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The report "Liver Fibrosis - Pipeline Review, H1 2017" provides comprehensive information on the therapeutics under development for Liver Fibrosis (Gastrointestinal), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Liver fibrosis is a scarring process which results in inflammation and liver cell death. Symptoms include abdominal pain, easy bruising, lack of appetite, nausea, tenderness and enlargement of the liver, weight loss and yellowing of skin and eyes. Risk factors include age, heavy alcohol consumption, and chronic infection with hepatitis B or C virus and weakened immune system. Liver Fibrosis (Gastrointestinal) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Companies discussed in this report include  AdAlta Ltd, Advinus Therapeutics Ltd, Allergan Plc, Angion Biomedica Corp, Asubio Pharma Co Ltd, aTyr Pharma Inc, Beijing Kawin Technology Share-Holding Co Ltd, BioLineRx Ltd, Bioneer Corp, BiOrion Technologies BV, Bird Rock Bio Inc, Cellmid Ltd, ContraVir Pharmaceuticals Inc, Dicerna Pharmaceuticals Inc, Dr. Falk Pharma GmbH, Dynavax Technologies Corp, Evotec AG, Galectin Therapeutics Inc, Genfit SA, GenKyoTex SA, GNI Group Ltd, HanAll Biopharma Co Ltd, HEC Pharm Co Ltd, Immuron Ltd, Intercept Pharmaceuticals Inc, INVENT Pharmaceuticals Inc, Isarna Therapeutics GmbH, KineMed Inc, Nitto Denko Corp, Pfizer Inc, Pharmaxis Ltd, Promedior Inc, Promethera Biosciences SA, ProMetic Life Sciences Inc, Ribomic Inc, RXi Pharmaceuticals Corp, Samumed LLC, Silence Therapeutics Plc, Sirnaomics Inc, TaiwanJ Pharmaceuticals Co Ltd, TCM Biotech International Corp, TRACON Pharmaceuticals Inc, Vascular Biogenics Ltd, Virobay Inc plc, and XTuit Pharmaceuticals Inc. Order a Purchase copy of this report @ http://www.rnrmarketresearch.com/contacts/purchase?rname=966744 . (This report is available at upto 25% Discount till June 02nd 2017.) "Liver Fibrosis Global Clinical Trials Review, H2, 2016" provides an overview of Liver Fibrosis clinical trials scenario. This report provides top line data relating to the clinical trials on Liver Fibrosis. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). GlobalData Clinical Trial Reports are generated using GlobalData's proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process. RnRMarketResearch.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 100+ leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports.


The report "Liver Fibrosis - Pipeline Review, H1 2017" provides comprehensive information on the therapeutics under development for Liver Fibrosis (Gastrointestinal), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Liver fibrosis is a scarring process which results in inflammation and liver cell death. Symptoms include abdominal pain, easy bruising, lack of appetite, nausea, tenderness and enlargement of the liver, weight loss and yellowing of skin and eyes. Risk factors include age, heavy alcohol consumption, and chronic infection with hepatitis B or C virus and weakened immune system. Liver Fibrosis (Gastrointestinal) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Companies discussed in this report include  AdAlta Ltd, Advinus Therapeutics Ltd, Allergan Plc, Angion Biomedica Corp, Asubio Pharma Co Ltd, aTyr Pharma Inc, Beijing Kawin Technology Share-Holding Co Ltd, BioLineRx Ltd, Bioneer Corp, BiOrion Technologies BV, Bird Rock Bio Inc, Cellmid Ltd, ContraVir Pharmaceuticals Inc, Dicerna Pharmaceuticals Inc, Dr. Falk Pharma GmbH, Dynavax Technologies Corp, Evotec AG, Galectin Therapeutics Inc, Genfit SA, GenKyoTex SA, GNI Group Ltd, HanAll Biopharma Co Ltd, HEC Pharm Co Ltd, Immuron Ltd, Intercept Pharmaceuticals Inc, INVENT Pharmaceuticals Inc, Isarna Therapeutics GmbH, KineMed Inc, Nitto Denko Corp, Pfizer Inc, Pharmaxis Ltd, Promedior Inc, Promethera Biosciences SA, ProMetic Life Sciences Inc, Ribomic Inc, RXi Pharmaceuticals Corp, Samumed LLC, Silence Therapeutics Plc, Sirnaomics Inc, TaiwanJ Pharmaceuticals Co Ltd, TCM Biotech International Corp, TRACON Pharmaceuticals Inc, Vascular Biogenics Ltd, Virobay Inc plc, and XTuit Pharmaceuticals Inc. Order a Purchase copy of this report @ http://www.rnrmarketresearch.com/contacts/purchase?rname=966744 . (This report is available at upto 25% Discount till June 02nd 2017.) "Liver Fibrosis Global Clinical Trials Review, H2, 2016" provides an overview of Liver Fibrosis clinical trials scenario. This report provides top line data relating to the clinical trials on Liver Fibrosis. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). GlobalData Clinical Trial Reports are generated using GlobalData's proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process. RnRMarketResearch.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 100+ leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports.


