Scientists Perform 'Tricky' Operation

Trichomonas vaginalis colonises the urogenital tract and causes the infection also known as "trick", the most common non-viral STI.

University of Queensland PhD scholar Rebecca Dunne was one of a team of 65 scientists that worked on the project to sequence the genome, which could offer clues to better treatments for both men and women.

Ms Dunne said the results would allow researchers to hone in on genes and gene families of interest, particularly those involved in drug resistance.

"The completion of the genome sequence by The Institute for Genomic Research (TIGR) and subsequent annotation of the genome database has opened many avenues of research by providing a searchable data set," Ms Dunne said.

"Drug resistance in many human pathogens is increasing. T. vaginalis is among these, with no alternative drugs approved to treat resistant infections.

"This is particularly an issue in developing countries, where the number of infected individuals is high and the access to public health services is low.

"Now that researchers have access to a complete genome dataset the search for alternative drug targets can really take-off."

Amazingly, the pesky parasite was found to have an exceptionally large collection of DNA, with the possibility of having more genes than humans.

But Ms Dunne said while the sequencing of the genome project has largely elevated awareness of T. vaginalis among researchers, public awareness remains low, especially in developing countries where it has the most impact.

"This is a problem as infection with T. vaginalis increases the transmission and acquisition of many other serious STIs, including HIV.

"Furthermore, prolonged infection with T. vaginalis associates with pre-term birth, low infant birth weight and some cervical cancers.

"Alarmingly, trichomoniasis is not considered a notifiable disease."

Routine gynaecological check-ups do not test for this particular STI and the infection does not require public health notification.

Because of this, and also due to the broad and non-specific nature of symptoms, which can range from severe to negligible depending on the individual, some people pass it on without knowing.

"Furthermore, the non-specific nature (or in some cases, absence) of trichomoniasis symptoms often confuses it with other STIs, making the process of diagnosis itself, difficult," Ms Dunne said.

"Many infections remain undiagnosed as a result."

It is hoped that the results of the project will help research and improve treatments, in turn sponsoring awareness.

Ms Dunne's contribution to the project involved the identification and annotation of several large families of genes related to those involved in various mechanisms of antimicrobial resistance.

As a result of the genome being sequenced, she has since been able to localise specific genes of interest to the whole chromosome and begin the mapping process.

"Mapping the genome is the next step in the genome sequencing of T. vaginalis and will create a visual blueprint of the parasite, allowing researchers to see where their genes fit in to the big picture."

The results of the collaborative project have been published in the prestigious international journal

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Contact: Lucy Manderson
Research Australia

Parasite Infection May Benefit MS Patients

A steady rise in autoimmune diseases such as multiple sclerosis (MS) has been noted in recent decades, and environmental factors could be the cause of this increase. One theory, similar to the "hygiene hypothesis" in which an excessively germ-free environment may contribute to an increase in allergies, holds that a decline in infectious diseases may play a role in increasing autoimmune disease incidence. The first study examining the relationship between parasite infections and MS in humans suggests that such infections may affect the immune response in a way that alters the course of MS. The study was published in the January 2007 issue of Annals of Neurology (http://www.interscience.wiley.com/journal/ana), the official journal of the American Neurological Association.

Previous studies involving animals have shown that parasite infection can influence the course of autoimmune diseases. These studies suggest that individuals with parasite infections have a diminished T cell response when unrelated antigens (foreign substances that generate an immune response) are present. The current study, conducted by Jorge Correale, M.D., and Mauricio Farez, B.Sc., of the RaГєl Carrea Institute for Neurological Research in Buenos Aires, Argentina, involved 12 patients with MS who also had a parasite infection, 12 controls with MS who were uninfected, and 12 healthy individuals. The two groups of MS patients had a similar disease course. Patients had a neurological exam every three months and a brain MRI every 6 months, while immunological evaluations were conducted during the last 12 to 18 months of the study. Patients were followed for an average of 4.6 years.

During the study period, there were three clinical relapses of MS in the infected group and 56 relapses in the uninfected group. Only two infected patients showed minimal Expanded Disability Status Score changes (EDSS is used to measure disability due to MS) that lasted less than three months, while the other 10 had no changes in EDSS scores. In the uninfected group, 11 patients showed an overall increase in EDSS. Since MS involves an inflammatory response associated with the production of certain regulatory proteins known as cytokines, the number of cells producing cytokine suppressants was measured and found to be significantly higher in infected patients.

