New Hampshire Governor John Lynch (D) on Tuesday signed into law a bill… (SB 171) creating a legislative committee to study how HIV/AIDS-related services are delivered in the state, Foster’s Daily Democrat reports (Manning, Foster’s Daily Democrat, 6/1). The committee will be made up of three state representatives and three state senators, who will be selected by the leaders of each chamber (SB 171 text, 6/2). According to state Sen. Iris Estabrook (D), who sponsored the measure, the purpose of the committee is to coordinate various state agencies and nongovernmental organizations to streamline HIV/AIDS-related programs and resources. Committee members also will be required to compare New Hampshire’s delivery of services to that of the other five New England states, assess the care needs of HIV/AIDS patients and research possible improvements to services, according to the Daily Democrat. Estabrook said the not-for-profit group AIDS Response Seacoast brought the matter to her attention by pointing out that New Hampshire might lose some federal HIV/AIDS funding after the reauthorization of the Ryan White CARE Act. “The best thing to do is to get everybody together and find out where we are,” Estabrook said, adding, “We need to start talking about how we are going to handle a reduction in federal funding” (Foster’s Daily Democrat, 6/1). The committee is required to have its first meeting before July 1 (SB 171 Text, 6/2). According to the state Department of Health & Human Services, there are 1,000 HIV-positive people living in New Hampshire (Foster’s Daily Democrat, 6/1).

“Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

The United States Agency for International Development (USAID) has awarded the Carolina Population Center at the University of North Carolina at Chapel Hill up to $181 million to continue its MEASURE Evaluation project.

The award is the largest ever received by UNC.

The award funds the monitoring and evaluation of family planning, maternal and child health, nutrition and HIV/AIDS programs around the world. The project also monitors and evaluates malaria, tuberculosis and avian influenza programs, and will expand to programs addressing poverty and gender equity.

Going into its third phase, MEASURE Evaluation builds on the previous two phases of the project and the earlier EVALUATION project which began in 1991. The project already has a presence in nearly 50 countries in Africa, Asia, Europe and Latin America and will expand to more. Besides the $181 million of project funding in this grant, the award includes the potential for countries to request evaluation activities valued at up to an additional $125 million over the five years.

“The size of this award is unprecedented,” said Barbara Entwisle, Ph.D., director of the Carolina Population Center (CPC) and Kenan Professor of Sociology in the UNC College of Arts and Sciences. “Faculty at UNC, specifically those at the Carolina Population Center who are part of the MEASURE Evaluation team, have achieved an international reputation for excellence in evaluation research.

The funding of this latest stage of the project acknowledges the great success of the MEASURE Evaluation team in its earlier phases.”

Sian Curtis, Ph.D., research associate professor of maternal and child health in the School of Public Health and a CPC fellow, is principal investigator and project director. Gustavo Angeles, Ph.D., assistant professor of maternal and child health in the School of Public Health and CPC fellow, is co-principal investigator and deputy director.

“Good information is essential to improve the health of the world’s population,” Curtis said. “This award provides a fabulous opportunity to strengthen our understanding of global health programs and improve the collection, analysis and use of population and health information.”

The project’s partners includes John Snow Inc., Macro International, Tulane University, The Futures Group International and Management Sciences for Health.

The MEASURE (Monitoring and Evaluation to Assess and Use Results) Evaluation project uses different strategies to collect and use data about health issues. For example, a tool for assessing and modifying HIV/AIDS prevention programs locally or nationally called the Priorities for Local AIDS Efforts (PLACE) method can identify geographic areas that contain key HIV transmission networks. The PLACE method was developed by Sharon Weir, Ph.D., research assistant professor of epidemiology in the School of Public Health and a CPC fellow.

The project will focus on developing the expertise of health workers and officials in host countries to collect, analyze and use data that are gathered. Building on its existing monitoring and evaluation training courses, researchers will launch a distance learning component to increase the number of people who are trained to monitor and evaluate health programs. Communities of practice will also be created so people from different countries who work on the same health issue can share information and learn from each other.

