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Myocardial revascularization is an alternate procedure for patients suffering from ischemic heart disease and who cannot undergo interventions like heart bypass surgery due to widespread coronary artery disease, procedure failure, small coronary arteries, or cardiac stenosis. Further, reparative stem cells can restore the function of damaged tissue by renewing cell growth in cardiac cells destroyed by heart disease.

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Introduction

Although novel drugs have successfully entered the clinical arena of heart failure with reduced ejection fraction (HFrEF), such as the PARADIGM-HF-derived angiotensin receptor neprilysin inhibitor (ARNI), disease-modifying therapies with a prognostic impact for patients affected by heart failure with preserved ejection fraction (HFpEF) are still lacking.15 HF is a complex and highly prevalent syndrome for which the heart undergoes a substantial structural remodeling in patients at risk for major cardiovascular diseases (CVDs) (Figure 1).16 Geneenvironment interactions can be mediated by specific patterns of epigenetic-sensitive changes (mainly DNA methylation and histone modifications) which may modulate the individual responsiveness to HF development.614 This complex molecular circuit seems to trigger early cardiomyocyte loss, cardiac-remodeling, and micro- and macrovascular damage contributing to the development of major CVDs which may lead to differential HF clinical phenotypes.614 Of note, the reversible nature of epigenetic-sensitive changes has been translated in the clinical management of specific hematological malignancies with the approval by the Food and Drug Administration (FDA) of some epidrugs, such as decitabine (Dacogen) and azacitidine (Vidaza), as DNA methylation inhibitors, as well as vorinostat (Zolinza), belinostat (Beleodaq), romidepsin (Istodax), and panobinostat (Farydak), as histone deacetylase inhibitors (HDACi).15 Epidrugs are now providing a novel vision for personalized therapy of HF and heart transplantation, opening up novel options for management of the affected patients.1518 At molecular level, we can classify the epidrugs in: direct epidrugs [eg, the bromodomain and extra-terminal (BET) protein inhibitor apabetalone]; and repurposed drugs with potential, indirect (non-classical) epigenetic-oriented interference by which they may exert cardioprotective functions [eg, hydralazine, metformin, statins, and sodium-glucose co-transporter-2 inhibitors (SGLT2i)] or nutraceutical compounds [eg, omega-3 polyunsaturated fatty acids (PUFAs)]. Encouraging results are coming from large randomized trials evaluating the putative beneficial effects of combining epidrugs with the conventional therapy in patients with HF.1422 Our goal is to update on the emerging epigenetic-based strategies which may be useful in the prevention and treatment of HFrEF and HFpEF (Figure 1).

Figure 1 The possible role of epitherapy in the current framework of HFrEF and HFpEF management. The unstable transition state from the ACC/AHA Stage A/B to Stage C/D-Acute/Hospitalized HF is the key point in the treatment of HFrEF and HFpEF. The epitherapy, mainly apabetalone, statins, metformin, SGLT2i, and PUFAs in addition to the standard of the care may improve personalized therapy of affected patients.

Abbreviations: HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; SGLT2i, sodium glucose co-transporter 2 inhibitors; PUFAs, polyunsaturated fatty acids.

The bromodomain and extra terminal domain (BET) proteins, including the ubiquitous BRD2, BRD3, BRD4, and the testis-restricted BRDT, are epigenetic readers (via bromodomains) existing in the form of nuclear multidomain docking platforms which control the cell-specific activation of gene expression profiles.23 Experimental data demonstrated that BETs regulate vascular cells, cardiac myocytes, and inflammatory cells,24 and their activity may be extended to the regulation of calcification, thrombosis, as well as lipid and lipoprotein metabolism, all of which participate in atherogenesis.2527 In particular, BRD4 facilitated the expression of multiple proinflammatory and proatherosclerotic targets involved in thrombosis, leukocyte adhesion, and endothelial barrier function, thus identifying BRD4 as a possible therapeutic target in CVD setting.24 The quinazolone (RVX-208), known as apabetalone, is a derivative of the plant polyphenol resveratrol. Apabetalone acts as a direct epidrug by selectively targeting the BET family member BRD4 to block its interaction with acetylated lysines located in histones.28 Apabetalone-BRD4 binding can impact cholesterol levels and inflammation; in fact, apabetalone stimulates ApoA-I gene expression and increases high-density lipoprotein (HDL).29,30 Besides, apabetalone may attenuate the development of cardiac hypertrophy31 and cardiac fibrosis,32 suggesting novel options for the management of HF.

Resverlogix developed apabetalone (RVX-208), a first-in-class, orally available, small molecule for the treatment of atherosclerosis and associated CVDs.20 BETonMACE (NCT02586155) is the first Phase 3 clinical trial evaluating the cardiovascular efficacy and safety of apabetalone.22 Recent results from the BETonMACE study have demonstrated that apabetalone is associated with a reduction in first HF hospitalization and cardiovascular death in patients with type 2 diabetes and recent acute coronary syndrome as compared to controls (placebo-treated patients).22 Additionally, a significant increase in HDL and a decrease in alkaline phosphatase levels have been observed following 24 weeks of apabetalone treatment as compared to the placebo group.22 However, investigators were unable to make a distinction between HF in the setting of preserved or reduced ejection fraction. Thus, further clinical trials should be designed to evaluate the putative beneficial effects of apabetalone in HFrEF and HFpEF, separately.

Preclinical studies demonstrated that pharmacological HDACi,3336 BET inhibitors,31,37 and DNA methylation inhibitors38 can attenuate cardiac remodeling (cardiomyocyte hypertrophy and fibrosis). Although not originally developed as epidrugs, hydralazine (anti-hypertensive drug), metformin, and SGLT2i (anti-diabetic drugs), statins (anti-dyslipidemic drugs), and PUFAs (nutraceuticals) might have downstream epigenetic-oriented effects in cardiac cells. Hydralazine, for example, lowers blood pressure by a direct relaxation of vascular smooth muscle; additionally, it may reduce DNA methylation and improve cardiac function through increasing sarcoplasmic reticulum Ca2+-ATPase (SERCA2a) and modulating calcium homeostasis in cardiomyocytes.39 Statins are used as a first-line treatment to decrease serum cholesterol levels in dyslipidemic patients and as primary and secondary prophylaxis against atherosclerosis and associated CVDs.6 Many of their non-classical pleiotropic properties relevant for endothelial health are mediated by epigenetic mechanisms which improve blood flow, decrease LDL oxidation, enhance atherosclerotic plaque stability and decrease proliferation of vascular smooth muscle cells and platelet aggregation.6 Metformin is a first-line drug in the treatment of overweight and obese type 2 diabetic patients.10 Mechanistically, metformin may also have epigenetic-oriented effects through activating the AMP-activated protein kinase (AMPK) which, in turn, can phosphorylate and inhibit epigenetic enzymes such as histone acetyltransferases (HATs), class II HDAC, and DNA methyltransferases (DNMTs).40 Both metformin41,42 and statins43,44 may reduce cardiac fibrosis; however, whether their beneficial effects are mediated by epigenetic-oriented responses has yet to be demonstrated. Furthermore, SGLT2i are a new group of oral drugs used for treating type 2 diabetes and its cardiovascular/renal complications.45 Animal models have demonstrated that empagliflozin46,47 and dapagliflozin48 may improve hemodynamics in HF by increasing renal protection and cardiac fibrosis. Interestingly, inflammation and glucotoxicity (AGE/RAGE signaling) were epigenetically prevented by empagliflozin;49 this observation has provided insights about mechanisms by which SGLT2i can reduce cardiovascular mortality in man (EMPA-REG trial).50

