News Article | December 23, 2016
SEATTLE, WA--(Marketwired - Dec 23, 2016) - Atossa Genetics, Inc. ( : ATOS) today announced that Jack Cuzick, PhD, FRS, FMedSci, FRCP (hon), has been appointed as Scientific Advisor. Dr. Cuzick is widely regarded as one of the foremost authorities in the field of breast cancer prevention and has led some of the most important clinical studies involving chemoprevention drugs. He is Director of Wolfson Institute of Preventive Medicine in London and head of Centre for Cancer Prevention and the John Snow Professor of Epidemiology at Queen Mary, University of London. He is a Fellow of the Royal Society, the Academy of Medical Sciences, the Royal Statistical Society, the Institute of Mathematical Statistics and he is an Honorary Fellow of the Royal College of Physicians. Dr. Cuzick was chosen by Thompson Scientific as one of the twelve hottest researchers in all of science in 2007. He was awarded the AACR Cancer Prevention Prize in 2012 and the American Cancer Society Medal of Honor in 2015. Dr. Cuzick is the author of more than 500 peer-reviewed papers and has published in all the major medical journals. In 2014, the Cancer Research UK's Translational Cancer Research Prize was awarded to Dr. Cuzick's research team for their trials of tamoxifen and aromatase inhibitors for chemoprevention of breast cancer in women with a high risk of developing the disease. Dr. Steve Quay, President and CEO, commented, "Dr. Cuzick's insight and expertise will be invaluable as we continue development of our endoxifen drug candidate for women who do not respond to tamoxifen and, importantly, as we develop additional indications for endoxifen in the earlier stages of breast cancer and other serious breast health conditions." Dr. Cuzick added, "I look forward to working with Atossa as it begins the clinical studies of endoxifen. Far too many women die from breast cancer. I believe that a key to reducing the incidence of this deadly disease is by integrating risk assessment into the screening appointment and offering appropriate preventive treatments for high risk women." Atossa Genetics, Inc., is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com. Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa, lower than anticipated rate of patient enrollment, results of clinical studies, the safety and efficacy of Atossa's products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.
News Article | October 26, 2016
Screening strategy could prevent about 600 heart attacks in people under the age of 40 The researchers from QMUL's Wolfson Institute of Preventive Medicine estimate that, with effective treatment, the screening strategy could prevent about 600 heart attacks in people under the age of 40, each year in England and Wales, if the programme was rolled out by public health agencies. Familial hypercholesterolaemia (FH) is a genetic disorder characterised by high cholesterol levels and is the main inherited cause of early heart disease. Without preventive medication young FH adults have about a 10-fold increased risk of a heart attack before the age of 40. In the largest study to date of cholesterol and FH mutations in children, the prevalence of FH mutations in children was found to be about 1 in 270, nearly double that previously reported (1 in 500). Because of the inherited nature of the disorder every child identified with the disorder will have one parent also affected. This offers the opportunity of screening two generations at the same time - so-called child-parent screening. Lead researcher Professor David Wald said: "This is the first demonstration that child-parent screening works on a large scale. It's the only screening method that stands a reasonable chance of covering the whole population and identifying those at highest risk of an early heart attack. "Now that we've demonstrated this as being effective across England, the next step is for public health agencies to consider offering this routinely at the time of childhood vaccination to test all children aged 1-2 years." The study, published in the New England Journal of Medicine and funded by the Medical Research Council, involved screening at 92 general practices across England. 