Archive for the "Respiratory / Asthma" Category

14
Aug

Only 1% of people living with HIV/AIDS worldwide have been screened for tuberculosis, according to a report recently released by the coalition Advocacy To Control TB Internationally, or ACTION, Reuters reports. The report, which is based on World Health Organization statistics, was released Thursday at the XVII International AIDS Conference in Mexico City.

According to the report, of the 33 million HIV-positive people worldwide, only 314,394 have been tested for TB, and of those screened, more than one in four were found to have active TB (Shankar, Reuters, 8/8). People living with HIV are 50 times more likely than HIV-negative people to develop TB, and without proper treatment, 90% typically will die within months, according to WHO data. None of the world’s three largest HIV/AIDS donors — the Global Fund To Fight AIDS, Tuberculosis and Malaria; the President’s Emergency Plan for AIDS Relief; and the World Bank — requires mandatory TB testing for HIV-positive individuals (IRIN/PlusNews, 8/8).

Researchers from ACTION at the AIDS conference said the low TB screening rate is “unacceptable.” The group recommended universal TB screening for HIV-positive individuals, along with access to the three “I”s: intensified TB case detection, infection control and isoniazid preventive therapy. According to Jim Yong Kim, chief of the Division of Social Medicine and Health Inequalities at Harvard Medical School, screening tests for TB are inexpensive compared with the cost of antiretroviral drugs. Kim added that an integrated approach is necessary to address HIV/TB coinfection (Reuters, 8/8). Advocates at the AIDS conference also called on global leaders to commit to universal access to high quality HIV/TB care by 2015 (ACTION release, 8/7).

According to Kim, the initial pressure to deal with HIV/AIDS led to HIV services developing separately from TB services. “But now the focus needs breadth,” Kim said, adding that people living with HIV need a “full range of public health services, including TB care.” Kim noted that TB diagnosis tools may be outdated but that HIV programs could perform better even with existing TB diagnostic technology. “TB is a very curable disease,” Kim said, adding that even extensively drug-resistant TB can be treated, according to a study conducted in Peru. “It is a crime for people with access to [antiretrovirals] to continue to die from TB,” Kim said. Vuyiseka Dubula, secretary general of South Africa’s Treatment Action Campaign, added that “[i]gnoring TB screening and care undermines all the gains made in HIV treatment,” (IRIN/PlusNews, 8/8). According to Michel Sidibe, assistant secretary general and deputy executive director of UNAIDS, TB is a “preventable plague inside a devastating epidemic” (Reuters, 8/8).

In an effort to address HIV/TB coinfection, several HIV/AIDS and TB advocacy groups at the AIDS conference collected more than 10,000 postcards signed by people affected by HIV/AIDS and TB. The postcards will be sent to heads of the Global Fund, PEPFAR and the World Bank, as well as to the ministers of health in four countries — Botswana, Kenya, Nigeria and South Africa — with high HIV and TB burdens (ACTION release, 8/7).

The report is available online (.pdf).

Kaisernetwork.org was the official webcaster of the XVII International AIDS Conference in Mexico City.

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

14
Aug

EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, announced that it has initiated its Phase 2b right-heart catheter study of PRX-08066 in patients with chronic obstructive pulmonary disease (COPD) and moderate-to-severe pulmonary hypertension (PH). PRX-08066 is a novel serotonin type 2B receptor (5-HT2B) antagonist that may represent a new mechanism of action for treating PH.

“There are currently no approved drugs to treat PH associated with COPD and it is estimated that this disease may affect up to six million people worldwide,” said Elkan Gamzu, Ph.D., interim chief executive officer of EPIX. “These patients have a very poor prognosis and, consequently, there is a significant unmet medical need for an effective treatment. We believe that PRX-08066 may be the only 5-HT2B antagonist being developed for pulmonary hypertension that has the potential to selectively and safely reduce pulmonary artery blood pressure in these patients without affecting their systemic blood pressure.”

“There is an undeniable need for safe and effective treatments for patients with PH associated with COPD,” said Aaron Waxman, M.D., Ph.D., assistant professor of medicine, Harvard Medical School and Massachusetts General Hospital, Pulmonary and Critical Care Medicine and lead investigator of this Phase 2b study. “We believe this drug may be an important advance toward effective treatment for patients with this progressive lung disease, and hope to see reductions in pulmonary artery blood pressure and improvements in exercise capacity in this trial similar to those seen in previous trials with PRX-08066 using more rigorous techniques.”

