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Seattle, MD, United States

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Seattle, MD, United States
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Federal Communications Commission (FCC), ICASA, OPIC, IFC, Microsoft Corporation, HP Enterprise, International Telecommunications Union (ITU) and more set to speak at leading spectrum sharing conference Cape Town, South Africa, 20 April 2017: With three weeks to go until the Dynamic Spectrum Alliance’s Fifth Annual Global Summit, which is this year returning to Africa, co-host ICASA, the Independent Communications Authority of South Africa, has published draft regulations on the use of TV White Space (TVWS) in the region. The draft regulations, which are open for public consultation until 19 May 2017, highlight the progress South Africa is making in enabling affordable Internet through dynamic spectrum access. These draft regulations – which the DSA fully welcomes - and technologies will be discussed at the DSA Global Summit, taking place in Cape Town between 9 to 11 May 2017, where a whole host of leading industry figures and regulators from around the world have been announced to speak, including the US Federal Communications Commission (FCC) and the International Telecommunications Union (ITU). “In the past, exclusive licenses for specific frequency bands and specific purposes dominated spectrum allocation policy and regulations,” said Pakamile Kayakethu Pongwana, CEO of ICASA. “While these models are good for monetizing the spectrum and for coordination between multiple services and operators to avoid interference, they often result in underutilization of spectrum. In the last decade, however, governments and regulators around the world have embraced the concept of ‘spectrum commons’ as another way to bring citizens innovation on new wireless technologies.” The event will open on 9 May with a full day regulator workshop on spectrum sharing and dynamic spectrum access. Alongside ICASA, other regulators in attendance will include Korea Radio Promotion Association (RAPA), Agência Nacional del Espectro (ANE), the Ministry of Communications for Argentina and Agência Nacional de Telecomunicações (ANATEL). Day one of the Global Summit will be opened with keynote addresses from Kalpak Gude, President of the Dynamic Spectrum Alliance, and ICASA CEO, Pakamile Kayalethu Pongwana, followed by panel sessions on spectrum sharing and enabling the Internet of Things (IoT) through dynamic access technologies. The latter panel will feature Dr. F. Mekuria, Chief Research Scientist at the Council for Scientific and Industrial Research (CSIR) South Africa, where he leads research on dynamic spectrum access. His perspective on how to connect underserved populations in emerging economies will add another dimension to the panel, which also includes Facebook, University of Strathclyde, and VistaLifeSciences Inc. A panel session on closing the digital divide will address financial challenges associated with large-scale network deployments, with speakers including: Mr. Alexander Hadden, Director, Structured Finance & Insurance, Overseas Private Investment Corporation (OPIC); Mr. Chikioke Egejuru, Investment Analysis, International Finance Corporation; Mr. Lumko Mtimde, CEO, the Universal Service and Access Agency of South Africa (USAASA) and will be moderated by Mr. Frank McCosker, General Manager, Affordable Access & Smart Financing, Microsoft Corporation. Other confirmed speakers on day one include Ira Keltz, Deputy Chief of Policy and Rules Division, Office of Engineering and Technology, US Federal Communications Commission (FCC), who will join the panel on Wi-Fi for the 5G World. On the final day of the Summit, Ira will start with a keynote address, before joining the Regulator Leadership Summit later in the day. ICASA CEO Pongwana will return to speak on day two of the Summit to speak on a panel titled Creating Opportunities for Deployment, which will be moderated by Emeritus Executive Director of the DSA, Prof. H Sama Nwana. The panel will bring together policy makers to discuss challenges and solutions to establishing regulatory frameworks for enabling investment in infrastructure – something that is crucial to bridging the digital divide in South Africa, and around the world. Other speakers confirmed on the agenda include representatives from: Facebook, Adaptrum Inc., C3 Limited, the Communications Authority of Kenya, Aruba (a Hewlett Packard Enterprise company) and New American Foundation. Platinum sponsors of this year’s event include Microsoft and Nominet. Gold sponsors include Adaptrum Inc. and MBC, while MedyaCity is a Silver sponsor. To secure your place at the Dynamic Spectrum Alliance’s Fifth Annual Global Summit in Cape Town, South Africa (9-11 May 2017), visit: https://www.eventbrite.com/e/dynamic-spectrum-alliance-2017-global-summit-tickets-28614617090. To view the full Summit agenda, visit: http://dynamicspectrumalliance.org/global-summit/agenda/. About the Dynamic Spectrum Alliance The Dynamic Spectrum Alliance is a global organization advocating for laws and regulations that will lead to more efficient and effective spectrum utilization. The DSA’s membership spans multinationals, small- and medium-sized enterprises, and academic, research, and other organizations from around the world, all working to create innovative solutions that will increase the amount of available spectrum to the benefit of consumers and businesses alike. For further information about the Dynamic Spectrum Alliance, please visit www.dynamicspectrumalliance.org/, or follow @dynamicspectrum on Twitter. Alternatively join the Alliance on Facebook or LinkedIn. Media Contact For all media enquiries, please contact Sian Borrill by emailing sian.borrill@proactive-pr.com.


