News Article | May 31, 2017
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 | July 10, 2017
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.
News Article | March 2, 2017
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
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
Poonia B.,Institute of Human Virology |
Pauza C.D.,Institute of Human Virology
Cytotherapy | Year: 2012
Background aims. Immunotherapy using γδ T cells capable of mediating antibody-dependent cellular cytotoxicity (ADCC) is a promising anti-human immunodeficiency virus (HIV) strategy. Approved aminobispohsphonate drugs, for example zoledronate (Zometa), stimulate γδ T cells in cancer patients, where they may promote direct tumor killing. Knowing that γδ T cells are modulated during HIV disease, documenting their responses and potential for controlling HIV is important. We investigated whether zoledronate/interleukin (IL)-2 could expand cytotoxic Vδ2 cells from HIV+ donors and whether these cells functioned in ADCC. Methods. Peripheral blood mononuclear cells from uninfected controls and HIV+ individuals receiving anti-retroviral therapy were treated with isopentenyl pyrophosphate (IPP) or zoledronate plus IL-2 to expand the Vδ2+ subset. Immunophenotyping and functional analyzes (cytotoxicity or cytokine expression) allowed us to compare cell properties from individual donors and to compare the responses to each stimulating agent. Results. Zoledronate stimulated a greater expansion of Vδ2 cells in HIV+ individuals compared with phosphoantigen IPP, and these cells expressed CD16. CD56 expression (a marker for cytotoxic cells) was lower on zoledronate-expanded cells, consistent with significantly lower cytotoxicity against the Daudi tumor cell line. Cells expanded with either zoledronate or IPP were active in ADCC, were similar in terms of interferon (IFN)-γ and tumor necrosis factor (TNF)-α expression, and degranulated in response to Fc receptor cross-linking. Conclusions. Zoledronate causes ex vivo expansion of Vδ2 cells from HIV+ individuals. Despite lower expression of CD56 and decreased direct cytotoxicity, these effectors were potent in ADCC. Zoledronate/IL-2- expanded cells have potential for immunotherapy to activate Vδ2 cells in HIV patients and enhance ADCC. © 2012 Informa Healthcare.
Tebit D.M.,Case Western Reserve University |
Ndembi N.,Institute of Human Virology |
Weinberg A.,Case Western Reserve University |
Quinones-Mateu M.E.,Case Western Reserve University
Current HIV Research | Year: 2012
Since the beginning of the AIDS pandemic, and following the discovery of the human immunodeficiency virus (HIV) as the etiological agent of the disease, it was clear that the virus gains access to the human host predominantly through the mucosal tissue after sexual exposure. As a consequence, the female genital tract (vaginal and cervical), as well as the rectal, penile, and oral mucosae have been extensively studied over the last thirty years towards a better understanding of - and to develop strategies to prevent - sexual HIV transmission. This review seeks to describe the biology of the events leading to HIV infection through the human mucosa and introduce some of the approaches attempted to prevent the sexual transmission of HIV. © 2012 Bentham Science Publishers.
Amoroso A.,Institute of Human Virology |
Etienne-Mesubi M.,Institute of Human Virology |
Edozien A.,Institute of Human Virology |
Ojoo S.,Institute of Human Virology |
And 5 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2012
Background: Although used globally, little data exist on the efficacy of nevirapine (NVP) used in combination with tenofovir (TDF)/emtricitabine or lamivudine (XTC), and no large randomized prospective control trials exists comparing this combination with efavirenz (EFV)/TDF/(XTC). Methods: As part of the AIDSRelief program, a retrospective review of patient medical chart information along with a cross-sectional viral load, and adherence measurement was conducted between 2004 and 2009. An on-treatment analysis excluded patients who died, transferred out of care, or were lost to follow-up. A switch of antiretrovirals for any reason was considered a failure in the intent-to-treat analysis. Patients with only clinically relevant reasons for switching such as toxicity, adverse effects, viral failure or clinical/immunological failure, lost to follow-up, and death were considered failures as part of the modified-intent-to-treat analysis. Step-wise multiple regression analysis was used to identify variables that were associated with viral suppression. Results: A random sample of 3862 patients met criteria and were included in this analysis. In the on-treatment analysis, older age (P < 0.004) and baseline CD4 <100 cells per cubic millimeter (P < 0.021) were the most significant variables impacting viral load. Patients on TDF/XTC/EFV achieved higher rates of viral suppression compared with patients on TDF/XTC/NVP or azidothymidine (AZT)/lamivudine (3TC)/NVP. Conclusion: Our data show that patients on TDF/XTC/EFV had better outcomes than patients on TDF/XTC/NVP, AZT/3TC/EFV, or AZT/3TC/NVP. High rates of virologic suppression seen in patients on this regimen are consistent with previous studies and indicate the need to increase use of this regimen in HIV programs to promote sustainable viral suppression over time. © 2012 Lippincott Williams & Wilkins.
