Charity Action Duchenne Combines Social Networking With E-commerce For Innovative New Website

Action Duchenne, the Duchenne Muscular Dystrophy Charity, has launched its new website which combines the best in Web 2.0 technologies including social networking, wikipedia, blogging and micro-blogging. The new site Action Duchenne also enables the charity to take donations from registered members and the general public. Users may also create their own sponsorable events with donations going directly to Action Duchenne.

Nick Catlin, CEO of Action Duchenne commented, “We set up Action Duchenne eight years ago to provide support and education for families affected by Duchenne Muscular Dystrophy, and to raise money to find a cure. While we are closer to finding that cure, there is still a way to go, and in the meantime families find the help and support offered by our Duchenne community very comforting.’ Nick continued “Our new website has been designed to provide that interactive community so that families living with Duchenne can communicate more freely, share information about fund raising events, find information, we have a whole library of articles and papers many eminent scientists and people can donate those all important funds to help us continue our working in finding a cure for this most cruel of conditions.”

Duchenne Muscular Dystrophy affects 1 in 3,500 male births in the UK, and is the most common and severe type of muscular dystrophy – sufferers are diagnosed usually by the age of 5. Patients with DMD and Becker Muscular Dystrophy (BMD) are boys and young men who lack dystrophin, a protein that is critical to the structural stability of muscle fibres. Patients develop progressive muscle weakness. Duchenne affects all muscles including the heart and respiratory system leaving young people paralysed by late teens and many patients do not live past their twenties.

The new website provides a wealth of information about Duchenne, what causes it and the current treatments, about campaigns, education and inclusion programmes, fund raising events, blogs, conferences and news. As well as this registered users can set up their own Stop Wasting web page, post pictures, post their own news, network with friends, blog and micro-blog and generally interact in the same was as on sites like Facebook and Twitter. The site also includes a Donations facility and an online store for Duchenne and Stop Wasting merchandise.

Anton Faulconbridge, Director of Rantmedia who built the site said, “We are delighted to continue our relationship with Action Duchenne on this very exciting project. Our ‘eCharity’ platform, with its full social networking, wiki-knowledgebase, e-commerce shop and user events has given Action Duchenne a cutting edge website that provides visitors with a complete community in which to share, interact and fund raise.”

Carl Tilson, aged 22, living with Duchenne and an active campaigner for the charity commented, “The new website is great. Social networking is the way forward and is an advantage when your mobility is severely restricted. It enables me to interact and keep in touch with my fellow soldiers in the Duchenne community.” Carl continued “Having such an interactive website will assist the charity making that much needed awareness worldwide and great awareness will then guide us into a new beginning, a fresh start and will finally lead us into victory against this monstrous disease”

Source
Action Duchenne

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California Gov. Schwarzenegger Should Sign Bill Allowing Condom Distribution In Prisons To Prevent Spread Of HIV, Editorial Says

Despite “laws forbidding” sex between prison inmates and prison officials’ denial that it occurs, inmates do have “unprotected sex,” making “prisons prime settings for the spread of deadly bloodborne viruses like hepatitis C and HIV,” a New York Times editorial says. CDC last year “underscored this point” when it “urged states without condom-distribution programs to think about starting them as a way of preventing the spread of HIV behind bars,” according to the editorial. It adds that by “protecting the inmates, the state would also protect the all-too-vulnerable wives and lovers to whom they inevitably return when their sentences are completed.”

The California Legislature last year “tried to take” CDC’s advice by “passing a landmark bill that would have allowed public health agencies to enter prisons and distribute condoms to inmates who wanted them,” the Times says. Although the bill had the “overwhelming support of the voting public,” Gov. Arnold Schwarzenegger (R) vetoed it and used the “familiar know-nothing excuse that handing out condoms would justify illegal sexual activity,” according to the editorial. The “experience of jurisdictions that allow condoms does not support this view,” the Times says, adding that “public health officials now recognize that condom-distribution programs are integral to any meaningful AIDS prevention program.” Such programs are operating in prisons in Canada, in much of the European Union and in jails in Los Angeles, New York City, Philadelphia, San Francisco and Washington, D.C., according to the editorial.