CAPE TOWN, South Africa--(BUSINESS WIRE)--With three weeks to go until the Dynamic Spectrum Alliance’s Fifth Annual Global Summit, which is this year returning to Africa, co-host ICASA, the Independent Communications Authority of South Africa, has published draft regulations on the use of TV White Space (TVWS) in the region. The draft regulations, which are open for public consultation until 19 May 2017, highlight the progress South Africa is making in enabling affordable Internet through dynamic spectrum access. These draft regulations – which the DSA fully welcomes - and technologies will be discussed at the DSA Global Summit, taking place in Cape Town between 9 to 11 May 2017, where a whole host of leading industry figures and regulators from around the world have been announced to speak, including the US Federal Communications Commission (FCC) and the International Telecommunications Union (ITU). “In the past, exclusive licenses for specific frequency bands and specific purposes dominated spectrum allocation policy and regulations,” said Pakamile Kayakethu Pongwana, CEO of ICASA. “While these models are good for monetizing the spectrum and for coordination between multiple services and operators to avoid interference, they often result in underutilization of spectrum. In the last decade, however, governments and regulators around the world have embraced the concept of ‘spectrum commons’ as another way to bring citizens innovation on new wireless technologies.” The event will open on 9 May with a full day regulator workshop on spectrum sharing and dynamic spectrum access. Alongside ICASA, other regulators in attendance will include Korea Radio Promotion Association (RAPA), Agência Nacional del Espectro (ANE), the Ministry of Communications for Argentina and Agência Nacional de Telecomunicações (ANATEL). Day one of the Global Summit will be opened with keynote addresses from Kalpak Gude, President of the Dynamic Spectrum Alliance, and ICASA CEO, Pakamile Kayalethu Pongwana, followed by panel sessions on spectrum sharing and enabling the Internet of Things (IoT) through dynamic access technologies. The latter panel will feature Dr. F. Mekuria, Chief Research Scientist at the Council for Scientific and Industrial Research (CSIR) South Africa, where he leads research on dynamic spectrum access. His perspective on how to connect underserved populations in emerging economies will add another dimension to the panel, which also includes Facebook, University of Strathclyde, and VistaLifeSciences Inc. A panel session on closing the digital divide will address financial challenges associated with large-scale network deployments, with speakers including: Mr. Alexander Hadden, Director, Structured Finance & Insurance, Overseas Private Investment Corporation (OPIC); Mr. Chikioke Egejuru, Investment Analysis, International Finance Corporation; Mr. Lumko Mtimde, CEO, the Universal Service and Access Agency of South Africa (USAASA) and will be moderated by Mr. Frank McCosker, General Manager, Affordable Access & Smart Financing, Microsoft Corporation. Other confirmed speakers on day one include Ira Keltz, Deputy Chief of Policy and Rules Division, Office of Engineering and Technology, US Federal Communications Commission (FCC), who will join the panel on Wi-Fi for the 5G World. On the final day of the Summit, Ira will start with a keynote address, before joining the Regulator Leadership Summit later in the day. ICASA CEO Pongwana will return to speak on day two of the Summit to speak on a panel titled Creating Opportunities for Deployment, which will be moderated by Emeritus Executive Director of the DSA, Prof. H Sama Nwana. The panel will bring together policy makers to discuss challenges and solutions to establishing regulatory frameworks for enabling investment in infrastructure – something that is crucial to bridging the digital divide in South Africa, and around the world. Other speakers confirmed on the agenda include representatives from: Facebook, Adaptrum Inc., C3 Limited, the Communications Authority of Kenya, Aruba (a Hewlett Packard Enterprise company) and New American Foundation. Platinum sponsors of this year’s event include Microsoft and Nominet. Gold sponsors include Adaptrum Inc. and MBC, while MedyaCity is a Silver sponsor. To secure your place at the Dynamic Spectrum Alliance’s Fifth Annual Global Summit in Cape Town, South Africa (9-11 May 2017), visit: https://www.eventbrite.com/e/dynamic-spectrum-alliance-2017-global-summit-tickets-28614617090. To view the full Summit agenda, visit: http://dynamicspectrumalliance.org/global-summit/agenda/. The Dynamic Spectrum Alliance is a global organization advocating for laws and regulations that will lead to more efficient and effective spectrum utilization. The DSA’s membership spans multinationals, small- and medium-sized enterprises, and academic, research, and other organizations from around the world, all working to create innovative solutions that will increase the amount of available spectrum to the benefit of consumers and businesses alike. For further information about the Dynamic Spectrum Alliance, please visit www.dynamicspectrumalliance.org/, or follow @dynamicspectrum on Twitter. Alternatively join the Alliance on Facebook or LinkedIn.


