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News Article | November 21, 2016
Site: www.eurekalert.org

Researchers have made significant progress in the development of a potential vaccine to protect against HIV infection. For the first time, researchers have shown that a combined approach - using a common cold virus to introduce a vaccine into the body, as well as an injection of a DNA-based vaccine - results in the immune system actively protecting against HIV in the gut and bodily cavities. The laboratory studies, conducted so far in mice and now published in the Nature journal Scientific Reports, represent an important step forward in attempts to introduce a first line of defense against HIV at the site of infection. "With sexual activity being one of the primary methods of HIV transmission, it's necessary to try to protect those parts of the body that are most likely to encounter the virus first," says senior author Dr Branka Grubor-Bauk, from the Discipline of Surgery at the University of Adelaide and Basil Hetzel Institute for Translational Health Research, Queen Elizabeth Hospital. "A possible reason why previous HIV vaccine trials have not been successful is because of this lack of a frontline protection. "In mice, we delivered a rhinovirus (or common cold virus) inside the nose, and this virus had been altered to include HIV proteins. At the same time, the mice also received an injection into the skin containing a DNA-based vaccine. This approach resulted in very specific responses in the immune system," Dr Grubor-Bauk says. "Importantly, this vaccine approach encompasses two different arms of the immune system: white blood cells that attack the HIV virus, and specific antibodies that recognize and shut down HIV-positive cells." The Head of the Virology Group conducting this research is Professor Eric Gowans, also from the University's Discipline of Surgery, based at the Basil Hetzel Institute. "There's an element of HIV known as Tat that helps the virus to replicate quite rapidly. One of the beauties of our vaccine approach is that the antibodies inhibit the Tat effect, preventing HIV from replicating itself," Professor Gowans says. "Overall, we found that infection was considerably reduced in the mice we studied. The findings of our work now support the need for further testing of this targeted approach to an HIV vaccine," he says. This study was supported with funding from The Hospital Research Foundation and the National Health and Medical Research Council (NHMRC). The findings are announced ahead of World AIDS Day (Thursday 1 December 2016). Dr Branka Grubor-Bauk Senior Research Officer, Virology Group Discipline of Surgery, The University of Adelaide and Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital branka.grubor@adelaide.edu.au Professor Eric Gowans Head, Virology Group Discipline of Surgery, The University of Adelaide and Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital eric.gowans@adelaide.edu.au


SAN DIEGO--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today reported final results from its Phase 1 trial of AB-SA01, a proprietary investigational bacteriophage (phage) cocktail targeting Staphylococcus aureus (S. aureus) infections, in patients with chronic rhinosinusitis (CRS). AB-SA01 met the trial’s primary endpoints of safety and tolerability and all nine patients enrolled in the study experienced a reduction in the quantity of S. aureus infecting their sinuses, with some patients showing complete eradication of the bacterial infection. “We are delighted with the final results of this trial and are particularly encouraged that we saw a decrease in S. aureus bacterial load in all patients treated with AB-SA01,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “The fact that the patients enrolled in this study had all failed standard of care treatment, including previous sinus surgery, combined with compelling preclinical results in an animal model of CRS and these positive Phase 1 findings, gives us tremendous confidence in our decision to advance AB-SA01 into a Phase 2 trial in 2017.” The Phase 1 clinical trial in patients with CRS was initiated in January 2016 and was conducted at the Queen Elizabeth Hospital in Adelaide, Australia in collaboration with the University of Adelaide and Flinders University. All nine patients enrolled received AB-SA01 in one of three dose regimens: Cohort 1 patients received low-dose twice daily for seven days; Cohort 2 patients received low-dose twice daily for 14 days; and Cohort 3 patients received high-dose twice daily for 14 days. Detailed results from the Phase 1 trial of AB-SA01 in CRS patients will be presented by Dr. Mian Ooi, of the University of Adelaide and The Queen Elizabeth Hospital’s department of Otolaryngology, Head and Neck Surgery, at an upcoming medical conference in 2017. CRS is defined as a single sinusitis episode that lasts more than 12 weeks. This condition affects approximately 30 million adults in the U.S. each year. Patients with CRS experience quality-of-life scores that are often worse than those suffering from congestive heart failure or chronic back pain. Current care includes nasal washes, steroids and antibiotics. Patients who do not respond to these treatments often require invasive sinus surgery to improve sinus drainage. An estimated 300,000 such surgeries are performed in the U.S. annually with infection returning in about 20% of those patients. These unresponsive patients often have no option beyond another sinus surgery that could lead to a similar outcome. AmpliPhi’s goal is to provide these patients with an effective treatment option. As previously announced, AmpliPhi Biosciences will hold a business update conference call on Wednesday, January 4, 2017 beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time). The conference call dial-in number is (877) 287-2401 for domestic callers and (216) 562-0057 for international callers, and the passcode is 30920092. A live webcast of the call will be available on the Investor Relations section of www.ampliphibio.com. A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use passcode 30920092 to access the recording. A webcast replay will be available on the Investor Relations section of www.ampliphibio.com for 30 days, beginning approximately two hours after the completion of the call. Bacteriophages, or more simply “phages,” are the natural predators of bacteria and are thought to be the most abundant life form on earth, outnumbering even the stars in our universe. Over eons, phages have evolved an incredible diversity of specialist strains that typically prey upon just one strain of bacteria, enabling a phage-based therapeutic to precisely target a pathogenic bacterial population while sparing the beneficial microbiota. Phages can effectively infect and kill bacteria, regardless of whether they are antibiotic-resistant or not and even when they have formed protective biofilms. Such biofilms are a major line of defense for bacteria that phages are able to penetrate to produce strong local therapeutic effects without the side-effects commonly associated with conventional antibiotics. AmpliPhi Biosciences Corporation is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi has reported final results from two Phase 1 clinical trials of AB-SA01, one for the treatment of S. aureus in chronic rhinosinusitis patients and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa (P. aeruginosa) and Clostridium difficile (C. difficile) in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies. For more information, visit www.ampliphibio.com. Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements about the potential advancement of AB-SA01 into a Phase 2 trial in 2017, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the potential benefits of phage therapy, and AmpliPhi’s development of bacteriophage-based therapies. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. Among the factors that could cause actual results to differ materially from those indicated in these forward-looking statements are risks and uncertainties associated with AmpliPhi’s business and financial condition and the other risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, as filed with the SEC, and other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.


