The U.S. Food and Drug Administration (“FDA”) announced the approval of EVOLENCE® for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. EVOLENCE® is a new advanced collagen-based structural dermal filler, and a first of its kind product. The introduction of EVOLENCE® marks the first dermal filler entry for the Aesthetics Group of OrthoNeutrogena. While new to the United States, EVOLENCE® has been available in other markets such as in Canada, Western and Eastern Europe, Israel, South Korea and Russia since 2004.

“EVOLENCE® represents a new generation of facial fillers, an innovative structural agent providing beautiful, immediate results by replacing the collagen lost with long-lasting, naturally sourced collagen,” said Annie Heremans, M.D., Ph.D., Vice President, responsible for the Company’s research and development of the Medical and Aesthetic Dermatology franchises. “We are pleased to enter the U.S. aesthetic space with a differentiated dermal filler designed for optimal patient outcomes. Given our rich heritage in skin care and commitment to science, we anticipate EVOLENCE® will be a welcome addition to current aesthetic treatment options.”

EVOLENCE® will be introduced throughout the second half of 2008, in coordination with physician training, to ensure optimal patient satisfaction and outcomes.

EVOLENCE® represents a breakthrough in aesthetics. As one of nature’s most fundamental and abundant building blocks, collagen comprises up to 80% of the dermis and it helps maintain skin strength, structure and support. Collagen naturally breaks down as a person ages, leading to the appearance of wrinkles, lines and folds.

EVOLENCE®, and its proprietary GLYMATRIX™ Technology, uses naturally sourced collagen to replace the body’s lost collagen, adding volume and structural support in depleted areas, for a more naturally youthful appearance. In addition, no pre-test is needed, and GLYMATRIX™ Technology delivers longer-lasting durability than previous collagen dermal fillers.

Results are visible and immediate at the time of treatment, with minimal to no bruising or swelling, allowing physician and patient to gauge the amount of wrinkle correction with more precision. EVOLENCE® is recommended for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds, to be injected in the mid-to-deep dermis.

“We now have a collagen filler that does not require a pre-test and delivers immediate, beautiful and natural-looking results that last with minimal to little downtime for the patient,” said Z. Paul Lorenc, M.D., F.A.C.S., Assistant Professor of Surgery, New York University School of Medicine and Principal Investigator on the EVOLENCE® U.S. pivotal study. “EVOLENCE® provides consistent and predictable results for all patients with every treatment.”

About EVOLENCE®

EVOLENCE® is an advanced collagen-based structural dermal filler that provides long-lasting treatment of moderate to deep facial wrinkles and folds, such as nasolabial folds. The results of treatment with EVOLENCE® are immediate, with little to no downtime post-treatment and clinically proven to last through six months. Additional data for 12-month duration approval is being filed with the FDA.

Unlike other dermal fillers that use hyaluronic acid (HA), which absorb water to create their effect, EVOLENCE® is a true structural agent due to its three-dimensional collagen matrix. This collagen structure benefits patients as it is directly linked to the minimal bruising and swelling that might result. EVOLENCE® does not use chemicals for cross-linking like many other products do, but instead uses natural sugar to improve durability. EVOLENCE® collagen is cross-linked through its patented GLYMATRIX™ Technology using the natural sugar, D-Ribose. The GLYMATRIX™ process is designed to:

- Mimic naturally occurring collagen in the skin by creating a true structural framework with natural, durable cross-links to ensure filler longevity
- Provide consistent and predictable results
- Use natural ingredients for natural-looking results

The naturally sourced porcine collagen used in EVOLENCE® is the most genetically similar to human collagen and has been used safely and effectively for decades in various medical applications, including heart valve replacement.

This new generation collagen filler is intended for injection into the mid-to-deep dermis for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. The most common side effects of EVOLENCE® injections are usually injection-site related and include mild swelling, redness, and pain. Other rare side effects include the development of small areas of firmness under the skin at the treated sites that may be noticed when the areas are pressed upon.

EVOLENCE® has undergone rigorous testing and has been demonstrated to be safe and effective through clinical studies. For more information on the product, visit http://www.evolence.com.

