News Article | May 8, 2017
ATLANTA, GA--(Marketwired - May 8, 2017) - GeoVax Labs, Inc. ( : GOVX), a biotechnology company developing human vaccines, today announced its financial results for the three months ended March 31, 2017 and provided an update on its vaccine development programs. Robert T. McNally, Ph.D., GeoVax's President and CEO, commented, "During the first quarter of 2017, GeoVax made progress in each of our vaccine development programs. Our MVA-VLP vaccine platform continues to prove itself through our expanding product portfolio, our growing list of high-quality corporate and academic collaborators, and promising preclinical and clinical testing results. Recent highlights include: We reported very impressive preclinical results (100% protection) for our Zika vaccine from a highly rigorous lethal challenge model conducted by the Centers for Disease Control and Prevention (CDC). Importantly, our approach to a Zika vaccine is unique as it is based on the non-structural-1 protein of the Zika virus and thus will avoid the Antibody Dependent Enhancement (ADE) of infection safety issue, which is a concern for other Zika vaccines under development. We initiated a new clinical trial for our preventive clade B HIV vaccine for the developed world. This trial is being fully funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). And we continued our work under a $7.8 million NIAID contract for production of the DNA component of our vaccine intended for later stage clinical trials. We were awarded a $658,000 grant from NIAID to continue our work toward a clade C HIV vaccine for the developing world. We began a collaboration with American Gene Technologies International, Inc. (AGT) with the goal of developing a functional cure for HIV infection. We expect AGT to begin human clinical trials using our combined technologies later this year. We initiated a new program to develop a malaria vaccine through a collaboration with The Burnet Institute in Australia. Our work on developing the vaccine constructs is complete and we expect the initial preclinical proof-of-concept studies to commence during the second quarter. We added Georgia State University and Peking University as collaborators to develop a therapeutic vaccine for chronic hepatitis B infection and have now begun the initial preclinical proof-of-concept studies. We continued our collaboration with ViaMune, Inc. for co-development of our cancer immunotherapy programs. The proof-of-concept preclinical studies are ongoing, with data readouts expected in June or July. We formed a Scientific Advisory Board composed of world-class scientists including Thomas Monath, MD; Stanley Plotkin, MD; Barney Graham, MD, PhD; Scott Weaver, PhD; and Olivera Finn, PhD. This expert group is already making its mark through their direction and advice for our various development programs." GeoVax reported a net loss for the three months ended March 31, 2017 of $548,341, or $0.01 per share, based on 55.4 million weighted average shares outstanding. For the three months ended March 31, 2016, the Company reported a loss of $1,296,279, or $0.04 per share, based on 34.6 million weighted average shares outstanding. The Company reported revenues of $295,735 for the three months ended March 31, 2017, related to grants from the NIH. This compares to $47,600 of grant revenues reported for the same period in 2016. Research and development (R&D) expenses were $551,795 for the three months ended March 31, 2017, compared with $438,004 for the comparable period in 2016. General and administrative (G&A) expenses were $292,667 and $906,505 for the three months ended March 31, 2017 and 2016, respectively. G&A expense for the 2016 period includes a non-cash charge of $469,799 related to certain stock purchase warrant modifications. Cash balances were $166,749 at March 31, 2017, as compared to $454,030 at December 31, 2016. Summarized financial information is attached. Further information concerning the Company's financial position and results of operations are included in its Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission. GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) vaccine platform. The Company's development programs are focused on preventive vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com. Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.
Deeks S.G.,San Francisco General Hospital |
Lewin S.R.,Monash University |
Lewin S.R.,Burnet Institute |
Havlir D.V.,San Francisco General Hospital
The Lancet | Year: 2013
The success of antiretroviral therapy has led some people to now ask whether the end of AIDS is possible. For patients who are motivated to take therapy and who have access to lifelong treatment, AIDS-related illnesses are no longer the primary threat, but a new set of HIV-associated complications have emerged, resulting in a novel chronic disease that for many will span several decades of life. Treatment does not fully restore immune health; as a result, several infl ammation-associated or immunodefi ciency complications such as cardiovascular disease and cancer are increasing in importance. Cumulative toxic eff ects from exposure to antiretroviral drugs for decades can cause clinically-relevant metabolic disturbances and end-organ damage. Concerns are growing that the multimorbidity associated with HIV disease could aff ect healthy ageing and overwhelm some health-care systems, particularly those in resource-limited regions that have yet to develop a chronic care model fully. In view of the problems inherent in the treatment and care for patients with a chronic disease that might persist for several decades, a global eff ort to identify a cure is now underway.