An effective therapy for HFpEF has yet to be established. Hydralazine is frequently used in HFrEF, and represents a potential DNA methylation inhibitor.39 DNA methylation is the most studied direct epigenetic change with potential clinical implications in major CVDs and the development of HF.7,14 This epigenetic signature mainly involves methylation of CpG islands in the gene promoters leading to a specific long-term silencing of gene expression.7,14 A completed Phase 2 clinical trial (NCT01516346) evaluated the effect of prolonged therapy (24 weeks) with isosorbide dinitrate (ISDN) hydralazine on arterial wave reflections (primary endpoint) as well as left ventricular (LV) mass, fibrosis and diastolic function, and exercise capacity (6-minute walk test) in patients with HFpEF, New York Heart Association (NYHA) Class IIIV symptoms, and standard therapy as defined by ACEi, ARB, beta-blockers, or calcium channel blockers (CCBs).51 Results from this trial reported that ISDN, with or without hydralazine, had deleterious effects on reflection magnitude, LV remodeling, or submaximal exercise thus not supporting their routine use in patients with HFpEF.51

Metformin has been associated with a reduced mortality in patients with HFpEF, even if female gender was associated with worse outcomes.52 Recently, it has been observed that a long-term treatment with metformin can improve LV diastolic function and hypertrophy, decrease the incidence of new-onset HFpEF, and delay disease progression in patients with type 2 diabetes and hypertension.53 Besides, a prospective phase 2 clinical trial (NCT03629340) is testing the therapeutic efficacy of metformin in patients with pulmonary hypertension and HFpEF by evaluating exercise hemodynamics, functional capacity, skeletal muscle signaling, and insulin sensitivity. However, results have not been published. A recent study based on the JASPER registry, a multicenter, observational, prospective cohort of Japanese patients aged 20 years requiring hospitalization for acute HFpEF has reported that the use of statins could reduce mortality in affected patients without coronary heart disease.54 Furthermore, the use of statins was associated with improved clinical outcomes in patients with HFpEF but not in patients with HFrEF (or mid-range ejection fraction).55 A reduced rate of major adverse cardiac events, cardiovascular death and all-cause mortality was associated with SGLT2i treatment in both HFpEF and HFrEF patients as compared to placebo.56,57 However, the observed cardiovascular and renal benefits cannot be fully explained by improvement in risk factors (such as glycemia, blood pressure or dyslipidemias) suggesting that other molecular mechanisms may explain the cardiovascular benefits.56 Interestingly, the SGLT2i-related epigenetic interference may arise from their ability to increase the circulating and tissue levels of -hydroxybutyrate, a specific molecule able to generate a pattern of histone modifications (known as -hydroxybutyrylation) which are associated with the beneficial effects of fasting.58 Besides, the DELIVER (NCT03619213) multicenter, randomized, double-blind, placebo-controlled study of 6263 HFpEF patients will evaluate the effect of dapagliflozin 10 mg (1 per day) as compared to placebo in addition to the standard of care in order to reduce the composite of cardiovascular death or HF events. However, results have not yet been published.

The use of metformin has been generally considered a contraindication in HFrEF patients owing the potential risk of lactic acidosis; however, recent evidence has reported that metformin can provide beneficial effects in reducing the risk of incident HF and mortality in diabetic patients.5961 A completed, observational clinical trial (NCT03546062) has recently performed the evaluation of seriated cardiac biopsies from healthy implanted hearts in type 2 diabetes recipients during 12-month follow-up upon heart transplantation.21 Even if the intra-cardiomyocyte lipid accumulation in type 2 diabetes recipients may start in the early stages after heart transplantation, metformin therapy could reduce lipid accumulation independently of immunosuppressive therapy.21 The DANHEART trial (NCT03514108), a multicenter, randomized, double-blind, placebo-controlled study in 1500 patients with HFrEF will evaluate: 1) whether hydralazine-isosorbide dinitrate as compared to placebo may reduce the incidence of death and HF hospitalization, and 2) if metformin as compared to placebo may reduce the incidence of death, worsening of HF, acute myocardial infarction, and stroke in patients with diabetes or prediabetes. Two large randomized trials demonstrated that statins did not have beneficial effects in management of patients with HFrEF.62,63 Specifically, the CORONA phase 3 trial randomized more than 5000 patients with ischemic HFrEF to rosuvastatin as compared to placebo resulting in no benefits on the primary endpoints, as death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke.62 According to CORONA trial, the GISSI-HF study randomized almost 5000 patients with clinically apparent HF of any cause to rosuvastatin as compared to placebo and observed no benefits on the primary endpoints, as all-cause death or cardiovascular hospitalization.63 However, it is needed to highlight that both trials demonstrated that statins are safe in HF patients. In contrast with the previous evidence, the trial based on the Swedish Heart Failure Registry (21,864 patients with HFrEF, of whom 10,345 were treated with statins) reported an association between the use of statins and improved outcomes, as all-cause mortality, cardiovascular mortality, HF hospitalization, and combined all-cause mortality or cardiovascular hospitalization, especially in patients with ischemic HF.64 Thus, further randomized controlled trials focused on ischemic HF may be warranted. Omega-3 polyunsaturated fatty acids (PUFAs), mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are key players in modulating inflammatory process by limiting leucocyte chemotaxis, adhesion molecule expression, leucocyte-endothelium interaction as well as T cell reactivity.65 EPA and DHA are mainly gained from marine food consumption and large population-based studies have shown that Mediterranean diet with PUFA supplementation may aid to prevent CVDs owing to their ability in promoting the release of nitric oxide from endothelial cells and decreasing serum levels of triglycerides.66 Recent evidence has indicated that PUFAs can significantly affect the cellular epigenome mainly thought DNA methylation-sensitive mechanisms.67,68 The GISSI multicenter, double-blind trial enrolled 6975 HF patients (New York Heart Association class IIIV, irrespective of cause and LV ejection fraction) and randomized them to low dose (0.84 g per day) of PUFAs as compared to placebo. PUFAs supplementation reduced risk for total mortality and HF hospitalization when added to standard therapy.19 Furthermore, in the OMEGA-REMODEL trial, high-dose of PUFAs (3.4 g per day) for 6 months post-myocardial infarction reduced infarct size and non-infarct myocardial fibrosis as well as improved ventricular systolic function.69 Taken together, these results suggest that PUFAs may aid to prevent HFrEF. More recently, the MESA longitudinal trial including 6562 participants 45 to 84 years has demonstrated that higher plasma levels of EPA were significantly associated with reduced risk both in HFpEF and HFrEF.70

Although the possibility of improving the HF standard of care with epidrugs is still in its infancy, the BETonMACE study has provided promising results about the use of apabetalone in reducing hospitalization and cardiovascular death. Preclinical models of cardiac remodeling demonstrated that metformin, statins, SGLT2i, and PUFAs4148 can improve vascular health and cardiac fibrosis by modulating specific molecular pathways, and, in part, through downstream epigenetic interference, especially for hydralazine39 and empagliflozin (Figure 2).49 Of note, metformin and SGLT2i can impact on the epigenetic memory phenomenon. This latter suggests that an early glycemia normalization can arrest hyperglycemia-induced epigenetic processes associated with enhanced oxidative stress and glycation of cellular proteins and lipids.71,72 In parallel, an increasing number of clinical trials is evaluating the putative beneficial repurposing of metformin, statins, SGLT2i, and PUFAs in patients with HFpEF and/or HFrEF;19,6264,69,7375 however, despite experimental evidence, none of these trials evaluated their potential epigenetic effects involved in improving the cardiac function. This gap should be overcome to improve personalized therapy of patients with HF. Thus, further randomized trials are needed to clarify whether apabetalone, as well as non-canonical repurposed epidrugs, will really be able to save failing hearts in different HF clinical phenotypes or prevent irreversible damages in high-risk patients. In this context, Network Medicine approaches may help to evaluate a possible repurposing of epidrugs in patients with major CVDs.15,76,77

Figure 2 Direct and indirect epigenetic drugs in preclinical models of HF. Cardiac remodeling includes different pathological phenotypes and each type of drug can selectively improve inflammation, cardiac fibrosis and hypertrophy, calcium homeostasis, and lipid metabolism.

