchers attribute this marked difference to the difference in social norms. According to the UC San Diego study, over 82 percent of Chinese and Korean immigrant smokers in California reported that they were familiar with the state’s anti-smoking campaigns through print, television, or radio. This familiarity shows an awareness of the new social norm.

Changing the social norm not only makes more smokers try to quit, it also makes them more likely to keep on trying, even if earlier tries ended in relapse. Repeated tries will ultimately lead to success.

Zhu points out, “The large difference in annual quit rates is almost completely explained by the difference in proportions of smokers trying to quit. In China, for example, the quit rate is low because a very low proportion of smokers try to quit each year. In California, by contrast, a very high proportion of Chinese smokers try to quit each year. More tries means more success. Cessation aids like nicotine patches, gum, and so on, contribute only in a minor way to these smokers’ dramatically higher quit rate because few of these immigrants use them.”

What does the UCSD study mean for tobacco control? Social norm change is more powerful than people may have realized, said Zhu. Passing new laws and mounting media campaigns is not only a cost effective plan, but will also have dramatic, population-wide impact, the report concludes.

The study, supported by the National Cancer Institute, was conducted by a team of California healthcare professionals, including: lead investigator Shu-Hong Zhu, Ph.D., UCSD; research fellow Shiushing Wong, Ph.D., UCSD; Chih-Wen Shi, M.D. assistant adjunct professor, Department of Family and Preventive Medicine, UCSD; Hao Tang, M.D., Ph.D., California Department of Health Services; and Moon Chen, Ph.D., M.P.H, University of California, Davis.

The Data

Data for the study came from three tobacco surveys conducted in California. Two focused specifically on Asian populations:

The 2003 California Chinese American Tobacco Use Survey (Carr et al., 2005a) and

The 2003 California Korean American Tobacco Use Survey (Carr et al., 2005b).

Both surveys recruited respondents by randomly telephoning numbers from purchased lists of households with Chinese and Korean surnames. A professional survey research service, Strategic Research Group, Inc. used a computer assisted telephone interviewing (CATI) system and trained telephone interviewers to screen people at random from the telephone lists.

The third source of data for this present study was the 2002 California Tobacco Survey (CTS), a population-based, random-digit-dialed survey conducted in English and Spanish, every 3 years, for evaluation of the California Tobacco Control Program (Gilpin et al., 2003).

University of California, San Diego Health Sciences
200 West Arbor Dr.
San Diego, CA 92103
United States
medicine.ucsd.edu