Chan J.A.,Burnet Institute
Cellular and molecular life sciences : CMLS | Year: 2014
Understanding the targets and mechanisms of human immunity to malaria caused by Plasmodium falciparum is crucial for advancing effective vaccines and developing tools for measuring immunity and exposure in populations. Acquired immunity to malaria predominantly targets the blood stage of infection when merozoites of Plasmodium spp. infect erythrocytes and replicate within them. During the intra-erythrocytic development of P. falciparum, numerous parasite-derived antigens are expressed on the surface of infected erythrocytes (IEs). These antigens enable P. falciparum-IEs to adhere in the vasculature and accumulate in multiple organs, which is a key process in the pathogenesis of disease. IE surface antigens, often referred to as variant surface antigens, are important targets of acquired protective immunity and include PfEMP1, RIFIN, STEVOR and SURFIN. These antigens are highly polymorphic and encoded by multigene families, which generate substantial antigenic diversity to mediate immune evasion. The most important immune target appears to be PfEMP1, which is a major ligand for vascular adhesion and sequestration of IEs. Studies are beginning to identify specific variants of PfEMP1 linked to disease pathogenesis that may be suitable for vaccine development, but overcoming antigenic diversity in PfEMP1 remains a major challenge. Much less is known about other surface antigens, or antigens on the surface of gametocyte-IEs, the effector mechanisms that mediate immunity, and how immunity is acquired and maintained over time; these are important topics for future research.
Degenhardt L.,University of New South Wales |
Degenhardt L.,Burnet Institute |
Hall W.,University of Queensland
The Lancet | Year: 2012
This paper summarises data for the prevalence, correlates, and probable adverse health consequences of problem use of amphetamines, cannabis, cocaine, and opioids. We discuss findings from systematic reviews of the prevalence of illicit drug use and dependence, remission from dependence, and mortality in illicit drug users, and evidence for acute and chronic effects of illicit drug use. We outline the regional and global distribution of use and estimated health burden from illicit drugs. These distributions are likely to be underestimates because they have not included all adverse outcomes of drug use and exclude those of cannabis - the mostly widely used illicit drug. In high-income countries, illicit drug use contributes less to the burden of disease than does tobacco but a substantial proportion of that due to alcohol. The major adverse health effects of cannabis use are dependence and probably psychotic disorders and other mental disorders. The health-related harms of cannabis use differ from those of amphetamine, cocaine, and opioid use, in that cannabis contributes little to mortality. Intelligent policy responses to drug problems need better data for the prevalence of different types of illicit drug use and the harms that their use causes globally. This need is especially urgent in high-income countries with substantial rates of illicit drug use and in low-income and middle-income countries close to illicit drug production areas. © 2012 Elsevier Ltd.
Gold J.,Burnet Institute
Journal of medical Internet research | Year: 2012
Online social networking sites offer a novel setting for the delivery of health promotion interventions due to their potential to reach a large population and the possibility for two-way engagement. However, few have attempted to host interventions on these sites, or to use the range of interactive functions available to enhance the delivery of health-related messages. This paper presents lessons learnt from "The FaceSpace Project", a sexual health promotion intervention using social networking sites targeting two key at-risk groups. Based on our experience, we make recommendations for developing and implementing health promotion interventions on these sites. Elements crucial for developing interventions include establishing a multidisciplinary team, allowing adequate time for obtaining approvals, securing sufficient resources for building and maintaining an online presence, and developing an integrated process and impact evaluation framework. With two-way interaction an important and novel feature of health promotion interventions in this medium, we also present strategies trialled to generate interest and engagement in our intervention. Social networking sites are now an established part of the online environment; our experience in developing and implementing a health promotion intervention using this medium are of direct relevance and utility for all health organizations creating a presence in this new environment.