This single-arm, open-label, Phase 2b study is designed to evaluate the mean pulmonary artery blood pressure change from baseline as measured directly by right-heart catheterization and will also measure the change from baseline in the standard six-minute walk distance test after three months of treatment. Patients will be treated with 500 mg of PRX-08066 on day one of the trial followed by twice-daily dosing of 300 mg of PRX-08066 for three months. The trial is designed to enroll adult patients with COPD and moderate-to-severe PH.

PRX-08066 may represent a novel mechanism for selectively dilating diseased pulmonary arteries without affecting systemic blood pressure. Expression of the 5-HT2B receptor is increased in the pulmonary arteries of patients with PH. Blocking the 5-HT2B receptor in patients with PH may reduce or prevent the acute rise in pulmonary blood pressures which occurs when patients increase their activity. This mechanism means that the heart would do less work for a given level of activity, allowing for improvements in exercise tolerance. Moreover, by blocking the serotonin-dependent growth of pulmonary vascular smooth muscle cells, which further increases pulmonary blood pressures and increases workload demand on the heart, PRX-08066 could potentially slow the progression of PH. Over time, this effect could translate into long-term improvements in exercise tolerance and slowing of the vascular and cardiac remodeling that leads to right heart failure. These kinds of effects have been seen with PRX-08066 in pre-clinical animal models of hypoxia-induced pulmonary hypertension.

COPD is a progressive lung disease that affects nearly 30 million people worldwide and is characterized by airflow obstruction which interferes with normal breathing and impairs the ability to exercise and perform daily activities. According to a December 2007 Datamonitor report, PH is estimated to be present in up to 20 percent of patients with COPD. Despite the fact that patients with COPD and concomitant moderate-to-severe PH generally have poor prognoses, there are no agents currently approved to treat this patient population.

About PRX-08066

Discovered and designed using EPIX’s proprietary G-protein coupled receptor (GPCR) modeling and optimization technology, EPIX is developing PRX-08066 to provide both symptomatic improvement of PH, through selective dilation of diseased pulmonary arteries, and to also slow disease progression by inhibiting the serotonin-mediated thickening of the pulmonary artery vessels. EPIX believes PRX-08066 may be a first-in-class selective antagonist of the 5-HT2B receptor for the treatment of PH.

In a Phase 2a, randomized, double-blind, placebo-controlled trial of 71 patients, 62 of whom were evaluable, treatment with PRX-08066 resulted in statistically significant (p=0.043) reductions in median systolic pulmonary artery pressure (SPAP) compared with placebo after two weeks of treatment. Responder (defined as greater than or equal to a 4mmHg drop in SPAP) rates were 45% on 400 mg of PRX-08066 given once-daily vs. 14% on placebo. The company has also completed several Phase 1 trials with PRX-08066 in healthy volunteers, including a Phase 1b study that assessed the effects of PRX-08066 on pulmonary artery blood pressure in athletes whose pulmonary pressures were increased by exposure to a reduced oxygen level (hypoxia). The results of this Phase 1b trial indicated that 200 mg of PRX-08066 given orally twice daily significantly reduced the increase in pulmonary artery blood pressure during hypoxic exercise (by 3.6mmHg vs. placebo), without affecting systemic blood pressure. The half life of PRX-08066 is approximately 20 hours and the agent has shown good oral absorption. PRX-08066 was well-tolerated when given alone and when combined with standard medications for COPD patients as all of the patients in the Phase 2a trial were on several concomitant medications. One patient in the 400 mg dose group who continued into the six-week open-label extension experienced a modest increase in liver enzyme levels at the end of the extension that was believed to be drug-related. These values returned to normal within two weeks and the patient remained asymptomatic.

About EPIX

EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics and Bayer Schering Pharma.

This news release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on current expectations of management. These statements relate to, among other things, our expectations regarding our Phase 2b study of PRX-08066 in patients with COPD and moderate-to-severe PH and the potential efficacy of PRX-08066. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things: risks that PRX-08066 may fail in the clinic or may not be successfully marketed or manufactured; risks relating to our ability to advance the development of PRX-08066; failure to obtain the financial resources to complete development of PRX-08066; our inability to achieve commercial success for our products and technologies; our failure to comply with regulations relating to our products and product candidates, including FDA requirements; the risk that the FDA may interpret the results of our studies differently than we have; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional information regarding these and other risks that we face, see the disclosure contained in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.

