Institute of Human Virology

Abuja, Nigeria

Institute of Human Virology

Abuja, Nigeria
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News Article | August 2, 2017
Site: www.eurekalert.org

BALTIMORE, Md. - The University of Maryland School of Medicine's (UM SOM) Institute for Global Health (IGH) and the Institute of Human Virology (IHV) have been awarded a $2 million five-year grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development to study the impact exposure to HIV has on the immune systems of infants in utero and how those changes impact the ability of infants to fight off infections after birth. The research will be conducted at the IGH's long-standing research site in Blantyre, Malawi and will follow pregnant women during pregnancy until the infants reach nine months of age. Research will be conducted at the Blantyre Malaria Project (BMP) Research Clinic in the Ndirande Health Centre, which is an affiliate of the University of Malawi College of Medicine. UM SOM researchers have been conducting clinical studies among pregnant women and others living with HIV at this location since 1998. The Principal Investigators for the UM SOM Grant are Cristiana Cairo, PhD, Assistant Professor of Medicine in IHV and Miriam K. Laufer, MD, MPH, Associate Professor of Pediatrics and Director of the Division of Malaria Research and Associate Director of IGH. "Our long-term goal is to identify an approach for preventing mother-to-child transmission of HIV that also minimizes the impact of maternal infection on the immune development of infants exposed to HIV but not infected," said Drs. Cairo and Laufer. The research comes as nearly 30 percent of all infants born in sub-Saharan Africa are exposed to HIV in utero but are uninfected at birth. It is estimated that in sub-Saharan Africa alone, more than 13.8 million women of childbearing age are living with HIV infection and more than 1.5 million HIV-positive women give birth each year. Women in sub-Saharan Africa are routinely screened for HIV infection at their first pre-natal visit, which typically takes place at in the second or third trimester. They are then treated with antiretroviral treatment (ART) if diagnosed with HIV infection. While most infants prenatally exposed to HIV do not become infected as a result ART, these infants still have higher morbidity and mortality in the first two years of life due to common infections. The precise mechanism of the increased susceptibility to infection is not yet known and this study will provide one of the most in-depth immunological investigations to begin to understand this phenomenon. UM SOM researchers will analyze the adaptive immune responses of infants with different HIV exposure in utero. They will compare if infants born to HIV-infected mothers who were on ART prior to conception are different from mothers who are first diagnosed with HIV infection and treated during their pregnancy. The first group of infants will be exposed to very low levels of HIV, while the second will be exposed to a high level of HIV infection throughout most of the mother's pregnancy The study could ultimately lead to earlier HIV testing and related pre-natal care. "Early HIV testing in all women of child bearing age may have a significant impact on infant health and survival," said Dr. Laufer, who is also Director of the Division of Malaria Research and Associate Director of Institute of Global Health. "It is of critical importance to clearly understand the impact of maternal HIV infection on exposed uninfected infant immunity, in order to identify the right strategy to improve the health of HIV-exposed infants throughout the world," said Dr. Cairo. Co-investigators for this project include Kirsten E. Lyke, MD., Associate Professor of Medicine; Marcelo B. Sztein, MD, Professor of Pediatrics; and Franklin R. Toapanta Yanchapaxi, MD, PhD, Assistant Professor of Medicine. This research is supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number U01HD092308