The authors suggest that their findings provide evidence to support that an autoimmune response as a result of parasite infection can result in a decrease in the normal inflammatory response associated with MS. They note that evidence for production of regulatory T cells (which inhibit the immune response) in parasite infection is now emerging, which offers an explanation for the mechanism by which infected hosts exhibit an altered immune response that affects a secondary antigen, as was the case in the current study. "Thus, parasites may lead to increased regulatory T cell numbers or activity, either by generating new cells or by activating/expanding existing cells," they state.

Because parasites inhabit their hosts for long periods of time, they can develop molecules that generate strong anti-inflammatory responses, which enhance their survival. Further investigation is warranted in order to identify which molecules cause immune system effects that dampen the inflammatory reactions normally seen in autoimmune diseases, the authors note. They conclude that "induction of a regulatory anti-inflammatory network generated by persistent parasite infections may offer a potential explanation for environment-related suppression of MS development in areas with low disease prevalence."

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Article: "Association Between Parasite Infection and Immune Responses in MS," Jorge Correale, Mauricio Farez, Annals of Neurology, January 2007, (DOI: 10.1002/ana.21067).

Contact: Amy Molnar
John Wiley & Sons, Inc.

E.U. Resolution Calls On Libya To Release Medical Workers Sentenced To Death In Libyan HIV Infection Case

The European Parliament on Thursday in a resolution called on European Union member states to review their trade relations with Libya and to urge Libya to release six medical workers sentenced to death for allegedly intentionally infecting hundreds of Libyan children with HIV, Reuters South Africa reports. The resolution called on E.U. members to review "the common policy of engagement with Libya in all relevant fields." Bulgarian E.P. member Philip Dimitrov said the resolution sends a "clear signal of intent to Libya from the E.U. and with the support of the member states and the European Commission, it will show the E.U.'s solidarity on the matter" (Ennis, Reuters South Africa, 1/18). The five Bulgarian nurses and Palestinian doctor in May 2004 were sentenced to death by firing squad for allegedly infecting 426 children through contaminated blood products at Al Fateh Children's Hospital in Benghazi, Libya. They also were ordered to pay a total of $1 million to the families of the HIV-positive children. The Libyan Supreme Court in December 2005 overturned the medical workers' convictions and ordered a retrial in a lower court. A court in Tripoli, Libya, last month convicted the health workers and sentenced them to death. The health workers say they are innocent of the charges, claiming that they were forced to confess and that they were tortured by Libyan officials during interrogations (Kaiser Daily HIV/AIDS Report, 1/11). According to Reuters South Africa, the case has negatively affected Libyan leader Muammar Gaddafi's efforts to renew the country's ties with Western nations. In addition, some reports have said Gaddafi would release the medical workers if a Libyan who is in a Scottish jail for the 1988 Lockerbie bombing were released and if Libya received financial compensation for the alleged intentional HIV infections. Meglena Kuneva, E.U. consumer affairs commissioner, said there would not be a negotiation (Reuters South Africa, 1/18). "This has nothing to do with the Lockerbie case," Kuneva said, adding, "There isn't the slightest proof that these people are guilty, and the E.U. will not allow any other case to be used as a leverage." Bulgarian Foreign Minister Ivailo Kalfin last week said the medical workers likely will be in jail for one more year during an appeals process, adding that Bulgaria will increase international pressure if an appeal is unsuccessful. The E.U. on Thursday is expected to vote on the resolution (Ennis, Reuters Health, 1/17). In addition, Italian Prime Minister Romano Prodi on Wednesday said that he plans to urge Gaddafi to release the nurses at a Jan. 27 meeting of the African Union (Reuters, 1/17).

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

Sirion Therapeutics Initiates Enrollment Of Phase III Clinical Trials For The Treatment Of Inflammation Following Ocular Surgery

Sirion Therapeutics, Inc., an ophthalmic-focused biopharmaceuticals company, announced today that it has begun enrollment of two phase III clinical trials, which will evaluate ST-601 (difluprednate) in the treatment of inflammation following ocular surgery.

ST-601 (difluprednate) was acquired by Sirion last year through an exclusive licensing agreement with Senju Pharmaceutical Co., Ltd. of Japan. The agreement gives Sirion the U.S. rights to develop and market a topical ophthalmic emulsion containing the steroid compound difluprednate for the treatment of inflammatory eye diseases.

"Initiating patient enrollment in our phase III clinical trials for difluprednate is another important milestone for Sirion," said Barry Butler, President and Chief Executive Officer of Sirion Therapeutics, Inc. The company recently announced the initiation of a phase II proof of concept trial for ST- 602 (fenretinide) for the treatment of geographic atrophy. "Difluprednate is a good strategic fit with our company mission of finding treatments for sight threatening diseases and conditions. Inflammation of the eye that is untreated or undertreated can contribute to loss of sight. We hope that difluprednate will offer help to the millions of people in the U.S. that have eye surgery each year," concluded Butler.