EPIX Pharmaceuticals

14
Aug

Up to one-third of older people with asthma remain undiagnosed due to a combination of under-reporting of symptoms and complexity of diagnosis.

COPD in the older person is also under-diagnosed.

To help address this growing problem, the National Asthma Council Australia will host a special Rural Health Education Foundation satellite broadcast program on September 9, 2008, funded by the Australian Government Department of Health and Ageing.

The program, “Breathlessness in the Older Adult: Is it Asthma?”, will be chaired by ABC Radio National’s Dr Norman Swan and will feature a panel of experts comprising a respiratory physician, general practitioner, respiratory clinical nurse consultant and community pharmacist.

The panel will explore the differential diagnosis and management of asthma in older adults with breathlessness, with interrelated discussion of COPD, and address ‘live’ questions from viewers.

After viewing the program, participants will be able to improve their ability to assess and diagnose asthma and COPD in older adults; identify appropriate management strategies; and, understand the effects of ageing on self-management of asthma and COPD. Participants will also qualify for CME Points from AACRM, RACGP, PSA and APA. For more details, including local broadcast times and viewing sites, visit: http://www.rhef.com.au

“Breathlessness in the Older Adult: Is it Asthma?” will be re-screened on September 12. It will also be available on DVD and video and via web-streaming or pod-cast as a resource for all health professionals working with older Australians.

A link to the September broadcast and access to seven previous National Asthma Council Australia broadcasts can be found at: http://www.NationalAsthma.org.au, together with up to date asthma management resources for health professionals and patients.

National Asthma Council Australia

14
Aug

Research published in the Proceedings of the National Academy of Sciences, USA (PNAS) explores the mechanisms behind the common cold virus and how it causes asthma attacks.

The research, funded by the British Lung Foundation, Asthma UK, the Medical Research Council, Imperial College London and the Wellcome Trust, is good news for the five million asthma sufferers in the UK because it may lead to a way of preventing attacks in future.

“The common cold is the main reason why people with asthma get bad attacks,” says Professor Neil Barnes, spokesperson for the British Lung Foundation. “This research is important because it helps us to understand exactly what happens in our lungs during an asthma attack and it may lead to a way of preventing attacks in future.”

1. The British Lung Foundation is the only UK charity working for everyone affected by lung disease. The charity focuses its resources on providing support for people affected by lung disease today; and works in a variety of ways (including funding world-class research) to bring about positive change, to improve treatment, care and support for people affected by lung disease in the future.

2. It provides information via the website http://www.lunguk.org and telephone helpline 08458 50 50 20.

3.In 2007 the charity launched a membership scheme with the aim of recruiting the 8 million people with lung disease in the UK and anyone with an interest in lung disease.

4.One person in every seven in the UK is affected by lung disease - this equates to approximately 8 million people

5.Respiratory disease is the second biggest killer in the UK (117,456 deaths in 2004) after all non-respiratory cancers combined which only account for slightly more deaths (122,500 deaths in UK in 2004)

6.Respiratory disease now kills one in five people in the UK

7.The UK’s death rate from respiratory disease is almost double the European average and the 6th highest in Europe

8.Respiratory disease is the most commonly reported long term illness in children and the third most commonly reported in adults. One in 7 boys and 1 in 8 girls aged 2 - 15 report having long term respiratory illness in England

British Lung Foundation

12
Aug

A weather alert service run by the UK’s Meteorological Office that forecasts when weather is likely to be bad for COPD patients and alerts them to take simple precautions, has achieved a 20 per cent drop in COPD hospital admissions in areas that use the scheme.

According to the Meteorological Office (Met Office), over 8,500 patients from 160 practices are already signed up to the scheme, which essentially does two things: it warns people when the outdoor environment is likely to be bad for their health, and it reminds them what to do to keep themselves well.

Called Healthy Outlook(R) COPD Forecast Alert, the scheme costs 18 pounds per patient per winter (plus a set up fee) and includes training in health forecasting for healthcare professionals, a weekly (twice weekly in the winter) email COPD forecast, a COPD patient register, and a direct to patient contact scheme for when the forecast reaches the “elevated” category.

Chronic Obstructive Pulmonary Disease (COPD) is an umbrella term covering lung conditions like bronchitis and emphysema that are long-term and gradually get worse. There is no cure but a lot can be done to relieve the symptoms of COPD.