News Article | August 7, 2017
Site: www.eurekalert.org

URLs go live when the embargo lifts Both bisphosphonates and denosumab improve bone mineral density (BMD) in men with nonmetastatic prostate cancer who are receiving androgen deprivation therapy (ADT). The results from a systematic review and meta-analysis are published in Annals of Internal Medicine. One in two men with prostate cancer receives ADT at some point after diagnosis. While ADT has been the mainstay of treatment for decades, it is associated with many potential adverse effects, including significant bone loss and increased risk of fractures. Gaps in quality bone health care for men with prostate cancer and low rates of education about the adverse effects of ADT have led experts to call for a more systematic approach to the prevention of bone loss and fracture risk among men with this disease. A multi-disciplinary panel reviewed 30 studies evaluating the effectiveness of bone-targeted therapies aimed at preventing fracture and improving bone mineral density in men with nonmetastatic prostate cancer receiving ADT. Overall, evidence showed improvements in BMD with bisphosphonates, but whether this is associated with reduced fractures remains unclear. Evidence from available trials showed fracture reduction was restricted to one drug: denosumab. Further trials studying fracture outcomes among this population are needed, researchers say. Media contact: For an embargoed PDF, please contact Cara Graeff at cgraeff@acponline.org. For an interview with Shabbir Alibhai, MD or Katherine Zukotynski, MD, please contact Maggie Paiva at Maggie.Paiva@cancercare.on.ca or Jayani Perera at Jayani.Perera@cancercare.on.ca. 2. HCV treatment administered by nonspecalist providers as safe and effective as that provided by specialists Task-shifting to general practitioners could bridge existing gaps in the care for patients with HCV URLs go live when the embargo lifts Direct-acting antiviral (DAA) therapy administered by nonspecialist providers, such as nurse practitioners and primary care physicians, is safe and effective and could expand treatment access for previously challenging subpopulations affected by the hepatitis C virus (HCV) epidemic. The findings of a nonrandomized clinical trial are published in Annals of Internal Medicine. Highly-effective and well-tolerated DAA therapy for HCV has raised the possibility of treatment expansion and widespread cure. Despite this scientific breakthrough, 2.7 million Americans are still living with HCV infection and the current specialist workforce is insufficient to meet the demand. Task-shifting of HCV therapy to general practitioners may be an effective strategy for patients with uncomplicated infections and can improve access to HCV care. However, there is limited data on the success of nonspecialists practicing independent of specialist supervision. Investigators from the Institute of Human Virology at the University of Maryland School of Medicine sought to determine the efficacy of HCV treatment by nonspecialist providers from a real-world cohort of patients in an urban setting. In the ASCEND (A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia) trial, 600 patients with chronic HCV infection were assigned in a nonrandomized fashion to receive treatment from 1 of 3 provider types: licensed NP, primary care physician or a specialist (gastroenterology-hepatology and infectious disease physicians). Of those, 516 patients achieved sustained virologic response (SVR) and response rates were consistent across the three provider types. These findings support the efficacy of general DAA therapy and suggest that most patients with uncomplicated cases of HCV infection who adhere to medication will achieve cure, regardless of provider type. Media contact: For an embargoed PDF, please contact Cara Graeff at cgraeff@acponline.org. For an interview, please contact Nora Samaranayake at nsamaranayake@gvn.org. Dr. Sarah Kattakuzhy can also be reached directly at skattakuzhy@ihv.umaryland.edu. Routine monitoring of viral suppression status and subsequent treatment is important for reducing transmission risk URLs go live when the embargo lifts A review of data reported to the National HIV Surveillance System through June 2016 suggests that a single measure of viral load may overestimate how many persons with HIV infection have durable viral suppression. The data also showed that some persons who seemed to have received regular care for HIV infection still had viral loads high enough to substantially increase transmission risk. The brief report is published in Annals of Internal Medicine. Researchers from the Centers for Disease Control and Prevention (CDC) reviewed data for 630,965 persons aged 13 years or older who were diagnosed with HIV infection through 2013 to determine the usefulness of a single measure of viral load for understanding long-term suppression and to examine the extent of cumulative HIV burden for understanding the potential risk for transmission. The researchers used information about sex, age, transmission category, and race/ethnicity to calculate the percentage of persons with HIV infection whose last viral load in 2014 was less than 200 copies/mL. They also calculated the percentage of persons in whom all viral loads in 2014 were less than 200 copies/mL (durable viral suppression), the percentage of persons in whom all viral loads in 2014 were 200 copies/mL or greater (viral suppression never achieved), and "copy year," which is a measure of viremia that assesses a person's exposure to HIV over time similar to the way pack-years measures a person's exposure to tobacco smoke over time. The data showed that of all persons with HIV infection, 57.3 percent had a suppressed viral load on their most recent test in 2014, a total of 47.6 percent had durable viral suppression throughout 2014, and 8.1 percent never achieved viral suppression during 2014. Those who never achieved viral suppression in 2014 had an average of 17,530 copy-years of viremia and 56.3 percent of those people had at least two tests for viral load in 2014, suggesting that they had regular care for their infection. The findings emphasize the importance of routine monitoring of viral suppression status and of more effective delivery of appropriate therapy in response to the results of such monitoring. Media contact: For an embargoed PDF, please contact Cara Graeff at cgraeff@acponline.org. For an interview with an author, please contact the CDC's National Center for HIV/AIDS/ Viral Hepatitis, STD and TB Prevention at NCHHSTPmediateam@cdc.gov or 404-639-8895. Also new in this issue: Annals Understanding Clinical Research: Evaluating the Meaning of a Summary Estimate in a Meta-analysis URL goes live when the embargo lifts