News Article | May 25, 2017
Site: www.sciencedaily.com

A team of investigators from Agriculture and Agri-Food Canada, Guelph, Ontario, has discovered a gene that confers resistance to the important broad-spectrum antibiotic, fosfomycin. The researchers found the gene in isolates of the pathogen, Salmonella enterica, from broiler chickens. The research is published in Antimicrobial Agents and Chemotherapy, a journal of the American Society for Microbiology. The gene, dubbed fosA7, confers a high level of resistance to fosfomycin, which is otherwise a safe and effective agent for eliminating infections caused by multidrug resistant bacteria. (The "7" in fosA7 indicates that this is the seventh antibiotic resistant fosA gene that has been discovered.) Currently, there is only limited fosfomycin resistance among Salmonella species, said corresponding author Moussa S. Diarra, PhD, Research Scientist in Food Safety at Agriculture and Agri-Food Canada. But the powerful resistance the fosA7 gene confers is worrisome, said Diarra. It could spread among different Salmonella serovars (a serovar is a strain of a species), as well as other bacterial pathogen species, via horizontal gene transfer, due to increased use of fosfomycin in both clinical and veterinary settings, said Diarra. Thus, "vigilant monitoring for the spread of fosfomycin resistance in bacteria, isolated from humans and animals, is needed." With that in mind, the researchers tested the strength of the resistance the gene could confer on the closely related Salmonella enterica serovar Enteritidis. To do so, they cloned the gene, and inserted it into the chromosome of non-antibiotic resistant S. Enteriditis. Their worries were confirmed: the gene boosted the minimum concentration of fosfomycin required to inhibit reproduction in the microbe by more than 256-fold. These results provided strong support for the hypothesis that fosA7 is, indeed, responsible for fosfomycin resistance, and that if fosA7 were transferred to plasmids -- renegade pieces of DNA that can insert themselves into different bacteria -- it could induce a high level of resistance in the recipient bacterial strain, according to the report. The product of the fosA7 gene is an enzyme called glutathione-S-transferase. It inactivates fosfomycin by binding to it, and rupturing a molecular ring structure which is part of the antibiotic. Fosfomycin resistance genes are often present in multidrug resistant bacteria. "This could further challenge the use of fosfomycin as an alternative treatment approach against urinary tract infections caused by both multidrug resistant E. coli, and blood infections from multidrug resistant Salmonella," said Diarra. So far, the investigators have found fosA7 only on S. enterica serovar Heidelberg and three other serovars of this species. A serovar is a strain of a species. Salmonella enterica serovar Heidelberg -- the strain in which the researchers found fosA7 -- is among the most common causes of human salmonellosis worldwide. The rise of resistance to multiple antibiotics, particularly to extended spectrum cephalosporins in Heidelberg has limited the number of therapeutic options against this Salmonella serovar. In the current study, the investigators found this resistance gene in all of 15 Salmonella Heidelberg isolates in their collection. The American Society for Microbiology is the largest single life science society, composed of over 50,000 scientists and health professionals. ASM's mission is to promote and advance the microbial sciences. ASM advances the microbial sciences through conferences, publications, certifications and educational opportunities. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences.


News Article | May 12, 2017
Site: www.prnewswire.co.uk

Kristine Lofthus started the 2 May as Head of Quality Assurance.  Kristine comes to Oncoinvent from the Institute for Energy Technology (IFE) where she has worked as QA and QP responsible for the release of radiopharmaceuticals and for quality systems for the past five years.  Prior to working at IFE, she was Head of the Manufacturing Department at the Oslo University Hospital Pharmacy. Kristine Lofthus has a cand.pharm. from the University of Oslo and a post-graduate degree in radiopharmacy. Kristin Fure started the 2 May as Production Engineer responsible for production of Ra224 and Radspherin®.  Kristin also comes to Oncoinvent from the Institute for Energy Technology (IFE).  Kristin is a Research Scientist that has seventeen years' experience in the manufacturing of radioisotopes.  Kristin graduated with a cand. scient. in Nuclear Chemistry from the University of Oslo. Ole Peter Nordby who has been acting as Oncoinvent's interim CFO has been appointed Chief Financial Officer as of May 2. Ole Peter has more than fifteen years in positions as portfolio manager, investment director and financial analyst at several funds and investment companies. Through the main part of his career as fund manager and analyst he has been occupied with listed Nordic companies in the Life Science sector.  He holds a MBA from the Norwegian Business School BI and is a Certified European Financial Analyst (CEFA). Kari Skinnemoen has accepted the position of Head of Regulatory Affairs and will be starting 1 June. Kari has thirty-seven years' experience within development and registration of new products in the pharmaceutical and medical device industry, including twenty-eight years' experience in global regulatory affairs, most recently at Alere Technologies AS. She has also held managing positions within Quality Assurance and R&D. Kari holds a cand.real. degree in Organic Chemistry from the University of Oslo. "We are very pleased that we have been able to attract such qualified and experienced people to the Oncoinvent team. Their addition will greatly help the company in the commercialization of Radspherin® and the development of the company" said Jan A. Alfheim, Oncoinvent's CEO. This information was brought to you by Cision http://news.cision.com The following files are available for download:


Phase 1/2 trial in patients with achromatopsia due to CNGB3 mutations is currently enrolling patients; Phase 1/2 trial in patients with CNGA3-related achromatopsia is scheduling patients for enrollment WASHINGTON, May 11, 2017 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced the presentation of new data from studies in animal models of achromatopsia (ACHM) and X-linked retinitis pigmentosa (XLRP) that support the company’s clinical development programs in these indications. The data were presented at the American Society of Gene and Cell Therapy 20th Annual Meeting, taking place in Washington, D.C., May 10-13. ACHM and XLRP are rare inherited retinal diseases. ACHM results from mutations in either of the CNGB3 or CNGA3 genes. Mutations in these genes account for approximately 75 percent of the total achromatopsia patient population. Individuals with achromatopsia have markedly reduced visual acuity, extreme light sensitivity, and complete loss of color discrimination. AGTC is currently enrolling patients in a clinical trial for its CNGB3 gene-related ACHM treatment candidate, and is currently scheduling patients to be enrolled in a clinical trial for its CNGA3 gene-related ACHM treatment candidate. Patients and caregivers interested in participating in or learning more about these trials may find more information at www.agtc.com/patients-and-caregivers or by contacting advocacy@agtc.com. XLRP affects boys, causing night blindness by the time they are ten, and progresses to legal blindness by their early forties. AGTC is developing a gene-based therapy for XLRP in collaboration with Biogen and expects to file an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration for this product candidate this year. Lisa R. Keyes, Ph.D., Research Scientist at AGTC, will present the ACHM data in an abstract titled, “Evaluating Safety and Efficacy of the AAV2tYF-PR1.7-CNGA3 Vector in CNGA3-Deficient Sheep” (Abstract #299) today in an oral session from 4:15 p.m. to 4:30 p.m. EDT. These data are from a study that assessed toxicity, CNGA3 expression and efficacy of two subretinally administered vectors [AAV2tYF-PR1.7-hCNGA3 and AAV5-PR2.1-hCNGA3 (a vector previously shown to rescue cone photoreceptor responses)] in an animal model of ACHM, over a 12-week evaluation period. No systemic toxicity was associated with treatment and no consistent test article-related effects were observed. Two out of five animals treated with the higher dose of AAV2tYF-PR1.7-CNGA3 had microscopic findings of outer retinal atrophy, with or without inflammatory cells in the retina and choroid that were considered procedural- and/or test article-related. All vector-treated eyes demonstrated CNGA3 expression, and developed cone-mediated electroretinogram (ERG) responses with no change in rod-mediated ERG responses. Improvements in maze navigation times and obstacle collisions were observed in all vector-treated eyes compared with control eyes and with pre-dose results in the treated eyes. The researchers conclude that these results support the use of AAV2tYF-PR1.7-hCNGA3 in clinical studies in patients with achromatopsia caused by mutations in CNGA3. “The improvements in maze navigation times, obstacle collisions and ERG responses observed with the product candidate in this study suggest that AAV-based gene therapy has important potential in the treatment of ACHM resulting from mutations in the CNGA3 gene,” said Sue Washer, President and CEO of AGTC. “The favorable tolerability profile observed in this study also supports the use of this vector construct in human clinical trials. These study findings provided the basis for the design of the Phase 1/2 clinical trial of our gene-based therapy for ACHM resulting from CNGA3 mutations, which is currently scheduling patients for enrollment.” Jilin Liu, Associate Scientist at AGTC, will present the XLRP data in an abstract titled, “Evaluation of AAV2tYF-GRK1-RPGR Vectors in a Canine Model of RPGR-XLRP” (Abstract #692) in a poster session May 12, from 5:45 p.m. to 7:45 p.m. EDT. The poster will include results from a study evaluating the efficacy of two vectors (AAV2tYF-GRK1-RPGRco and AAV2tYF-GRK1-RPGRstb) containing the AAV2tYF capsid, human GRK1 promoter and a codon-optimized or stabilized version of the human RPGR gene administered subretinally in an animal model of mid-stage XLRP resulting from mutations in the RPGR gene. In this model, mid-stage disease occurs when animals are approximately 12 weeks of age and is associated with an approximate 40% loss of photoreceptors. Two animals per group received RPGRco in the right eye and RPGRstb in the left eye at each of three dose levels. Rescue of photoreceptor structure was assessed by clinical examination and histology and/or immunohistochemistry on retinal cryosections eight weeks post injection. No abnormal ophthalmic findings were noted in any eyes at the middle- or low-dose levels. Fundoscopic examination at 8 weeks post-dosage showed signs of retinal detachment and inflammation in the eyes injected with the high dose of either RPGRco or RPGRstb. Dose-dependent RPGR transgene expression was observed with both vectors, with greater RPGR expression noted in eyes injected with RPGRco compared with contralateral eyes injected with RPGRstb at the same dose levels. Correction of rod opsin and middle/long wavelength cone opsin mislocalization was demonstrated in all AAV-RPGR treated eyes. Researchers conclude that the results demonstrate greater RPGR expression with RPGRco compared with RPGRstb, and that the middle doses of both vectors resulted in optimal correction at mid-stage disease with limited inflammation in this animal model of XLRP. Data from both the ACHM and XLRP studies were also presented earlier in the week at ARVO 2017, the Association for Research in Vision and Ophthalmology Annual Meeting, which took place in Baltimore from May 7-11. AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases, with an initial focus in ophthalmology. AGTC's lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTC's product pipeline includes ophthalmology programs in X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), achromatopsia, wet age-related macular degeneration, and our optogenetics program with Bionic Sight. AGTC's non-ophthalmology programs include its adrenoleukodystrophy program and its otology program, which is in pre-clinical development, and the company expects to advance several otology product candidates into clinical development in the next few years. Each of AGTC's XLRS, XLRP and adrenoleukodystrophy programs is partnered with Biogen. AGTC employs a highly-targeted approach to selecting and designing its product candidates, choosing to develop therapies for indications having high unmet medical need that it believes are clinically feasible and present commercial opportunities. AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as, expertise in the formulation, manufacture and physical delivery of gene therapy products. This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs. Forward-looking statements include information concerning possible or assumed future results of operations, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: no gene therapy products have been approved in the United States and only two such products have been approved in Europe; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate; uncertainty inherent in the regulatory review process; risks and uncertainties associated with drug development and commercialization; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2016, as filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.


