Medicine Man

A major cross institutional research collaboration aimed at reducing the number of patients harmed in Australia has received $8.4 million in funding in the latest round of National Health and Medical Research Council (NHMRC) program grants.

With current research showing that patient harm occurs in 10 per centof hospital admissions, and that less than half of all patients receive recommended care, this research aims to investigate how and why this occurs. The major focus will be on the roles of teamwork, safe medication use and the application of enhanced Information Technology (IT) to support improved decision-making.

'Despite widespread recognition of the need for reliable measures of the state of healthcare in Australia, we still have a poor understanding of what exactly is going wrong and in turn how we can fix it,' said the University of Sydney's Professor Johanna Westbrook, one of the project's Chief Investigators.

'IT enhancements in the health care system have the potential to dramatically improve the effectiveness and safety of care, however we need to better understand the current determinants of safe practice to ensure we see a return on investments in these systems.'

The research program is the result of alarming statistics proving that patient safety is a growing concern both within Australia and internationally. In Australia 10 per centof admissions to acute care hospitals are associated with an adverse event, however at least as much harm also occurs post-discharge with a million general practice incidents a year demonstrating problems between, as well as within, the layers of health care in Australia.

Led by five Chief Investigators from across the University of Sydney, the University of New South Wales and the University of South Australia, the research will run over five years commencing in 2009. The program brings together leading experts in the field of patient safety including team leaders Professor Johanna Westbrook (USYD), Professors Jeffrey Braithwaite, Enrico Coiera and Ric Day (UNSW) and Professor Bill Runciman (UniSA).

http://www.usyd.edu.au

Genetic Immunity, a US/Hungarian clinical-stage company focused on development of nanomedicines for targeted immune amplification, today announced it has treated the first subject in a Phase II clinical study to evaluate DermaVir Patch.

DermaVir Patch, the Company's lead nanomedicine candidate for treatment-na? HIV-infected individuals, is designed to amplify de novo HIV-specific memory T-cell responses of HIV-infected individuals and improve the ability of their own immune system to control the disease.

The placebo controlled, multicenter, Phase II study (GIEU006) is designed to evaluate safety, immunogenicity and antiviral activity while establishing a safe, well-tolerated dosing regimen for DermaVir Patch. The trial is being conducted in HIV-infected individuals not yet eligible for antiretroviral drug treatment according to present guidelines.

Previous studies demonstrated that DermaVir Patch differs from traditional therapies in safety, mechanism of action and dosing. A Phase I/II trial has shown DermaVir Patch induces long-lasting HIV-specific memory T-cells that play an important role in controlling viral load and disease progression. DermaVir Patch toxicities have been limited to mild, reversible local skin reactions. The needle-free, topically-applied DermaVir Patch could be administered nine times per year or less, contrasting sharply with traditional antiretroviral drugs that require continuous daily dosing.

Principal investigator Jan van Lunzen, MD of the University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit said, "Our clinical team is excited to participate in research therapies that can feasibly offer clinical benefit to HIV patients around the world. An early stage immune therapy that can slow disease progression would provide a significant public health benefit and encourage more people to pursue AIDS testing and enter treatment. Therefore, we are excited to observe the outcome of DermaVir Patch administration on HIV-infected patients who are not yet sick enough to receive antiretroviral drugs."

Julianna Lisziewicz, PhD, CEO of Genetic Immunity, said, "Each trial is an important step toward marketing approval and our ability to help people living with HIV. We are excited to bring DermaVir Patch to Phase II and are optimistic that it might be possible to prolong patients' time before requiring antiretroviral therapy. In previous trials, this nanomedicine candidate has demonstrated amplification of the immune system and the reconstitution of HIV-specific T-cell precursors that expand to kill HIV-infected cells. This novel mechanism of action makes DermaVir Patch attractive for early-stage HIV-infected individuals who are not yet eligible for traditional antiretroviral therapy."

GIEU006 is a Phase II, randomized, placebo-controlled, multi-center study being conducted in Germany to evaluate DermaVir Patch in 36 treatment-na? HIV-1-infected patients. The primary objectives are to evaluate safety and tolerability while establishing a safe and well-tolerated dosing regimen. Secondary objectives assess DermaVir Patch's antiretroviral activity via HIV-1 RNA measurements and immunogenicity as well as changes in CD4+ and CD8+ T-cell counts during treatment.