Sirnaomics lead product candidate, STP705, is an anti-fibrosis and anti-inflammatory siRNA (small interfering RNA) therapeutic which takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly diminish both fibrotic and inflammatory activity. The product has received both US FDA and Chinese FDA IND approval for Hypertrophic Scar Reduction and it is expected to have efficacy in many diseases across therapeutic areas. The Orphan Drug application was supported by recent studies in vivo that revealed improvement in serum biomarkers and improved fibrosis scoring in CCL4 induced liver fibrosis models. "This is a very significant milestone for Sirnaomics and a strategy we are taking to accelerate our novel siRNA therapeutic programs into clinic and finally to the patient," stated Dr. Patrick Lu, founder and CEO. "The fact that we are able to achieve this designation speaks to the company's ability to execute on its commitment to investors. This is the third major clinical milestone we have achieved in the past six months including our FDA and CFDA IND approval for STP705 for the treatment of Hypertrophic scar reduction. The future looks very encouraging for Sirnaomics and we are very excited to continue our recent noteworthy progress as we move towards multiple clinical programs in 2017 and 2018." "The Orphan designation for PSC is potentially a major win for the clinical management of this devastating disease," stated Dr. Michael Molyneaux, Sirnaomics, Inc. CMO. "It fits very well with our mission to alleviate human suffering and target diseases with high unmet clinical need and, with the current progress of our ongoing IND enabling studies for treatment of human liver fibrosis, we anticipate filing an IND for PSC sometime in the first half of 2018.  PSC is a devastating disease and it is our hope that our ongoing clinical development can lead to a viable treatment alternative for patients living with this disease." About PSC Primary sclerosing cholangitis (PSC) is a chronic fibrotic disease of the liver that causes damage to the bile ducts. Bile is a digestive liquid that is made in the liver and travels through the bile ducts to the gallbladder and the small intestine, where it helps digest fats and fatty vitamins. In patients with PSC, the bile ducts become blocked due to inflammation and fibrosis. This causes bile to accumulate in the liver, where it damages liver cells causing fibrosis and eventually leading to cirrhosis. As cirrhosis progresses the liver slowly loses its ability to function. The scar tissue may block drainage of the bile ducts leading to infection. Many people with PSC will ultimately need a liver transplant, typically about 10 years after being diagnosed with the disease. Patients with PSC also have a very high risk of development of an untreatable form of bile duct cancer known as cholangiocarcinoma. There is currently no approved medical therapy for PSC. Studies have shown that significantly higher expression of TGF-β1 was observed in PSC patient liver samples compared to healthy controls and COX-2 was strongly expressed in PSC-associated Cholangiocarcinoma (CCA) tissues compared with non-neoplastic bile duct epithelial cells (BDECs) in PSC patients. Therefore, STP705's dual-targeted property will be a promising approach for PSC treatment. About STP705 STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, and formulated in nanoparticles with Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs and combining the two siRNA's produces a synergistic effect that diminishes pro-fibrogenic and pro-inflammatory factors. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with fibrosis including: α-SMA, Col1A1, and Col3A1. Additional data suggests that reductions in TGF-β1 and COX-2 led to proapoptotic effects in fibroblasts. These observations suggest that STP705 has the potential for broad application in many inflammatory and fibrotic driven disease states. Orphan Drug Designation The Orphan Drug Act (ODA) from US FDA provides for granting special status to a drug or biological product ("drug") to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA's implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated. About Sirnaomics, Inc. Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The company's mission is to alleviate human suffering and advance patient care in areas of high unmet medical need.  Members of the senior management team have extensive experience in the biopharmaceutical, financial, clinical and business management arenas in both the USA and China and the company is supported with funding from private investors, corporate partnerships and government grants. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of interest include anti-fibrotic and anti-inflammatory disease states as well as cancer (amongst others).