Ratner N.,Burnet Institute |
Miller S.J.,Burnet Institute
Nature Reviews Cancer | Year: 2015
Neurofibromatosis type 1 (NF1) is a common genetic disorder that predisposes affected individuals to tumours. The NF1 gene encodes a RAS GTPase-activating protein called neurofibromin and is one of several genes that (when mutant) affect RAS-MAPK signalling, causing related diseases collectively known as RASopathies. Several RASopathies, beyond NF1, are cancer predisposition syndromes. Somatic NF1 mutations also occur in 5-10% of human sporadic cancers and may contribute to resistance to therapy. To highlight areas for investigation in RASopathies and sporadic tumours with NF1 mutations, we summarize current knowledge of NF1 disease, the NF1 gene and neurofibromin, neurofibromin signalling pathways and recent developments in NF1 therapeutics. © 2015 Macmillan Publishers Limited. All rights reserved.
Gerondakis S.,Burnet Institute
Cold Spring Harbor perspectives in biology | Year: 2010
This article focuses on the functions of NF-kappaB that vitally impact lymphocytes and thus adaptive immunity. NF-kappaB has long been known to be essential for many of the responses of mature lymphocytes to invading pathogens. In addition, NF-kappaB has important functions in shaping the immune system so it is able to generate adaptive responses to pathogens. In both contexts, NF-kappaB executes critical cell-autonomous functions within lymphocytes as well as within supportive cells, such as antigen-presenting cells or epithelial cells. It is these aspects of NF-kappaB's physiologic impact that we address in this article.
Barry A.E.,Burnet Institute
Molecular & cellular proteomics : MCP | Year: 2011
Individuals that are exposed to malaria eventually develop immunity to the disease with one possible mechanism being the gradual acquisition of antibodies to the range of parasite variant surface antigens in their local area. Major antibody targets include the large and highly polymorphic Plasmodium falciparum Erythrocyte Membrane Protein 1 (PfEMP1) family of proteins. Here, we use a protein microarray containing 123 recombinant PfEMP1-DBLα domains (VAR) from Papua New Guinea to seroprofile 38 nonimmune children (<4 years) and 29 hyperimmune adults (≥15 years) from the same local area. The overall magnitude, prevalence and breadth of antibody response to VAR was limited at <2 years and 2-2.9 years, peaked at 3-4 years and decreased for adults compared with the oldest children. An increasing proportion of individuals recognized large numbers of VAR proteins (>20) with age, consistent with the breadth of response stabilizing with age. In addition, the antibody response was limited in uninfected children compared with infected children but was similar in adults irrespective of infection status. Analysis of the variant-specific response confirmed that the antibody signature expands with age and infection. This also revealed that the antibody signatures of the youngest children overlapped substantially, suggesting that they are exposed to the same subset of PfEMP1 variants. VAR proteins were either seroprevalent from early in life, (<3 years), from later in childhood (≥3 years) or rarely recognized. Group 2 VAR proteins (Cys2/MFK-REY+) were serodominant in infants (<1-year-old) and all other sequence subgroups became more seroprevalent with age. The results confirm that the anti-PfEMP1-DBLα antibody responses increase in magnitude and prevalence with age and further demonstrate that they increase in stability and complexity. The protein microarray approach provides a unique platform to rapidly profile variant-specific antibodies to malaria and suggests novel insights into the acquisition of immunity to malaria.
Burnet Institute, Walter and Eliza Hall Institute of Medical Research | Date: 2014-12-23
The present invention relates to the identification of proteins which bind the dendritic cell marker known as Clec9A. The present invention provides new compounds for targeting therapeutic agents such as antigens to dendritic cells. Also provided are methods of modulating a humoral and/or T cell mediated immune response to the antigen, methods of delivery of a cytotoxic agent to dendritic cells thereof involved in diseased states, methods of modulating the uptake and/or clearance of cells with a disrupted cell membrane, cells infected with a pathogen, dying cells or dead cells, or a portion thereof, and methods of modulating antigen recognition, processing and/or presentation, as well as immune responses to material derived from cells with a disrupted cell membrane, cells infected with a pathogen, dying cells or dead cells, or a portion thereof.
Burnet Institute | Date: 2015-02-27
The present invention relates generally to a method of down-regulating an inflammatory response in a mammal and to agents useful for same. More particularly, the present invention relates to a method of down-regulating an inflammatory response in the reproductive tract or external genital tissue of a female mammal by contacting the mucosal tissue of the reproductive tract and/or genitalia with lactic acid and to agents useful for same. The method of the present invention is useful, inter alia, in the treatment and/or prophylaxis of conditions characterised by an aberrant, unwanted or otherwise inappropriate inflammatory response including, for example, atrophic vaginitis, irritant vaginitis or infectious vaginitis.