News Article | August 9, 2017
Site: www.theguardian.com

At the start of the millennium, a positive HIV test was equivalent to a death sentence. Average life expectancy after diagnosis was just one to two years for those in low-to-middle-income countries, and one of the main reasons to get tested was to have time to prepare for death. But now the scales have tipped. For the first time since the start of the epidemic, more than half of people living with HIV and Aids (PLWHA) are having treatment. The number of Aids-related deaths has almost halved since 2005 and in high-income countries, the life expectancy of PLWHA comes close to that of people living without the virus. Treatment is working, but stubborn challenges remain. People continue to be infected, around one million still die from the virus every year and while 53% of PLWHA now have access to treatment, a significant number still do not. At present, the global HIV community of researchers, policymakers and healthcare providers is working towards UNAids’ 90-90-90 targets. The targets state that by 2020, 90% of people living with HIV will know their status; 90% of those who are HIV positive will be on antiretroviral (ARV) treatment; and 90% of all people receiving treatment will have viral suppression – where HIV is undetectable. So what advances in HIV prevention, testing, treatment and care are needed to work towards these targets? This was the central question examined at a seminar organised by the Guardian and supported by Gilead Sciences, a biopharmaceutical company. The event was held alongside the ninth IAS Conference on HIV Science in Paris and hosted an audience of researchers, pharmacists and clinicians. According to the Global Fund to Fight Aids, Tuberculosis and Malaria, the next stage of the fight begins with key populations – those who are most vulnerable to infection and less likely to be able to access diagnosis and treatment, particularly in the developing world. Key populations are generally considered to be people who inject drugs, men who have sex with men (MSM), transgender people, sex workers and prisoners. In Thailand, where around half of all new infections occur among transgender women and MSM, community-led programmes are helping to bridge the gap between HIV services and key populations. “The community decides which services are needed to address the HIV epidemic, meaning that services are demand-driven and have the client at the centre,” said Reshmie Ramautarsing, a clinical research physician at the Thai Red Cross Aids Research Centre. “These services aim to be friendly for key populations by offering flexible service hours and a setting that’s free of the stigma and discrimination they often face in traditional healthcare settings.” Community involvement was also an important step, said Papa Salif Sow, vice-president of programme development and management in emerging markets at Gilead. “We are working in rural Tanzania with local NGOs, the government and the Vatican to test and treat 20,000 people in the community, to train healthcare workers and build facilities.” The number of people being tested is increasing and adherence to treatment is high. “The project shows the importance of community involvement for increasing access to drugs and viral suppression,” he added. Peer support has also been shown to reach those who don’t already know their HIV status. In Brazil, where an estimated 830,000 people are living with HIV, the ministry of health is conducting a three-year nationwide rapid-testing project in partnership with NGOs, in which people belonging to key populations are encouraged to take an on-the-spot test in a social or community venue as a means of removing the stigma of seeking diagnosis. To date, 120,000 people have been tested this way. “Overall, the rate of positive test results was around 2%, but in key populations it was 10%,” said Adele Benzaken, director of the ministry’s department for sexually transmitted infections, HIV/Aids and viral hepatitis. “One of the most important things is that 50% of these people had never been tested before. This shows that we are going the right way.” The World Health Organization (WHO) recently prequalified the first HIV self-test, meaning that it can be procured by the UN. Using oral fluids as a specimen, the test gives results in 20 minutes. “People can do it easily and accurately – it’s showing good links to treatment and prevention services,” said Rachel Baggaley, HIV prevention and testing coordinator at the WHO. There is often stigma associated with going to an HIV clinic to be tested, so it is hoped that self-testing will encourage more people to find out their status. The method has proved popular with men, who are often reluctant to access health services. In Malawi, women have been given self-testing kits to test their partners at home. “Men often reported being coerced into testing by their wives,” said Baggaley. “We took this as slightly negative, but they were pleased. They said they need to be persuaded because they won’t take time off work [to get tested].” The response to the HIV epidemic had also failed to reach children, who responded differently to HIV infection and ARV treatment than adults, the seminar heard. Even in countries with a higher prevalence of the virus, it was difficult to find children living with HIV and help them access treatment. “It’s a needle in a haystack situation,” said Nadia Sam-Agudu, a specialist in HIV at the Institute of Human Virology in Nigeria, home to the highest number of children living with HIV, according to UNAids. “We need to find the mothers in order to find the children.” Considering this barrier, an audience member asked when schools and the Nigerian education ministry should be involved in efforts to reach and test children. While it would be beneficial for schools and government ministries to work together, some on the panel said there was often resistance from schools, parents and other adults due to the stigma associated with HIV being a sexually transmitted disease. Children in Nigeria can be tested for HIV, but testing is often only available at the discretion of healthcare workers, many of whom are reluctant to do so. “There are healthcare workers who won’t test unless there’s a law, and others still have personal biases against testing people younger than 18 because they think they’re not supposed to be having sex,” said Sam-Agudu. “We have to work out how to get around that,” said Peter Godfrey-Faussett, senior science adviser at UNAids. “We need to get comprehensive sex education into schools. In terms of transmission, the most risky time is when people leave school. That’s why keeping girls in school for an extra year or two makes a big difference.” The potential of HIV drug resistance was a common concern raised throughout the debate. In six of 11 global south countries recently surveyed by the WHO, more than 10% of people starting ARV therapy had a strain of the virus resistant to some of the most widely used HIV medicines. “So how worried should we be about drug resistance?” asked Lucy Lamble, global development executive editor at the Guardian and chair of the debate. The HIV community ought to be alert, but not alarmed, said Godfrey-Fausett, referring to public health impact assessments conducted in several countries by Pepfar – the US President’s Emergency Plan for Aids Relief. “In Malawi, Zambia and Zimbabwe, they have taken a random sample of people taking ARVs and found that their viral suppression is extremely high, despite the fact that those same countries are beginning to report rising levels of drug resistance. In terms of turning the tide on HIV, I don’t think drug resistance is yet the major threat,” Godfrey-Fausett added. The panel emphasised that making sure people took their ARVs and ensuring there were enough drugs available would be key to minimising the chances of any resistance developing. Technology could play an important part in this, said Salif Sow. “In Kenya, for example, patients can receive a text message every morning saying ‘Mambo?’ – ’How are you?’ in Swahili – to remind them to take their medication.” Faced with the daunting task of testing those who did not know their status and reaching the large number of PLWHA who still did not have access to treatment, panellists were encouraged by the high proportion of young people in the audience. “Young people really got us to where we are,” said Baggaley. “We wouldn’t have 19 million people on treatment now without the activists. “The younger generation are really stepping up to the mark and demanding governments and donors provide PrEP [pre-exposure prophylaxis] and self-testing.” The panel agreed that young people and young activists would be key players in the renewed push to end the epidemic and ensure that no one was left without treatment.


NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES Devonian Health Group Inc. ("Devonian" or the "Corporation") (TSX VENTURE:GSD) today announced the nomination of Mr. Jacques Bernier, BPharm., MBA and Dr. Louis Flamand, PhD. effective as of May 30th, 2017. "As Devonian progresses, rapidly within its pharmaceutical program, the time has come to expand the Board of Directors to ensure the Corporation achieves its goals. The Devonian's Board of Directors is extremely pleased to be welcoming Mr. Jacques Bernier and Dr. Louis Flamand as directors of the Corporation. They bring with them a wealth of Pre-clinical and pharmaceutical experience that enhances the bench strength of the Board of Directors" said Dr. André P. Boulet, President and Chief Executive Officer of the Corporation. From 2008 until 2014, Mr. Bernier was CEO of Folia Biotech Inc. ("Folia"), a clinical stage biopharmaceutical corporation focused on exploiting its proprietary immune-therapeutic platform to bring to market therapeutic products in oncology and certain infectious diseases. During his tenure, he has concluded several business partnerships that have strengthened the development of Folia's technology. Prior to joining Folia, Mr. Bernier acquired a broad management experience as the owner of a group of pharmacies and as a member of the Board of Directors of various pharmaceutical corporations. He has a profound understanding of the pharmaceutical industry and an acute experience in business development. Dr. Flamand is a full professor and vice-chair of the department of microbiology-infectious-disease-immunology at the Faculty of medicine, Université Laval and senior researcher in the division of infectious and immune diseases at the CHU de Quebec research center. Before joining Laval University, Dr. Flamand obtained his PhD at the University of Montreal and post-doctoral training at the National Institutes of Health and at the Institute of Human Virology (Maryland, USA). He received his MBA in pharmaceutical management from Université Laval. Since 2008, he is President of the biohazards risk committee at Université Laval. He is also member of the HHV-6 Foundation scientific advisory board since 2006. Dr. Flamand has experience in pre-clinical development. Throughout his career, Dr. Flamand has received several competitive scholarship awards and continuous funding support from several funding agencies for his work in virology. Dr. Flamand is the author of more than 80 peer-reviewed publications and is lead Editor of the book "Human Herpesviruses HHV-6A, HHV-6B & HHV-7: Diagnosis and Clinical Management" 3rd edition. The Corporation also announced that as of May 30, 2017, Mr. François Michaud will not be acting as Chief Financial Officer of the Corporation. Ms. Colette Laurin, the Corporate's Corporate Controller, will assume Mr. Michaud's responsibilities as the Corporation's interim Chief Financial Officer. The Corporation also announces Mr. Matt Peppler has resigned as a member of the Corporation's Board of Directors. Dr. André P. Boulet, commented, "On behalf of the management team and the Devonian's Board of Directors, I would like to thank Matt and François for their contribution to Devonian over the last two years". Devonian is a late stage botanical pharmaceutical corporation with novel therapeutic approaches targeting unmet medical needs. Devonian's core strategy is to develop prescription botanical drugs. This strategy is supported by US-FDA set of regulatory guidelines favouring a more efficient drug development pathway versus traditional prescription medicines. Devonian is based on a broad-based platform originating from over ten years of research. This platform provides a unique process of extraction, purification, stabilization and conditioning of a molecular complex responsible for the photosynthetic process in plants and algae: The Supra Molecular Complex Extraction and Stabilisation Technology (SUPREX). The "Thykamine™" is the first product issued from this platform. The potent anti-inflammatory and anti-oxidative activities of "Thykamine™" have been demonstrated in several pre-clinical experiments as well as in a Phase 2a "proof of concept" clinical study in patients with mild-to-moderate distal ulcerative colitis. The product is now moving into large phase 2 clinical trials in two therapeutic areas: Ulcerative Colitis and Atopic Dermatitis. While the development of prescription botanical drugs is its core business, Devonian is also involved in the development of high value derma-cosmeceutical products as part of a secondary strategy to generate short-term revenues and optimize manufacturing efficiency. This press release contains forward-looking statements about Devonian's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, Devonian's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical and dermo-cosmeceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Devonian to take advantage of business opportunities in the pharmaceutical and dermo-cosmeceutical industries, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Devonian's prospectus dated April 21st, 2017 under the heading "Risk Factors" related to Devonian's business. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