###

For more about the MEASURE Evaluation Project: https://www.cpc.unc.edu/measure

UNC Tomorrow: For more information about how the MEASURE Evaluation project addresses the global competitiveness recommendations of the UNC Tomorrow Commission, click here.

Source: Patric Lane

University of North Carolina at Chapel Hill Continue reading →

Cold Spring Harbor Protocols, an online journal that publishes methods used in a wide range of biology laboratories, has added over 40 new peer-reviewed protocols to its archive today. The new collection highlights two techniques for characterizing protein interactions, which will aid many cell and molecular biologists–including those who seek to identify the molecular basis of human diseases. Both of these methods are freely accessible from the journal’s website: cshprotocols/.

Given the importance of characterizing the molecular networks and signaling pathways that form the biological basis of all living organisms, techniques aimed at probing protein interactions have come to the forefront in recent years. The new methods published today by CSH Protocols will be useful for researchers seeking to identify the molecular partners–such as other proteins or DNA–to which specific proteins bind.

The featured protocols describe how proteins of interest can be labeled with detectable markers and then used to probe thousands of different DNA and protein sequences. The protein-DNA and protein-protein interactions that are identified will eventually be useful for tracking down the causes of diseases, as well as for designing new drugs to aid in their prevention and treatment.

The latest issue of CSH Protocols also includes a variety of other standard and specialized techniques that will be useful to many researchers. These include methods for synchronizing cell growth, investigating embryonic development, and preparing specimens for immunostaining.

###

ABOUT COLD SPRING HARBOR PROTOCOLS: CSH Protocols (cshprotocols/) is an online, peer-reviewed journal of techniques used in a wide range of biology laboratories. It is structured as an interactive database, with each protocol cross-linked to related methods, descriptive information panels, and illustrative material to maximize the total information available to investigators. Each protocol is clearly presented and designed for easy use at the bench–complete with reagents, equipment, and recipe lists. Life science researchers can access the entire collection via institutional site licenses, and can add their suggestions and comments to further refine the techniques.

ABOUT COLD SPRING HARBOR LABORATORY PRESS: Cold Spring Harbor Laboratory Press is an internationally renowned publisher of books, journals, and electronic media, located on Long Island, New York. It is a division of Cold Spring Harbor Laboratory, an innovator in life science research and the education of scientists, students, and the public. For more information, visit cshlpress/.

Contact: Maria Smit

Cold Spring Harbor Laboratory Continue reading →

Scientists have demonstrated for the first time that a certain class of RNA (known as long non-protein-coding RNA [lncRNA]) are involved in the host response to viral infection. These findings, published today in the online journal mBio®, could greatly change the way scientists look at the body’s response to viral infection.

“To our knowledge, our study is the first to use comprehensive deep-sequencing technology to clearly demonstrate that lncRNAs are involved in the host response to viral infection and innate immunity,” says Michael Katze of the University of Washington, and STRIDE (Center for Systems and Translational Research on Infectious Disease) in Seattle, a lead researcher on the study.

RNA molecules are transcribed from the DNA and help translate the genetic code. They often serve as templates for building compounds the body needs to function including proteins.

Most studies of how animals’ cells respond to viral infections focus only on protein-coding genes, which assemble germ-fighting or inflammation-inducing proteins used by the immune system. However there is growing evidence that thousands of RNAs are transcribed that do not code for proteins.

“The relevance of lncRNAs to viral infections has not been systematically studied, in part because these ncRNAs have not been easily accessible with typically available technologies,” says Katze. “With the advent of next-generation sequencing technologies, whole transcriptome analysis of the host response, including ncRNAs, is now possible.”

The library of RNA transcripts inside of a cell is called its transcriptome and is a reflection of gene activity. Many different RNAs can be read from a single gene. Therefore a transcriptome contains much more complex instructions than would seem possible from the DNA code. Unlike the genome, the transcriptome varies in different types of cells in the body and in accordance with ever- changing conditions inside and outside the cell.

Katze and his research team used highly advanced technologies, such as next generation sequencing (NGS), to perform a whole transcriptome analysis of the host response to severe acute respiratory syndrome coronavirus (SARS-CoV) and influenza infection in four strains of mice, some more susceptible to the viruses than others. Using this deep-sequencing technology, the researchers analyzed whole transcriptomes in cells from infected lung samples collected from the mice.