Abbreviations: HF, heart failure; SGLT2i, sodium glucose co-transporter 2 inhibitors.

This work was supported by PRIN2017F8ZB89 from Italian Ministry of University and Research (MIUR) (PI Prof Napoli) and Ricerca Corrente (RC) 2019 from Italian Ministry of Health (PI Prof. Napoli).

The authors report no conflicts of interest in this work.

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54. Marume K, Takashio S, Nagai T, et al. Effect of statins on mortality in heart failure with preserved ejection fraction without coronary artery disease. Report from the JASPER Study. Circ J. 2019;83:357367. doi:10.1253/circj.CJ-18-0639.

55. Lee MS, Duan L, Clare R, et al. Comparison of effects of statin use on mortality in patients with heart failure and preserved versus reduced left ventricular ejection fraction. Am J Cardiol. 2018;122:405412. doi:10.1016/j.amjcard.2018.04.027.

56. Lam CSP, Chandramouli C, Ahooja V, Verma S. SGLT-2 inhibitors in heart failure: current management, unmet needs, and therapeutic prospects. J Am Heart Assoc. 2019;8:e013389. doi:10.1161/JAHA.119.013389.

57. Zannad F, Ferreira JP, Pocock SJ, et al. SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials. Lancet. 2020;396:819829. doi:10.1016/S0140-6736(20)31824-9.

58. Nishitani S, Fukuhara A, Shin J, et al. Metabolomic and microarray analyses of adipose tissue of dapagliflozin-treated mice, and effects of 3-hydroxybutyrate on induction of adiponectin in adipocytes. Sci Rep. 2018;8:8805. doi:10.1038/s41598-018-27181-y.

59. Wong AK, AlZadjali MA, Choy AM, et al. Insulin resistance: a potential new target for therapy in patients with heart failure. Cardiovasc Ther. 2008;26:203213. doi:10.1111/j.1755-5922.2008.00053.x.

60. Pantalone KM, Kattan MW, Yu C, et al. The risk of developing coronary artery disease or congestive heart failure, and overall mortality, in type 2 diabetic patients receiving rosiglitazone, pioglitazone, metformin, or sulfonylureas: a retrospective analysis. Acta Diabetol. 2009;46:145154. doi:10.1007/s00592-008-0090-3.

61. Papanas N, Maltezos E, Mikhailidis DP. Metformin and heart failure: never say never again. Expert Opin Pharmacother. 2012;13:18. doi:10.1517/14656566.2012.638283.

62. Kjekshus J, Apetrei E, Barrios V, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007;357:22482261. doi:10.1056/NEJMoa0706201.

63. Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:12311239. doi:10.1016/S0140-6736(08)61240-4.

64. Alehagen U, Benson L, Edner M, et al. Association between use of statins and outcomes in heart failure with reduced ejection fraction: prospective propensity score matched cohort study of 21 864 patients in the Swedish Heart Failure Registry. Circ Heart Fail. 2015;8:252260. doi:10.1161/CIRCHEARTFAILURE.114.001730.

65. Calder PC. Omega-3 polyunsaturated fatty acids and inflammatory processes: nutrition or pharmacology? Br J Clin Pharmacol. 2013;75:645662. doi:10.1111/j.1365-2125.2012.04374.x.

66. Mohebi-Nejad A, Bikdeli B. Omega-3 supplements and cardiovascular diseases. Tanaffos. 2014;13:614.

67. Burdge GC, Lillycrop KA. Fatty acids and epigenetics. Curr Opin Clin Nutr Metab Care. 2014;17:156161. doi:10.1097/MCO.0000000000000023.

68. de la Rocha C, Prez-Mojica JE, Len SZ, et al. Associations between whole peripheral blood fatty acids and DNA methylation in humans. Sci Rep. 2016;6:25867. doi:10.1038/srep25867.

69. Heydari B, Abdullah S, Pottala JV, et al. Effect of omega-3 acid ethyl esters on left ventricular remodeling after acute myocardial infarction: the OMEGA-REMODEL randomized clinical trial. Circulation. 2016;134:378391. doi:10.1161/CIRCULATIONAHA.115.019949.

70. Block RC, Liu L, Herrington DM, et al. Predicting risk for incident heart failure with omega-3 fatty acids: from MESA. JACC Heart Fail. 2019;7:651661. doi:10.1016/j.jchf.2019.03.008.

71. Berezin A. Metabolic memory phenomenon in diabetes mellitus: achieving and perspectives. Diabetes Metab Syndr. 2016;10:S17683. doi:10.1016/j.dsx.2016.03.016.

72. Sommese L, Benincasa G, Lanza M, et al. Novel epigenetic-sensitive clinical challenges both in type 1 and type 2 diabetes. J Diabetes Complications. 2018;32:10761084. doi:10.1016/j.jdiacomp.2018.08.012.

73. Trum M, Wagner S, Maier LS, et al. CaMKII and GLUT1 in heart failure and the role of gliflozins. Biochim Biophys Acta Mol Basis Dis. 2020;1866:165729. doi:10.1016/j.bbadis.2020.165729.

74. Nikolic M, Zivkovic V, Jovic JJ, et al. SGLT2 inhibitors: a focus on cardiac benefits and potential mechanisms. Heart Fail Rev. 2021. doi:10.1007/s10741-021-10079-9.

75. Mohammadzadeh N, Montecucco F, Carbone F, et al. Statins: epidrugs with effects on endothelial health? Eur J Clin Invest. 2020;50:e13388. doi:10.1111/eci.13388.

76. Benincasa G, DeMeo DL, Glass K, Silverman EK, Napoli C. Epigenetics and pulmonary diseases in the horizon of precision medicine: a review. Eur Respir J. 2020 Nov 19:2003406. doi:10.1183/13993003.03406-2020.77.

77. Benincasa G, Marfella R, Della Mura N, et al. Strengths and opportunities of network medicine in cardiovascular diseases. Circ J. 2020 Jan 24;84(2):144152. doi:10.1253/circj.CJ-19-0879.

Original post:
Epigenetic therapies for heart failure | VHRM - Dove Medical Press

A passion for the natural world drives many of our adventures. And when were not actually outside, we love delving into the discoveries about the places where we live and travel. Here are some of the best natural history links weve found this week.

Elephants are dying in droves in Botswana: Between January and March 2021, 39 Africa elephants turned up dead in Botswana. All deaths occurred in the Moremi Game Reserve, the same region where 350 elephants died in mid-2020. Preliminary results indicate that cyanobacteria toxins are to blame. Water sources in the area are becoming warmer, creating an environment in which the toxic cyanobacteria thrive.

Scientists have grown a mini beating heart: Researchers in Vienna have grown tiny 3D heart-like organs in the lab. Made from human stem cells, the organoids, as theyre called, are the size of a sesame seed and beat the same way our hearts do. Unlike previous efforts that required artificial scaffolding, these cells organized themselves to grow a hollow chamber. Scientists hope that the mini-hearts will provide a better understanding of how the cardiac system responds to disease.

The largest iceberg in the world. Photo: ESA/Earth Observation

Worlds largest iceberg breaks away from Antarctic ice shelf: An iceberg bigger than Majorca has broken away from the Ronne Ice Shelf into the Weddell Sea. Unimaginatively named A-76, the iceberg is 4,320 square kilometres in area and is currently the largest iceberg in the world. Of course, it is bigger than Rhode Island, the standard comparison for such giant objects. The Antarctic region from which it comes is generally unaffected by climate change. [The break-off] is part of a natural cycle, says Alex Brisbourne, a glaciologist at the British Antarctic Survey.