About Sirion Therapeutics, Inc. and Sirion Holdings, Inc.

Sirion Therapeutics is a Tampa, Florida based biopharmaceutical company, with additional offices in La Jolla, California, dedicated to the development and commercialization of innovative ophthalmic products. Sirion Holdings, Inc. is Sirion's parent company. For more information regarding Sirion and the matters announced in this press release, please visit Sirion's website at http://www.siriontherapeutics.com/.

Forward-Looking Statements

This press release contains forward-looking statements and information about Sirion Holdings, Inc.'s and Sirion Therapeutics, Inc.'s business, product candidates, and product development schedule. These forward-looking statements are only predictions, are uncertain and involve substantial known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from the results anticipated, expressed or implied by these forward-looking statements. Among the factors that could cause actual results to differ materially are the following: the success or failure of research, development and marketing activities, decisions by regulatory authorities regarding whether and when to approve our drug applications, and the speed with which regulatory authorizations may be achieved. Please see Sirion Holdings, Inc.'s public filings with the Securities and Exchange Commission for further discussion of these risks, uncertainties and related cautionary statements regarding our business and such forward-looking statements.

Sirion Therapeutics, Inc.
http://www.siriontherapeutics.com/

Sequella Receives FDA Fast Track Status For TB Drug

Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing improved treatment paradigms for diseases of epidemic potential, today announced it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SQ109, the company's proprietary lead drug candidate for treatment of pulmonary tuberculosis (TB). With a mechanism of action distinct from other antibiotics used in TB therapy, SQ109 shows excellent in vitro activity against drug susceptible and drug resistant TB bacteria, including XDR-TB, as well as potent in vivo activity against pulmonary TB alone and with other TB drugs.

"This FDA Fast Track designation validates SQ109 as a potentially unique addition to the TB therapeutic armamentarium," said Dr. Carol Nacy, CEO of Sequella. "This is an important regulatory milestone and recognition that SQ109 may address unmet needs in TB therapy to improve and shorten the current treatment regimen."

According to a letter from the FDA, SQ109 received fast track designation based on the following: "SQ 109 has the potential to fulfill an unmet medical need, and the preclinical information available thus far demonstrates that SQ 109 has the potential to enhance the treatment of tuberculosis during the first two months of intensive therapy and to treat multi-drug resistant TB." The FDA letter also stated that: "In 2002 the estimated number of active cases of tuberculosis was 9 million, with approximately 2 million deaths, worldwide."

Mandated by the FDA Modernization Act of 1997, Fast Track designation expedites the development and review of a New Drug Application (NDA) for approval.

About Tuberculosis (TB)

TB is a contagious infectious disease caused by the bacterium Mycobacterium tuberculosis. TB bacteria can be inhaled into lungs and are able to avoid destruction by certain white blood cells. Without containment by immune cells, the bacteria can spread throughout the body, multiply, survive and remain dormant for years. TB is the leading cause of global deaths that result from a single-agent infectious disease. Nine million new cases of active TB disease are reported every year. The World Health Organization (WHO) estimates that one-third of the world's population is infected with TB.

About SQ109

SQ109 is an orally active small molecule antibiotic that inhibits cell wall synthesis and acts on multiple cellular pathways in a select group of microorganisms, including Mycobacterium tuberculosis, the bacteria that cause TB. SQ109 enhances, both in vitro and in vivo, the activity of the anti- tubercular drugs isoniazid and rifampin, thereby shortening by 25% the time required to cure mice of experimental TB. SQ109 is currently in Phase I clinical trials under a US IND, and could replace one or more of the current first-line anti-TB drugs, simplify therapy, and shorten the treatment regimen. Since 2000, Sequella has applied its scientific expertise in TB research and product development to identify, characterize, and complete preclinical evaluation of SQ109. SQ109 was developed in partnership with the NIH, with several grants from the National Institute of Allergy and Infectious Diseases (NIAID) and the assistance of the NIAID and the National Cancer Institute Inter-Institute Program (NCI IIP) for IND-enabling studies.

About Sequella, Inc.

Sequella is a clinical-stage biopharmaceutical company focused on commercializing improved treatment paradigms for diseases of epidemic potential. The company leverages its global influence, infectious disease expertise, and diverse product portfolio to proactively address emerging health threats with significant market opportunity. The Company's lead drug candidate SQ109, a new orally-active diamine antibiotic for the treatment of tuberculosis (TB) and other infectious diseases, is presently in Phase I clinical studies. The company's lead diagnostic product candidate, the TB Patch, is completing several international clinical trials in anticipation of world-wide product registration. For more information, please visit http://www.sequella.com.