Sirnaomics lead product candidate, STP705, is an anti-fibrosis and anti-inflammatory siRNA (small interfering RNA) therapeutic which takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly diminish both fibrotic activity and inflammatory activity. The product has currently received both US FDA and Chinese FDA IND approval for Hypertrophic Scar Reduction and it is expected to have efficacy in many diseases across therapeutic areas. The two liver fibrosis animal studies were designed to demonstrate the impact of STP705 on liver function biomarker reduction (AST, ALT, and Total Bilirubin) as well as independent blinded pathology, based on the company's initial observation of liver histological improvement of STP705 treated mice using the same CCL4 disease induction model. In the first study, STP705 achieved statistically significant reduction in liver function biomarkers (AST, ALT, and Total Bilirubin) compared to untreated control group, and better efficacy than group treated with OCA (Obeticholic Acid). OCA is an US FDA approved drug for the treatment of patients with Primary Biliary Cholangitis (PBC), and in a clinical phase III study for NASH). The second study demonstrated that STP705 achieved statistically significant reduction in pericelluar fibrosis compared to untreated control group, and equivalent efficacy to group treated with Temisartan (a clinical stage drug for NASH).  When studying the modulation of fibrotic liver disease is it necessary to demonstrate both improvement in potential surrogate endpoint marker such as AST, ALT and Total bilirubin as well as demonstration of histological improvement in liver fibrosis which is currently felt to provide more robust evidence of long term disease modulation.  Both studies were performed by independent animal research Contract Research Organizations having no affiliation with Sirnaomics, Inc. "This is a major milestone for Sirnaomics and the results underscore that we are a company with significant promise in the emerging siRNA space," stated Dr. Patrick Lu, founder and CEO. "We feel strongly that it is our unique delivery system that sets us apart and contributes to the benefits we are witnessing in these independent robust animal liver fibrosis study models. We have a significant portfolio of preclinical IND enabling safety data to support the safety of the platform and we are now witnessing the emergence of encouraging efficacy data across many different disease areas with fibrotic and inflammation disease states being our near-term targets for clinical development. The future looks very encouraging for Sirnaomics and we are very excited to continue our recent significant progress as we move towards multiple clinical programs in 2017 and 2018." "This represent a landmark achievement for Sirnaomics and the results validate our previously stated belief that STP705 has the potential to be a game changer and have significant beneficial impact on fibrotic and inflammatory disease conditions across multiple therapeutic areas," stated Dr. Michael Molyneaux, MD, CMO.  "The fact that STP705 was able to demonstrate statistically significant reduction in both liver biomarker measurements and histology evaluation of liver fibrosis in 2 separate independent fibrotic liver disease models is a ground breaking achievement for our company."  Dr. Molyneaux added, "The knowledge gained from these rigorous large scale animal studies will better prepare us for study in humans and support our upcoming IND filings in human liver fibrosis treatment. It is also very encouraging to see the product is well tolerated in the animal studies with no difference being demonstrated in safety metrics between control groups and treatment groups." "These results support the underlying mechanism of action that is the foundation of this program.  With these findings, an efficient development strategy can be refined, advancing STP705 into clinical study, FDA review and patient care," observed Brian E. Harvey, MD, PhD, retired FDA Gastroenterology Division Director and advisor to Sirnaomics.  "With the new commitment by FDA to Biomarkers under the recently passed 21st Century Cures Act, STP705 is positioned to take advantage of the evolving regulatory paradigm in the U.S." Fibrosis of the liver and its end stage, cirrhosis, represents a massive public health burden throughout the world with increasing incidence on a global scale. In the West, the main causes of liver fibrosis are chronic hepatitis C infection, alcohol consumption and NASH (non-alcoholic steatohepatitis). In the Middle East and Asia, viral hepatitis predominates as the major causes of liver fibrosis leading to end stage liver disease.  The recent changing patterns of alcohol consumption in the West and the increasing incidence of the metabolic syndrome suggests that the rapid advances in preventing and treating viral hepatitis may be offset by an increasing burden of fibrosis and cirrhosis related to alcohol and NASH. The therapeutic options for the treatment of liver fibrosis and cirrhosis is severely limited and is related to two main broad categories. Removal of the underlying injurious stimulus when possible, such as viral eradication in hepatitis B- and C-mediated liver disease, and Liver transplantation. The recent advances in treatment of viral hepatitis and the expected shift toward non-viral causes of liver fibrosis, highlights the urgent need for effective anti-fibrotic therapies. STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, and formulated in nanoparticles with Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs and combining the two siRNA's produces a synergistic effect that diminishes pro-fibrogenic and pro-inflammatory factors. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with fibrosis including: α-SMA, Col1A1, and Col3A1. Additional data suggests that reductions in TGF-β1 and COX-2 led to a proapoptotic effects in fibroblasts. These observations suggest that STP705 has the potential for broad application in many inflammatory and fibrotic driven disease states. Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The company's mission is to alleviate human suffering and advance patient care in areas of high unmet medical need.  Members of the senior management team have extensive experience in the biopharmaceutical, financial, clinical and business management arenas in both the USA and China and the company is supported with funding from private investors, corporate partnerships and government grants. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of interest include anti-fibrotic and anti-inflammatory disease states as well as cancer amongst others. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sirnaomics-advances-leading-sirna-therapeutic-candidate-stp705-for-treatment-of-liver-fibrosis-300474135.html