Scientists dig deepest ocean hole in history: Researchers off the coast of Japan have drilled the deepest ocean hole in the history in the Pacific Ocean. The hole reaches nine kilometres below the surface of the ocean. It took just two hours and 40 minutes for the giant piston corer to reach the bottom of the Japan Trench. The team extracted a 37m-long sediment core from the bottom of the sea. The site is very close to the epicentre of the 2011 Tohoku-oki earthquake, the largest ever to strike Japan. Scientists hope that the sediments will help them understand the regions earthquake history.

Researcher want to find out if tardigrades could survive in space. Photo: Forbes.com

Tardigrades shot from gun to see if they can survive space travel: Tardigrades, also known as water bears and moss piglets, are microscopic invertebrates that are found almost everywhere water exists. If required (by drought, for example), they are able to drain their cells of liquid and enter suspended animation. In this state, they can survive everything from subzero temperatures to radiation. Researchers have put the Tardigrades into nylon bullets and fired them at sand targets in a vacuum chamber at speeds of up to 1,000 metres per second to see if they could withstand being shot onto other planets.

Death Valley is no longer the hottest place on Earth: Death Valley has held the record for the worlds hottest air temperature since 1913 when Furnace Creek reached 56.7C. Recently, two locations have surpassed Death Valley at its hottest. Satellite data reveal that the Lut Desert in Iran and the Sonoran Desert along the Mexican-U.S. border have reached a sizzling 80.8C.

Rebecca is a freelance writer and science teacher based in the UK.

She is a keen traveler and has been lucky enough to backpack her way around Africa, South America, and Asia. With a background in marine biology, she is interested in everything to do with the oceans and aims to dive and open-water swim in as many seas as possible.

Her areas of expertise include open water sports, marine wildlife and adventure travel.

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Science Links of the Week Explorersweb - ExplorersWeb

Exosome therapeutic marketis expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

International Exosome Therapeutic market report offers the best market and business solutions to pharmaceutical industry in this rapidly revolutionizing market place to thrive in the market. Market definition of the document gives the scope of particular product with respect to the driving factors and restraints in the market. Competitor strategies such as new product launches, expansions, agreements, joint ventures, partnerships, and acquisitions can be utilized well by the pharmaceutical industry to take better steps for selling goods and services. Exosome Therapeutic market analysis report is a careful investigation of current scenario of the market and future estimations which spans several market dynamics.

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The major players covered in the report are evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global. Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Key questions answered in Exosome Therapeutic Report:

Scope of the Exosome Therapeutic Market

The global exosome therapeutic market is segmented on the basis of countries into U.S., Mexico, Turkey, Hong Kong, Australia, South Korea, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua and Uruguay.

All country based analysis of the exosome therapeutic market is further analyzed based on maximum granularity into further segmentation. On the basis of type, the market is segmented into natural exosomes and hybrid exosomes. Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. On the basis of therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. On the basis of transporting capacity, the market is segmented into bio macromolecules and small molecules. On the basis of application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. On the basis of route of administration, the market is segmented into pa oral and parenteral. On the basis of end user, the market is segmented into hospitals, diagnostic centers and research & academic institutes and others.

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Exosome Therapeutic Market Drivers:

Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

Exosome Therapeutic Market Restraints:

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market.

TOC of Exosome Therapeutic Market Report Contains:

Request for Detailed TOC:https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market&kb

Customization Available:Global Exosome Therapeutic Market

Data Bridge Market Researchis a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customised to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analysed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.

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Global Exosome Therapeutic Market Updates, Future Growth, Industry Analysis and Comprehensive Study on Key Players-ReNeuron Group plc, Capricor...

The Induced Pluripotent Stem Cells market is expected to grow at a CAGR of 8.77% and is poised to reach $XX Billion by 2027 as compared to $XX Billion in 2020. The factors leading to this extraordinary growth is attributed to various market dynamics discussed in the report. Our experts have examined the market from a 360 degree perspective thereby producing a report which is definitely going to impact your business decisions.In order to make a pre-order inquiry, kindly click on the link below:-https://decisivemarketsinsights.com/induced-pluripotent-stem-cells-market/93040505/pre-order-enquiry

Key Companies Operating in this Market

Thermo Fisher Scientific Inc., FUJIFILM Corporation, Horizon Discovery Ltd., Takara Bio Inc, Cell Applications, Inc., Lonza Group AG, Evotec A.G., ViaCyte, Inc., CELGENE CORPORATION, Fate Therapeutics, Astellas Pharma Inc.,

Market by Type(Hepatocytes, Fibroblasts, Keratinocytes, Amniotic Cells, Neuronal Cells, Cardiac Cells, Vascular Cells, Immune Cells, Renal Cells, Liver Cells, Others

Market by ApplicationAcademic Research, Drug Development & Discovery, Toxicity Screening, Regenerative Medicine

The report initiated at DECISIVE MARKETS INSIGHTS describes the various business activities of a particular company to give the readers an overall idea about the process which a company follows to create an advantage for itself from a competitive angle thus depicting a thorough overall idea about the Value Chain analysis. Several effective strategies are prevailing in the current global Induced Pluripotent Stem Cells Market that can be implemented for effective organizational growth over the forecasted period of 2020-2027. Some of the key investment areas are thoroughly elucidated in the report as well as an overall idea about conducting the process of modern Induced Pluripotent Stem Cells Market evaluation is well-included.

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A technique known as Real-estate crowd funding is becoming immensely popular in the modern market nowadays. It is the process of raising an adequate amount of money for investment in the real estate sector of businesses worldwide by reaching out to a handful of investor groups for assistance with a little amount of money. A lot of effective strategies are implemented for promoting the overall market like email marketing, product promotion, affiliate marketing, and various other social media platforms.

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Induced Pluripotent Stem Cells Market 2021 | Industry Scenario and Key Vendors Thermo Fisher Scientific Inc., FUJIFILM Corporation, Horizon Discovery...

Full Guideline: Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice GuidelineJCEM | March 2018

Shalender Bhasin, Juan P. Brito, Glenn R. Cunningham, Frances J. Hayes, Howard N. Hodis, Alvin M. Matsumoto, Peter J. Snyder, Ronald S. Swerdloff, Frederick C. Wu, Maria A. Yialamas

Differences between the 2010 and 2018 guidelines:

+1.0 Diagnosis of Hypogonadism in Men

1.1 We recommend diagnosing hypogonadism in men with symptoms and signs of testosterone deficiency and unequivocally and consistently low serum total testosterone and/or free testosteroneconcentrations (when indicated). (1 |O)

1.2 We recommend against routine screening of men in the general population for hypogonadism. (1 |OO)

1.3 In men who have hypogonadism, we recommend distinguishing between primary (testicular) and secondary (pituitaryhypothalamic) hypogonadism by measuring serum luteinizing hormone and follicle stimulating hormone concentrations. (1 |O)

1.4 In men with hypogonadism, we suggest further evaluation to identify the etiology of hypothalamic, pituitary, and/or testicular dysfunction. (2 |OO)

+2.0 Treatment of Hypogonadism with Testosterone

2.1 We recommend testosterone therapy in hypogonadal men to induce and maintain secondarysex characteristics and correct symptoms of testosterone deficiency. (1 |O)