About OrthoNeutrogena, Aesthetics Group

EVOLENCE® is marketed in the United States by the Aesthetics Group of OrthoNeutrogena, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., and part of the Johnson & Johnson family of companies. This innovative collagen structural dermal filler was developed by ColBar LifeScience, Ltd., a biotechnology company specializing in reconstructive medicine and tissue engineering. The company has perfected a technique in which collagen, a main building block of living organisms, can be purified and transformed so as to create a variety of products that are structurally stable and safe for medical applications. ColBar LifeScience Ltd., is also subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

(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 http://www.sec.gov, http://www.jnj.com 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.)

http://www.evolence.com Continue reading →

Teaching young women to delay sex until marriage is a good start but is not enough to prevent the spread of HIV and other sexually transmitted diseases, says Tulane international health researcher Sohail Agha. In fact, Agha’s research showed that years of education was a stronger predictor of both delaying sex and using condoms.

The research team analyzed data from 5,534 unmarried Zambian women between 13 and 20 years old. Data included questions about their religious affiliation, income level, educational level, age of first sex and condom use during the first sexual act. According to Agha, this is one of the first studies to look at both behaviors. Overall, nearly 50 percent of the women surveyed had not initiated sex. Of those who had, only one in four reported using a condom the first time they had sex.

Overall, religious affiliation did not affect either the age of first sex or use of a condom during the first sexual event. However, women belonging to the more conservative denominations abstained longer, with 59 percent of Jehovah’s Witnesses and 54 percent of Seventh Day Adventists reporting that they had never had sex. The survey also showed that only one in five women in these denominations used a condom the first time they had sex, compared to one in four overall.

###

The research was published in a recent issue of the journal of Adolescent Health.

Contact: Madeline Vann

Tulane University Continue reading →

After being shut down since August for having salmonella-tainted shell eggs and substandard farming conditions, Wright County Egg LLC of Galt, Iowa can resume trading again from two hen houses on one of its six farms, the Food and Drug Administration (FDA) informed today. The FDA explains that it is satisfied that Wright County Egg has taken the necessary steps at the two hen-houses to deal with all four contamination pathways that contributed to last summer’s multi-state outbreak of Salmonella Enteritidis.

Margaret A. Hamburg, M.D., FDA Commissioner, said:
“During the outbreak, I said that FDA would not agree to the sale of eggs to consumers from Wright County Egg until we had confidence that they could be shipped and consumed safely. After four months of intensive work by the company and oversight, testing, and inspections by FDA, I am satisfied that time has come.”
The four pathways the company is said to have addressed are:

Egg-laying environment – all egg-laying hens were removed and their houses thoroughly cleaned and sanitized. They were then tested to make sure they were clear of any salmonella contamination. The company also developed a biosecurity plan to prevent future contamination from other houses and farms.
Infected young chickens (pullets) – pullets that had been in the houses have been taken out. Vaccinated pullets have replaced them.
Rates and mice – the company has addressed the “severe rodent problem”. A system to control and monitor rodents on a weekly bases has been put into place.
Chicken feed – measures have been taken to prevent the contamination of feed, including cleaning and disinfecting the feed mill, addressing some structural defects, clearing away egg shells, bones and meat from the feed, and regularly testing the feed and its ingredients for salmonella.

Don Kraemer, deputy director of FDA’s Center for Food Safety and Nutrition, said:
“These extensive corrective actions address the significant contamination problems and support the resumption of distribution of eggs to the table market from these two hen houses.”
According to the FDA, the corrective measures implemented by the company will significantly reduce the risk of a recurrence of another outbreak. FDA inspections in October and November confirm these corrective measures took place and were done properly.

The eggs have been tested three times, twice by the FDA and once by the company itself, in all three tests they were negative for salmonella contamination. The company assures the FDA that the hen-houses will be tested monthly.

After 13 FDA investigators clocked up 900 man-hours, the collection and analysis of 40 feed and 236 environmental samples, and 13,900 shell eggs, as well as examining all testing and FDA inspection data, the FDA has “concluded that distribution of shell eggs from these two houses is warranted.”