News Article | August 7, 2017
Site: www.marketwired.com

Continued Success and Progress in Vaccine Development Programs for Zika, HIV, Lassa Fever, Ebola, Malaria, Hepatitis B and Cancer ATLANTA, GA--(Marketwired - Aug 7, 2017) - GeoVax Labs, Inc. ( : GOVX), a biotechnology company developing human vaccines using its novel viral vector platform technology, announced its financial results for the quarter ended June 30, 2017, and provided an overview of recent accomplishments for its research and development programs. Robert T. McNally Ph.D., GeoVax's President and CEO, commented, "To date, 2017 has been marked by several important achievements further demonstrating the excellent efficacy and broad utility of our MVA-VLP vaccine platform, as well as scientific recognition through our growing list of exceptional corporate and academic collaborators. We continue to engage in active discussions with additional research collaborators and potential strategic partners. I am pleased to provide this update on our progress." Progress in Zika Vaccine Development. In June, at the American Society for Microbiology (ASM) conference (ASM MICROBE 2017), GeoVax presented research showing that a single dose of its Zika vaccine (GEO-ZM02) gave 100% protection in mice challenged with a lethal dose of Zika virus (ZIKV) delivered directly into the brain. This is the first report of i) a Zika vaccine based on the ZIKV non-structural (NS1) protein, and ii) single-dose protection against ZIKV using an immunocompetent lethal mouse challenge model. The vaccine was tested at the Centers for Disease Control and Prevention (CDC) in Ft. Collins, CO with funding by a grant from the CDC. Importantly, GeoVax's approach to a Zika vaccine is unique as it is based on the NS1 protein of ZIKV and thus will avoid the Antibody Dependent Enhancement (ADE) of infection safety issue, which is a concern for other Zika vaccines under development. Also in June, the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), awarded GeoVax a Small Business Innovative Research (SBIR) grant of $600,000 to support advanced preclinical testing, including non-human primates studies, for its Zika vaccine development program in preparation for a Phase 1 human clinical study. Promising Results for Lassa Fever Vaccine. In July, GeoVax reported a significant step forward in the development of a vaccine candidate for protection against Lassa hemorrhagic fever virus (LASV). Efficacy testing in a murine challenge model (using a chimeric LASV reassortant) showed a single dose of GEO-LM01, provided 100% protection to mice infected with a lethal dose of the challenge virus. The study was conducted, and successfully repeated, at the Institute of Human Virology at the University of Maryland School of Medicine. GeoVax recently expanded its LASV vaccine development efforts through a collaboration with The Scripps Research Institute. With no vaccine available, LASV continues to kill more than 5000 people each year in West African countries where the virus is endemic. Earlier, a single dose of GeoVax's Ebola (EBOV) vaccine (GEO-EM01) was shown to protect 100% of rhesus monkeys against death. GeoVax is also developing vaccines against Sudan virus (SUDV) and Marburg virus (MARV), two other lethal hemorrhagic fever viruses for which no effective vaccine currently exists. In addition to developing the four individual hemorrhagic fever vaccines (EBOV, LASV, SUDV, MARV), the Company's goal is to combine the vaccines into a single tetravalent vaccine to provide broad protection for individuals at-risk for these viruses. HIV Preventive Vaccine Development - New Clinical Trial Begun with NIH Support. In January, GeoVax initiated a human clinical trial of its preventive HIV vaccine, GOVX-B11, being developed to address the clade B HIV subtype prevalent in the U.S. and other areas of the developed world. The Phase 1 trial (designated HVTN 114) is being conducted by the HIV Vaccine Trials Network (HVTN) with funding from NIAID. HVTN 114 will enroll up to 30 individuals who participated in an earlier Phase 2a trial of GOVX-B11 and will test the ability of additional vaccinations to increase the antibody responses elicited by the GeoVax vaccine. During 2017, GeoVax continued its work under a NIAID contract of up to $7.8 million for production of the DNA component of GOVX-B11 intended for later-stage clinical trials. The Company also continued work under two SBIR grants from NIAID for both its clade B HIV vaccine, and for its vaccine for the clade C HIV subtype prevalent in Africa. HIV Therapeutic Vaccine Development - Collaboration to Focus on Functional Cure. In March, GeoVax began a collaboration with American Gene Technologies International, Inc. (AGT) with the goal of developing a functional cure for HIV infection. The Company expects AGT to file an Investigation New Drug (IND) application later this year and to initiate human clinical trials of the companies' combined technologies in early 2018. Malaria Vaccine Program Initiated. In January, GeoVax initiated a new program to develop a malaria vaccine using its MVA-VLP viral vector platform through collaboration with The Burnet Institute in Australia. The Company has completed construction of 4 vaccine candidates and expects the initial preclinical proof-of-concept studies to commence in September 2017. Ongoing Therapeutic Development Programs for Chronic Hepatitis B and Cancer. During the first quarter, GeoVax added Georgia State University and Peking University as collaborators to develop a therapeutic vaccine for chronic Hepatitis B infection. Initial preclinical proof-of-concept studies are ongoing. GeoVax is also continuing its collaboration with ViaMune, Inc. for co-development of the companies' respective cancer immunotherapy programs, with initial and confirmatory data readouts expected during the third quarter. Establishment of World-Class Scientific Advisory Board. In January, GeoVax 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 the Company's various development programs. GeoVax reported a net loss of $516,881 ($0.01 per share) for the three months ended June 30, 2017, compared to $575,835 ($0.02 per share) for the same period in 2016. For the six months ended June 30, 2017, the Company's net loss was $1,065,222 ($0.02 per share) as compared to $1,872,114 ($0.05 per share) in 2016. The Company reported grant and collaboration revenues of $352,137 and $647,872 for the three-month and six-month periods of 2017, respectively. This compares to $166,280 and $213,880 of grant revenue reported for the comparable periods of 2016. As of June 30, 2017, there is $910,774 in approved grant funds remaining and available for use. Research and development (R&D) expenses were $518,098 and $1,069,893 for the three-month and six- month periods of 2017, respectively, as compared to $397,576 and $835,580 for the comparable periods of 2016. R&D expenses include direct costs funded by NIH grants, as well as other vaccine manufacturing and testing costs. General and administrative (G&A) expenses were $352,191 and $644,858 for the three-month and six-month periods of 2017, respectively, as compared to $344,818 and $1,251,323 for the comparable periods of 2016. GeoVax reported cash balances of $822,597 at June 30, 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 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 Particles (MVA-VLP) vaccine platform. The Company's development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in 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.