2.2. We recommend against testosterone therapy in men planning fertility in the near term or in men with breast or prostate cancer, a palpable prostate nodule or induration, a prostate-specific antigen level >4 ng/mL, a prostate-specific antigen level >3 ng/mL combined with a high risk of prostate cancer(without further urological evaluation), elevated hematocrit, untreated severe obstructive sleep apnea,severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke withinthe last 6 months, or thrombophilia. (1 |OO)

2.3 In hypogonadal men 55 to 69 years old, who are being considered for testosterone therapy andhave a life expectancy >10 years, we suggest discussing the potential benefits and risks of evaluatingprostate cancer risk and prostate monitoring and engaging the patient in shared decision makingregarding prostate cancer monitoring. For patients who choose monitoring, clinicians should assessprostate cancer risk before starting testosterone treatment and 3 to 12 months after starting testosterone. (2 |OOO) In hypogonadal men being considered for testosterone therapy who are 40 to69 years old and at increased risk of prostate cancer (e.g., African Americans and men with a first-degreerelative with diagnosed prostate cancer), we suggest discussing prostate cancer risk with the patient andoffering monitoring options. (2 |OOO)

2.4 We suggest against routinely prescribing testosterone therapy to all men 65 years or older withlow testosterone concentrations (1 |OO). In men.65 years who have symptoms or conditionssuggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistentlyand unequivocally low morning testosterone concentrations, we suggest that clinicians offertestosterone therapy on an individualized basis after explicit discussion of the potential risks andbenefits. (2 |OO)

2.5 We suggest that clinicians consider short-term testosterone therapy in HIV-infected men with low testosterone concentrations and weight loss (when other causes of weight loss have been excluded)to induce and maintain body weight and lean mass gain. (2 |OO)

2.6 In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommendagainst testosterone therapy as a means of improving glycemic control. (1 |OO)

+3.0 Monitoring of Testosterone Replacement Therapy

3.1 In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen. (Ungraded Good Practice Statement)

3.2 We recommend a urological consultation for hypogonadal men receiving testosterone treatmentif during the first 12 months of testosterone treatment there is a confirmed increase in prostate specificantigen concentration >1.4 ng/mL above baseline, a confirmed prostate-specific antigen >4.0 ng/mL, or a prostatic abnormality detected on digital rectal examination. After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient. (2 |OO)

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Testosterone Therapy for Hypogonadism Guideline Resources ...

If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease.

HavaH has extensive clinical experience with CLAR-121 in more than 1,000 Australian women (more than 6,200 implants) with breast disease, and Clarus expects that access to HavaH's pharmacokinetics, safety and early efficacy data in PDM will expedite progression to Phase 2/3 clinical studies in the U.S. Clarus estimates that the annual U.S. market size for PDM exceeds $400 million.2,3,4With this new pipeline asset, Clarus may also pursue, alone or in partnership, future indications in ER+ breast cancer, macromastia, granulomatous mastitis, and autoimmune induced breast pain.

"This licensing agreement marks the beginning of an exciting new partnership with HavaH. Their experience coupled with the significant amount of clinical data generated in Australia will benefit Clarus greatly as we begin our development activities in the U.S.," said Dr. Robert Dudley, Clarus's founder, president and CEO. "CLAR-121 allows us to leverage our expertise in androgen biology, as exemplified by JATENZO, a testosterone replacement therapy (TRT) for male hypogonadism and Clarus's first commercial product, and expands our development pipelinewith an initial focus on PDM in women a debilitating, painful disease with very limited treatment options, short of invasive surgery. This treatment, if approved, has the potential to be life-changing for women who suffer from PDM, and its development fits well with our mantra: 'good is never good enough'. Our goal is to provide treatment options that not only produce a positive clinical outcome, but also provide a positive therapeutic experience for patients."

Under the terms of the licensing agreement, Clarus will be responsible for future global development and regulatory activities for CLAR-121, excluding Australia. Clarus will pay HavaH an upfront payment of $500,000 upon signing and HavaH may be eligible for up to $10.75 million in potential development and regulatory milestone payments. HavaH will retain the right to promote HAVAH T+Aiin Australia. Additionally, HavaH would be eligible for a modest royalty and up to $30 million in potential commercial milestones.

"We developed HAVAH T+Ai to address a significant unmet need in women's health, and our partnership with Clarus will enable us to advance this therapeutic approach not only for inflammatory breast disease but, more widely we hope, for ER+ breast cancer where data now unambiguously demonstrates that the androgen receptor has an important tumor suppressor role in this form of breast cancer,"5 said Stephen Birrell, MD, PhD, HavaH founder, chairman and chief medical officer.

"In Clarus, we found a partner who understands and appreciates the potentially profound importance of androgen action in the context of inflammatory breast disease, as well as its role as an adjunctive endocrine therapy for certain forms of breast cancer," said Kathy Harrison, HavaH CEO.

Reedland Capital Partners, acting through Weild & Co., member FINRA/SIPC, served as financial advisor to HavaH in connection with this transaction. For more information, please visit http://www.reedland.com.

About Clarus Therapeutics, Inc.

Clarus is a pharmaceutical company with expertise and interest in developing androgen and metabolic therapies for men and women, including potential therapies for orphan indications.Clarus successfully developed and brought to market JATENZO (testosterone undecanoate oral capsules; CIII) a new state-of-the-art oral TRT. JATENZO was launched in February 2020 as the first and only FDA-approved oral softgel for TRT in adult males who have low or no testosterone due to certain medical conditions.6,7,8For more information, visit http://www.clarustherapeutics.com and http://www.JATENZO.com.

At the end of April, Clarus announced a new chapter for the company as it entered into a definitive business combination agreement with Blue Water Acquisition Corp. (NASDAQ: BLUW), a special purpose acquisition company (SPAC), that will result in Clarus becoming a publicly traded company when the transaction closes in the third quarter of 2021.

About HavaH Therapeutics

HavaH Therapeutics is an Australia-based women's hormonal health biopharmaceutical company founded in 2005. HavaH's transition into the U.S. market was facilitated by the appointment in 2017 of San Francisco-based Executive Director Ronald Martell.

HavaH is developing innovative, proprietary hormonal therapies that aim to improve quality of life for women across the world. HavaH brings together a world-class team passionate about helping women live lives free from the suffering caused by breast pain, debilitating menopausal symptoms and breast cancer. More information is available at http://www.havahtx.com

Clarus Forward-Looking Statement

Certain statements in this press release and the information incorporated herein by reference may constitute "forward-looking statements" for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our product development activities and clinical trials, including our estimates regarding timing to commence future clinical trials, the potential attributes and benefits of our product candidates, the potential attributes and benefits of product candidates, including CLAR-121, our ability to obtain and maintain regulatory approval for our product candidates and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading "Risk Factors" in the preliminary proxy/prospectus for our proposed business combination, and those that are included in any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

About JATENZO

Indication

JATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of use

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONS

JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

These are not all the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at http://www.jatenzo.com.

1 Zhang, Yanna et al. Clinical characteristics, classification, and surgical treatment of periductal mastitis. J Thorac Dis 2018; 10(4): 2420-2427.

2 Dixon JM, et al. Periductal mastitis and duct ectasia: different conditions with different aetiologies. Br J Surg 1996; 83: 820-822.

3 Eberl MM, Phillips RL, Jr., Lamberts, H, et al. Characterizing breast symptoms in family practice. Ann Fam Med 2008; 6(6):528-33.

4 US Census Bureau, accessed on 06/15/2020: https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2018_SHS_Table_A-18.pdf.

5 Hickey, TE, Selth, LA, Chia, KM, et al. The androgen receptor is a tumor suppressor in estrogen receptor positive breast cancer. Nat. Med. 2021; 27: 310-320.