According to the British Lung Foundation, the vast majority of people have never heard of COPD, yet it’s the UK’s fifth biggest killer and claims about 30,000 lives a year.

Every year the NHS spends 600 million pounds looking after people with COPD and there are 100,000 COPD-related hospital admissions in England.

The Healthy Outlook scheme issues an email twice a week in winter and once a week in summer. The email forecasts the COPD risk over the coming week, giving it either a “Normal” or “Elevated” category, and it also includes an outlook for the following week.

The scheme includes a direct patient contact register that is triggered when the risk is “Elevated”. Operated in conjuction with Medixine, the system contacts registered patients by telephone to warn them of the expected worsening conditions and asks them to look at their information pack for further advice. It then asks them whether their symptoms are worse than normal, and whether they have enough medication for the next two weeks.

The patients’ practice staff also get an email the day before the calls are made and also when they are complete. The patient’s responses are kept in a database that practice staff can look at to do any follow up.

GPs can put patients on the direct contact register by sending them an invititation letter. They can add patients to the register using a simple web-based form.

The Met Office said areas that joined the scheme last winter include: Rhondda Cynon Taff Local Health Board, East Lothian, Moray and West Glasgow Community Health Partnerships, Worcestershire, Bradford, Cornwall and West Cheshire Primary Care Trusts.

New areas that have signed up to use the scheme this winter include Stoke, Torbay, Devon, and another in Northern Ireland.

According to the BBC, the Met Office has surveyed over 3,000 patients on the scheme and found that one third of them were prompted to contact their GP to get a repeat prescription and 11 per cent asked their doctor about worsening symptoms. Some patients said the service made them feel someone cared, and one patient said it was useful for “adjusting lifestyle to take account of the weather conditions”, and in “planning and ordering medication”.

Chief executive of the British Lung Foundation, Dame Helena Shovelton, told the BBC that the scheme was a “great benefit”, and that:

“Being aware of detrimental weather conditions enables people to plan ahead and avoid situations that could aggravate their condition.”

But she said being on the scheme should not make patients complacent and it should not be seen as a replacement for important services like rehabilitation classes which can help patients increase their lung fitness, and seeing specialist nurses, although she admitted that not everyone has access to these services.

Click here for more information about Healthy Outlook(R) COPD Forecast Alert (Met Office).

Sources: Met Office, BBC.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today

8
Aug

As we come close to the Olympic Games, a review article in CMAJ (Canadian Medical Association Journal) reminds us that the heat and humidity in the region will present a formidable challenge to all athletes. Moreover, poor quality of air can also affect all athletes, especially those with asthma.

“With exposure to an environment that has poor quality, air pollutants may trigger symptoms of asthma in a dose-dependent manner,” say Donald McKenzie and Louis-Philippe Boulet. “With the high minute ventilation (amount of air breathed in one minute) seen during exercise, the effects of exposure to these pollutants are more noticeable in athletes than in non-athletes and likely more evident in people with asthma than in those without asthma.”

Physical activity and regular exercise can improve the control of asthma and is recommended to patients. However, there is mounting evidence that frequent, intense exercise by highly trained athletes could itself contribute to the development of asthma. Long-term endurance training may influence the structure and function of airways in the lungs and make them hyperresponsive, contributing to the development of asthma.

McKenzie and Boulet say that athletes with asthma need an individualized management plan that needs to comply with the anti-doping regulations of the International Olympic Committee and the World Anti-Doping Agency. For example, athletes who wish to use an inhaled medication, such as one of the permissible beta-2 agonists, need to document the need for this medication by appropriate lung function testing and submit an application to the International Olympic Committee’s Medical Commission.

China has implemented strategies in the region to improve air quality during the Olympic Games. “However, a significant percentage of the pollution (about 35%) at the Olympic Stadium can be attributed to sources outside . Controlling only local sources of pollution may not be sufficient to achieve the air quality goal set for the games,” say McKenzie and Boulet.

“Asthma, outdoor air quality and the Olympic Games”
Donald C. McKenzie MD PhD, Louis-Philippe Boulet MD
Canadian Medical Association Journal (CMAJ)
CMAJ 2008 0: cmaj.080982
Click here to view article (PDF)

CMAJ (Canadian Medical Association Journal)

CMAJ is the leading health sciences journal in Canada. CMAJ is a general medical journal publishing original research and review articles, commentaries and editorials, practice updates, an arts and ideas section and health news. Published continuously since 1911, new issues are uploaded on www.cmaj.ca every second Monday at 4:30 p.m. EST/EDT. www.cmaj.ca contains the complete editorial contents of CMAJ, supplemented by a variety of interactive features and additional content.

www.cmaj.ca

7
Aug

If you think your ragweed allergies are getting worse, you may be right. And global warming may be the culprit, according to the American Academy of Allergy, Asthma & Immunology.