10,059 children were tested for high cholesterol and FH genetic mutations and 40 were found to be FH positive. Once an FH positive child was found, the parents were then contacted for screening, revealing an additional FH positive parent. Overall, one person at high risk of early heart attack was identified for every 125 people tested. The child-parent screening strategy identifies children and their parents together so that early preventive action can be taken. Medication, including statins, can be started immediately in the parents and in children as teenagers, and advice can be given on sensible diets and avoidance of smoking. Professor Wald added: "This is an example of an effective screening strategy being combined with routine vaccination, which has clear advantages. No extra clinic visits are needed and uptake is high because parents are already focussed on the future health of their children and the family as a whole. The one-stop service requires no new clinical infrastructure and is simple and inexpensive to implement." The researchers say that GPs and parents welcomed the screening opportunity, with 84 per cent of families accepting it. Research paper: 'Child-Parent Familial Hypercholesterolemia Screening in Primary Care'. David S. Wald, F.R.C.P., Jonathan P. Bestwick, M.Sc., Joan K. Morris, Ph.D., Ken Whyte, Lucy Jenkins, F.R.C.Path., and Nicholas J. Wald, F.R.S. The New England Journal of Medicine 2016;375:1628-37. DOI: 10.1056/NEJMoa1602777
News Article | December 9, 2016
Women taking tamoxifen to prevent breast cancer were less likely to continue taking the drug if they suffered nausea and vomiting, according to new data presented at the San Antonio Breast Cancer Symposium* today (Friday). The researchers found that women who experienced these symptoms after starting tamoxifen as part of the Cancer Research UK funded International Breast Cancer Intervention Study (IBIS-1),** were more likely to stop taking the medication. But this new analysis also reveals that women given a placebo who experienced the same symptoms were equally as likely to stop. This suggests that some symptoms due to other causes, were being mistaken for side effects of tamoxifen. Previous results from the IBIS-1 trial showed that tamoxifen reduces the incidence of breast cancer among women at a high risk of the disease by over 30 per cent. These preventive effects last for more than 20 years. However, a third of women on the trial did not continue with treatment for the recommended five years. In this examination of the trial data, the researchers based at the University of Leeds and Queen Mary University of London, looked at symptoms that may have led to women not taking the full course of therapy. While some women who stopped the medication experienced menopausal side effects*** including hot flushes and gynaecological changes, others may have stopped after mistakenly linking vomiting and nausea to the drug. This suggests that the understanding of what may be causing certain symptoms could be an important barrier to some women continuing with tamoxifen. The highest drop-out rates occurred within the first 12 months of the IBIS-1 trial, highlighting a period during which interventions to support women should be targeted. Dr Samuel Smith, a Cancer Research UK fellow and university academic fellow at the University of Leeds, said: "Our findings have implications for how doctors talk to patients about the benefits and side effects of preventive therapies such as tamoxifen. "It's important to manage expectations and provide accurate information on the likelihood of experiencing specific side effects and how these differ from symptoms that women may experience anyway. "The high drop-out rate observed in the early stages of the trial suggest that more support is needed to help women understand and manage side-effects that may be linked to their treatment." Sarah Williams, Cancer Research UK's health information manager, said: "Breast cancer is the most common cancer in the UK but research is helping us find new ways of preventing the disease in women at high risk. "While drugs such as tamoxifen and anastrozole can cut the risk of the disease, they do cause side effects. Research like this to understand more about the side effects women experience and the decisions this leads them to make, is vital to offering them appropriate support so they can make the best choice for them. "It's important for anyone experiencing symptoms that are unusual for them, that don't clear up, or that keep coming back to tell their doctor." For media enquiries contact Kathryn Ingham in the Cancer Research UK press office on 020 3469 5475 or, out of hours, on 07050 264 059. ** IBIS-I was carried out at the Wolfson Institute of Preventive Medicine, Queen Mary University of London, with Professor Jack Cuzick as its principal investigator. This trial looked at whether the hormone therapy drug tamoxifen could reduce the risk of breast cancer developing in women who are at a high risk of getting it. This trial was supported by Cancer Research UK. *** Side effects of Tamoxifen include typical menopausal symptoms such as hot flushes and gynaecological changes as well as headaches, nausea and vomiting. For further information about Cancer Research UK's work or to find out how to support the charity, please call 0300 123 1022 or visit http://www. . Follow us on Twitter and Facebook