Poonia B.,Institute of Human Virology |
Kijak G.H.,United States Military HIV Research Program |
Pauza C.D.,Institute of Human Virology
PLoS ONE | Year: 2010
Background:We investigated the genetics of Fc receptors, which function as activating receptors on immune cells and help to control HIV through antibody-mediated cellular cytotoxicity. Thus, Fc receptors may be important for virus immunity but might also promote immune hyperactivation that would enhance infection. Methodology/Principal Findings: We measured abundance of low and high activity alleles in two Fc receptor genes, FCGR2A and FCGR3A, for persons with HIV disease, natural virus suppressors (HIV+, without disease) and healthy controls to show whether genotypes were associated with infection and disease. Individuals homozygous for the high activity allele of FCGR3A (158VV) were predominantly found among HIV progressors and this group was also skewed toward higher allele frequencies for the V158 variant. Both of the HIV positive groups (progressors and natural virus suppressors) had significantly higher frequencies of the V158 allele compared with uninfected controls. There were no apparent associations among FCGR2A alleles and HIV status. Conclusions/Significance:Our results indicate that high activity alleles of FCGR3A may be risk factors for HIV infection or progression and we need to understand how allelic variants affect the balance between virus control and immune activation. © 2010 Poonia et al.
Global trends in antiretroviral resistance in treatment-naïve individuals with HIV after rollout of antiretroviral treatment in resource-limited settings: A global collaborative study and meta-regression analysis
Gupta R.K.,University College London |
Jordan M.R.,Tufts University |
Sultan B.J.,Mortimer Market Center |
Hill A.,University of Liverpool |
And 7 more authors.
The Lancet | Year: 2012
Background The emergence and spread of high levels of HIV-1 drug resistance in resource-limited settings where combination antiretroviral treatment has been scaled up could compromise the eff ectiveness of national HIV treatment programmes. We aimed to estimate changes in the prevalence of HIV-1 drug resistance in treatment-naïve individuals with HIV since initiation of rollout in resource-limited settings. Methods We did a systematic search for studies and conference abstracts published between January, 2001, and July, 2011, and included additional data from the WHO HIV drug resistance surveillance programme. We assessed the prevalence of drug-resistance mutations in untreated individuals with respect to time since rollout in a series of random-eff ects meta-regression models. Findings Study-level data were available for 26 102 patients from sub-Saharan Africa, Asia, and Latin America . We recorded no diff erence between chronic and recent infection on the prevalence of one or more drug-resistance mutations for any region. East Africa had the highest estimated rate of increase at 29% per year (95% CI 15 to 45; p=0·0001) since rollout, with an estimated prevalence of HIV-1 drug resistance at 8 years after rollout of 7·4% (4·3 to 12·7). We recorded an annual increase of 14% (0% to 29%; p=0·054) in southern Africa and a non-signifi cant increase of 3% (-0·9 to 16; p=0·618) in west and central Africa. There was no change in resistance over time in Latin America, and because of much country-level heterogeneity the meta-regression analysis was not appropriate for Asia. With respect to class of antiretroviral, there were substantial increases in resistance to non-nucleoside reverse transcriptase inhibitors (NNRTI) in east Africa (36% per year [21 to 52]; p<0·0001) and southern Africa (23% per year [7 to 42]; p=0·0049). No increase was noted for the other drug classes in any region. Interpretation Our fi ndings suggest a signifi cant increase in prevalence of drug resistance over time since antiretroviral rollout in regions of sub-Saharan Africa; this rise is driven by NNRTI resistance in studies from east and southern Africa. The fi ndings are of concern and draw attention to the need for enhanced surveillance and drug-resistance prevention eff orts by national HIV treatment programmes. Nevertheless, estimated levels, although increasing, are not unexpected in view of the large expansion of antiretroviral treatment coverage seen in low-income and middleincome countries-no changes in antiretroviral treatment guidelines are warranted at the moment.
Kaye J.,University of Oxford |
Meslin E.M.,Indiana University Bloomington |
Knoppers B.M.,McGill University |
Juengst E.T.,University of North Carolina at Chapel Hill |
And 12 more authors.
Science | Year: 2012
We need an international infrastructure for the ethical, legal, and social implications of genomic research.