The California Legislature again has “taken up the condom bill,” which is sponsored by Assembly member Sandre Swanson (D), the editorial says, adding that the bill “deserves to pass the legislature, just as it did last year.” However, this time, Schwarzenegger should “sign the bill,” the Times says, concluding that it would “give California’s public health community a powerful tool to fight the spread of a deadly disease” (New York Times, 7/18).

“Reprinted with 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 . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Euroscience Calls For Support For Convicted Health Workers In Libya

Euroscience calls on other academic and scientific organisations to protest at the conviction of six foreign medical workers, by a Libyan court of conspiring to deliberately inject 426 Libyan children with HIV virus.

On December 19, 2006 six foreign medical workers, Kristiyana Valtcheva, Nasya Nenova, Valentina Siropulo, Valya Chervenyashka, Snezhana Dimitrova and Ashraf al-Hajuj were convicted and sentenced to death by firing squad by a Libyan court. The six health workers were accused of conspiring to deliberately inject 426 Libyan children with HIV virus. This is the second time that a Libyan court has sentenced the 6 health workers to death: an earlier death sentence was overturned by the Libyan Supreme Court in 2005.

Euroscience is a grass-roots organisation which representing European scientists of all disciplines. Professor Enric Banda, President of Euroscience in calling for a reaction from all scientists said, “It is a tragedy that children have been infected by HIV virus at a hospital in Libya, but it is against justice to accuse a group of health workers for this incident when strong scientific evidence shows that they could not be responsible for the origin of this infection”.

A scientific report presented by some of the world most prominent experts in HIV, Professor Luc Montagnier and Prof. Vittorio Colizzi proves that the HIV was already present in Libya in 1997, long before the Bulgarian health workers arrived, pointing at poor hygiene at the hospital as the real cause of the infections. Other scientific data published online by Nature, 6 December, 2006 and backed by international forensic experts also present a firm alibi for the six medical workers facing the death penalty in Libya.

Euroscience asks other academic and scientific organisations to react fast against this injustice by public statements in national and international media or by writing directly to: His Excellency Mu’ammar al-Gaddafi, Leader of the Revolution, Office of the Leader of the Revolution, Tripoli, Libya.

EUROSCIENCE
8 rue des Ecrivains
F-67000 Strasbourg
Euroscience/

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Researchers Induce HIV-Neutralizing Antibodies That Recognize HIV-1 Envelope Protein, Lipids

For the first time, researchers have experimentally induced antibodies that neutralize HIV-1 and simultaneously recognize both HIV-1 envelope protein and lipids. The results were reported by U.S. Military HIV Research Program (MHRP) researchers on Aug. 25 in the online version of AIDS, the official journal of the International AIDS Society.

The lead investigators, Dr. Gary Matyas and Dr. Carl Alving, researchers in the Division of Retrovirology, MHRP, Walter Reed Army Institute of Research (WRAIR), and their collaborators, conducted the exploratory study using small synthetic HIV-1 peptides encapsulated in liposomes containing lipid A as an adjuvant.

The monoclonal antibodies, produced after immunizing mice, have binding characteristics that look similar to two well-known broadly neutralizing human monoclonal antibodies, known as 2F5 and 4E10, which also bind to HIV-1 protein and lipid. These antibodies, 2F5 and 4E10, are widely viewed as models of the types of neutralizing antibodies that might be useful in an effective HIV-1 vaccine. Until now, the HIV field has been unable to induce neutralizing antibodies that have both protein-binding and lipid-binding characteristics similar to 2F5 or 4E10. This study employed widely used, clinically acceptable, well-tolerated and relatively inexpensive generic antigen-adjuvant constituents that potentially could be used as part of a human formulation.

Dr. Carl Alving, Chief of the Department of Adjuvant and Antigen Research, said, “Some of the strongest naturally occurring antibodies that broadly neutralize HIV have the unique characteristics of recognizing both HIV protein and lipid. It has been believed that it might be difficult to induce such antibodies experimentally, and historically, this has been considered a potential roadblock to creation of an effective HIV vaccine. This study demonstrates that such antibodies might be induced with immuno-stimulating liposomes.”