Phase 1/2 trial in patients with achromatopsia due to CNGB3 mutations is currently enrolling patients; Phase 1/2 trial in patients with CNGA3-related achromatopsia is scheduling patients for enrollment WASHINGTON, May 11, 2017 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced the presentation of new data from studies in animal models of achromatopsia (ACHM) and X-linked retinitis pigmentosa (XLRP) that support the company’s clinical development programs in these indications. The data were presented at the American Society of Gene and Cell Therapy 20th Annual Meeting, taking place in Washington, D.C., May 10-13. ACHM and XLRP are rare inherited retinal diseases. ACHM results from mutations in either of the CNGB3 or CNGA3 genes. Mutations in these genes account for approximately 75 percent of the total achromatopsia patient population. Individuals with achromatopsia have markedly reduced visual acuity, extreme light sensitivity, and complete loss of color discrimination. AGTC is currently enrolling patients in a clinical trial for its CNGB3 gene-related ACHM treatment candidate, and is currently scheduling patients to be enrolled in a clinical trial for its CNGA3 gene-related ACHM treatment candidate. Patients and caregivers interested in participating in or learning more about these trials may find more information at www.agtc.com/patients-and-caregivers or by contacting advocacy@agtc.com. XLRP affects boys, causing night blindness by the time they are ten, and progresses to legal blindness by their early forties. AGTC is developing a gene-based therapy for XLRP in collaboration with Biogen and expects to file an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration for this product candidate this year. Lisa R. Keyes, Ph.D., Research Scientist at AGTC, will present the ACHM data in an abstract titled, “Evaluating Safety and Efficacy of the AAV2tYF-PR1.7-CNGA3 Vector in CNGA3-Deficient Sheep” (Abstract #299) today in an oral session from 4:15 p.m. to 4:30 p.m. EDT. These data are from a study that assessed toxicity, CNGA3 expression and efficacy of two subretinally administered vectors [AAV2tYF-PR1.7-hCNGA3 and AAV5-PR2.1-hCNGA3 (a vector previously shown to rescue cone photoreceptor responses)] in an animal model of ACHM, over a 12-week evaluation period. No systemic toxicity was associated with treatment and no consistent test article-related effects were observed. Two out of five animals treated with the higher dose of AAV2tYF-PR1.7-CNGA3 had microscopic findings of outer retinal atrophy, with or without inflammatory cells in the retina and choroid that were considered procedural- and/or test article-related. All vector-treated eyes demonstrated CNGA3 expression, and developed cone-mediated electroretinogram (ERG) responses with no change in rod-mediated ERG responses. Improvements in maze navigation times and obstacle collisions were observed in all vector-treated eyes compared with control eyes and with pre-dose results in the treated eyes. The researchers conclude that these results support the use of AAV2tYF-PR1.7-hCNGA3 in clinical studies in patients with achromatopsia caused by mutations in CNGA3. “The improvements in maze navigation times, obstacle collisions and ERG responses observed with the product candidate in this study suggest that AAV-based gene therapy has important potential in the treatment of ACHM resulting from mutations in the CNGA3 gene,” said Sue Washer, President and CEO of AGTC. “The favorable tolerability profile observed in this study also supports the use of this vector construct in human clinical trials. These study findings provided the basis for the design of the Phase 1/2 clinical trial of our gene-based therapy for ACHM resulting from CNGA3 mutations, which is currently scheduling patients for enrollment.” Jilin Liu, Associate Scientist at AGTC, will present the XLRP data in an abstract titled, “Evaluation of AAV2tYF-GRK1-RPGR Vectors in a Canine Model of RPGR-XLRP” (Abstract #692) in a poster session May 12, from 5:45 p.m. to 7:45 p.m. EDT. The poster will include results from a study evaluating the efficacy of two vectors (AAV2tYF-GRK1-RPGRco and AAV2tYF-GRK1-RPGRstb) containing the AAV2tYF capsid, human GRK1 promoter and a codon-optimized or stabilized version of the human RPGR gene administered subretinally in an animal model of mid-stage XLRP resulting from mutations in the RPGR gene. In this model, mid-stage disease occurs when animals are approximately 12 weeks of age and is associated with an approximate 40% loss of photoreceptors. Two animals per group received RPGRco in the right eye and RPGRstb in the left eye at each of three dose levels. Rescue of photoreceptor structure was assessed by clinical examination and histology and/or immunohistochemistry on retinal cryosections eight weeks post injection. No abnormal ophthalmic findings were noted in any eyes at the middle- or low-dose levels. Fundoscopic examination at 8 weeks post-dosage showed signs of retinal detachment and inflammation in the eyes injected with the high dose of either RPGRco or RPGRstb. Dose-dependent RPGR transgene expression was observed with both vectors, with greater RPGR expression noted in eyes injected with RPGRco compared with contralateral eyes injected with RPGRstb at the same dose levels. Correction of rod opsin and middle/long wavelength cone opsin mislocalization was demonstrated in all AAV-RPGR treated eyes. Researchers conclude that the results demonstrate greater RPGR expression with RPGRco compared with RPGRstb, and that the middle doses of both vectors resulted in optimal correction at mid-stage disease with limited inflammation in this animal model of XLRP. Data from both the ACHM and XLRP studies were also presented earlier in the week at ARVO 2017, the Association for Research in Vision and Ophthalmology Annual Meeting, which took place in Baltimore from May 7-11. AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases, with an initial focus in ophthalmology. AGTC's lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTC's product pipeline includes ophthalmology programs in X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), achromatopsia, wet age-related macular degeneration, and our optogenetics program with Bionic Sight. AGTC's non-ophthalmology programs include its adrenoleukodystrophy program and its otology program, which is in pre-clinical development, and the company expects to advance several otology product candidates into clinical development in the next few years. Each of AGTC's XLRS, XLRP and adrenoleukodystrophy programs is partnered with Biogen. AGTC employs a highly-targeted approach to selecting and designing its product candidates, choosing to develop therapies for indications having high unmet medical need that it believes are clinically feasible and present commercial opportunities. AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as, expertise in the formulation, manufacture and physical delivery of gene therapy products. This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs. Forward-looking statements include information concerning possible or assumed future results of operations, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: no gene therapy products have been approved in the United States and only two such products have been approved in Europe; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate; uncertainty inherent in the regulatory review process; risks and uncertainties associated with drug development and commercialization; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2016, as filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.