Hughes A.,The Queen Elizabeth Hospital
Current diabetes reviews | Year: 2010

Pancreatic islet transplantation is a promising treatment option for Type 1 Diabetics, offering improved glycaemic control through restoration of insulin production and freedom from life-threatening hypoglycaemic episodes. Implementation of the Edmonton protocol in 2000, a glucocorticoid-free immunosuppressive regimen has led to improved islet transplantation success. >50% of islets are lost post-transplantation primarily through cytokine-mediated apoptosis, ischemia and hypoxia. Gene therapy presents a novel strategy to modify islets for improved survival post-transplantation. Current islet gene therapy approaches aim to improve islet function, block apoptosis and inhibit rejection. Gene transfer vectors include adenoviral, adeno-associated virus, herpes simplex virus vectors, retroviral vectors (including lentiviral vectors) and non-viral vectors. Adeno-associated virus is currently the best islet gene therapy vector, due to the vectors minimal immunogenicity and high safety profile. In animal models, using viral vectors to deliver genes conferring local immunoregulation, anti-apoptotic genes or angiogenic genes to islets can significantly improve islet survival in the early post-transplant period and influence long term engraftment. With recent improvements in gene delivery and increased understanding of the mechanisms underlying graft failure, gene therapy for islet transplantation has the potential to move closer to the clinic as a treatment for patients with Type 1 Diabetes.


Brinn M.P.,The Queen Elizabeth Hospital
Cochrane database of systematic reviews (Online) | Year: 2010

The mass media have been used as a way of delivering preventive health messages. They have the potential to reach and to modify the knowledge, attitudes and behaviour of a large proportion of the community. To evaluate the effectiveness of mass media interventions to prevent smoking in young people in terms of reduced smoking uptake, in addition to secondary outcomes including improved smoking outcomes, attitudes, behaviours, knowledge, self-efficacy and perception. We searched the Cochrane Tobacco Addiction Group Specialised Register and conducted additional searches of MEDLINE and EMBASE in July 2010. Randomized trials, controlled trials without randomization and time series studies that assessed the effectiveness of mass media campaigns (defined as channels of communication such as television, radio, newspapers, bill boards, posters, leaflets or booklets intended to reach large numbers of people and which are not dependent on person to person contact) in influencing the smoking behaviour (either objective or self-reported) of young people under the age of 25 years. Information relating to the characteristics and the content of media interventions, participants, outcomes, methods of the study and risk of bias was abstracted by two independent reviewers. Studies were combined using qualitative narrative synthesis. Seven out of a total of 84 studies reporting information about mass media smoking campaigns met all of the inclusion criteria. All seven studies used a controlled trial design. Three studies concluded that mass media reduced the smoking behaviour of young people. All of the effective campaigns had a solid theoretical basis, used formative research in designing the campaign messages, and message broadcast was of reasonable intensity over extensive periods of time. There is some evidence that mass media can prevent the uptake of smoking in young people, however the evidence is not strong and contains a number of methodological flaws.