The researchers observed that virus infection triggered activity in about 500 lncRNAs transcribed from known locations on the genome and about 1,000 from previously unspecified genomic regions.. They were also interested to discover, through studies of subsets of the lncRNAs and genomic regions, that most of these were similarly regulated in response influenza virus infection. This profile contained unique “signatures” of lncRNA activity and these signatures were associated with lethal infection.

“These findings represent the first discovery of the widespread differential expression of long ncRNAs in response to virus infection and suggest that ncRNAs are involved in regulating the host response, including innate immunity,” says Katze. “In the future, it is likely that a detailed knowledge of ncRNA regulation and function will be necessary for a full understanding of viral pathogenesis.”

This project was supported by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, through grant U54 AI081680 (Pacific Northwest Regional Centers of Excellence ) and contract no. HHSN272200800060C (A Systems Biology Approach for Infectious Diseases Research).

Source:
Jim Sliwa
American Society for Microbiology Continue reading →

VOA News on Saturday examined efforts to address HIV/AIDS in Papua New Guinea. Some estimates place the country’s HIV/AIDS prevalence at 2%, and some studies indicate that about 10% of the population could be living with the disease by 2025. According to VOA News, young women and older men are disproportionately affected by the disease, and most HIV cases are transmitted through heterosexual intercourse.

Papua New Guinea’s military recently announced that it will help distribute more than 40 million condoms provided by Australian agencies. Don Baxter of the Australian Federation of AIDS Organizations said that the military’s involvement in HIV/AIDS efforts is vital. “I think Papua New Guinea is perhaps the most difficult country in the world to mount a national HIV response,” he said, adding, “It has over 700 different language groups, no national transport system to speak of and few government services that actually operate outside of the capital, Port Moresby.” Baxter said that the “military is one of the few organizations which actually can operate nationally effectively.”

In addition, a local group recently announced that it has partnered with more than 90 hotels and guest houses to distribute two million no-cost condoms. According to Papua New Guinea Prime Minister Sir Michael Somare, people living with HIV/AIDS in the country often are abandoned by their families, and the fear surrounding the disease hinders efforts to curb it. According to VOA News, some people in the country associate HIV/AIDS with sorcery and witchcraft, and there have been reports of HIV-positive people being buried alive, starved to death or thrown into rivers. Human rights organizations recorded 50 such deaths in 2008 (Mercer, VOA News, 4/4).

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

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

Fran Balkwill, Professor of Cancer Biology at the Barts & The London, Queen Mary’s Medical School, is the 2004 winner of
the EMBO Award for Communication in the Life Sciences. Balkwill receives the award in recognition of her outstanding
contribution to science communication for children. The cancer researcher has authored 13 children’s books that take a novel
look at a range of topics from genetics to HIV and AIDS. Balkwill is also the Director of the ‘Centre of the Cell’, an
exciting new interactive bioscience centre in London’s East End.

The EMBO Award for Communication is presented annually to a practising life scientist in Europe who has made significant
contributions to public understanding of science. The award highlights the exceptional efforts made by many scientists to
combine science communication activities with a full-time research career. Winners of the EMBO Communications Award are also
put forward for the European Commission’s Descartes Prize for Science Communication.

The International jury applauded Balkwill for ‘her spectacular work in communicating important scientific concepts to the
young and her untiring efforts to bring critical science and health messages to deprived communities’. The prize of Euro
5,000 and a handcrafted gold and silver medal were presented to Fran Balkwill on November 5, 2004 at the EMBL/EMBO Science &
Society Conference, “Time and Aging – Mechanisms and Meanings” in Heidelberg, Germany.

Frances Balkwill said: “I am delighted to receive this award, but I don’t look on it as an individual achievement. Without
illustrator, Mic Rolph, the books would never have been a success and there are numerous other people in the UK, Europe,
South Africa and the US, who have helped and inspired me. The award is a great honour and I hope it will help stress the
importance of science education for the young and bring attention to the plight of children at risk of HIV in Africa today.”