Periodic FDA inspections will continue to make sure safety measures are being done and working, the FDA wrote in a communiqu?©.

Written by Christian Nordqvist

Copyright: Medical News Today

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The prostate cancer community joins together in congratulating Us TOO International Prostate Cancer Education & Support Network in their 20th anniversary of continued prostate cancer support, education and advocacy.

The grassroots organization was founded in 1990 by a group of prostate cancer survivors on a mission to help not just other prostate cancer patients but also their families and loved ones being impacted by the disease. For 20 years, Us TOO has provided peer-to-peer guidance and support to men and their families dealing with prostate cancer as well as free information and materials so patients can make informed decisions about early detection, treatment options, and life after treatment. To mark this milestone Us TOO will be celebrating its 20th anniversary this month by hosting a two-day event on August 20-21.

Themed “From Passion To Action: Us TOO at 20″ The Us TOO International Summit, Symposium & Celebration for Men and Their Families Battling Prostate Cancer will be held at the Hyatt Regency O’Hare in Rosemont, Illinois. The event will include a health exhibit and an educational symposium led by researchers and urologists from across the country featuring discussions on the latest in therapy, prostate cancer research conducted by programs through the U.S. Department of Defense, and intimacy and incontinence.

Representatives from other prostate cancer non-profit organizations will also be in attendance to recognize Us TOO for its 20 years of service.

“What the people at Us TOO have done for patients and their families over the years is simply admirable. We at Men’s Health Network share a strong sense of camaraderie with them as we all work towards a common goal of helping those affected by prostate cancer,” said Scott Williams, VP of Men’s Health Network a national non-profit organization whose mission is to reach men and their families where they live, work, play and pray.

“We applaud Tom Kirk, Us TOO’s President and CEO, and his Board, volunteer and staff team for their achievement as an organization and for their continued contributions in prostate cancer awareness, education and support. The event is a testament to their commitment to tackle the issues surrounding prostate cancer,” said Merel Nissenberg of the National Alliance of State Prostate Cancer Coalitions, an umbrella organization driven to form prostate cancer coalitions in every state.

A highlight of the event is an advocacy summit that addresses the on-going debate about the Prostate-Specific Antigen (PSA) test and treatment options. “This will be a tremendous opportunity for people on both sides of the issue to lay it all out on the table and engage in a healthy discussion. The PSA test may have some flaws, but it is still the best tool available for early detection of prostate cancer. Thank you to Us TOO for bringing everyone together so we can finally make progress on this issue,” said Skip Lockwood, CEO of ZERO The Project to End Prostate Cancer, a national healthcare non-profit organization dedicated to putting an end to prostate cancer.

This statement is endorsed by the following prostate cancer organizations:

AUA Foundation

Ed Randall’s Bat for the Cure

Malecare Prostate Cancer Support

Men’s Health Network

National Alliance of State Prostate Cancer Coalitions

Prostate Cancer Foundation

Prostate Cancer International

Prostate Conditions Education Council

Prostate Health Education Network

The Prostate Net

Women Against Prostate Cancer

ZERO The Project to End Prostate Cancer

Source: Men’s Health Network Continue reading →

Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Geodon® (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.

Bipolar disorder, which affects approximately 5.7 million adults in the United States, is a debilitating, chronic condition that requires lifelong treatment and management.1 More than 90 percent of patients with bipolar disorder have recurring mood episodes,2 making it important to establish a long-term treatment plan to help prevent recurrence and stabilize mood. The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients’ lives, and the disease is associated with high rates of disability.3

“The FDA approval of Geodon provides an additional treatment option for patients with bipolar disorder, who require maintenance therapy to keep the symptoms of the disease under control,” said Charles Bowden, clinical professor of psychiatry and pharmacology, University of Texas Health Science Center.

The efficacy and safety of Geodon for the adjunctive maintenance treatment of bipolar disorder were studied in a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder. After an open-label stabilization period of 10 to 16 weeks, 240 patients were randomized to continue on Geodon plus lithium or valproate, or to have Geodon replaced by placebo.4 The primary endpoint in this study was time to recurrence of a mood episode requiring intervention.