Source:
Lisa Reilly

Henry M. Jackson Foundation for the Advancement of Military Medicine

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FDA Confirms E. Coli O157:H7 In Prepackaged NestlГ© Toll House Refrigerated Cookie Dough

Today, the U.S. Food and Drug Administration announced that it has found E. coli O157:H7 (a bacterium that can cause serious food borne illness) in a sample of prepackaged NestlГ© Toll House refrigerated cookie dough currently under recall by the manufacturer and marketer, NestlГ© USA. The contaminated sample was collected at NestlГ©’s facility in Danville, Va. on June 25, 2009.

On June 19, the FDA and the U.S. Centers for Disease Control and Prevention warned consumers not to eat any varieties of prepackaged NestlГ© Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7. The warning was based on an epidemiological study conducted by the CDC and several state and local health departments. As of Thursday, June 25, the CDC reports that 69 persons from 29 states have been infected with the outbreak strain. Thirty-four persons have been hospitalized, nine with a severe complication called hemolytic uremic syndrome. No one has died.

Further laboratory testing is needed to conclusively link the E. coli strain found in the product to the same strain that is causing the outbreak.

NestlГ© USA has fully cooperated with the FDA and CDC investigation and has recalled all of its prepackaged NestlГ© Toll House refrigerated cookie dough products.

For answers to consumer questions about this recall and warning, go to: fda/Food/ResourcesForYou/Consumers/ucm168346.htm.

For more information about E. coli, visit the CDC Web site here.

Consumers who have additional questions about these products should contact NestlГ© USA consumer services at 1-800-559-5025 and/or visit its Web site at verybestbaking.

For a complete listing of NestlГ© USA recalled products go here.

Source
U.S. Food and Drug Administration

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Customized Virus Kills Brain Tumor Stem Cells That Drive Lethal Cancer

A tailored virus destroys brain tumor stem cells that resist other therapies and cause lethal re growth of cancer after surgery, a research team led by scientists at The University of Texas M. D. Anderson Cancer Center reports in the Sept. 18 edition of the Journal of the National Cancer Institute.

“We have shown first in lab experiments and then in stem cell derived human brain cancer in mice, that we have a tool that can target and eliminate the cells that drive brain tumors,” says co senior author Juan Fueyo, M.D., associate professor in M. D. Anderson’s Department of Neuro Oncology. A request to launch a clinical trial of the virus, called Delta 24 RGD, is expected to go to federal regulators this month.

The virus was tested against the most aggressive brain tumor glioblastoma multiforme, which originates in the glial cells that surround and support neurons. It is highly resistant to radiation and chemotherapy and so invasive that surgery almost never eliminates it. Patients suffering from this malignant glioma live on average for about 14 months with treatment.

Fueyo and colleagues developed Delta-24-RGD to prey on a molecular weakness in tumors and altered the virus so it could not replicate in normal tissue. They showed in a JNCI paper in 2003 that the virus eliminated brain tumors in 60 percent of mice who received injections directly into their tumors. The virus spreads in a wave through the tumors until there are no cancer cells left, then it dies.

Since 2004 scientists have found that brain tumors are driven by haywire stem cells that replicate themselves, differentiate into other types of cells, and bear protein markers like normal stem cells.

“Research has shown that these cancer stem cells are the origin of the tumor, that they resist the chemotherapy and radiation that we give to our patients, and that they drive the renewed growth of the tumor after surgery,” Fueyo said. “So we decided to test Delta-24-RGD against glioma stem cells and tumors grown from them.”

The research team led by Fueyo, co-senior author Frederick Lang, M.D., professor in M. D. Anderson’s Department of Neurosurgery, and first author Hong Jiang, Ph.D., instructor in neuro-oncology, derived four brain tumor stem cell lines from four specimens of glioblastoma multiforme. All four lines exhibited the characteristics and protein signatures of stem cells. Delta-24 succeeded in killing all four types in the lab.

Next, the researchers grafted the stem cell lines into the brains of mice and treated the resultant tumors with injections of Delta-24-RGD. Untreated mice had a mean survival time of 38.5 days, while treated mice had a mean survival of 66 days. Two of the eight treated mice survived for 92 days, until the end of the experiment, with no neurological symptoms.

“It’s important in animal models to see improvement in survival in the majority of animals, but to have some be cured and survive a long time without neurological symptoms is very rare,” Fueyo said. “We have to be cautious, because an animal model doesn’t fully represent humans, but the tumors grown by these stem cells closely resemble the tumors we see in our patients, which is an exciting finding in itself.”