As well as her full-time role as a researcher and Director of the Cancer Research UK Translational Oncology Centre at Queen
Mary, Fran Balkwill is a dedicated science communicator. She has written 13 acclaimed children’s books including the
prize-winning Cells Are Us and Cell Wars. Illustrated by Mic Rolph, the books combine punchy narrative with lively graphics,
taking readers on a journey through the wonders of biology. The latest two books, although equally entertaining, have a far
more profound aim – saving lives. Staying Alive: Fighting HIV/AIDS and the revised edition, You, Me and HIV are aimed at
educating children at risk of contracting HIV in Africa.

Research for Balkwill and Rolph’s first book on HIV and Aids took the author and illustrator to South Africa, where they
talked to children, teachers and health care professionals to determine the educational needs of the local communities.
Funding for the project was organised by Siamon Gordon of Oxford University, who also came up with the original idea in 2000.
In 2002, in collaboration with Cold Spring Harbor Laboratory Press, 19,000 copies of Staying Alive: Fighting HIV/AIDS were
distributed free of charge throughout South Africa.

The second edition, You, Me and HIV, also published by Cold Spring Harbor Laboratory Press, is the result of a further trip
to South Africa to assess the impact of the first book and incorporates revisions from teachers, students and community
workers who have been working with the book. You, Me and HIV will be available from January 2005 and thanks to funding from
the Bill and Melinda Gates Foundation, will reach 100,000 more children and educators in sub-Saharan Africa.

Since 2001 Frances Balkwill has also been the driving force behind another major science education project much closer to
home. Housed within the new building for Bart’s and The London, Queen Mary’s School of Medicine in London’s East End, the
Centre of the Cell will open its doors to children, teenagers and teachers from the surrounding areas in April 2006. The
Centre of the Cell is the first science education centre to be located within a medical school with working research
laboratories. The aim is to allow visitors to experience the ‘real thing’ and draw them into the exciting world of biomedical
research through a series of interactive exhibits and hands-on activities.

Deadline for 2005 EMBO Award for Communication in the Life Sciences: May 31, 2005

About EMBO

The European Molecular Biology Organisation (EMBO) promotes biosciences in Europe. Through initiatives such as fellowships,
courses and workshops, EMBO supports transnational mobility, training and exchange at all stages of the scientific career.
The organisation was founded in 1964 and an example of its early impact was the establishment of the well-known laboratory,
EMBL. EMBO elects new members annually on the basis of proven excellence in research. Today the organization has
approximately 1200 European members and 100 associate members worldwide including some 38 Nobel Laureates. embo

About the Barts and The London, Queen Mary’s School of Medicine and Dentistry

Created from two historic medical schools: St Bartholomew’s Hospital Medical College (Barts, established in 1843) and the
Royal London Hospital Medical College (The London, England’s oldest medical college established in 1785), the School of
Medicine and Dentistry moved into a new phase in 1995 with the merger of these famous clinical schools with Queen Mary,
University of London. The School has a strong tradition of providing high quality, state-of-the-art undergraduate education
and an acclaimed reputation in clinical, medical and health research. www.qmul.ac

Contacts:

EMBO
Lindsay Johnson
Communications Officer
EMBO
Postfach 102240
D-69012 Heidelberg
Germany
Tel: 49-6221-8891-108
Fax: 49-6221-8891-200
Lindsay.Johnsonembo

Queen Mary’s School of Medicine and Dentistry
Sally Webster
Deputy Head of Press & PR
External Relations & Communications Department
Queen Mary, University of London
Mile End Road
London
E1 4NS
England
Tel: 44-20-7882-5404
s.websterqmul.ac

Contact: Lindsay Johnson
Lindsay.Johnsonembo
49-6221-8891-108
European Molecular Biology Laboratory Continue reading →

Immunitor USA Inc, announced today that its licensed vaccine candidate V-1 Immunitor (V1) has shown promising results in
Phase II, placebo-controlled, clinical trial involving 47 HIV-infected individuals.

emediawire/releases/2004/12/emw186195.htm

The study was published in the special December issue of the Journal of Clinical Virology – the official journal of The Pan
American Society for Clinical Virology and The European Society for Clinical Virology. The abstract of the paper is now
available on PubMed – the website of the National Library of Medicine ncbi.nlm.nih/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15567095