The data demonstrated that Geodon plus lithium or valproate was superior to placebo plus lithium or valproate in increasing the time to recurrence of a mood episode. During six months of treatment, 19.7 percent of patients in the Geodon arm required intervention for a mood episode, compared with 32.4 percent of patients in the placebo arm.4

The adjunctive Geodon treatment regimen was generally well-tolerated.4 Discontinuation due to adverse events occurred in 13 percent of patients in the placebo group, compared with 9 percent of those in the Geodon group.5 The safety and tolerability data from this study are consistent with Geodon’s already well-established safety profile in adult patients.

“The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients’ lives,” said Dr. Ilise Lombardo, senior medical director, Pfizer Specialty Care. “This approval underscores Pfizer’s commitment to supporting people suffering from serious mental health disorders.”

Geodon is also FDA-approved for the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia. Since the FDA approval of Geodon in February 2001, nearly 2 million adult patients have been treated with this important therapy.6

1 National Institute of Mental Health. Bipolar disorder. Available here. Accessed October 27, 2009.

2 Solomon DA, Keitner GI, Miller IW, Shea MT, Keller MB. Course of illness and maintenance treatments for patients with bipolar disorder. J Clin Psychiatry. 1995;56:5-13.

3 Sajatovic M. Bipolar disorder: disease burden. Am J Manag Care. 2005;11:S80-S84.

4 Vieta E, Bowden C, Ice KS, et al. A 6-month, randomized, placebo-controlled, double-blind trial of ziprasidone plus a mood stabilizer in subjects with bipolar I disorder. Poster presented at the 17th European Psychiatric Association European Congress of Psychiatry, January 25, 2009, Lisbon, Portugal.

5 Pfizer Inc. Clinical study report synopsis: Protocol A1281137. A phase 3, randomized, 6-month, double blind trial in subjects with bipolar I disorder to evaluate the continued safety and maintenance of effect of ziprasidone plus a mood stabilizer (vs placebo plus a mood stabilizer) following a minimum of 2 months of response to open-label treatment with both agents.

6 Data on file. Pfizer Inc.

Source
Pfizer Inc.

View drug information on Geodon; Ziprasidone. Continue reading →

AGUILAS, a San Francisco-based Latino gay/bisexual non-profit organization offering programs focused on HIV/AIDS awareness, prevention, education, and outreach is holding a press conference Tuesday, February 19, 2008, 11 am PST, at Lesbian Gay Bisexual Transgender Community Center in San Francisco. The organization facing a budget crisis that will force the organization to shut down and move out of its facility by March 31, 2008 unless necessary funding is acquired. AGUILAS has only received partial grant monies from the AIDS Office of the San Francisco Department of Public Health in 2005, and 2008 grant distribution for new HIV prevention services is expected to be delayed from local, state, and federal sources until 2010. The organization is requesting that the City and County of San Francisco provide the level of funding needed to sustain its HIV prevention services as neither the city nor the county has been paying the full bill for services rendered, which is the norm for agencies such as AGUILAS. AGUILAS is one of two local organizations to receive lower funding for its program.

If AGUILAS is forced to close its doors, San Francisco will lose a powerful HIV prevention program that has effectively served a population at highest risk for HIV infection, and which is difficult to reach due to cultural norms. Program evaluation data collected over the past seven years clearly shows that AGUILAS has demonstrated a 42% to 70% reduction in high risk sexual activity among its program participants (comparing baseline data to data collected at 6-month follow up).

WHAT: The press conference will provide journalists with detailed information concerning: AGUILAS’ significant role as the only, fiscally-responsible organization in the Western United States established, developed, and administered by and for Latino gay and bisexual men; the financial support needed to enable AGUILAS to provide essential HIV/AIDS-related services to Latinos, one of the HIV Prevention Planning Council’s (HPPC) highest priority populations with HIV prevalence among Latino MSM (men having sex with men) ranging from 5.8% to 19%; and pertinent statistical data, including local counseling and testing data from 2001 which suggests that Latino MSM have the highest HIV incidence (3.5%) of all racial/ethnic groups (SFDPH Epidemiology Annual Report, 2001). Further, a CDC six-city study also found that HIV incidence among Latinos was 3.5% compared with 2.5% among whites.