Singh K.,The Queen Elizabeth Hospital
The American journal of emergency medicine | Year: 2013

Takotsubo cardiomyopathy (TTC) is uncommon emergency condition usually precipitated by emotional or physical stress and is characterized by near-normal coronary arteries and regional wall motion abnormalities that extend beyond a single coronary vascular territory. Variants of TTC include classic apical ballooning syndrome and less commonly, mid, basal, and biventricular variants. Cardiac arrest is an uncommon complication of TTC. In the convalescence phase of TTC, prolonged QTc interval may cause cardiac arrest, but the reason for cardiac arrest in the acute phase when QTc interval is normal is unclear. We report 3 cases of mid ventricular TTC, with out-of-hospital cardiac arrest as the presenting feature. All 3 patients had normal QTc interval and were found to have normal coronary arteries on cardiac catheterization at presentation. Mid ventricular TTC was confirmed on contrast left ventriculography and echocardiography. Cardiac arrest myocarditis was ruled out by myocardial biopsy in 2 deceased patients and by cardiac magnetic resonance imaging in the one who survived.


Carson K.V.,The Queen Elizabeth Hospital
Cochrane database of systematic reviews (Online) | Year: 2012

Cigarette smoking is one of the leading causes of preventable death world wide. There is good evidence that brief interventions from health professionals can increase smoking cessation attempts. A number of trials have examined whether skills training for health professionals can lead them to have greater success in helping their patients who smoke. To determine the effectiveness of training health care professionals in the delivery of smoking cessation interventions to their patients, and to assess the additional effects of training characteristics such as intervention content, delivery method and intensity. The Cochrane Tobacco Addiction Group's Specialised Register, electronic databases and the bibliographies of identified studies were searched and raw data was requested from study authors where needed. Searches were updated in March 2012. Randomized trials in which the intervention was training of health care professionals in smoking cessation. Trials were considered if they reported outcomes for patient smoking at least six months after the intervention. Process outcomes needed to be reported, however trials that reported effects only on process outcomes and not smoking behaviour were excluded. Information relating to the characteristics of each included study for interventions, participants, outcomes and methods were extracted by two independent reviewers. Studies were combined in a meta-analysis where possible and reported in narrative synthesis in text and table. Of seventeen included studies, thirteen found no evidence of an effect for continuous smoking abstinence following the intervention. Meta-analysis of 14 studies for point prevalence of smoking produced a statistically and clinically significant effect in favour of the intervention (OR 1.36, 95% CI 1.20 to 1.55, p= 0.004). Meta-analysis of eight studies that reported continuous abstinence was also statistically significant (OR 1.60, 95% CI 1.26 to 2.03, p= 0.03).Healthcare professionals who had received training were more likely to perform tasks of smoking cessation than untrained controls, including: asking patients to set a quit date (p< 0.0001), make follow-up appointments (p< 0.00001), counselling of smokers (p< 0.00001), provision of self-help material (p< 0.0001) and prescription of a quit date (p< 0.00001). No evidence of an effect was observed for the provision of nicotine gum/replacement therapy. Training health professionals to provide smoking cessation interventions had a measurable effect on the point prevalence of smoking, continuous abstinence and professional performance. The one exception was the provision of nicotine gum or replacement therapy, which did not differ between groups.


Chandratilleke M.G.,The Queen Elizabeth Hospital
Cochrane database of systematic reviews (Online) | Year: 2012

People with asthma may show less tolerance to exercise due to worsening asthma symptoms during exercise or other reasons such as deconditioning, as a consequence of inactivity. Some may also restrict activities as per medical advice or family influence and this might result in reduced physical fitness. Physical training programs aim to improve physical fitness, neuromuscular coordination and self confidence. Subjectively, many people with asthma report that they are symptomatically better when fit, but results from trials have varied and have been difficult to compare because of different designs and training protocols. Also, as exercise can induce asthma, the safety of exercise programmes need to be considered. To gain a better understanding of the effect of physical training on the respiratory and general health of people with asthma, from randomised trials. We searched the Cochrane Airways Group Specialised Register of trials up to April 2011. We included randomised trials of people over eight years of age with asthma who were randomised to undertake physical training. Physical training had to be undertaken for at least twenty minutes, two times a week, over a minimum period of four weeks. Two review authors independently assessed eligibility for inclusion and the quality of trials. Nineteen studies (695 participants) were included in this review. Physical training was well tolerated with no adverse effects reported. None of the studies mentioned worsening of asthma symptoms following physical training. Physical training improved cardiopulmonary fitness as measured by a statistically and clinically significant increase in maximum oxygen uptake (MD 5.57 mL/kg/min; 95% confidence interval (CI) 4.36 to 6.78; six studies on 149 participants) and maximum expiratory ventilation (6.0 L/min, 95% CI 1.57 to 10.43; four studies on 111 participants) with no significant effect on resting lung function (performed in four studies). Although there were insufficient data to pool due to diverse reporting tools, there is some evidence available to suggest that physical training may have positive effects on health-related quality of life, with four of five studies producing a statistically and clinically significant benefit. This review demonstrated that physical training can improve cardiopulmonary fitness and was well tolerated among people with asthma in the included studies. As such, people with stable asthma should be encouraged to partake in regular exercise training, without fear of symptom exacerbation.