At the end of 6-month study volunteers who were treated with V1 had statistically significant increase in CD4-positive T-cell
numbers (p=0.01). However, in the placebo group that has received sham pills, the changes in T-cell counts failed to reach
the significance threshold (p=0.33). The clinical potential of V1 was further supported by an elevation in CD4/CD8 ratio
among V1 recipients and decline in CD4/CD8 ratio in patients on placebo. The average weight gain among patients on V1 was 1.8
kg while placebo group lost 0.5 kg. These results indicate that V1 can delay or reverse the HIV disease progression without
any concurrent toxicity.

“Our published data supports earlier published, Phase I studies of V1 demonstrating increase in T-lymphocyte numbers,
decrease in viral load, body weight gain, and improved survival of end-stage AIDS patients,” said Vichai Jirathitikal, the
inventor of the oral vaccine technology. “The study provides additional evidence that this type of vaccine might ultimately
be effective as a safe and effective treatment for AIDS and potentially other autoimmune diseases as well.”

” The very first clinical study of V1 was published in 2002. In just two years we were able to achieve the major milestone in
drug development process, which is the pivotal Phase II trial. We have accomplished this despite major and obvious
difficulties and we are looking forward to confirm such results in Phase III clinical trial,” said Dr. Aldar S. Bourinbaiar,
CEO.

Due to toxicity and drug resistance problems associated with conventional antiviral chemotherapy, the therapeutic use of AIDS
vaccines is receiving increased attention in the medical community. There has been considerable experience with this type of
approach, with several dozen clinical trials reported over the last twenty years. While the immune response appeared to
change as a result of therapeutic vaccination in most, if not all studies, there was no demonstrable clinical benefit.
Despite this setback many clinical studies of various therapeutic vaccines are in progress, which may eventually help to
identify an effective strategy.

V-1 Immunitor is an experimental AIDS vaccine made as an ordinary pill and comprises heat- and chemically-inactivated viral
antigens derived from the pooled blood of HIV-positive donors. V1, which is taken orally on a daily basis, is thought to
function by modulating the mucosal immune response. This innovative method of vaccine administration places the emphasis on
oral tolerization of alloantigens delivered through the gut. V1 is the first therapeutic AIDS vaccine that has shown the
clinical improvement in AIDS patients when administered orally. Continue reading →

Tibotec Pharmaceuticals announced today that the European Commission adopted the decision to broaden the indication for PREZISTA® (darunavir), a protease inhibitor, in combination with ritonavir and other antiretroviral medicinal products to the treatment of HIV-1 infection in all treatment-experienced adult patients. Darunavir was developed by Tibotec Pharmaceuticals, Cork, Ireland. Tibotec, a division of Janssen-Cilag, is the organisation responsible for marketing the brand in Europe.

“The availability of darunavir for the full spectrum of treatment-experienced patients in the European Union (EU) provides caregivers and patients with important additional options to manage HIV,” said Roger Pomerantz, M.D., President of Tibotec Research and Development. “Our scientists and development teams are deservingly proud of the difference they make in helping to address the unmet needs of people living with HIV. We will continue our commitment to developing innovative treatment options to help fight HIV and other infectious diseases.”

This Commission decision signifies that the treatment is authorised for use in the European Union, valid in all 27 EU member states. In 2007, a conditional marketing authorisation was granted to darunavir, taken in combination with ritonavir and other antiretroviral medicinal products. This earlier conditional approval limited the use of darunavir to the treatment of highly pre-treated adult patients who failed on more than one regimen containing a protease inhibitor. The full marketing authorisation from the European Commission is expected by the end of December 2008.

Following today’s decision, darunavir, co-administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients, including those that have been highly pre-treated.