Nagtegaal I.D.,Radboud University Nijmegen |
Duffy S.W.,Wolfson Institute of Preventive Medicine
Breast Cancer Research and Treatment | Year: 2013
Population screening has brought about changes in both the incidence and mortality rates of patients with breast cancer. Large numbers of small screen-detected tumors have inspired discussions about overdiagnosis based on potential biological differences between screen-detected and symptomatic cancers. In the current systematic review, we analyzed the relation and the interaction of tumor size and nodal status in correlation with screening. Smaller tumors were more frequently screen detected (pT1 78.5 %) than symptomatic (pT1 61.7 %, p < 0.001), with a RR of 1.6 (95 % CI 1.4-1.8, n = 41,209). In the screened population, pT1 tumors were also more frequent (68.5 vs 49.9 %, n = 51,171, p < 0.001). Positive lymph nodes were less frequent in screen-detected tumors (26.8 vs 46.3 %, n = 43,705, p < 0.001) as well as in screened populations as a whole (24.1 vs 44.9 %, n = 49,581, p < 0.001). The relation between size and nodal status was not different between the screen-detected and the symptomatic tumors [pT2+N+ OR 2.42 (95 % CI 1.69-3.48) vs OR 2.91 (95 % CI 2.41-3.51)], suggesting that biological differences, if present, are small. In this systematic review, we confirmed both the association of screening with smaller tumor size at presentation and the consequent reduction in lymph node metastases. © 2012 Springer Science+Business Media New York.
Wald N.J.,Wolfson Institute of Preventive Medicine |
Bestwick J.P.,Wolfson Institute of Preventive Medicine
PLoS ONE | Year: 2013
Background: Prenatal screening for Down's syndrome is performed using biochemical and ultrasound markers measured in early pregnancy such as the Integrated test using first and second trimester markers. Recently, DNA sequencing methods have been introduced on free DNA in maternal plasma, yielding a high screening performance. These methods are expensive and there is a test failure rate. We determined the screening performance of merging the Integrated test with the newer DNA techniques in a protocol that substantially reduces the cost compared with universal DNA testing and still achieves high screening performance with no test failures. Methods: Published data were used to model screening performance of a protocol in which all women receive the first stage of the Integrated test at about 11 weeks of pregnancy. On the basis of this higher risk women have reflex DNA testing and lower risk women as well as those with a failed DNA test complete the Integrated test at about 15 weeks. Results: The overall detection rate was 95% with a 0.1% false-positive rate if 20% of women were selected to receive DNA testing. If all women had DNA testing the detection rate would be 3 to 4 percentage points higher with a false-positive rate 30 times greater if women with failed tests were treated as positive and offered a diagnostic amniocentesis, or 3 times greater if they had a second trimester screening test (Quadruple test) and treated as positive only if this were positive. The cost per women screened would be about one-fifth, compared with universal DNA testing, if the DNA test were 20 times the cost of the Integrated test. Conclusion: The proposed screening protocol achieves a high screening performance without programme test failures and at a substantially lower cost than offering all women DNA testing. © 2013 Wald, Bestwick.
Morris J.K.,Wolfson Institute of Preventive Medicine
American Journal of Medical Genetics, Part A | Year: 2012
The aim of this study was to quantify the maternal age-specific risk for trisomy 21 mosaicism. Data were obtained on 322 trisomy 21 diagnoses with mosaicism and 27,943 simple trisomy 21 diagnoses recorded in the National Down Syndrome Cytogenetic Register from 1989 to 2009 in England and Wales. Trisomy 21 cases with mosaicism have a mean maternal age of 33.1 years compared to 35.0 years for free trisomy 21 cases. Sixty-seven percent of trisomy 21 diagnoses with mosaicism are maternal age dependent, with a risk 0.8% that of the corresponding maternal age specific risk for simple trisomy 21. However 33% (0.8 per 100,000 births) are not maternal age dependent, indicating that maternal age is not the only risk factor for mosaicism. Trisomy 21 diagnoses with mosaicism are more likely to be female than free trisomy 21 diagnoses, however there was no association of fetal sex with maternal age which indicates that there is another factor involved in the presence of mosaicism not associated with maternal age, but associated with fetal sex. © 2012 Wiley Periodicals, Inc.