News Article | May 10, 2017
Site: www.eurekalert.org

SAN ANTONIO, Texas, U.S.A -- UT Health San Antonio researchers discovered epigenetic changes that contribute to one-fifth of cases of acute myeloid leukemia (AML), an aggressive cancer that arises out of the blood-forming cells in bone marrow. The mutations also play a role in a large majority of low-grade gliomas, which are among the most-treatable brain tumors. The UT Health scientists describe the finding in this week's issue of Cancer Cell. "The best way to treat a cancer is to understand it," said Ricardo C.T. Aguiar, M.D., Ph.D., professor of medicine at The University of Texas Health Science Center, now called UT Health San Antonio. "We have added to the understanding of a broad swath of cancers that carry what is called the IDH mutation." Dr. Aguiar, a hematology-oncology researcher and member of the UT Health San Antonio Cancer Center, is senior author of the study. He said in the future cancers will be classified not by where they are located but by their genetic defect - such as the IDH mutation. IDH is short for isocitrate dehydrogenase. The UT Health team found that IDH mutations alter an epigenetic process called RNA methylation, which leads to deregulation of hundreds of other genes and processes inside the tumor cell. Changes that amplify -- or silence -- genes Epigenetic modifications change gene activity but don't structurally change the body's genetic blueprints. Diet, aging, environmental exposure and other factors can prompt epigenetic changes that amplify or silence certain genes. A drug that inhibits the IDH mutant enzymes is in non-UT Health-related clinical trials. The UT Health discovery provides evidence for why the drug may help patients with AML and low-grade gliomas. "Acute myeloid leukemia remains a very difficult-to-treat tumor and, unfortunately, the majority of patients still die of their disease," Dr. Aguiar said. "In this paper, in addition to sophisticated genetic models created in our lab, we also studied primary AML samples to demonstrate that, in the very IDH-mutant tumors from the patients, we detected this change in RNA methylation. By better understanding how the IDH-dependent cancers work, we may be able to fine-tune future therapies and improve survival." The work in Dr. Aguiar's lab was co-led by postdoctoral fellow Sara Elkashef, Ph.D., and Research Scientist An-Ping Lin, M.D. Patricia Dahia, M.D., Ph.D., professor of medicine at UT Health San Antonio, and Heinz Sill, M.D., University of Graz, Austria, collaborated with Dr. Aguiar's group in this project. This research was funded by an award from the Cancer Prevention & Research Institute of Texas. Dr. Aguiar is also funded by the Leukemia and Lymphoma Society. Learn more about acute myeloid leukemia from the UT Health San Antonio Cancer Center. For current news from the UT Health Science Center San Antonio, now called UT Health San Antonio™, please visit our online newsroom, like us on Facebook or follow us on Twitter. The University of Texas Health Science Center at San Antonio, with missions of teaching, research and healing, is one of the country's leading health sciences universities and is now called UT Health San Antonio™. UT Health's schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced more than 33,000 alumni who are advancing their fields throughout the world. With four campuses in San Antonio and Laredo, UT Health has a FY 2017 revenue operating budget of $806.6 million and is the primary driver of its community's $37 billion biomedical and health care industry. For more information on the many ways "We make lives better®," visit http://www. .


Phase 1/2 trial in patients with achromatopsia due to CNGB3 mutations is currently enrolling patients; Phase 1/2 trial in patients with CNGA3-related achromatopsia is scheduling patients for enrollment WASHINGTON, May 11, 2017 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced the presentation of new data from studies in animal models of achromatopsia (ACHM) and X-linked retinitis pigmentosa (XLRP) that support the company’s clinical development programs in these indications. The data were presented at the American Society of Gene and Cell Therapy 20th Annual Meeting, taking place in Washington, D.C., May 10-13. ACHM and XLRP are rare inherited retinal diseases. ACHM results from mutations in either of the CNGB3 or CNGA3 genes. Mutations in these genes account for approximately 75 percent of the total achromatopsia patient population. Individuals with achromatopsia have markedly reduced visual acuity, extreme light sensitivity, and complete loss of color discrimination. AGTC is currently enrolling patients in a clinical trial for its CNGB3 gene-related ACHM treatment candidate, and is currently scheduling patients to be enrolled in a clinical trial for its CNGA3 gene-related ACHM treatment candidate. Patients and caregivers interested in participating in or learning more about these trials may find more information at www.agtc.com/patients-and-caregivers or by contacting advocacy@agtc.com. XLRP affects boys, causing night blindness by the time they are ten, and progresses to legal blindness by their early forties. AGTC is developing a gene-based therapy for XLRP in collaboration with Biogen and expects to file an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration for this product candidate this year. Lisa R. Keyes, Ph.D., Research Scientist at AGTC, will present the ACHM data in an abstract titled, “Evaluating Safety and Efficacy of the AAV2tYF-PR1.7-CNGA3 Vector in CNGA3-Deficient Sheep” (Abstract #299) today in an oral session from 4:15 p.m. to 4:30 