Lim W.J.,The Queen Elizabeth Hospital
Cochrane database of systematic reviews (Online) | Year: 2012

Asthma is a chronic respiratory condition causing inflammation and changes to the airways. Care of people with asthma includes routine and urgent management across primary and tertiary care; however, due to sub-optimal long-term care and delays in obtaining help during acute exacerbations, the mortality and morbidity related to asthma is still a major health concern. There is reason to believe that non-invasive positive pressure ventilation (NPPV) could be beneficial to patients with severe acute asthma; however, the evidence surrounding the efficacy of NPPV is unclear, despite its common use in clinical practice. To determine the efficacy of NPPV in adults with severe acute asthma in comparison to usual medical care with respect to mortality, tracheal intubation, changes in blood gases and hospital length of stay. We carried out a search in the Cochrane Airways Group Specialised Register of trials (July 2012). Following this, the bibliographies of included studies and review articles were searched for additional studies (July 2012). We included randomised controlled trials of adults with severe acute asthma as the primary reason for presentation to the emergency department or for admission to hospital. Asthma diagnosis was defined by internationally accepted criteria. Studies were included if the intervention was usual medical care for the management of severe acute asthma plus NPPV applied through a nasal or facemask compared to usual medical care alone. Studies including patients with features of chronic obstructive pulmonary disease (COPD) were excluded unless data were provided separately for patients with asthma in studies recruiting both COPD and asthmatic patients. A combination of two review authors independently assessed trial quality and extracted data. Study authors were contacted for additional information where required. All data were analysed using RevMan 5.1. For continuous variables, a mean difference and 95% confidence interval were used and for dichotomous variables, risk ratio with 95% confidence interval were calculated. We identified six trials for inclusion. Five studies on 206 participants contributed data, while one study was available in abstract form only and was not fully incorporated into this review. For the primary outcome of endotracheal intubation there were two studies that contributed data: two intubations were needed in 45 participants on NPPV and no intubations in 41 control patients (risk ratio 4.48; 95% CI 0.23 to 89.13). There were no deaths in either of these studies. Length of hospital stay was reported in two studies, though meta-analysis was not possible. Hospitalisation was reported in one small study, in which there were three admissions out of 17 on NPPV and 10 admissions out of 16 in control patients (RR 0.28, 95% CI 0.09, 0.84). This review of studies has highlighted the paucity of data that exist to support the use of NPPV in patients in status asthmaticus. As such this course of treatment remains controversial despite its continued use in current clinical practice. Larger, prospective randomised controlled trials of rigorous methodological design are needed to determine the role of NPPV in patients with asthma.


Carson K.V.,The Queen Elizabeth Hospital
Cochrane database of systematic reviews (Online) | Year: 2012