Forward-Looking Statement

This press release contains forward-looking statements that are subject to risks and uncertainties, and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Sequella disclaims any intent or obligation to update forward-looking statements, except as required by law.

Sequella, Inc.
http://www.sequella.com

Change In Sexual Behaviors Needed To Curb Spread Of HIV In Africa, Some Health Experts Say

An increasing number of health experts believe that there is a need to change sexual behaviors, including a reduction in the number of sexual partners, to reduce the spread of HIV in Southern Africa, the Financial Times reports. Although a large amount of funding is directed toward HIV prevention programs, "far less effort has gone into persuading people to change their" sexual behaviors, according to the Times. "Prevention has concentrated on testing, condoms, safe blood and mother-to-child transmission -- things that fall easily off bureaucrats' lips," Derek von Wissell -- head of Nercha, Swaziland's official National Emergency Response Council on HIV/AIDS -- said, adding, "Behavior change is the difficult side. It needs a whole societal shift." Recent efforts in Swaziland and other African countries "reflect a new determination to tackle" behavior change -- a "sensitive subject" that has "long been politicized," the Times reports. In the U.S. and other countries, the debate surrounding HIV prevention has become "polarized" around which element of the ABC prevention method -- which stands for abstinence, be faithful and use condoms -- "should receive priority," according to the Times. "There was an immediate polarization between those saying condoms were evil and those who argued that only condoms were good," Daniel Halperin of the Harvard School of Public Health said. Halperin and some other public health experts have said that while all three elements of the ABC method are important, changing sexual behavior and partner reduction efforts have been the "neglected middle child" in ABC. Although condom use has been central to reducing the spread of HIV in countries like Brazil, Cambodia and Thailand, Ambassador Mark Dybul -- who serves as the U.S. global AIDS coordinator and administers the President's Emergency Plan for AIDS Relief -- said that a decrease in the number of men visiting commercial sex workers also contributed to the reduction in HIV cases. "Applying lessons (of condom use) from a concentrated epidemic to a region where there is a generalized epidemic was bordering on scientific insanity," Dybul said, adding, "We have not listened enough to Africans. It is tough to find one who doesn't say, 'A, B and C is what we need.'"

Movement Toward Behavior Change?
Although there is "no single or satisfactory explanation" for why HIV prevalence is higher in Southern Africa than the rest of the world, a "growing body of evidence points to the predominant role of one aspect of sexual behavior" -- that men and women often have "concurrent sexual partners over months or years," the Times reports. This practice contributes to the spread of HIV because the virus' ability to be transmitted peaks during the weeks after a person becomes infected, meaning that an HIV-positive person with multiple partners can spread the virus quickly to others, according to the Times. In addition, long-term sexual partners are less likely to use condoms -- increasing the likelihood that if one partner is HIV-positive, the virus will be transmitted to the other. The effect of such behaviors on the spread of HIV is beginning to be acknowledged, according to the Times. A report presented last year at a conference convened by the Southern African Development Community examined instances in which the number of HIV cases appeared to be decreasing and linked these reductions to successful behavior change programs in countries such as Kenya, Uganda and Zimbabwe (Jack, Financial Times, 1/18).

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

NIH Grant To Develop Rapid Outpatient Device To Detect Bird Flu And Bioterror Agents

The new integrated device the researchers are developing may allow cost effective, point-of-care diagnosis of bird flu and bioterror agents within one to two hours, according to principal investigator Kelly Henrickson, M.D., professor of pediatrics and microbiology at the Medical College. Dr. Henrickson is also a pediatric infectious disease specialist at Children's Hospital of Wisconsin.

Dr. Henrickson previously developed the Hexaplex diagnostic test, using specialized reagents and genetic data for rapid, accurate simultaneous detection of the seven most common lower respiratory viruses, including several varieties of influenza. This technology is the basis for an array of products for physicians worldwide to rapidly detect the microbes responsible for a variety of illnesses such as aseptic meningitis, chicken pox, chronic cough syndrome, encephalitis, herpes, influenza, pneumonia, SARS, shingles, and West Nile virus.

"Our laboratory has pioneered a flexible, rapid, sensitive and specific method of simultaneously detecting multiple pathogens," says Dr. Henrickson. "We have recently developed two BioTplex assays that detect many (15) category 'A' bioterrorism agents. However, new amplified DNA detection and nucleic acid purification methods beyond those used in the Hexaplex diagnostic test allow for the development of a single 'point-of-care' device that may enhance the speed, flexibility, throughput, and cost effectiveness of multiplex assays."