6 JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.

7 US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.

8 US Food & Drug Administration. NDA Approval Letter. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206089Orig1s000ltr.pdf

SOURCE Clarus Therapeutics Inc.

https://clarustherapeutics.com/

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Clarus Therapeutics And HavaH Therapeutics Announce Licensing Agreement For Product To Treat Androgen-Dependent Inflammatory Breast Disease And...

InForGrowth added a new report on Male Hypogonadism Market Growth Analysis 2021-2026 provides an in-depth study on the current state of the global Industry by explicating the key development trends, limitations, challenges, and opportunities that will mold the business dynamics in the coming years. Also, the Male Hypogonadism Market report highlights the top regional markets and reveals the major areas to further business development, while providing a comprehensive account of the prominent companies in this domain. Apart from this, it also gauges the impact of the COVID-19 pandemic on revenue generation and breaks down the business strategies employed by well-established organizations to adapt to the changes in this industry.

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By the product type, the market is primarily split into

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Table of Content of Male Hypogonadism Market Report 2021-2026:Chapter 1: Male Hypogonadism Market OverviewChapter 2: Economic Impact on IndustryChapter 3: Market Competition by ManufacturersChapter 4: Production, Revenue (Value) by RegionChapter 5: Supply (Production), Consumption, Export, Import by RegionsChapter 6: Production, Revenue (Value), Price Trend by TypeChapter 7: Market Analysis by ApplicationChapter 8: Manufacturing Cost AnalysisChapter 9: Industrial Chain, Sourcing Strategy and Downstream BuyersChapter 10: Marketing Strategy Analysis, Distributors/TradersChapter 11: Market Effect Factors AnalysisChapter 12: Male Hypogonadism Market ForecastContinued

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Trending Report of Male Hypogonadism Market Drivers, Strategies, Applications and Competitive Landscape 2026 Brockville Observer - Brockville...

If scientific studies are to be believed, men also go through hormonal changes after the age of 50. However, it is very different from what women go through.

This has been a controversial topic for several years. According to a study, male menopause is nothing like female menopause. Female menopause is a natural part of ageing for women, whereas, male menopause doesnt even affect some older men. Due to the significant differences between the two conditions, doctors prefer calling it andropause or late-onset hypogonadism.

In andropause, the production of testosterone and other hormones decline in men. Testosterone is a hormone that leads to changes during puberty, manages your physical and mental health, maintains muscle mass, fuels sex drive and other important functions in the body.

The condition is also known as testosterone deficiency and late-onset hypogonadism. It is often associated with hypogonadism, which shows similar symptoms to this condition.

Here is everything you need to know about andropause or male menopause.

As per studies, this condition can cause a variety of symptoms and complications in the body.

Not able to focus on things

Reduced bone density and muscle mass

Your doctor might take a blood sample to test your testosterone levels. However, in most cases, the symptoms are manageable without treatment. Making healthy lifestyle choices can help you alleviate the symptoms. So, eating healthy, regular exercise, adequate sleep, and less stress are some lifestyle changes that may help.

In case youre experiencing depression, your doctor may prescribe antidepressants, therapy and the above-mentioned lifestyle changes.

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Male menopause: Here's everything you need to know about andropause - Pulse Ghana

Clarus Therapeutics And HavaH Therapeutics Announce Licensing Agreement For Product To Treat Androgen-Dependent Inflammatory Breast Disease And Certain Forms Of Breast Cancer

Agreement aims to accelerate development of a unique testosterone treatment for inflammatory breast diseases and estrogen-receptor positive breast cancer

NORTHBROOK, Ill. and NORTH ADELAIDE, South Australia, May 25, 2021 /PRNewswire/ -- Clarus Therapeutics Inc. ('Clarus'), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, and HavaH Therapeutics ('HavaH'), an Australia-based biopharmaceutical company developing androgen therapies for inflammatory breast disease and certain forms of breast cancer by using the innate breast-tissue-specific hormone/immune interface, today announced a licensing agreement whereby Clarus will acquire the exclusive worldwide (excluding Australia) development and commercialization rights for HAVAH T+Ai (CLAR-121).

If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease.

CLAR-121 is a proprietary combination of testosterone (T) (natural ligand for the androgen receptor; AR) and anastrozole (inhibitor of T conversion to estradiol) delivered by a subcutaneous implant for treatment of AR-mediated breast disease that predominantly affects women. If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease, including inflammatory periductal mastitis (PDM) and estrogen receptor-positive (ER+) breast cancer. Clarus's initial clinical development target is PDM - a destructive autoimmune inflammatory process of the retro-areolar milk ducts that results in multiple fistulae and inevitably results in disfiguring surgery and a high risk of recurrence. There is no known treatment for this condition apart from surgery, which has significant limitations.1 Due to the low prevalence of PDM in the U.S., Clarus anticipates this disease could qualify for orphan drug designation by the U.S. Food and Drug Administration and plans to petition the agency for that status for CLAR-121.

HavaH has extensive clinical experience with CLAR-121 in more than 1,000 Australian women (more than 6,200 implants) with breast disease, and Clarus expects that access to HavaH's pharmacokinetics, safety and early efficacy data in PDM will expedite progression to Phase 2/3 clinical studies in the U.S. Clarus estimates that the annual U.S. market size for PDM exceeds $400 million.2,3,4 With this new pipeline asset, Clarus may also pursue, alone or in partnership, future indications in ER+ breast cancer, macromastia, granulomatous mastitis, and autoimmune induced breast pain.

'This licensing agreement marks the beginning of an exciting new partnership with HavaH. Their experience coupled with the significant amount of clinical data generated in Australia will benefit Clarus greatly as we begin our development activities in the U.S.,' said Dr. Robert Dudley, Clarus's founder, president and CEO. 'CLAR-121 allows us to leverage our expertise in androgen biology, as exemplified by JATENZO, a testosterone replacement therapy (TRT) for male hypogonadism and Clarus's first commercial product, and expands our development pipeline with an initial focus on PDM in women - a debilitating, painful disease with very limited treatment options, short of invasive surgery. This treatment, if approved, has the potential to be life-changing for women who suffer from PDM, and its development fits well with our mantra: 'good is never good enough'. Our goal is to provide treatment options that not only produce a positive clinical outcome, but also provide a positive therapeutic experience for patients.'

Under the terms of the licensing agreement, Clarus will be responsible for future global development and regulatory activities for CLAR-121, excluding Australia. Clarus will pay HavaH an upfront payment of $500,000 upon signing and HavaH may be eligible for up to $10.75 million in potential development and regulatory milestone payments. HavaH will retain the right to promote HAVAH T+Ai in Australia. Additionally, HavaH would be eligible for a modest royalty and up to $30 million in potential commercial milestones.

'We developed HAVAH T+Ai to address a significant unmet need in women's health, and our partnership with Clarus will enable us to advance this therapeutic approach not only for inflammatory breast disease but, more widely we hope, for ER+ breast cancer where data now unambiguously demonstrates that the androgen receptor has an important tumor suppressor role in this form of breast cancer,'5 said Stephen Birrell, MD, PhD, HavaH founder, chairman and chief medical officer.

'In Clarus, we found a partner who understands and appreciates the potentially profound importance of androgen action in the context of inflammatory breast disease, as well as its role as an adjunctive endocrine therapy for certain forms of breast cancer,' said Kathy Harrison, HavaH CEO.

Reedland Capital Partners, acting through Weild & Co., member FINRA/SIPC, served as financial advisor to HavaH in connection with this transaction. For more information, please visit http://www.reedland.com.

About Clarus Therapeutics, Inc.