News Article | July 10, 2017
Site: www.marketwired.com

ATLANTA, GA--(Marketwired - Jul 10, 2017) - GeoVax Labs, Inc. ( : GOVX), a biotechnology company developing human vaccines, announced today a significant step forward in the development of a vaccine candidate for protection against Lassa hemorrhagic fever virus (LASV). Efficacy testing in a murine challenge model (using a LASV reassortant) showed a single dose of the candidate vaccine, GEO-LM01, provided 100% protection to mice infected with a lethal dose of the challenge virus. During testing, mice were given a single-dose vaccination of GEO-LM01 into muscle tissue, then infected with 1000 Plaque Forming Unit of the challenge virus by intracranial inoculation. All vaccinated mice survived whereas all unvaccinated mice died within one week of infection. Vaccinated animals produced a strong T cell immune response against LASV at 10 days post vaccination. The study was conducted at the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore. A repeat of the study confirmed the findings. LASV, a member of the Arenaviridae virus family, causes severe and often fatal hemorrhagic illnesses in an overlapping region with Ebola virus (EBOV). In contrast to the unpredictable epidemics of filoviruses such as EBOV, LASV is endemic in West Africa with an annual incidence of over 300,000, and leading to 5,000 to 10,000 deaths. Recent study data suggests that the number of annual LASV cases may in fact be significantly higher, with three million infections and 67,000 deaths (placing upwards of 200 million individuals at risk). Today, no treatment or vaccine is available to stem LASV epidemics, even though LASV kills more people in one year than the EBOV did in the last 41 years after its first epidemic in 1976 in West Africa. GEO-LM01 uses GeoVax's proven MVA-VLP vaccine platform that has been shown to be safe and to induce durable antibody and T cell responses in multiple human clinical trials for GeoVax's prophylactic HIV vaccine. Using the same platform, a single dose of GeoVax's Ebola vaccine has been shown to protect 100% of rhesus monkeys against death. GeoVax is also developing vaccines against Sudan virus (SUDV) and Marburg virus (MARV), two other lethal filoviruses for which no effective vaccine currently exists. In addition to developing the four individual vaccines (EBOV, LASV, SUDV, MARV), the Company's goal is to combine the vaccines into a single tetravalent vaccine to provide broad protection for individuals at-risk for these viruses. "The fact that the GeoVax platform combines variable (glycoprotein) and conserved (matrix protein) antigens should broaden its protective capabilities and reduce the severity of infection by related pathogens", noted Dr. Maria Salvato, Professor of Medicine, Institute of Human Virology, at the University of Maryland School of Medicine. Farshad Guirakhoo, PhD, GeoVax's Chief Scientific Officer, commented, "We are extremely pleased with our collaborations with Dr. Salvato who has conducted research on the molecular/cell biology of arenaviruses like LCMV and LASV, and their virus:host interactions for more than three decades. With this work, we have now shown single-dose efficacy with three of our vaccines based on different families of viruses (Zika, EBOV and LASV) validating the broad utility of our MVA-VLP platform for infectious diseases and oncology. Lassa fever has a greater human impact than any other hemorrhagic fever virus, except for dengue fever, and despite this clear need, no vaccine has yet entered human clinical trials. We are now ready for advanced preclinical testing leading to initiation of human clinical trials." For more information about LASV, visit https://www.cdc.gov/vhf/lassa/index.html. GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus Like Particles (MVA-VLP) vaccine platform. The Company's development programs are focused on vaccines against HIV, ZIKV, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in 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.


ATLANTA, GA--(Marketwired - Jul 24, 2017) -  GeoVax Labs, Inc. ( : GOVX), a biotechnology company developing human vaccines, announced today that it is collaborating with The Scripps Research Institute (TSRI) in La Jolla, CA, and the Institute of Human Virology (IHV) at the University of Maryland Medical School in Baltimore, MD, for advanced development of a preventive vaccine against Lassa hemorrhagic fever virus (LASV). GeoVax previously announced that its LASV vaccine candidate, GEO-LM01, provided 100% protection after single immunization, to mice infected with a lethal dose of a LASV reassortant. The intent of the three-way collaboration with TSRI and IHV is to evaluate additional LASV vaccine candidates to elucidate involvement of humoral and cellular arms of immunity in protection against LASV infections. Farshad Guirakhoo, PhD, GeoVax's Chief Scientific Officer, commented, "We are pleased to expand our collaboration with IHV, and to now work with Professor Erica Ollmann Saphire, PhD at TSRI as well, an expert in the structure of LASV and other viral hemorrhagic fever viruses. Our MVA-VLP vaccine platform is well-suited for quickly generating various candidates and testing them using a LASV reassortant challenge model developed at IHV." "The structural studies from the Saphire lab will help broaden and strengthen humoral immune responses to LASV. Fortunately, the MVA platform can easily accommodate these new constructs," noted Maria Salvato, PhD, Professor of Medicine, Institute of Human Virology, University of Maryland School of Medicine. "A major scientific challenge will be finding the best way to elicit a protective antibody response," said Dr. Saphire. "Combining approaches and collaborative teams are the best way forward to developing these much-needed vaccines for human health." About Lassa LASV, a member of the Arenavirus family, causes severe and often fatal hemorrhagic illnesses in West Africa, a region recently associated with a devastating Ebola virus (EBOV) outbreak. In contrast to the unpredictable epidemics of filoviruses such as EBOV, LASV is endemic in West Africa with an annual incidence of over 300,000, and leading to 5,000 to 10,000 deaths. Recent study data suggests that the number of annual LASV cases may in fact be significantly higher, with three million infections and 67,000 deaths (placing upwards of 200 million individuals at risk). Today, no treatment or vaccine is available to stem LASV epidemics, even though LASV kills more people in one year than the EBOV did in the last 41 years after its first epidemic in 1976 in West Africa. For more information about LASV, visit https://www.cdc.gov/vhf/lassa/index.html. About GeoVax GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus Like Particles (MVA-VLP) vaccine platform. The Company's development programs are focused on vaccines against HIV, ZIKV, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax has shown 100% efficacy with a single dose vaccination for its novel Zika, Lassa or Ebola vaccines in various lethal challenge models. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in 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. Forward-Looking Statements 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.