That’s not good news for the estimated 36 million Americans who suffer from ragweed allergy, the primary cause of fall allergy symptoms. Ragweed season unofficially begins Aug. 15.

Global climate change is believed to be making ragweed season worse for allergy sufferers. Recent studies suggest that increasing temperatures and carbon dioxide levels are already resulting in longer ragweed seasons and more concentrated pollen counts. The Journal of Allergy and Clinical Immunology (JACI), the official scientific journal of the AAAAI, has devoted its September issue to exploring the effects of climate change on allergic disease - including ragweed allergy.

In a review article to be published next month in the JACI, Richard W. Weber, MD, FAAAAI, and chairman of the AAAAI Aerobiology Committee, writes that “there is now a wealth of evidence that climate change has had, and will have, further impact on a variety of allergenic plants.”

Researchers have decisively linked climate change to “longer pollen seasons, greater exposure and increased disease burden for late summer weeds such as ragweed,” Weber writes, citing among other findings that increased carbon dioxide has resulted in pollen production increases of 61-90 percent in some ragweed varieties.

According to data from the AAAAI one ragweed plant can produce 1 billion pollen grains in an average season. Due to the grains’ light weight, they can travel up to 400 miles with the breeze, leaving virtually no outdoor place ragweed-free.

Allergy shots, or immunotherapy, are effective treatment in up to 90 percent of patients with ragweed allergy. Individuals who suffer from ragweed allergy can also take simple steps to prevent or relieve symptoms:

-Keep windows closed to keep pollen outside homes and cars. Use the air conditioner, which filters, cools and dries air.
-Stay indoors when pollen counts are highest, typically between 10 a.m. and 4 p.m.
-Check daily pollen counts for your area at http://www.aaaai.org.
-Change clothing after time spent outdoors and avoid drying laundry outside.
-Sleep well by taking a shower before bed to wash pollen from your hair and face, preventing it from ending up on your pillow.

Many individuals with ragweed allergy also experience symptoms when eating fresh produce such as bananas, cucumbers, melons and zucchini. This occurs when the body confuses proteins in these foods with similar ones in ragweed.

Given its complications, an allergist/immunologist is the best-qualified medical professional to diagnose and treat ragweed allergy and other allergic diseases.

The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Established in 1943, the AAAAI has nearly 6,500 members in the United States, Canada and 60 other countries.

AAAAI

7
Aug

Nearly 11% of children headed back to school this fall have asthma. Annually, school aged children with asthma miss just under 13 million days in the classroom, making asthma related illness one of the most common reasons kids are absent from school. The American Lung Association offers parents a seven step checklist to ensure a safe and healthy school year for children who suffer from this sometimes debilitating disease.

To minimize asthma’s grip on this school year ahead, parents must first be aware that per government regulation, manufacturers are phasing out production of a common type of albuterol inhaler, often called a CFC inhaler. By December 31, 2008, CFC inhalers will not be available to the consumer public and will be replaced by an HFA inhaler.

The FDA has found that HFA inhalers are safe and just as effective as their CFC counterparts. One significant difference is that HFA inhalers do not contain ozone-depleting chemicals found in CFC inhalers.

“Some kids might find their new inhaler has a slightly different taste or feel,” said Norman Edelman, MD, Chief Medical Officer of the American Lung Association. “Also be aware that your pharmacy won’t be able to simply substitute the new HFA inhaler for your existing CFC inhaler prescription. Your child’s doctor will need to write a new prescription.”

“It is also important for parents to confer with their child’s doctor to ensure each of their asthma prescriptions are current and are best managing the child’s symptoms. This should be done at least once a year,” Dr. Edelman added.

In preparation for the school year ahead, the American Lung Association also urges parents who have children with asthma complete the following checklist:

— Schedule Asthma Check-up Doctor’s Appointment

Even if your child’s asthma is well managed, scheduling a check up with your pediatrician is critical to ensuring your child’s asthma continues to be effectively controlled. This is also an opportunity to evaluate medications and physical activity restrictions.