p.m. EDT. These data are from a study that assessed toxicity, CNGA3 expression and efficacy of two subretinally administered vectors [AAV2tYF-PR1.7-hCNGA3 and AAV5-PR2.1-hCNGA3 (a vector previously shown to rescue cone photoreceptor responses)] in an animal model of ACHM, over a 12-week evaluation period. No systemic toxicity was associated with treatment and no consistent test article-related effects were observed. Two out of five animals treated with the higher dose of AAV2tYF-PR1.7-CNGA3 had microscopic findings of outer retinal atrophy, with or without inflammatory cells in the retina and choroid that were considered procedural- and/or test article-related. All vector-treated eyes demonstrated CNGA3 expression, and developed cone-mediated electroretinogram (ERG) responses with no change in rod-mediated ERG responses. Improvements in maze navigation times and obstacle collisions were observed in all vector-treated eyes compared with control eyes and with pre-dose results in the treated eyes. The researchers conclude that these results support the use of AAV2tYF-PR1.7-hCNGA3 in clinical studies in patients with achromatopsia caused by mutations in CNGA3. “The improvements in maze navigation times, obstacle collisions and ERG responses observed with the product candidate in this study suggest that AAV-based gene therapy has important potential in the treatment of ACHM resulting from mutations in the CNGA3 gene,” said Sue Washer, President and CEO of AGTC. “The favorable tolerability profile observed in this study also supports the use of this vector construct in human clinical trials. These study findings provided the basis for the design of the Phase 1/2 clinical trial of our gene-based therapy for ACHM resulting from CNGA3 mutations, which is currently scheduling patients for enrollment.” Jilin Liu, Associate Scientist at AGTC, will present the XLRP data in an abstract titled, “Evaluation of AAV2tYF-GRK1-RPGR Vectors in a Canine Model of RPGR-XLRP” (Abstract #692) in a poster session May 12, from 5:45 p.m. to 7:45 p.m. EDT. The poster will include results from a study evaluating the efficacy of two vectors (AAV2tYF-GRK1-RPGRco and AAV2tYF-GRK1-RPGRstb) containing the AAV2tYF capsid, human GRK1 promoter and a codon-optimized or stabilized version of the human RPGR gene administered subretinally in an animal model of mid-stage XLRP resulting from mutations in the RPGR gene. In this model, mid-stage disease occurs when animals are approximately 12 weeks of age and is associated with an approximate 40% loss of photoreceptors. Two animals per group received RPGRco in the right eye and RPGRstb in the left eye at each of three dose levels. Rescue of photoreceptor structure was assessed by clinical examination and histology and/or immunohistochemistry on retinal cryosections eight weeks post injection. No abnormal ophthalmic findings were noted in any eyes at the middle- or low-dose levels. Fundoscopic examination at 8 weeks post-dosage showed signs of retinal detachment and inflammation in the eyes injected with the high dose of either RPGRco or RPGRstb. Dose-dependent RPGR transgene expression was observed with both vectors, with greater RPGR expression noted in eyes injected with RPGRco compared with contralateral eyes injected with RPGRstb at the same dose levels. Correction of rod opsin and middle/long wavelength cone opsin mislocalization was demonstrated in all AAV-RPGR treated eyes. Researchers conclude that the results demonstrate greater RPGR expression with RPGRco compared with RPGRstb, and that the middle doses of both vectors resulted in optimal correction at mid-stage disease with limited inflammation in this animal model of XLRP. Data from both the ACHM and XLRP studies were also presented earlier in the week at ARVO 2017, the Association for Research in Vision and Ophthalmology Annual Meeting, which took place in Baltimore from May 7-11. AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases, with an initial focus in ophthalmology. AGTC's lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTC's product pipeline includes ophthalmology programs in X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), achromatopsia, wet age-related macular degeneration, and our optogenetics program with Bionic Sight. AGTC's non-ophthalmology programs include its adrenoleukodystrophy program and its otology program, which is in pre-clinical development, and the company expects to advance several otology product candidates into clinical development in the next few years. Each of AGTC's XLRS, XLRP and adrenoleukodystrophy programs is partnered with Biogen. AGTC employs a highly-targeted approach to selecting and designing its product candidates, choosing to develop therapies for indications having high unmet medical need that it believes are clinically feasible and present commercial opportunities. AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as, expertise in the formulation, manufacture and physical delivery of gene therapy products. This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs. Forward-looking statements include information concerning possible or assumed future results of operations, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: no gene therapy products have been approved in the United States and only two such products have been approved in Europe; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate; uncertainty inherent in the regulatory review process; risks and uncertainties associated with drug development and commercialization; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2016, as filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.