Tumors in other mouse models tend to be round and self contained, explains co senior author and Frederick Lang, M.D., professor in M. D. Anderson’s Department of Neurosurgery. Malignant tumors in patients are never round, they invade other tissues and delve deeply into the brain. The cancer stem cell derived tumors in these experiments have the irregular shape and invasive characteristics of their human counterparts.

“That similarity to the human tumor is encouraging,” Lang said. “And it’s also encouraging that we got basically the same results with Delta-24-RGD in this experiment that we got in our earlier experiment using other tumor models.”

A clinical quality version of Delta-24-RGD has been manufactured by the National Cancer Institute and an independent consultant has completed a toxicology assessment. An Investigational New Drug Application to proceed with a phase I clinical trial is expected to be filed with the U.S. Food and Drug Administration in September. A clinical trial could began as early as this fall.

Delta-24-RGD exploits the fact that a protein called retinoblastoma (Rb) is either missing or defective in brain tumors. Rb normally guards against both the proliferation of cancerous cells and against viral infection. So the virus has an easier time invading tumors and replicating in its cells. Adenoviruses attacking normal cells employ their own protein, E1A, to counteract retinoblastoma’s defensive measures. To keep Delta-24-RGD out of normal cells, Fueyo and colleagues deleted a small part of the gene that produces E1A.

The JNCI paper shows that Delta-24 RGD forces tumor cells to devour themselves until they die. This self-cannibalization, called autophagy, occurs when a cell forms a membrane around part of its cytoplasm or an organelle and then digests the contents, leaving a cavity. A cell that dies from autophagy is riddled with cavities.

Cells normally employ autophagy temporarily to survive when nutrients are short, to recycle components to form new organelles, or to fend off viral or bacterial infection. In cancer research, there is evidence both that autophagy is a form of programmed cell death triggered to prevent the replication of damaged cells and that cancer cells in some instances employ it to survive attack.

“Our next experiments will address whether the cell kills itself or dies defending itself against the virus,” Fueyo says. Sure, the cell dies either way, but the distinction is important, Fueyo says, because the virus could be redesigned to either fuel or block autophagy to make it more effective. The autophagic protein Atg5 is heavily expressed in the dead tumor cells, making it a potential biomarker of the virus’ effectiveness.

The National Cancer Institute funded this research.

Co-authors with Fueyo, Lang and Jiang are Candelari Gomez-Manzano, Hiroshi Aoki, Marta Alonso, Seiji Kondo, Jing Xu, Yasuku Kondo, and Howard Colman, all of the M. D. Anderson Brain Tumor Center; B. Nebiyou Bekele, of M. D. Anderson’s Department of Biostatistics; and Frank McCormick, Cancer Research Institute and Comprehensive Cancer Center, University of California, San Francisco. Aoki also is affiliated with the Department of Neurosurgery, Brain Research Institute, Niigata University in Niigata, Japan.

University of Texas M. D. Anderson Cancer Center
1515 Holcombe Blvd., Box 229
Houston, TX 77030
United States
mdanderson

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Increased Risk Of Kaposi’s Sarcoma In Marijuana Users

The major active component of marijuana could enhance the ability of the virus that causes Kaposi’s sarcoma to infect cells and multiply, according to a team of researchers at Harvard Medical School. According to the researchers, low doses of ‘-9 tetrahydrocannabinol (THC), equivalent to that in the bloodstream of an average marijuana smoker, could be enough to facilitate infection of skin cells and could even coax these cells into malignancy.

While most people are not at risk from Kaposi’s sarcoma herpes virus (KSHV), researchers say those with lowered immune systems, such as AIDS patients or transplant recipients, are more susceptible to developing the sarcoma as a result of infection. Their findings, reported in the August 1 issue of Cancer Research, a journal of the American Association for Cancer Research, offer cautionary evidence that those with weakened immune systems should speak with their doctors before using marijuana medicinally or recreationally.