MarketStudyReport.com adds “Diabetic Retinopathy Market Size By Type (Proliferative Diabetic Retinopathy, Non-Proliferative Diabetic Retinopathy), By Management (Anti VEGF Drug, Intra-ocular Steroid Injections, Laser Surgeries, Vitrectomy), Industry Analysis Report, Regional Outlook (U.S., Canada, UK, Germany, Japan, China, Brazil, South Africa), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 ? 2023” new report to its research database. The report spread across 73 pages with table and figures in it. Diabetic Retinopathy Market size was evaluated at $6.51 billion for 2015 and CAGR of 6.9% was predicted during forecast period. Growing old age population, increasing occurrence of diabetes, fast rise in cases of blindness and rising consciousness about early identification of diabetic retinopathy are the few factors driving the industry expansion. Diabetic retinopathy is an eye disorder that causes damage to the retina blood vessels. It is a common diabetic condition affecting eyes. Persons suffering from diabetes are at greater risk of developing diabetic retinopathy. The condition is mainly caused by high levels of glucose in blood producing changes in eye blood vessels. Retinopathy treatment depends upon ailment phase and is aimed at blocking its growth. Corticosteroids injections, vitrectomy and laser surgery are few of the available ailment treatments. U.S. Diabetic Retinopathy Market size, by management, 2012 ? 2023 (USD Million) U.S. Diabetic Retinopathy Market size, by management, 2012 ? 2023 (USD Million) Screening of retina and line of treatment depends upon the seriousness of the situation ensuring delivery of proper treatment. Diabetes is considered to be main cause of blindness in people. To avoid blindness, people are demanding methods for early identification of ailment, fuelling diabetic retinopathy market trends. Also, old age population is more prone for contracting the ailment and hence promotes the industry growth. Further, technological breakthroughs in retinal screening methods and equipments like utilization of slit lamps and launching of new products like Gly-230 & Optima are the factors predicted to drive the industry expansion. Growing occurrence of diabetes predicted to affect more than 4.6% of world population will also enhance the industry growth. Industry Segmentation Types Different types of diabetic retinopathy are non-proliferative and proliferative. Non-proliferative retinopathy led the industry by contributing more than $4.6 billion in 2015. Growing diabetes occurrence, non-compliant retinal screening of patients and lack of right time diagnosis are factors predicted to fuel the increase in the industry share of non-proliferative retinopathy. Proliferative retinopathy is predicted to register highest CAGR of 7.5% during forecast timeframe. Rising occurrence of diabetes and increasing amount of old age population predicted to enter proliferative retinopathy phase will fuel the industry demand. Treatments Various treatments in diabetic retinopathy are anti-VEGF therapy, laser surgery, vitrectomy and intraocular steroid injection. Anti-VEGF contributed large portion of the industry share in 2015 due to popular utilization of these medicines in treating the ailment and helping patients to recover quickly. But, laser surgery is predicted to register CAGR of 9.4% during the forecast period which is highest among segments. Demand for laser surgery will grow enormously in future owing to increase in aging population and growing occurrence of diabetes all across the world. Regions North America is predicted to contribute maximum revenue share in access of $4 billion by end of forecast timeframe. Growing access to anti-VEGF items like lucentis, eyelea and avastin along with growing consciousness for early diagnosis to avoid further blindness related with diabetes are the factors predicted to drive the industry demand in the region. In 2012, rate of occurrence of diabetic retinopathy in U.S. was predicted to be 5.41% as per Prevent Blindness America with Arizona, New Mexico, Florida, California, Texas and New York having greatest density. In addition to this, favorable regulations, good healthcare facilities and fully grown healthcare infrastructure along with rapid access to different kinds of treatments are few of the key factors driving the industry growth in North America. Further, the old age population base of the region was measured nearly about 67.61 million for 2012 and predicted to touch approximately 81.61 million in 2022. This is also one of the key aspects contributing towards industry dominance by the region MEA and Latin America are predicted to register CAGR of 10.2% and 7.2% respectively and display a good industry growth during forecast timeframe. Favorable government policies and medical guidance are predicted to enhance the rate of detection and treatment propelling diabetic retinopathy market growth in these regions. Growing cases of diabetes mellitus and lack of skilled ophthalmologists are few of the factors contributing to the industry growth in Brazil. Key industry participants profiled in the report include: Actavis PLC Kowa Group ThromboGenics Bayer Healthcare Ampio Pharmaceuticals Glycadia Pharmaceuticals Novartis AG BCN Peptides Regeneron Pharmaceuticals Incorporation Alimera Sciences Genentech Sirnaomics Incorporation To receive personalized assistance, write to us @ [email protected] with the report title in the subject line along with your questions or call us at +1 866-764-2150

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