BALTIMORE--(BUSINESS WIRE)--The Global Virus Network (GVN) launched its Fourth Annual Short Course on Medical Virology held August 13-19, 2017 for 15 early career medical virologists from Australia, Brazil, India, Jamaica, Japan, Lithuania, Malaysia, Nigeria, Portugal, Russia, South Africa, and the United States. The preeminent one-week course on basic, translational, and clinical aspects of viruses features world-renowned researchers drawn from GVN Centers of Excellence, comprising 39 Centers of Excellence and six affiliates in 24 countries and comprises foremost experts in every class of virus causing disease in humans. The Short Course is designed to counter a declining number of researchers entering the field of medical virology. The announcement was made by Robert Gallo, MD, co-founder and scientific director, Global Virus Network. “This year’s program is one of the most robust, well-rounded agendas since the Short Course’s inception,” said Gallo, who is co-discoverer of HIV as the cause of AIDS and The Homer and Martha Gudelsky Distinguished Professor in Medicine, director, Institute of Human Virology, University of Maryland School of Medicine, a GVN Center of Excellence. “My colleagues and I have noticed a disturbing, declining trend in those entering the field of medical virus research. This decline is unacceptable, particularly as deadly viral threats are on the rise. The GVN Short Course is a model program that could be replicated worldwide to help reverse the decline of rising highly-trained medical virus researchers.” This year’s agenda includes discussions on important viruses such as hepatitis, Ebola, Marburg, Lassa, Zika, HIV, measles and, HPV, among others. Topics include, biosurveillance, combatting animal virus threats in a One Health approach, bioinformatics, and an insectary tour. For the complete program please visit http://ow.ly/YpRm30e6LcN. At the end of the annual course, participants elect a fellow participant as the “next emerging leader in medical virology” based on leadership and expertise. The nominee returns to the course the following year as a speaker. This year, all past nominees will speak during the course including Florian Krammer, PhD (2014), Associate Professor, Department of Microbiology, Icahn School of Medicine at Mount Sinai, USA; Christina Gavegnano, PhD (2015), Assistant Professor, Department of Pediatrics, Emory University, USA and, Miguel Garcia-Knight, PhD (2016), Centro de Investigaciones en Ciencias Microbiológicas, Benemérita Universidad Autónoma de Puebla, Mexico. “The Global Virus Network has created a worldwide infrastructure of renowned scientists and medical experts that links basic science research with translational application,” said Dr. Gavegnano. “The GVN short course provides a front-row seat to a framework for young people to embark on a career in virology; GVN paints a picture encompassing coursework, degrees, post-graduate opportunities, and ability to join cutting-edge science discovery that can impact the lives of millions.” "This course provides a broad perspective on medically important viruses from leading experts and is set up to encourage close interaction between invited speakers and international attendees,” said Dr. Garcia-Knight. “It’s an excellent opportunity to use the links within the GVN to advance research programs back home and is something I intend to take advantage of." This year’s Global Virus Network speakers, in addition to Dr. Gallo and others, include: Konstantin Chumakov, PhD, Associate Director for Research, Office of Vaccines Research and Review, U.S. Federal Drug Administration; Diane Griffin MD, PhD, Alfred and Jill Sommer Professor and Chair, Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health; Andrew Haddow, PhD, Researcher in the Virology Division at the U.S. Army Medical Research Institute of Infectious Diseases; Shyam Kottilil, MD, PhD, Professor of Medicine, Co-Director, Clinical Research Unit, Institute of Human Virology, University of Maryland School of Medicine; Erica Ollman- Saphire, PhD, Professor, Immunology & Microbial Science, The Scripps Research Institute and Director, Viral Hemorrhagic Fever Immunotherapeutic Consortium; and, Ab Osterhaus, PhD, DVM, Director, Research Center for Emerging Infections and Zoonoses, Professor, University of Veterinary Medicine Hannover, CEO, Artemis One Health Foundation. The GVN is a global authority and resource for the identification and investigation, interpretation and explanation, control and suppression, of viral diseases posing threats to mankind. It enhances the international capacity for reactive, proactive and interactive activities that address mankind-threatening viruses and addresses a global need for coordinated virology training through scholarly exchange programs for recruiting and training young scientists in medical virology. The GVN also serves as a resource to governments and international organizations seeking advice about viral disease threats, prevention or response strategies, and GVN advocates for research and training on virus infections and their many disease manifestations. The GVN, in partnership with The Peter Doherty Institute for Infection and Immunity and Institut Pasteur, will convene the 9th International Global Virus Network Meeting in Melbourne, Australia September 25-27, 2017. This year’s meeting will focus on “Pandemic, Epidemic and Emerging Viruses in the Asia Pacific Region.” More information can be found at www.gvn.org. The Global Virus Network (GVN) is a non-profit, 501(c)(3) organization, comprised of leading medical virologists from 24 countries. The GVN’s mission is to combat current and emerging pandemic viral threats through international collaborative research, training the next generation of medical virologists, and advocacy. For more information, please visit www.gvn.org. Follow us on Twitter @GlobalVirusNews