“These findings raise some serious questions about using marijuana, in any form, if you have a weakened immune system,” said lead study author Jerome E. Groopman, M.D., professor of medicine at Harvard Medical School. “While THC is best known as the main psychotropic part of marijuana, an analog of THC is the active ingredient of marinol, a drug frequently given to AIDS patients, among others, for increasing appetite and limiting chemotherapy-induced nausea and vomiting.”

While previous studies indicated that marijuana smoking was associated with Kaposi’s sarcoma, this is the first to demonstrate that THC itself can assist the virus in entering endothelial cells, which comprise skin and related tissue.

According to Dr. Groopman, the study illustrates the complicated role marijuana and other cannabinoids play in human health. Numerous types of cells display cannabinoid receptors on their outer surfaces, which act as switches that control cellular processes. Dr. Groopman’s laboratory had previously demonstrated that THC could have a protective effect against a certain form of invasive, drug-resistant lung cancer.

To study the combined effect of THC and KSHV, the researchers examined a culture of human skin cells, which are susceptible to infection and could provide a model of Kaposi’s sarcoma. These culture cells display many copies of two prominent cannabinoid receptors. Dr. Groopman and his colleagues found that by bonding to these receptors, low doses of THC activate two proteins responsible for maintaining a cell’s internal framework, or cytoskeleton. By altering the cytoskeleton, THC effectively opens the door for KSHV, allowing the virus to more easily enter and infect the cell. “We can take away that effect by using antagonists that block the two cannabinoid receptors, which adds evidence that THC is the culprit,” Dr. Groopman said.

Once a cell is infected, the presence of THC may also promote the cellular events that turn it cancerous, the researchers say. They found that THC also promotes the production of a viral receptor similar to one that attracts a cell-signaling protein called interleukin-8. Previous studies have noted that this receptor could trigger the cell to reproduce, causing Kaposi’s sarcoma-like lesions in mice. Indeed, the researchers saw that THC induced the infected cells to reproduce and form colonies in culture.

“Here we see both infection and malignancy going on in the presence of THC, offering some serious concerns about the safety of THC among those at risk,” Dr. Groopman said. “Of course, we still do not know the exact molecular events that are occurring here, but these results are just the first part of our ongoing research.”

###

The study was funded by the National Institutes of Health.

The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world’s oldest and largest professional organization dedicated to advancing cancer research. The membership includes nearly 26,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries.

AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care.

AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.

Source: Greg Lester

American Association for Cancer Research

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Elsevier Launches Current Opinion In Virology

Elsevier has announced the publication of the first issue of Current Opinion in Virology a new journal in its prestigious Current Opinion series, publishing six issues a year. Current Opinion in Virology was launched to provide a systematic, comprehensive and filtered approach to the ever-expanding wealth of research published on viruses and viral interaction: a platform to help busy specialists keep up-to-date with the latest trends and topics in virology research. The journal publishes invited review papers only and is divided into twelve annual sections, including viral genomics, antivirals and resistance, emerging viruses and virus evolution.

The editorial board is led by Editors in Chief Mary Estes (Baylor College of Medicine, USA) and Ab Osterhaus (Erasmus MC, The Netherlands). “Virology is a discipline that is dynamic, multidisciplinary and important to our lives in many ways,” states Dr. Estes. “When approached about starting a new journal in virology, we came to the conclusion that the principle and quality of the Current Opinion series in other topics made it an attractive medium to communicate new information in a broad range of virology topics. Looking beyond the successful launch of the journal,” Dr Estes concluded, “we look forward, as the virology field, technologies and world continues to change, to Current Opinion in Virology becoming one of the most highly respected journals in the field.”

Sources: Elsevier, AlphaGalileo Foundation.

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Pfizer’s Antiretroviral Maraviroc Reduces Viral Loads Among People Taking Additional Treatments, Study Says

Pharmaceutical company Pfizer on Tuesday at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago presented results of a new long-term study of its antiretroviral drug maraviroc, AFP/Yahoo! News reports. According to the company, data from a 48-week study showed that nearly three times as many HIV-positive people who took maraviroc in combination with a traditional treatment regimen achieved undetectable levels of HIV, compared with those receiving only the traditional regimen (AFP/Yahoo! News, 9/19). Pfizer also said that CD4+ T cell counts significantly were increased among people taking maraviroc, compared with participants who took only the standard regimen (AP/Yahoo! Finance News, 9/18).