Phase 1/2 trial in patients with achromatopsia due to CNGB3 mutations is currently enrolling patients; Phase 1/2 trial in patients with CNGA3-related achromatopsia is scheduling patients for enrollment WASHINGTON, May 11, 2017 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced the presentation of new data from studies in animal models of achromatopsia (ACHM) and X-linked retinitis pigmentosa (XLRP) that support the company’s clinical development programs in these indications. The data were presented at the American Society of Gene and Cell Therapy 20th Annual Meeting, taking place in Washington, D.C., May 10-13. ACHM and XLRP are rare inherited retinal diseases. ACHM results from mutations in either of the CNGB3 or CNGA3 genes. Mutations in these genes account for approximately 75 percent of the total achromatopsia patient population. Individuals with achromatopsia have markedly reduced visual acuity, extreme light sensitivity, and complete loss of color discrimination. AGTC is currently enrolling patients in a clinical trial for its CNGB3 gene-related ACHM treatment candidate, and is currently scheduling patients to be enrolled in a clinical trial for its CNGA3 gene-related ACHM treatment candidate. Patients and caregivers interested in participating in or learning more about these trials may find more information at www.agtc.com/patients-and-caregivers or by contacting advocacy@agtc.com. XLRP affects boys, causing night blindness by the time they are ten, and progresses to legal blindness by their early forties. AGTC is developing a gene-based therapy for XLRP in collaboration with Biogen and expects to file an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration for this product candidate this year. Lisa R. Keyes, Ph.D., Research Scientist at AGTC, will present the ACHM data in an abstract titled, “Evaluating Safety and Efficacy of the AAV2tYF-PR1.7-CNGA3 Vector in CNGA3-Deficient Sheep” (Abstract #299) today in an oral session from 4:15 p.m. to 4:30 p.m. EDT. These data are from a study that assessed toxicity, CNGA3 expression and efficacy of two subretinally administered vectors [AAV2tYF-PR1.7-hCNGA3 and AAV5-PR2.1-hCNGA3 (a vector previously shown to rescue cone photoreceptor responses)] in an animal model of ACHM, over a 12-week evaluation period. No systemic toxicity was associated with treatment and no consistent test article-related effects were observed. Two out of five animals treated with the higher dose of AAV2tYF-PR1.7-CNGA3 had microscopic findings of outer retinal atrophy, with or without inflammatory cells in the retina and choroid that were considered procedural- and/or test article-related. All vector-treated eyes demonstrated CNGA3 expression, and developed cone-mediated electroretinogram (ERG) responses with no change in rod-mediated ERG responses. Improvements in maze navigation times and obstacle collisions were observed in all vector-treated eyes compared with control eyes and with pre-dose results in the treated eyes. The researchers conclude that these results support the use of AAV2tYF-PR1.7-hCNGA3 in clinical studies in patients with achromatopsia caused by mutations in CNGA3. “The improvements in maze navigation times, obstacle collisions and ERG responses observed with the product candidate in this study suggest that AAV-based gene therapy has important potential in the treatment of ACHM resulting from mutations in the CNGA3 gene,” said Sue Washer, President and CEO of AGTC. “The favorable tolerability profile observed in this study also supports the use of this vector construct in human clinical trials. These study findings provided the basis for the design of the Phase 1/2 clinical trial of our gene-based therapy for ACHM resulting from CNGA3 mutations, which is currently scheduling patients for enrollment.” Jilin Liu, Associate Scientist at AGTC, will present the XLRP data in an abstract titled, “Evaluation of AAV2tYF-GRK1-RPGR Vectors in a Canine Model of RPGR-XLRP” (Abstract #692) in a poster session May 12, from 5:45 p.m. to 7:45 p.m. EDT. The poster will include results from a study evaluating the efficacy of two vectors (AAV2tYF-GRK1-RPGRco and AAV2tYF-GRK1-RPGRstb) containing the AAV2tYF capsid, human GRK1 promoter and a codon-optimized or stabilized version of the human RPGR gene administered subretinally in an animal model of mid-stage XLRP resulting from mutations in the RPGR gene. In this model, mid-stage disease occurs when animals are approximately 12 weeks of age and is associated with an approximate 40% loss of photoreceptors. Two animals per group received RPGRco in the right eye and RPGRstb in the left eye at each of three dose levels. Rescue of photoreceptor structure was assessed by clinical examination and histology and/or immunohistochemistry on retinal cryosections eight weeks post injection. No abnormal ophthalmic findings were noted in any eyes at the middle- or low-dose levels. Fundoscopic examination at 8 weeks post-dosage showed signs of retinal detachment and inflammation in the eyes injected with the high dose of either RPGRco or RPGRstb. Dose-dependent RPGR transgene expression was observed with both vectors, with greater RPGR expression noted in eyes injected with RPGRco compared with contralateral eyes injected with RPGRstb at the same dose levels. Correction of rod opsin and middle/long wavelength cone opsin mislocalization was demonstrated in all AAV-RPGR treated eyes. Researchers conclude that the results demonstrate greater RPGR expression with RPGRco compared with RPGRstb, and that the middle doses of both vectors resulted in optimal correction at mid-stage disease with limited inflammation in this animal model of XLRP. Data from both the ACHM and XLRP studies were also presented earlier in the week at ARVO 2017, the Association for Research in Vision and Ophthalmology Annual Meeting, which took place in Baltimore from May 7-11. AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases, with an initial focus in ophthalmology. AGTC's lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTC's product pipeline includes ophthalmology programs in X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), achromatopsia, wet age-related macular degeneration, and our optogenetics program with Bionic Sight. AGTC's non-ophthalmology programs include its adrenoleukodystrophy program and its otology program, which is in pre-clinical development, and the company expects to advance several otology product candidates into clinical development in the next few years. Each of AGTC's XLRS, XLRP and adrenoleukodystrophy programs is partnered with Biogen. AGTC employs a highly-targeted approach to selecting and designing its product candidates, choosing to develop therapies for indications having high unmet medical need that it believes are clinically feasible and present commercial opportunities. AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as, expertise in the formulation, manufacture and physical delivery of gene therapy products. This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs. Forward-looking statements include information concerning possible or assumed future results of operations, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: no gene therapy products have been approved in the United States and only two such products have been approved in Europe; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate; uncertainty inherent in the regulatory review process; risks and uncertainties associated with drug development and commercialization; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2016, as filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

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