Bhui K.,Wolfson Institute of Preventive Medicine
British Journal of Psychiatry | Year: 2010
Evidence-based mental healthcare is evolving rapidly. There is a need for well-tested and effective interventions that are suited to culturally diverse populations. This editorial considers the findings from the SITARA study. There are a substantial number of implications for research, policy and practice.
THERACOM: a systematic review of the evidence base for interventions to improve Therapeutic Communications between black and minority ethnic populations and staff in specialist mental health services.
Bhui K.,Wolfson Institute of Preventive Medicine
Systematic reviews | Year: 2013
Black and Minority Ethnic (BME) groups in receipt of specialist mental health care have reported higher rates of detention under the mental health act, less use of psychological therapies, and more dissatisfaction. Although many explanations have been put forward to explain this, a failure of therapeutic communications may explain poorer satisfaction, disengagement from services and ethnic variations in access to less coercive care. Interventions that improve therapeutic communications may offer new approaches to tackle ethnic inequalities in experiences and outcomes. The THERACOM project is an HTA-funded evidence synthesis review of interventions to improve therapeutic communications between black and minority ethnic patients in contact with specialist mental health services and staff providing those services. This article sets out the protocol methods for a necessarily broad review topic, including appropriate search strategies, dilemmas for classifying different types of therapeutic communications and expectations of the types of interventions to improve them. The review methods will accommodate unexpected types of study and interventions. The findings will be reported in 2013, including a synthesis of the quantitative and grey literature. A particular methodological challenge is to identify and rate the quality of many different study types, for example, randomised controlled trials, observational quantitative studies, qualitative studies and case studies, which comprise the full range of hierarchies of evidence. We discuss the preliminary methodological challenges and some solutions. (PROSPERO registration number: CRD42011001661).
Bhui K.,Wolfson Institute of Preventive Medicine
British Journal of Psychiatry | Year: 2016
This commentary takes up the notion proposed by Lewis-Fernández and colleagues that we need more balance in research priorities. Specifically, our reliance on neurobiology may be misplaced and likely to be unrewarding unless we ensure that: (a) research with better return for patients and the public is also pursued; (b) research findings are put into practice; and (c) we retain a focus on proportionate investment in service provision. Patient, public and economic perspectives should drive the decision making for better investment, and behaviour change might be better targeted at commissioners and policy makers rather than patients and providers. ©The Royal College of Psychiatrists 2016.
Wu J.,Wolfson Institute of Preventive Medicine |
Morris J.K.,Wolfson Institute of Preventive Medicine
European Journal of Human Genetics | Year: 2013
There is uncertainty over the population prevalence of people with Down's syndrome in England and Wales. This study aimed to estimate the population prevalence of Down's syndrome in England and Wales in 2011. A meta-analysis of published survival rates of people with Down's syndrome from 1938 to 2010 was conducted and the results were applied to the estimated numbers of babies born with Down's syndrome since 1938 in England and Wales. An estimated 37 090 people had Down's syndrome in England and Wales in 2011, a population prevalence of 0.66 per 1000 people; 650 under 1, 2673 aged 1-5, 7115 aged 5-18, 12819 aged 19-40, 10 626 aged 41-55 and 3207 aged 56 and older. The average life expectancy for babies with Down's syndrome born in 2011 was 51 years and the median life expectancy was 58 years. This study provides clarity on the number of people with Down's syndrome in England and Wales. Owing to sudden increases in the survival of babies with Down's syndrome in the 1950s there are a large proportion of people with Down's syndrome who are in their 40s. These people have an increased risk of developing dementia in the future and services should be aware of their potential needs. © 2013 Macmillan Publishers Limited All rights reserved.