FDA in August approved maraviroc, which belongs to a new class of antiretrovirals that could provide an alternative to HIV-positive people who have developed resistance to multiple drugs. FDA gave expedited approval of maraviroc for use in combination with other antiretrovirals. Maraviroc works by blocking a protein, called CCR5, on human immune system cells that HIV uses as a portal to enter and infect the cell. Pfizer has proposed using the drug to treat people with advanced HIV or AIDS who have not responded to other medications. FDA approved maraviroc on the condition that the drug’s label include a black-box warning — the strongest possible advisory. The drug also will have a warning about an increased risk of heart attack. FDA also is requiring Pfizer to conduct further research into the drug’s long-term side effects (Kaiser Daily HIV/AIDS Report, 8/7).

Pfizer on Tuesday said the side effects recorded among participants who took maraviroc resembled those experienced by participants who received only the traditional regimen, the AP/Yahoo! Finance News reports. The most common side effects reported included diarrhea, nausea, fatigue and headache. Pfizer also said that maraviroc, sold under the brand name Selzentry, is now on the market across the U.S. and that the company is working with private and public payers to secure coverage and reimbursement, the AP/Yahoo! Finance News reports (AP/Yahoo! Finance News, 9/18). “The safety and durability of response seen with Selzentry … in our study is reassuring,” Jacob Lalezari, director of Quest Clinical Research at the University of California, said, adding, “This drug is an important new weapon for clinicians who treat HIV” (AFP/Yahoo! News, 9/19).

J&J Presents Data on Antiretroviral Prezista
Johnson & Johnson on Tuesday at the ICAAC conference announced that its antiretroviral darunavir, sold under the brand name Prezista, proved as effective in a late-stage trial as Abbott Laboratories’ antiretroviral Kaletra in reducing HIV viral loads among people not previously treated for the virus, Reuters reports. For the study, researchers gave Prezista, a once-daily protease inhibitor, to participants along with Abbott’s Norvir and Gilead Science’s Truvada. A separate group of people was given Kaletra and Truvada. The study showed that HIV decreased to undetectable levels after 48 weeks among 84% of patients taking experimental 800mg doses of Prezista, compared with 78% of those on Kaletra.

The trial was the first to test Prezista among people who previously have not taken other antiretrovirals, Reuters reports. Abbott spokesperson Ilke Arici said the study’s findings are somewhat questionable because the trial design did not reflect how the drugs are distributed in real-life medical settings, Reuters reports. Arici said many participants were given a soft gel form of Kaletra, which she said is less effective than a new tablet formulation now widely available in the U.S. J&J spokesperson Pam Van Houten said that most participants taking Kaletra began on the soft gel form but later were switched to tablets after they became available. Van Houten said J&J plans to seek FDA approval by the end of 2007 for the use of Prezista by people never previously treated for HIV (Pierson, Reuters, 9/18).

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© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Kaletra Capsules and Oral Solution; Norvir; Prezista.

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Arpida Provides Further Comments On The Pivotal Phase III Trials

Further to the
press release published on 9 April, Arpida Ltd. (SWX: ARPN)
elaborates on some additional elements of the clinical programme with
intravenous iclaprim in complicated Skin and Skin Structure Infections
(cSSSI). Extensive data on ASSIST-1 has been presented at last year’s ICAAC
and IDSA meetings. Data on ASSIST-2 will be presented at the upcoming 18th
European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
which takes place in Barcelona, 19-22 April 2008.

As reported in November 2006 and July 2007, intravenous iclaprim
achieved its pre-specified primary endpoint in both of the pivotal Phase
III trials: ASSIST-1 and ASSIST-2. Generally, two independent trials are
preferred by regulatory authorities to confirm the robustness of the data.
ASSIST-1 and ASSIST-2 were similarly designed and importantly used the same
comparator (i.e. linezolid) which could allow regulators to pool and
further analyse the data. Noteworthy to say, that linezolid has been shown
to be superior to vancomycin in cSSSI for patients with MRSA infections
(Weigelt et al, AAC, June 2005, page 2260-2266).