— Confirm Medicines Are Up-to-Date and Fill Prescriptions

If your child uses an inhaler, ensure you have a current prescription for an HFA inhaler. Check your medicine cabinet to ensure your child’s asthma prescriptions have sufficient refills available and have not expired.

— Know About Prescription Assistance Services

No one should have to do without their asthma medications because offinancial need. Two organizations are available to help.

— Asthma Action Plan

All students with asthma should have a written Asthma Action Plan that details personal information about the child’s asthma symptoms, medications, any physical activity limitations and provides specific instructions about what to do if an asthma attack does not improve with prescribed medication.

— Visit Your Child’s School Nurse and Teachers

All of the student’s teachers, coaches, as well as the school nurse and/or office should have a current copy of their Asthma Action Plan. Discuss with your child’s teachers specific triggers and typical symptoms so that they can be prepared to effectively assist your child should an asthma attack occur during the school day.

— Advocate for Your Child

It is also important to learn if your child’s school allows students to carry and independently administer their asthma medication. Some schools require students to carry a note from their doctor. Learn what steps need to be taken to have your child carry and use their inhaler if recommended by their doctor.

— Know Your School’s Asthma Emergency Plan

Ensure that your child’s school knows how to contact you in case of an emergency. It is also important for parents to know the school’s past history of dealing with asthma episodes. Parents should confirm that school staff– including after-school coaches and bus drivers have been trained in responding to asthma emergencies.

About the American Lung Association: Beginning our second century, the American Lung Association is the leading organization working to prevent lung disease and promote lung health. Lung disease death rates are currently increasing while other major causes of death are declining. The American Lung Association funds vital research on the causes of and treatments for lung disease. With the generous support of the public, the American Lung Association is “Improving life, one breath at a time.”

American Lung Association
http://www.lungusa.org

7
Aug

For Easier Breathing

Author: admin

A chronic cough or change in breathing shouldn’t be dismissed as smoker’s cough or a sign of being out of shape.

These can be early symptoms of chronic obstructive pulmonary artery disease (COPD). The August issue of Mayo Clinic Health Letter discusses COPD, a progressive lung disease usually caused by smoking.

COPD is most commonly a combination of chronic bronchitis — characterized by persistent cough and phlegm production — and emphysema, which causes shortness of breath. These conditions develop gradually and produce few signs and symptoms in the early stages. But COPD, among older adults, is a leading cause of death in the United States.

Fortunately, when COPD is detected at a mild-to-moderate stage — as the majority of cases are — symptoms can remain mild if a person stops smoking and adopts a healthier lifestyle.

Strategies that can help mild-to-moderate COPD include:

– Avoid respiratory infections — Get the pneumonia vaccine and an annual flu vaccination and take basic preventive precautions such as frequent hand washing.

– Get daily exercise — The efficiency of the muscles and circulatory system will increase.

– Use short-acting bronchodilators — They can help relax muscles and prevent spasms and, as a result, relieve coughing and make breathing easier.

– Avoid irritants — Stop smoking and avoid secondhand smoke, air pollution, wood smoke, strong odors and dust.

– Maintain a well-balanced diet and healthy weight — Too thin can lead to frailness, while being overweight can increase shortness of breath.

Treatments for more severe COPD include long-acting bronchodilators, corticosteroids and supplemental oxygen.

Mayo Clinic
200 First St. SW
Rochester, MN 55902
United States
http://www.mayoclinic.com

7
Aug

Cortex Pharmaceuticals, Inc. (AMEX: COR - News) reported that top-line data from its first Phase IIa study in opiate-induced respiratory depression (RD) demonstrated that a single oral dose of 2100mg of AMPAKINE® CX717 achieved statistical significance over placebo on the primary endpoint measure. These results are being presented at the Bank of Montreal Capital Markets Focus on Healthcare Conference in New York City on Wednesday morning, August 6, 2008 at 9:30AM (EDT) by Dr. Roger G. Stoll, President & CEO of Cortex. This placebo controlled, double-blind, randomized two-way crossover trial (RD-02) was performed by Parexel’s clinical research unit in Europe. In this study, eight (8) volunteers per dose group each received either 900mg, 1500mg, or 2100mg of CX717 or matching placebo that was orally administered two hours before each subject received an intravenous infusion of the opiate agonist, alfentanil. The primary performance measures were derived from a CO2 re-breathing procedure that measured the breathing response of the subject to increased CO2 levels in the presence of alfentanil. The primary measure, the minute expiratory volume (VE) at 55mgHg CO2 (VE55), was reversed by 2100 mg CX717 in comparison to placebo (p<0.03).