WHO: The AGUILAS panel will feature HIV/AIDS prevention expert, Dr. Eduardo Morales, Ph.D., Executive Director of AGUILAS and Professor of the California School of Professional Psychology (CSPP) at Alliant International University, San Francisco Campus; an AGUILAS clients who will tell their personal stories about how AGUILAS saved their lives; and San Francisco Board of Supervisors Tom Ammiano and Bevan Dufty to answer questions about the issues at hand.

When/Where: Tuesday, February 19, 2008 at 11 am PST; at the Lesbian Gay Bisexual Transgender Community Center, Ceremonial Room, 1800 Market Street in San Francisco.

AGUILAS is a San Francisco-based Latino gay and bisexual non-profit organization offering programs focused on HIV/AIDS awareness, prevention, education, and outreach in a supportive and culturally sensitive environment. The services offered by the agency are consistent with the standards for services in the HIV Prevention Plan, and the agency meets all requirements of the City and County of San Francisco. It is registered with the Human Rights Commission, and has filed the required cultural competency plan. AGUILAS is the only organization in the Western part of the U.S. established, developed, and administered by and for Latino gay and bisexual men for any service delivery. AGUILAS’ target population is one of the HPPC’s highest priorities. AGUILAS is only one of three Latino gay/bisexual organizations in the country providing services. The other two are in Boston, Massachusetts and Austin, Texas.

Highlights to consider:

- AGUILAS is in danger of closing its doors, which means there will be a critical loss of services for Latinos, the group that has the highest incident rate of HIV among all demographic groups in the U.S.

- The key factor is the sustainability of HIV prevention services in the Latino Community.

- Cultural norms with the Latino community inhibit open discussion and disclosure of HID/AIDS-related issues. AGUILAS’ represents an essential safe haven for Latinos at risk for or suffering from HIV/AIDS.

- Latino MSM in San Francisco are more strongly affected by AIDS as compared with national data.

- Available data show that the primary behavior that places Latino men at risk for HIV is unprotected sex with men. Very few research studies have focused specifically on Latino men.

- Increasing sexually transmitted disease (STD) rates among Latino men point to high-risk sex.

AGUILAS Continue reading →

Research and Markets has announced the addition of the “Contraceptives in the United States 2008″ report to their offering.

About this report

The U.S. market for OTC contraceptives is in great demand, thanks to growing populations of young consumers who are the most likely to use contraceptives, but also due to an increased emphasis on pleasure, with personal lubrication and sexual enhancement products showing rapid growth. Mintel explores the current climate in the U.S. with in-depth analysis of the following:

– How manufacturer emphasis on sensitivity and pleasure has fueled sales, and how merchandising of sexual aids in mainstream drug chains has helped fuel sales of condoms

– The competitive context provided by advertising for oral prescription contraceptives and the use of OTC Plan B

– How ambivalence toward pregnancy and decreased fear of STDs are negatively impacting sales

– The dominance of drug stores in the market

– Analysis of branding and advertisement from leading suppliers, including conventional outlets, promotions, and online positioning

– Which condom lines are gaining and which are failing

– Condom usage in the GBLT community and opportunities for advancing sales in this high-use demographic

– New product development

There are 91 countries covered in this report.

Research and Markets
http://www.researchandmarkets.com Continue reading →

HIV and sexual health charity Terrence Higgins Trust (THT) will be launching a new City & Guilds course in understanding HIV and AIDS in Birmingham.

The qualification, a Level 2 Award in Understanding HIV and AIDS VRQ, is designed for people who are interested in HIV and AIDS or working in a role where knowledge of the issue would be beneficial to their work. It’s ideal for people who work as GPs, nurses, GP reception staff, voluntary workers, probation officers, police officers, teachers, social services staff, staff in drug support services and residential care services, amongst many others working in health and social care, as well as interested individuals.