Tobacco use in Indigenous populations (people who have inhabited a country for thousands of years) is often double that of the non-Indigenous population. A disproportionate burden of substance-related morbidity and mortality exists as a result. To evaluate the effectiveness of smoking cessation interventions in Indigenous populations and to summarise these approaches for future cessation programmes and research. The Cochrane Tobacco Addiction Group Specialised Register of Trials was searched (April 2011), with additional searches of MEDLINE (May 2011). Online clinical trial databases and publication references were also searched for potential studies. We included randomized and non-randomized controlled trials for smoking cessation interventions in Indigenous populations. Interventions could include pharmacotherapies, cognitive and behavioural therapies, alternative therapies, public policy and combination therapies. No attempts were made to re-define Indigenous status for the purpose of including a study in this review. Data pertaining to methodology, participants, interventions and outcomes were extracted by one reviewer and checked by a second, whilst methodological quality was extracted independently by two reviewers. Studies were assessed by qualitative narrative synthesis and where possible meta-analysis. The review process was examined by an Indigenous (Aboriginal) Australian for applicability, acceptability and content. Four studies met all of the eligibility criteria for inclusion within the review. Two used combination therapies consisting of a pharmacotherapy combined with cognitive and behavioural therapies, whilst the remaining two used cognitive and behavioural therapy through counselling, one via text message support and the other delivered via clinic doctors trained in smoking cessation techniques. Smoking cessation data were pooled across all studies producing a statistically and clinically significant effect in favour of the intervention (risk ratio 1.43, 95%CI 1.03 to 1.98, p=0.032), however following sensitivity analysis a statistically non-significant but clinically significant effect was observed in favour of the intervention (risk ratio 1.33, 95%CI 0.95 to 1.85, p=NS) . A significant health disparity exists, whereby Indigenous populations, a minority, are over-represented in the burden of smoking-related morbidity and mortality. This review highlights the paucity of evidence available to evaluate the effectiveness of smoking cessation interventions, despite the known success of these interventions in non-Indigenous populations. Due to this lack of published investigations, the external validity of this review is limited, as is the ability to draw reliable conclusions from the results. The limited but available evidence reported does indicate that smoking cessation interventions specifically targeted at Indigenous populations can produce smoking abstinence. However this evidence base is not strong with a small number of methodologically sound trials investigating these interventions. More rigorous trials are now required to assist in bridging the gap between tobacco related health disparities in Indigenous and non-Indigenous populations.


Carson K.V.,The Queen Elizabeth Hospital
Cochrane database of systematic reviews (Online) | Year: 2012

Tobacco use in Indigenous populations (people who have inhabited a country for thousands of years) is often double that in the non-Indigenous population. Addiction to nicotine usually begins during early adolescence and young people who reach the age of 18 as non-smokers are unlikely to become smokers thereafter. Indigenous youth in particular commence smoking at an early age, and a disproportionate burden of substance-related morbidity and mortality exists as a result. To evaluate the effectiveness of intervention programmes to prevent tobacco use initiation or progression to regular smoking amongst young Indigenous populations and to summarise these approaches for future prevention programmes and research. The Cochrane Tobacco Addiction Group Specialised Register was searched in November 2011, with additional searches run in MEDLINE. Online clinical trial databases and publication references were also searched for potential studies. We included randomized and non-randomized controlled trials aiming to prevent tobacco use initiation or progression from experimentation to regular tobacco use in Indigenous youth. Interventions could include school-based initiatives, mass media, multi-component community level interventions, family-based programmes or public policy. Data pertaining to methodology, participants, interventions and outcomes were extracted by one reviewer and checked by a second, whilst information on risk of bias was extracted independently by a combination of two reviewers. Studies were assessed by qualitative narrative synthesis, as insufficient data were available to conduct a meta-analysis. The review process was examined by an Indigenous (Aboriginal) Australian for applicability, acceptability and content. Two studies met all of the eligibility criteria for inclusion within the review and a third was identified as ongoing. The two included studies employed multi-component community-based interventions tailored to the specific cultural aspects of the population and were based in Native American populations (1505 subjects in total). No difference was observed in weekly smoking at 42 months follow-up in the one study assessing this outcome (skills-community group versus control: risk ratio [RR] 0.95, 95% CI 0.78 to 1.14; skills-only group versus control: RR 0.86, 95% CI 0.71 to 1.05). For smokeless tobacco use, no difference was found between the skills-community arm and the control group at 42 weeks (RR 0.93, 95% CI 0.67 to 1.30), though a significant difference was observed between the skills-only arm and the control group (RR 0.57, 95% CI 0.39 to 0.85). Whilst the second study found positive changes for tobacco use in the intervention arm at post test (p < 0.05), this was not maintained at six month follow-up (change score -0.11 for intervention and 0.07 for control). Both studies were rated as high or unclear risk of bias in seven or more domains (out of a total of 10). Based on the available evidence, a conclusion cannot be drawn as to the efficacy of tobacco prevention initiatives tailored for Indigenous youth. This review highlights the paucity of data and the need for more research in this area. Smoking prevalence in Indigenous youth is twice that of the non-Indigenous population, with tobacco experimentation commencing at an early age. As such, a significant health disparity exists where Indigenous populations, a minority, are over-represented in the burden of smoking-related morbidity and mortality. Methodologically rigorous trials are needed to investigate interventions aimed at preventing the uptake of tobacco use amongst Indigenous youth and to assist in bridging the gap between tobacco-related health disparities in Indigenous and non-Indigenous populations.

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