News Article | March 2, 2017
Site: www.prweb.com

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that two leading analytical experts from Catalent Biologics will be presenting a workshop on the development and validation of bioassays, at the upcoming first BEBPA U.S. Bioassay Conference, to be held at the Sheraton Fisherman’s Wharf, San Francisco, on March 8 – 10, 2017. The workshop, starting at 9 a.m. on Wednesday, March 8, is entitled “The Course Awakens: Moving Bioassays from Development to Phase-Appropriate Validation,” and will be hosted by Mike Sadick, Ph.D., Principal Scientist, Biologics Analytical Services, Development; and Mike Merges, Director of Strategic Growth of Biologics Analytical Services. The day-long workshop will present a number of topics covering all aspects of phase-appropriate validations, from Investigational New Drug/Phase I through to Phase III/post-Biologic License Application, and will include both practical and theoretical approaches to development. Regulatory guidelines in the area, such as ICH Q2(R1) and USP 1033 will be addressed, compared, and contrasted as part of the session, which will be an interactive forum where advice, challenges and practical tips can be discussed openly. Dr. Sadick has an extensive background in cellular biology, cellular immunology, receptor signaling, molecular biology and biochemistry. He has more than thirty years of experience in research and industry, with prior positions at Genentech, Eli Lilly and Aptuit before joining Catalent in 2012. His current role sees him lead Catalent’s activities in potency assays, both cell-based and enzyme-linked immunosorbent assay (ELISA) based, as well as molecular biology (including cloning and quantitative polymerase chain reaction (qPCR)), and protein/protein binding assessment. He holds a bachelor’s in biology from John Hopkins University, and a master’s and doctorate, both in immunology, from the University of Washington. Mr. Merges joined Catalent in 2011 as Director of Catalent Biologics Analytical Services, focusing on the transfer, development, validation, and performance of bioassays, immunoassays, microbiological assays, and viral clearance assays. Prior to that, he was Associate Director of Bioservices for Lonza Biologics, and has also held positions at the University of Maryland’s Institute of Human Virology, the National Cancer Institute and Johns Hopkins University, where he conducted viral immunology research. He obtained his bachelor’s degree in microbiology from the Pennsylvania State University, and his master’s degree in microbiology/virology from Hood College. For more information on the conference, visit: http://www.bebpa.org/conferences/, and to arrange a meeting with any of the Catalent executives attending the event, contact Richard Kerns at NEPR - richard(at)nepr(dot)eu For more information on Catalent Biologics, visit http://www.catalentbiologics.com About Catalent Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com


News Article | February 15, 2017
Site: www.prweb.com

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that Mr. Michael Merges, Director of Strategic Growth, Catalent Biologics Analytical Services, will be presenting at the upcoming WCBP Conference, to be held at the Mayflower Hotel, Washington DC, on Jan. 24 – 26, 2017. Mr. Merges’ presentation, on Tuesday, Jan. 24, at 1:30 p.m., is entitled “Benefits to Strategic Outsourcing,” and will discuss the underlying nature of growth in the biologics development market, which has led to bioassays being the most outsourced service by biomanufacturers, and the service expected to witness the highest future demand. The presentation will outline the principles, options and drivers for parties to create outsourcing partnerships, as well as demonstrating how such strategies can be effective through a case study. Mr. Merges joined Catalent in 2011 as Director of Catalent Biologics Analytical Services, focusing on the transfer, development, validation, and performance of bioassays, immunoassays, microbiological assays, and viral clearance assays. Prior to that, he was Associate Director of Bioservices for Lonza Biologics, and has also held positions at the University of Maryland’s Institute of Human Virology, the National Cancer Institute and Johns Hopkins University, where he conducted viral immunology research. He obtained his bachelor’s degree in microbiology from the Pennsylvania State University, and his master’s degree in microbiology/virology from Hood College. For more information on the Conference, visit: http://www.casss.org/page/WCBP1700 and to arrange a meeting with Mr. Merges at the event, contact Richard Kerns at NEPR - richard(at)nepr.eu. For more information on Catalent Biologics, visit http://www.catalentbiologics.com About Catalent Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 9,500 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com

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