The extended indication was based on the 48-week analysis of the phase 3 TITAN trial in treatment experienced lopinavir/r-na??ve patients. Forty-eight week results from TITAN in lopinavir/r-na??ve, treatment-experienced adults:

- Seventy-seven percent of patients in the darunavir/r arm (n=298) vs. 67 percent of patients in the lopinavir/r arm (n=297) reached less than 400 copies/mL, (study demonstrated non-inferiority, p

Before taking darunavir, patients should tell their doctor if they have any medical conditions, including liver problems, including hepatitis B or C, diabetes, symptoms of infections, change in body fat, haemophilia, musculoskeletal problems, or allergy to sulfa medicines and should tell their doctor if they are pregnant or planning to become pregnant, or are nursing.

Darunavir should not be used in patients allergic (hypersensitive) to darunavir or ritonavir or with severe liver problems.

There are some relevant drug-drug interactions with other medications commonly used in HIV patient populations, such as other antiretroviral medications. Patients should talk to their healthcare provider about all the medicines they are taking or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Darunavir does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Please see full Summary of Product Characteristics or visit emea.europa.eu for more details

About Tibotec Pharmaceuticals

Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company, with offices in Yardley, PA, USA and main research and development operations/labs in Mechelen, Belgium. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.

About Tibotec, a division of Janssen-Cilag

Tibotec, a division of Janssen-Cilag, brings innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa focusing on patients’ and healthcare providers’ specific needs in this disease domain. The company will also commercialise medicines to combat other viral diseases in the future.

About Janssen-Cilag

Janssen-Cilag is a leader in traditional and biological medicines for disorders such as in gastroenterology, women’s health, mental health and neurology as well as for pain, oncology, haematology and nephrology.

(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at sec, jnj or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

Tibotec is a member of the Johnson & Johnson family of companies.

Janssen-Cilag

View drug information on Prezista. Continue reading →

New research suggests that different treatments may be needed for chronic asthma, depending on whether it results from allergies or lung infections.

Previous studies have shown that certain lung infections such as Mycoplasma pneumoniae can linger on and contribute to a person later experiencing symptoms of asthma.

Researchers have now identified a particular gene that influences how severe a M. pneumoniae infection may be, which in turn suggests that a different strategy might be needed for treating asthma resulting from this and similar lung infections rather than allergies.

“What this shows is that infectious asthma might have a different mechanism than allergic asthma. Most people think asthma is asthma, but it may be multifaceted,” said Dr. Robert Hardy, an infectious disease specialist at UT Southwestern.

That’s an important implication because the latest statistics show that asthma is on the rise. According to the U.S. Centers for Disease Control, more than 20 million Americans currently have asthma and another 10 million have been diagnosed with asthma at some point in their life. Roughly 6.5 million American children, or nearly 9 percent of the nation’s pre-adult population, have asthma, figures released in December show.

Dr. Hardy, an assistant professor of internal medicine and pediatrics, has been using mice to study how certain pneumonia bacteria contribute to chronic asthma and, in this latest study, identified how a particular gene may contribute to more severe lung infection. The research appears in the January edition of Infection and Immunity.

Pneumonia is a lung infection typically characterized by breathing difficulties and spread by coughing and sneezing. Symptoms often include headache, fever, chills, coughs, chest pains, sore throat and nausea. Dr. Hardy’s research involves pneumonia caused by the bacterium M. pneumoniae, commonly called walking pneumonia, a typically less severe form of the disease that accounts for 20 percent to 30 percent of community-acquired pneumonia.

To investigate the mechanism by which M. pneumoniae causes lung disease and respiratory difficulties, the UT Southwestern researchers inoculated two different types of mice with this bacterium. The study contrasted the reaction of one normal group of mice with another group lacking a particular gene called IL-12, which is involved in immune response. The mice engineered without the gene showed significantly less lung inflammation than the mice that naturally had the gene, with some indicators showing seven times less inflammation.

“M. pneumoniae might be more of a cofactor in developing chronic asthma than a direct cause, similar to how high cholesterol or diabetes makes people more vulnerable to heart attacks,” Dr. Hardy said, pointing to a number of previous studies. “It’s probably not the only thing, but it’s one of them. In some people it might incite asthma or it might exacerbate it.”

Because the M. pneumoniae bacterium is difficult to kill and often remains in the lungs even after antibiotic treatment and the symptoms fade, Dr. Hardy said, it is important to find better treatments to prevent it from lingering.