The aim of these trials is to provide an unbiased assessment of the
treatment effect and takes into account all populations; particularly
relevant are the Intent-to-Treat (ITT) and the Per-Protocol (PP)
population. It is essential and standard practice in any study to remove
any significant imbalances, in order to properly analyse the results. As
reported in July 2007, imbalances were noted in the ASSIST-2 trial – in
particular due to the use of prohibited antibiotics. The correction for
this imbalance in the PP population results in the Modified Clinically
Evaluable (“MCE”) population and shows that the MCE population is in close
agreement with the ITT population. The pre-specified primary endpoint for
both trials required that the lower bound of the confidence interval for
treatment difference remain within minus 12.5%, which was met in all
relevant populations.

As is usual in this indication, the pivotal Phase III trials were
designed to demonstrate non-inferiority to a comparator. The relevance of
this trial design was recently debated at an Anti-infective Drug Advisory
Committee meeting discussing Community-Acquired Pneumonia (CAP) in which
the panel unanimously confirmed the importance of non-inferiority trials
and full evaluation of benefit and risk.

Based on the Phase III results and on those of other studies carried
out, Arpida is confident that intravenous iclaprim has compelling
properties, both in terms of efficacy and safety. In both pivotal Phase III
trials, a high percentage of patients had MRSA infections and iclaprim
showed high eradication rates (in the ASSIST-2 trial the eradication rates
were 74% versus 75% for linezolid).

Iclaprim has been shown to be well tolerated in patients suffering from
cSSSI. In general, iclaprim was better tolerated than linezolid, with fewer
patients reporting adverse events in all categories, both in ASSIST-1 and
ASSIST-2. Similarly, a small, transient QTc prolongation was observed in
both trials. No cardiovascular events related to QTc elevation were
reported.

About Arpida Ltd.

Arpida (SWX: ARPN) is a biopharmaceutical company with research
facilities in Reinach, Switzerland and in the USA. It focuses on the
discovery and development of novel drugs that seek to overcome the growing
problem of microbial resistance. The most advanced compounds include an
antibacterial under regulatory review and an antifungal in Phase III.

Arpida’s leading product candidate is intravenous iclaprim, a potent
antibacterial that targets severe infections requiring hospital treatment,
including those caused by methicillin-resistant Staphylococcus aureus
(MRSA). The clinical programme for the first indication, complicated skin
and skin structure infections (cSSSI), has been completed. The submission
of the NDA to the US FDA was completed in March 2008.

In December 2007, Arpida announced the enrolment of the first patients
in a Phase II clinical study with intravenous iclaprim in the treatment of
patients with hospital-acquired pneumonia (HAP), ventilator-associated
pneumonia (VAP) or healthcare associated pneumonia (HCAP).

In January 2008, the US FDA granted authorisation to progress oral
iclaprim into a Phase II ‘intravenous-to-oral’ switch trial. Iclaprim could
be offered not only as an intravenous therapy for hospital use in acute
situations, but also as an oral formulation, allowing early patient
discharge followed by outpatient treatment. This switch could be a valuable
instrument in reducing healthcare costs and enhancing patient comfort.

Arpida’s fourth most advanced antibiotic programme, AR-709, targets
upper and lower respiratory tract infections acquired in the community
setting. AR-709 exhibited potent activity against a large panel of
pneumococcal clinical isolates including those resistant to currently used
drugs. Promising results of “first-in-man” studies with AR-709 were
published in March 2007.

An additional compound, AR-2474, has achieved in vivo proof of concept.
AR-2474 has been shown to be effective in eradicating pathogens in
preclinical models of skin infection and nasal carriage.

Apart from the antibiotic programmes, Arpida has an innovative
antifungal therapy (TLT) which is in Phase III clinical trials in Europe,
targeting onychomycosis.

Moreover, the company has several other leads in optimisation and
additional discovery programmes derived from its own discovery platform at
various research stages.

This press release contains specific forward-looking statements, e.g.
statements including terms like believe, assume, expect or similar
expressions. Such forward-looking statements are subject to known and
unknown risks, uncertainties and other factors which may result in a
substantial divergence between the actual results, financial situation,
development or performance of the company and those explicitly or
implicitly presumed in these statements. Against the background of these
uncertainties readers should not place undue reliance on forward-looking
statements. The company assumes no responsibility to update forward-looking
statements or to adapt them to future events or developments.

Arpida Ltd.
arpida.ch

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