Clarus is a pharmaceutical company with expertise and interest in developing androgen and metabolic therapies for men and women, including potential therapies for orphan indications. Clarus successfully developed and brought to market JATENZO (testosterone undecanoate oral capsules; CIII) - a new state-of-the-art oral TRT. JATENZO was launched in February 2020 as the first and only FDA-approved oral softgel for TRT in adult males who have low or no testosterone due to certain medical conditions.6,7,8 For more information, visit http://www.clarustherapeutics.com and http://www.JATENZO.com.

At the end of April, Clarus announced a new chapter for the company as it entered into a definitive business combination agreement with Blue Water Acquisition Corp. (NASDAQ: BLUW), a special purpose acquisition company (SPAC), that will result in Clarus becoming a publicly traded company when the transaction closes in the third quarter of 2021.

About HavaH Therapeutics

HavaH Therapeutics is an Australia-based women's hormonal health biopharmaceutical company founded in 2005. HavaH's transition into the U.S. market was facilitated by the appointment in 2017 of San Francisco-based Executive Director Ronald Martell.

HavaH is developing innovative, proprietary hormonal therapies that aim to improve quality of life for women across the world. HavaH brings together a world-class team passionate about helping women live lives free from the suffering caused by breast pain, debilitating menopausal symptoms and breast cancer. More information is available at http://www.havahtx.com

Clarus Forward-Looking Statement

Certain statements in this press release and the information incorporated herein by reference may constitute 'forward-looking statements' for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our product development activities and clinical trials, including our estimates regarding timing to commence future clinical trials, the potential attributes and benefits of our product candidates, the potential attributes and benefits of product candidates, including CLAR-121, our ability to obtain and maintain regulatory approval for our product candidates and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words 'anticipate,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading 'Risk Factors' in the preliminary proxy/prospectus for our proposed business combination, and those that are included in any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

About JATENZO

Indication

JATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of use

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONS

JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

These are not all the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at http://www.jatenzo.com.

1 Zhang, Yanna et al. Clinical characteristics, classification, and surgical treatment of periductal mastitis. J Thorac Dis 2018; 10(4): 2420-2427.

2 Dixon JM, et al. Periductal mastitis and duct ectasia: different conditions with different aetiologies. Br J Surg 1996; 83: 820-822.

3 Eberl MM, Phillips RL, Jr., Lamberts, H, et al. Characterizing breast symptoms in family practice. Ann Fam Med 2008; 6(6):528-33.

4 US Census Bureau, accessed on 06/15/2020: https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2018_SHS_Table_A-18.pdf.

5 Hickey, TE, Selth, LA, Chia, KM, et al. The androgen receptor is a tumor suppressor in estrogen receptor - positive breast cancer. Nat. Med. 2021; 27: 310-320.

6 JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.

7 US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.

8 US Food & Drug Administration. NDA Approval Letter. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206089Orig1s000ltr.pdf

Disclaimer

Blue Water Acquisition Corporation published this content on 25 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 May 2021 16:46:07 UTC.

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Blue Water Acquisition : Clarus Therapeutics And HavaH Therapeutics Announce Licensing Agreement For Product To Treat Androgen-Dependent Inflammatory...

Hormone Replacement Therapy Market is valued atUSD 21.04 Billionin 2020 and expected to reachUSD 36.54 Billionby 2027 with theCAGR of 8.20%over the forecast period.

Global Hormone Replacement Therapy Market: Global Size, Trends, Competitive, Historical & Forecast Analysis, 2021-2027The growing awareness on post-menopausal issues among women is one of the major factors driving the growth of Global Hormone Replacement Therapy Market.

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Hormone replacement therapy is a treatment used to release symptoms of the menopause. The main advantage is that it is a very effective method of controlling menopausal symptoms, and it can make an important difference to a womans quality of life and security. Hormone replacement therapy can also reduce a womans risk of developing osteoporosis and cancer of the colon and rectum. Additionally, hormones are secreted predominantly from the endocrine glands and absorbed into the bloodstream. The hormones that have been most commonly utilised in hormone replacement therapy are progesterone, estrogen, testosterone, adrenal hormones, DHEA, thyroid hormones, pregnenolone, melatonin, and human growth hormone. It is the most effective treatment for menopause symptoms. Systemic hormone replacement therapy helps in treating cancer, rheumatoid arthritis and other diseases. Moreover, this treatment is particularly favorable for patients with growth hormone deficiency, women nearing menopause and elderly people suffering from hypogonadism. It may also protect against osteoporosis.

Global Hormone Replacement Therapy market report is segmented on the basis of product, administration, disease and region & country level. Based upon product, global hormone replacement therapy market is classified into estrogen replacement therapy, human growth hormone replacement therapy, thyroid replacement therapy and testosterone replacement therapy. Based upon administration, the market is divided into oral, parenteral and transdermal. Based upon disease, global hormone replacement therapy market is classified into menopause, hypothyroidism, male hypothyroidism, growth hormone deficiency, cancer and other.

The regions covered in this Hormone Replacement Therapy market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, market of Hormone Replacement Therapy sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Afria, etc.

Global Hormone Replacement Therapy report covers prominent players Abbott Laboratories, Novo Nordisk, Novartis, Merck Serono, Bayer Healthcare, Eli Lilly, Mylan Laboratories, Roche, Genentech, Orion Pharma AB, Allergen Plc and others.

News-

September 12th, 2017; after a massive study of hormone replacement therapy was halted due to higher rates of breast cancer, heart attack and stroke among women assigned to the drugs to treat menopausal symptoms, a new follow-up study has found those women had no higher risk of death as of 2014 than participants who took a placebo.

Increasing healthcare expenditure due to growing awareness about health related problems. For example, According to OECD, the US spent $10,209 on healthcare per capita, or per person, in 2017. Thats more than any other country in OECDs 36-country consortium, and over $2,000 more than Switzerland, the second-highest spending country. In addition, rising drug development and hormonal imbalance disorders with rising geriatric population are also boosting the hormone replacement therapy market growth. Additionally, the rising womens population between the age group of 45 to 60, which increases the range of menopausal window due to this factor the demand of hormonal replacement therapy, is also growing. However, the hormone replacement therapy has number of side effects which may hamper the market growth. For example, fluid retention, indigestion, headache, and depression, bloating, swelling, nausea, leg cramps. Combined hormone replacement therapy slightly increases the risk of developing breast cancer, womb cancer, ovarian cancer and stroke. For example, Women who take hormone replacement therapy for more than 1 year have a higher risk of breast cancer than women who never use hormone replacement therapy. The risk is linked to all types of hormone replacement therapy except vaginal oestrogen. In spite of that, technological advancements in this field may create the number of opportunities within the forecast period.

North America is expected to dominate the global hormone replacement therapy market due to the increasing awareness about the hormonal replacement therapy And Increasing number of womens which have menopause problems in this region. For example, National Center for Biotechnology Information, in the United States, approximately 1.3 million women become menopausal each year and, 1% of women experience premature menopause before the age of 40. The Asia Pacific is expected to experience surge of demand too, owing to the factors such as increased awareness levels among the end users and improving healthcare infrastructure. Rising geriatric population is one of the primary factors responsible for the growth of the hormonal replacement therapy marketin the Europe.

By Product:

By Administration:

By Disease:

As the novel coronavirus (COVID-19) crisis takes over the world, we are continuously tracking the changes in the markets, as well as the industry behaviours of the consumers globally and our estimates about the latest market trends and forecasts are being done after considering the impact of this pandemic.

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Our Market Research Solution Provides You Answer to Below Mentioned Question:

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Continued here:
Hormone Replacement Therapy Market Size to Surpass US$ 36.54 Billion by 2027 with the CAGR of 8.20% The Manomet Current - The Manomet Current

The aim of a well attended Campus meeting organised by the SIG Reproductive Endocrinology in May was to present the latest findings on how sex hormones from various organs influence the brain, not vice versa and to emphasise that theres a psychological as well as physical effect in women.