The course has already run successfully in Leeds, Manchester and London and is launching in Birmingham from 16 June, accredited through the UK’s leading vocational education provider, City & Guilds. Areas of study on the course include:

- Transmission and prevention of HIV
- Stigma and discrimination in HIV and AIDS
- Managing HIV and AIDS

Joanna Hurren, Head of Function at City & Guilds, said: “This course is invaluable for anyone wanting to enter a career in the HIV sector. It is also the ideal career development support for someone already working in a role where they need to be aware of issues relating to HIV and AIDS.”

Jackie Redding, Director of Social Care and Service Development for THT said: “We’re delighted to be running this course in Birmingham. It raises vital awareness of HIV and gives individuals the knowledge and skills to support individuals affected and tackle the stigma that still sadly exists. I’d encourage anyone interested to get in touch and find out more.”

The distance learning course is structured into three units, with two face to face study days held in central Birmingham and 44 hours of study time for all units. The course costs ??350 + VAT for private sector workers and ??250 + VAT for public sector workers.

Students who have completed the course said:

“The course is a must do for all working in social care or sexual education, no-matter the level.”

“I would recommend the course to anyone non-medically trained working, or hoping to work, in the field of HIV.”

To sign up for the course or get further information visit this page.

Notes

1. City & Guilds is the expert and leading authority in vocational education and training – both in the UK and beyond. In operation for the last 130 years, City & Guilds is the UK’s leading awarding body for work-related qualifications. Twenty million people in the UK have City & Guilds qualifications, and the organisation awards a further 1.5 million qualifications to learners every year.

Source
Terrence Higgins Trust Continue reading →

Researchers at the University of Pennsylvania School of Medicine have shed new light on how Kaposi’s Sarcoma-associated Herpes Virus (KSHV) subverts normal cell machinery to cause cancer. A KSHV protein called latency-associated nuclear antigen, LANA for short, helps the virus hide out from the immune system in infected cells. When LANA takes the place of other proteins that control cell growth, it can cause uncontrolled cell replication.

The findings appear in a recent issue of the Proceedings of the National Academy of Sciences (USA).

“This is the first report of LANA interfering with the crucial cellular protein called intracellular Notch,” says lead author Erle Robertson, PhD, Professor of Microbiology and the Program Leader of Tumor Virology at Penn’s Abramson Cancer Center. Notch is a signaling molecule that triggers cell development and maintains the stability of cells in many organs, such as the brain, heart, blood, and muscle.

“Intracellular notch, or ICN, promotes cell growth and proliferation, therefore it must be regulated so that these processes do not lead to cancer,” says Robertson. “We found that regulation of ICN through binding to another protein called Sel10, a cell-cycle regulatory protein, is derailed. The large complex of ICN, Sel10, and other factors is marked for degradation by a process called ubiquitination,” says Robertson. In normal uninfected cells, the level of ICN, and thus cell growth and proliferation, is fine-tuned by regulating ICN degradation.

LANA interferes with the degradation of ICN because it competes with ICN for the same binding site on Sel10. If LANA sits on Sel10, ICN cannot be degraded and cell growth and proliferation are no longer controlled. Kaposi’s sarcoma and primary effusion lymphoma are two of the viral-associated cancers that are common in immune-compromised patients.

This is the second mechanism discovered by Robertson and his associates by which KSHV subverts control of normal cell growth. Robertson’s group previously found that LANA marks tumor suppressors, such as p53 and VHL, for degradation.

Other herpes viruses, such as the one that causes cold sores and Epstein-Barr virus, which causes mononucleosis, are able to hide out in cells as well. “Whether these latent herpes viruses use some of the same strategies that we have found for LANA in KSHV has not been determined,” says Robertson.

This new role for LANA was discovered using specific human cell lines. The next step is to test whether LANA works the same way in animals infected with KSHV. “We have completed some studies in mice that indicate that LANA can contribute to tumor development in an animal in ways similar to what we have observed in cell culture,” says Robertson. The animal models will be useful for testing new drug therapies that may inhibit the activity of LANA and eventually prevent the growth of viral-associated cancers.