Patients will be randomized to six treatment arms to receive one of three doses of DermaVir (two, four or eight patches with 0.1 mg DNA per patch) or equivalent placebo patches. The total group of 36 patients will consist of nine in each treatment dosing group and three in each placebo group.

Subjects will be immunized every six weeks over an 18-week period with assessment of primary endpoints at Week 24. After Week 24, subjects will be followed for additional safety and immunogenicity evaluations through Week 48, after which safety follow-up will be performed every 26 weeks for an additional 234 weeks.

Genetic Immunity's nanomedicine immune amplification platform technology is comprised of two principal components: NanoComp and DermaPrep. NanoComp is a patented nanoformulation technology that includes disease-specific plasmid DNA encoded antigens. DermaPrep is the topical administration device that delivers NanoComp to lymph node dendritic cells to induce targeted T-cell-mediated immune responses. These two components, together with the Company's proprietary plasmid DNA, make up the DermaVir Patch. The plasmid DNA within the NanoComp nanoparticles is HIV-specific and topically delivered via DermaPrep to amplify the immune system to kill only HIV-infected cells.

http://www.geneticimmunity.com

Patients who start and eventually stop regimens of a common class of osteoporosis drugs called bisphosphonates may be unable to benefit from parathyroid hormone (PTH), which can rebuild bone mass lost due to advanced stage osteoporosis. PTH has been proven to increase the volume and strength of the honeycomb-like bone infrastructure, the inner mesh that begins to diminish in old age.

Bisphosphonates, the active ingredient in widely prescribed osteoporosis medications such as Fosamax, Actonel, and Boniva are currently taken by more than thirty million Americans.

"These medicines work by preventing further bone loss," explains Dr. Warren Levy, president and CEO of Unigene Laboratories, Inc. "However, recent reports suggest that some patients using bisphosphonates may be unable to repair or replace older or damaged bone. Furthermore, it has been reported that the prior use of certain bisphosphonates may blunt the effects of PTH, which could render the only currently available bone growth drug ineffective. Since bisphosphonates typically deposit in the bones for years, the use of a bisphosphonate could compromise the ability to grow new bone later in life when it is most needed."

Estrogen alternatives have grown in recent years, including calcitonin, a naturally occurring hormone involved in calcium regulation and bone metabolism. In third-party clinical trials, calcitonin demonstrated a 62% reduction in the incidence of new vertebral fractures for a subgroup of women over seventy-five years of age, one of the most significant reductions demonstrated by any current osteoporosis therapy.

"Calcitonin has a proven, thirty-five-year record of safe human use with virtually no significant side effects and can be taken simultaneously with other medications," said Dr. Levy. "Since it is rapidly cleared by the body, it does not build up in the bone and may allow the patient to effectively employ PTH therapy in subsequent years if necessary."

Although, PTH injections have been shown to reduce the incidence of fractures by restoring bone, the treatment can be very costly and requires daily injections. Unigene and GlaxoSmithKline are jointly developing a low-cost, orally administered PTH treatment, and Unigene is currently performing a Phase I clinical study in the U.S. Twenty-four healthy postmenopausal women are enrolled in the study, which is designed to assess product safety and measure PTH blood levels.

The tablets being tested utilize the improved Enteripep? oral delivery technology. "One pill a day to treat bone fractures would be ideal for patients who need to take this medicine for life," adds Dr. Levy.

http://www.unigene.com

Swissmedic, the Swiss agency for therapeutic products, has approved Zevtera (ceftobiprole medocaril) for the treatment of complicated skin and soft tissue infections, including diabetic foot infections which have not spread to the bone.

Ceftobiprole is licensed from and co-developed with Basilea Pharmaceutica Ltd. Janssen-Cilag will market ceftobiprole in Switzerland under the trade name Zevtera. Swiss based Basilea Pharmaceutica Ltd will co-promote the drug in key European markets and North America.

Ceftobiprole is the first, broad-spectrum, anti-MRSA cephalosporin antibiotic with activity against a range of difficult-to-treat Gram-positive and Gram-negative hospital- and community-acquired pathogens including methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. In clinical trials, ceftobiprole has demonstrated high cure rates in patients with complicated skin infections, including those caused by the potentially deadly MRSA.