No reliable responses were seen in the 900mg and 1500mg CX717 groups, but procedural problems were detected by the Data Safety Monitoring Board (DSMB) for this study, which was authorized by the protocol to monitor safety and responses on an interim basis. Corrective procedural changes were instituted before the initiation of the last group of subjects in the 2100mg segment of the study.

“While we initiated this study using oral doses of CX717 and had only eight subjects per treatment group, we were pleased to obtain statistical significance using such small study groups,” said Dr. Roger Stoll the CEO of Cortex. The primary objective was to simply verify that the mechanism, which was seen functioning in animal studies, would also be operative in humans. Substantial investments were required to develop an intravenous dosage form of CX717, including formulation development and stability studies for such a dosage form as well as two species toxicology trials. The Company now feels that it can proceed with such studies. Cortex recently received verification of three months of accelerated stability for the experimental intravenous formulation of CX717 and plans to initiate toxicology trials in the fourth quarter 2008.

A second respiratory depression study has been performed by a group in Frankfurt, Germany. This study uses a single dose of 1500mg of CX717 and focuses on both the respiratory depression and the analgesic effects associated with alfentanil. The analysis of the data has been initiated and related results should be reported within a few weeks. Studies of CX717 in animal models by Dr. John Greer at the University of Alberta have shown that the AMPAKINE drugs do not interfere with the analgesic effects of opiates.

Cortex continues to advance other AMPAKINE compounds, particularly those newer compounds that have potential patent lives to 2028. It will also be reported at the BMO Capital Markets conference that Cortex has initiated human phase one safety and kinetic trials with CX1739 in normal volunteers. Assuming successful Phase I human trials with this compound, the Company plans to rapidly pursue the Attention Deficit-Hyperactivity disorder indication for CX1739 in the second half of 2009. The Company will also report on an initial animal trial with CX1942, a unique pro-drug analog of another low impact AMPAKINE drug that is highly water soluble, ideally suited for an intravenous dosage form. This compound rapidly hydrolyzes to the parent AMPAKINE drug in vivo. CX1942 has shown exceptionally rapid results in reversing respiratory depression due to intravenously administered fentanyl in rats. The Company plans to initiate toxicology studies with this unique analog during the last quarter of 2008.

High impact AMPAKINE compounds from recent patent applications are also being advanced with a focus on neurodegenerative diseases, such as Alzheimer’s and Parkinson’s diseases, as well as orphan drug indications like Huntington’s and Fragile X disease.

The conference presentation will be webcast and available for a period of thirty days after the conference by logging on to http://www.bmocm.com/conferences/2008healthcare/default.aspx.

Cortex Pharmaceuticals, Inc.

Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for treating psychiatric disorders, neurological diseases and brain mediated breathing disorders. Cortex is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain’s neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. Cortex has an alliance with Schering-Plough Corporation who acquired Cortex’s former partner N.V. Organon in November 2007. As a result of this acquisition, Schering-Plough has two AMPAKINE Phase II compounds Org24448 and Org 26576 for the treatment of schizophrenia and depression. In December 2007 Cortex terminated the research collaboration with Servier enabling Cortex to pursue the use of AMPAKINE compounds in the treatment of neurodegenerative diseases on a global basis. Servier retained the right to select up to three compounds developed during the collaboration for further development for the treatment of neurodegenerative diseases. Cortex may receive additional milestones and royalties if either Organon or Servier is successful in developing and commercializing AMPAKINE compounds. For additional information regarding Cortex, please visit Cortex Pharmaceuticals’ website at http://www.cortexpharm.com.

Forward-Looking Statement

This press release contains forward-looking statements concerning the Company’s research and development activities. The success of such activities depends on a number of factors, including the risks that the Company’s proposed compounds may at any time be found to be unsafe or ineffective for the indications under pre- clinical or clinical tests and that such studies may at any point be suspended or take substantially longer than anticipated to complete. The forward-looking statements are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Cortex, all as more fully described in the risk factors and other matters set forth in Cortex’s Annual Report on Form 10-K for the year ended December 31, 2007, and Cortex’s other filings with the Securities and Exchange Commission, As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease. Cortex disclaims any intent or obligation to update any forward-looking statements.

Cortex Pharmaceuticals, Inc.