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Other UT Southwestern researchers involved in the study were Dr. George McCracken, professor and chief of pediatric infectious diseases; Dr. Ana Gomez, assistant professor of pathology; Drs. Christine Salvatore, Asuncion Mejias and Cynthia Somers, pediatrics postdoctoral trainees; Kathy Katz-Gaynor, pediatrics research associate; and Monica Fonseca-Aten and Susanna Chavez-Bueno, former pediatric postdoctoral trainees.

The study was supported by the National Institutes of Health.

About UT Southwestern Medical Center

UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members – including four active Nobel Prize winners, more than any other medical school in the world – are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.

Dr. Robert Hardyl

Contact: Russell Rian

UT Southwestern Medical Center Continue reading →

Mpex Pharmaceuticals, Inc. today
announced the initiation of a Phase 1b clinical trial with its lead
compound, MP-376, in patients with cystic fibrosis (CF). MP-376 is a
proprietary aerosolized formulation of the antibiotic levofloxacin that is
being developed for the treatment of chronic lung infections due to
Pseudomonas aeruginosa in CF patients. Preclinical and early clinical
studies indicate that active levofloxacin concentrations in pulmonary
tissues after MP-376 administration are markedly increased compared to
those achieved when the antibiotic is delivered by other routes of
administration. The trial is being conducted under an open Investigational
New Drug Application (IND) that has been filed with the U.S. Food and Drug
Administration (FDA).

MP-376 employs a number of formulation enhancements and has been
designed for use in conjunction with a high efficiency nebulizer to rapidly
deliver high pulmonary concentrations of levofloxacin to the lung. Compared
to other treatment options, regimens of MP-376 are projected to have
powerful activity against key bacterial pathogens resident in the CF lung
and provide exposures that reduce the selection of bacterial resistance.

The current clinical trial is a randomized, placebo-controlled,
multi-center study in the U.S. that will evaluate the safety, tolerability,
pharmacokinetics, and microbiological effects of multiple daily doses of
MP-376 in stable cystic fibrosis patients with chronic infections due to
Pseudomonas aeruginosa. A total of 39 patients are planned to be enrolled,
and several dose levels will be evaluated.

This study complements a single dose, dose escalation study of MP-376
that was recently completed in healthy volunteers and CF patients in
Denmark. Together, the single and multiple dose trials are expected to
support a larger Phase 2 study that the company plans to initiate in 2008.

“We are collaborating with numerous CF physicians who are enthusiastic
about the potential for MP-376 in treating difficult chronic lung
infections,” stated Dr. Michael Dudley, Senior Vice President of Research
and Development for Mpex. “Based on our work to date, we believe MP-376 has
the potential to provide doctors and patients with a convenient, powerful
and well-tolerated new treatment option that addresses key pathogens in CF
and minimizes the potential for drug resistance. We look forward to working
with the CF community to rapidly advance MP-376 through clinical
development.”

About Mpex Pharmaceuticals:

Mpex Pharmaceuticals is a clinical stage biopharmaceutical company
whose mission is to develop critical new therapies to combat the growing
issue of antibiotic resistance. The company’s initial focus is on the
treatment of gram-negative bacterial pathogens such as Pseudomonas
aeruginosa, for which limited effective treatment options exist. Mpex’s
lead product candidate, MP-376, is currently in Phase 1b clinical trials
and is being developed for the treatment of chronic lung infections due to
Pseudomonas aeruginosa in cystic fibrosis patients. The company is also
pursuing applications related to its extensive intellectual property estate
around inhibitors of bacterial multi-drug resistant (MDR) efflux pumps
(EPIs). Efflux pumps have been shown to be a primary source of drug
resistance in gram-negative organisms. Mpex has identified a number of
promising lead EPI compounds that, when combined with existing antibiotics,
have been shown to restore the potency of these existing antibiotics
against previously resistant gram-negative organisms. These compounds are
being profiled in further preclinical studies and may be candidates for
clinical development. Additional information about Mpex can be obtained
from the company’s website at mpexpharma.

Mpex Pharmaceuticals, Inc.
mpexpharma Continue reading →