This work was funded by the National Institutes of Health and the Leukemia and Lymphoma Society of America. Co-authors are Ke Lan of Penn and the Chinese Academy of Science, and S.C. Verma, M. Marakami, B. Bajaj and R. Kaul, all from Penn.

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a national leader in cancer research, patient care, and education. The pre-eminent position of the Cancer Center is reflected in its continuous designation as a Comprehensive Cancer Center by the National Cancer Institute for 30 years, one of 39 such Centers in the United States. The ACC is dedicated to innovative and compassionate cancer care. The clinical program, comprised of a dedicated staff of physicians, nurse practitioners, nurses, social workers, physical therapists, nutritionists and patient support specialists, currently sees over 50,000 outpatient visits, 3400 inpatient admissions, and provides over 25,000 chemotherapy treatments, and more than 65,000 radiation treatments annually. Not only is the ACC dedicated to providing state-of-the-art cancer care, the latest forms of cancer prevention, diagnosis, and treatment are available to our patients through clinical themes that developed in the relentless pursuit to eliminate the pain and suffering from cancer. In addition, the ACC is home to the 300 research scientists who work relentlessly to determine the pathogenesis of cancer. Together, the faculty is committed to improving the prevention, diagnosis and treatment of cancer.

PENN Medicine is a $3.5 billion enterprise dedicated to the related missions of medical education, biomedical research, and excellence in patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System.

Penn’s School of Medicine is currently ranked #3 in the nation in U.S.News & World Report’s survey of top research-oriented medical schools; and, according to most recent data from the National Institutes of Health, received over $379 million in NIH research funds in the 2006 fiscal year. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

The University of Pennsylvania Health System includes three hospitals its flagship hospital, the Hospital of the University of Pennsylvania, rated one of the nation’s “Honor Roll” hospitals by U.S.News & World Report; Pennsylvania Hospital, the nation’s first hospital; and Penn Presbyterian Medical Center a faculty practice plan; a primary-care provider network; two multispecialty satellite facilities; and home care and hospice.

University of Pennsylvania School of Medicine
3600 Market St., Ste 240
Philadelphia, PA 19104
United States
http://www.med.upenn.edu Continue reading →

The U.S. Food and Drug Administration approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease. This is a new use for Xifaxan (rifaximin), a drug that has been approved for the treatment of traveler’s diarrhea.

Hepatic encephalopathy is a worsening of brain function that can occur in patients whose liver can no longer remove toxins from the blood. Increased levels of ammonia in the blood are thought to play a role in the development of HE, and Xifaxan works by reducing these levels.

“The approval of Xifaxan for this new indication provides an additional treatment option for patients with liver disease,” said Joyce Korvick, M.D., deputy director for safety of FDA’s Division of Gastroenterology Products. “Hepatic encephalopathy occurs commonly in patients with liver disease, and there are few effective treatments for this serious condition.”

The efficacy of Xifaxan was established in a randomized placebo-controlled clinical trial of adult patients from the United States, Canada, and Russia. Patients with liver disease who entered the trial had no or mild symptoms of HE. Patients treated with Xifaxan were less likely to develop HE during the trial, compared to placebo-treated patients.

Xifaxan was not studied in patients with the most severe forms of liver disease. Since most patients were also taking lactulose (a synthetic sugar which helps prevent absorption of ammonia from the intestine) during the trial, the efficacy of Xifaxan as a stand-alone treatment for HE could not be assessed.

The most common adverse reactions reported with the use of Xifaxan in patients with liver disease include swelling of the arms and legs (peripheral edema), nausea, gas, and headache.

Xifaxan received a priority review under FDA’s new drug application process and was granted orphan designation status. Xifaxan is manufactured by Salix Pharmaceuticals Inc. of Morrisville, N.C.

For more information

Information on specific drug products, Drugs@FDA

Source
U.S. Food and Drug Administration

View drug information on Xifaxan. Continue reading →