Infectious agents identified to pose the greatest potential threat (Category "A" agents) include Variola major (smallpox), Bacillus anthracis (anthrax), Yersinia pestis (plague), Clostridium botulinum toxin (botulism), Francisella tularensis (tularaemia), and a group of RNA viruses that cause hemorrhagic fevers (VHFs).

Another agent of grave concern is avian flu. Additional concern exists over bird-to-human spread of avian flu and the potential adaptation for human-to-human spread. Terrorists could take advantage of avian flu's flexibility and engineer more virulent strains, capable of causing worldwide pandemics. Current diagnostic assays are directed to the common human isolates of influenza A, but no assay is available to detect all of the avian varieties of influenza A, according to Dr. Henrickson.

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The Medical College of Wisconsin, Children's Hospital, Children's Research Institute, and Nanogen Inc. will participate in carrying out the work of the grant.

Contact: elasusa@mcw.edu
Medical College of Wisconsin

Time To Revise Policy On Self-Testing For HIV

A review of government policy about self-testing for HIV is needed in the UK in order to increase the uptake of HIV testing, according to a Viewpoint in the Lancet.

An estimated 31% of people in the UK are unaware of their HIV-positive status. But early diagnosis is important to manage the illness effectively, and so that people who are HIV positive can reduce the risk of transmitting the virus to others. Since 1992 it has been illegal to sell or provide any self-test for HIV to any member of the public in the UK.

Lucy Frith (Division of Primary Care, University of Liverpool, UK) challenges the case against self-testing for HIV in light of new technologies that enable rapid and accurate HIV testing, advances in antiretroviral therapy, and the increasing emphasis on patient autonomy. She notes that the trend in health care towards an emphasis on patient autonomy has led to greater self-diagnosis and screening. People have been encouraged to take responsibility for their own health and to make informed decisions without direct intervention from health-care professionals. She argues that if self-testing for HIV is not harmful, there should be no grounds for keeping it in a clinical setting. She discusses the most common arguments against self-testing-the absence of counselling before and after the test, the accuracy of self-tests, the ability of people to provide adequate samples and interpret the test correctly, and the possibility of abuse or testing someone without their consent-and recent changes in practice and advances in technology that undermine these arguments.

The author concludes: "If practitioners truly believe in patient autonomy, people should be allowed to choose where, when, and how they are tested for HIV, where the technology exists. When appropriate self-test kits become available, the UK needs to be in a position to benefit from their use."

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Contact: Lancet press office
Lancet

Chinese Province Requires People To Provide Real Names, Contact Information When Taking HIV Tests

China's Yunnan province has begun requiring people to provide their real names and contact information when taking HIV tests, Xinhua/People's Daily reports. According to Lu Lin, director of the Disease Prevention and Control Center of Yunnan, more than 150,000 people volunteered to take HIV tests in the province in 2006, an increase of 30,000 from the previous year. Providing real names and contact information will help medical workers provide follow-up treatment if people test HIV-positive, Lu said, adding that the requirement will enable HIV-positive people to "receive free medical treatment as soon as possible." Lu also pledged to protect the privacy of those who are tested, saying that medical workers will be prosecuted if they reveal HIV-positive people's personal information. Many people who take HIV tests give false personal information because of concerns related to stigma and discrimination, which means they miss the "best time for treatment," Lu said. Yunnan has 210 labs to screen and diagnose HIV/AIDS, and the number of labs might increase in the future, according to Lu (Xinhua/People's Daily, 1/18). According to official statistics, the number of HIV-positive people in Yunnan increased from 14,905 in 2003 to 40,157 by the end of 2005 (Kaiser Daily HIV/AIDS Report, 12/5/06). By the end of September 2006, the number increased to 47,314 (Xinhua/People's Daily, 1/18). The number of HIV cases in the province now accounts for one-quarter of the national HIV caseload. In addition, the Provincial Committee of AIDS Prevention and Control says HIV/AIDS cases have been detected in 128 of the province's 129 counties (Kaiser Daily HIV/AIDS Report, 12/5/06).

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

Press Conference Held On Measles Immunization Strategy

Participants:

Dr Margaret Chan, Director-General, World Health Organization (will be the first speaker)

Kathy Bushkin, Executive Director and Chief Operating Officer, United Nations Foundation

Dr. Julie L. Gerberding, M.D., M.P.H., Director, United States Centers for Disease Control and Prevention

Bonnie McElveen-Hunter, Chairwoman, American Red Cross

Ann M. Veneman, Executive Director, UNICEF

WHEN: Thursday, January 18, 2007,

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Contact: Lancet press office
Lancet