Data from the European Antimicrobial Resistance Surveillance System (EARSS) show that the prevalence of MRSA - a difficult to treat cause of hospital-and- community acquired infections - while varying considerably among countries, has been rising across Europe for the past six years.

The use of ceftobiprole in adults for the treatment of complicated soft tissue infections, including diabetic foot infections which have not spread to the bone, is under regulatory review in United States, Australia and in the European Union among other countries. In Canada, ceftobiprole was launched in August 2008 under the trade name Zevtera.

Complicated skin and soft tissue infections are among the most common infections in the hospital setting. Staphylococcus aureus is the predominant pathogen in these infections. In recent years, resistant strains, such as MRSA have become increasingly common and have been associated with increased morbidity and mortality. New broad-spectrum antibiotics that cover resistant bacteria such as MRSA, but also clinically important and problematic Gram-negative pathogens, address a high-unmet medical need in the treatment of severe skin and soft tissue infections.

Patients with chronic wounds or those who have recently received antibiotics may also be infected by Gram-negative pathogens. This is frequently the case for diabetic patients with foot infections. Adequate treatment of diabetic foot infections can require hospitalization, surgery and broad-spectrum intravenous antibiotics.

Ceftobiprole, the first anti-MRSA cephalosporin to be approved, is an intravenous antibiotic that belongs to the class of antibacterial drugs known as cephalosporins, which are used to treat serious infections caused by a broad range of bacteria, characterized as Gram-negative and Gram-positive, based on a classification process that is used to identify the specific type of bacteria.

Phase III clinical trials have demonstrated that ceftobiprole is clinically efficacious against the following pathogens: Enterobacter cloacae, Enterococcus faecalis, Proteus mirabilis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumonia and Pseudomonas aeruginosa.

The Janssen-Cilag company have a long and successful track record in developing and marketing treatments for a wide variety of conditions such as infectious disease, HIV, pain management, fungal infections, multiple myeloma, gastroenterological disorders, epilepsy, Alzheimer's disease, schizophrenia, acute bipolar mania, behavioural psychological symptoms of dementia, disruptive behaviour disorders, and autism.

http://www.janssen-cilag.com/

With the world abuzz of the news of his second pregnancy, Thomas Beatie tells the definitive story of his first pregnancy this Tuesday on Discovery Health.

Discovery Health presents the only documentary featuring professional footage of Thomas and his wife, Nancy, through the final weeks of his first pregnancy, the landmark birth of their first child and their eventual return home. Pregnant Man premieres Tuesday, November 18, at 9:00 PM ET/PT on Discovery Health. In addition, an encore presentation of Pregnant Man will air the following day, Wednesday, November 19, at 10:00 PM ET/PT.

Pregnant Man provides the only all-access look inside the everyday household of America's most unconventionally conventional family. Originally born female, Thomas, 34, underwent multiple medical treatments to biologically, socially and legally re-identify as a man. After marrying, the couple decided to start a family, but Nancy was unable to have children. Faced with this reality, Thomas made the unprecedented decision to suspend his testosterone treatments in hopes of becoming pregnant. Following successful artificial insemination, he gave birth to a healthy baby girl in June 2008.

Since announcing Thomas' pregnancy on national television, the Beaties have become a worldwide media obsession. Seeking to satisfy an insatiable public curiosity, journalists from countless countries have requested interviews and pictures of the family. The Beaties have ignited nonstop conversation and interest among everyday people from all walks of life -- some extremely supportive of the family, and others outraged at what they interpret as disregard for familial and societal norms.

In Pregnant Man, Thomas and Nancy welcome viewers into their idyllic suburban world in scenic Bend, Ore. Before Thomas' pregnancy, the Beaties looked and acted just like any other married couple in the neighborhood -- but once the world learned of Thomas' news, their charming Pacific Northwest town became the center of a global media storm. Constantly pursued by the press, Thomas and Nancy are barely able to leave their house to go to work each morning. Meanwhile, their neighbors are left to ponder the couple next door that is both drastically different yet strikingly similar to them. Pregnant Man is an engrossing examination of family, gender and tolerance in America today.

Pregnant Man is a co-production of September Films and Discovery Health. Sara Kozak is the executive producer for Discovery Health and Sheldon Lazarus is the executive producer for September Films.

http://www.discoveryhealth.com