The first part of the meeting provided a comprehensive update on the basics of how hormones - neuropeptides, AMH and hormonal contraceptives - affect the brain, and may even trigger depression and suicidal thoughts as a result of menstrual cycle syndromes.

Richard Anderson from the University of Edinburgh presented evidence on the key role that the so-called KNDy neurons expressing kisspeptin play in stimulating GnRH and LH, with elevated/fast secretion of these gonadotrophins a feature in PCOS patients. Therapeutic applications based on partial GnRH suppression may become available for PCOS and other conditions using NK3 receptor antagonists, and large clinical trials are under way. NK3 therapies have been associated in trials with a remarkable reduction in menopausal hot flushes, which are linked to GnRH pulses, according to Anderson.

LH over-secretion and reduced fertility characteristics akin to PCOS have also been linked to AMH overexposure, which Joop Laven from Erasmus University in the Netherlands said leads to aberrant wiring of the midbrain. High AMH levels have consequences too for PCOS offspring Laven presented findings showing the hormone impairs aromatase activity in the placenta with LH levels higher in PCOS daughters (and in sons) compared with controls. A possible clinical approach, he suggested, was that PCOS patients delay pregnancy to when embryo yields may be higher and aneuploidy lower.

Inger Sundstrom-Poromaa from Uppsala University Hospital in Sweden cited overwhelming evidence from RCTs for selective serotonin reuptake inhibitors (SSRIs) as a first line therapy for premenstrual dysphoric disorder (PMDD). She also highlighted the pros and cons of other treatments: low dose hormonal contraceptives, GnRH agonists (which alleviate symptoms but have side effects unacceptable to many), progesterone, which Sundstrom-Poromaa concluded is ineffective, and a future novel treatment ulipristal acetate (UA) shown to be effective in curing PMDD symptoms (50% UA group vs 22% placebo) but which cant currently be prescribed following an EMA review.(1)

Despite a 60-year history and widespread worldwide use, the contraceptive pills impact on brain structure via hormone suppression remains underexplored. The 160 Campus participants attending online from 48 countries heard how more (and better designed) longitudinal studies are still needed to establish associations (as suggested in current literature) between the range of progestogens used and brain effects - eg, increased working memory and depression.

During the second half of the meeting, on common fertility-related endocrine conditions, several presenters made lively cases for better treatments. Psychiatrist Vibe Frokjaer from Copenhagen University, Denmark, provided an update on sex hormone fluctuations, mental distress and associations with ART. Research by her and colleagues into women following GnRH agonist and GnRH antagonist protocols for ART suggests that mental distress during treatment is not causally linked to hypogonadism per se or to the choice of protocol.(2) Instead, estrogen sensitivity, brain-based mechanisms and neuroticism appear to play a role, and this needs to be translated into prevention/treatment, she said.

In a presentation on estradiol deficiency, Lawrence Nelson from the Mary Elizabeth Conover Foundation in the US outlined the dramatic consequences of low levels (eg, memory loss and anxiety) and appealed to ESHRE members for wider support of physiologic HRT (with transdermal patches) so women, notably POI patients, get the hormone they were meant to have.(3) Aled Rees, from Cardiff University in Wales, urged clinicians to screen PCOS patients in light of evidence of higher prevalence of emotional distress among these women, and for researchers to adjust for obesity in order to determine its role vs PCOS in psychological symptoms; and an update was given on endometriosis treatments including preliminary findings for publication next year on the role of virtual reality in alleviating chronic pelvic pain.

Campus organiser Cornelis Lambalk said there were many areas still to explore in the field of hormones and the brain, but the ambition is to cover these in a follow-up event next year.

1. Comasco E, Kopp Kallner H, Bixo M, et al. Ulipristal acetate for treatment of premenstrual dysphoric disorder: A proof-of-concept randomized controlled trial. Am J Psychiatr 2020: 178: 256-265. https://doi.org/10.1176/appi.ajp.2020.200302862. Stenbk D, Toftager M, Hjordt L, et al. Mental distress and personality in women undergoing GnRH agonist versus GnRH antagonist protocols for assisted reproductive technology. Hum Reprod 2015; 30; 103-110. https://doi.org/10.1093/humrep/deu2943. Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ 2019; 364; doi:10.1136/bmj.k4810

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The many effects of reproductive hormones on the brain - ESHRE

Market share, size, participants, growth and industry analysis are some of the prominent factors covered in this Hormone Replacement Therapy (HRT) market report. This comprehensive report starts with a goal to give information about market forecast, channel features, end-user market, key pricing structure and different geographies. Besides talking about this, it further mentions key regions, key companies along with their profiles and investment options available in the market. Hormone Replacement Therapy (HRT) market is anticipated to grow hugely during the forecasting period 2021-2027. It further proceeds with geographical analysis covering prominent regions such as North America, Europe, Middle East and Latin America.

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The study in this report will aid organizations in understanding the major threats and opportunities that retailers face in the global market. In addition, the study offers an all-around view of the competitive landscape as well as a SWOT analysis. This report contains extensive information on product or technological developments in the global Hormone Replacement Therapy (HRT) market, as well as an overview of the effect of these developments on the markets potential growth.To retain their supremacy in the global Hormone Replacement Therapy (HRT) industry, the majority of companies are currently implementing new technology, strategies, product innovations, expansions, and long-term contracts. Following a review of key companies, the report focuses on the startups that are helping to drive business growth. The reports authors identify possible mergers and acquisitions among startups and key organizations in the study. Key Players are working hard to adopt the latest technology to gain a strategic advantage over the competition as new technologies are introduced on a regular basis.

Major Manufacture:Novartis Pfizer Amgen Novo Nordisk Merck & Co. Bayer Eli Lily Wyeth Mylan Laboratories Abbott Laboratories Genentech

Worldwide Hormone Replacement Therapy (HRT) Market by Application:Menopause Hypothyroidism Male Hypogonadism Growth Hormone Deficiency Others

Worldwide Hormone Replacement Therapy (HRT) Market by Type:Oral Parenteral Transdermal Others

Table of Content1 Report Overview1.1 Product Definition and Scope1.2 PEST (Political, Economic, Social and Technological) Analysis of Hormone Replacement Therapy (HRT) Market2 Market Trends and Competitive Landscape3 Segmentation of Hormone Replacement Therapy (HRT) Market by Types4 Segmentation of Hormone Replacement Therapy (HRT) Market by End-Users5 Market Analysis by Major Regions6 Product Commodity of Hormone Replacement Therapy (HRT) Market in Major Countries7 North America Hormone Replacement Therapy (HRT) Landscape Analysis8 Europe Hormone Replacement Therapy (HRT) Landscape Analysis9 Asia Pacific Hormone Replacement Therapy (HRT) Landscape Analysis10 Latin America, Middle East & Africa Hormone Replacement Therapy (HRT) Landscape Analysis 11 Major Players Profile

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The study takes into account a broad range of market impact factors, as well as potential emerging factors for different Types, End-Users, Regions and also covers the COVID-19 impact on the market; in order to identify the most promising growth patterns in the global industry. The business ability and demand potential of more than 34 major powers are covered in the research for presenting the most promising investment fields in North America, Europe, Asia Pacific, and Latin America, Middle East, and Africa, offering useful opinions on strategic changes for existing groups and new entrants.

In-depth Hormone Replacement Therapy (HRT) Market Report: Intended AudienceHormone Replacement Therapy (HRT) manufacturersDownstream vendors and end-usersTraders, distributors, and resellers of Hormone Replacement Therapy (HRT)Hormone Replacement Therapy (HRT) industry associations and research organizationsProduct managers, Hormone Replacement Therapy (HRT) industry administrator, C-level executives of the industriesMarket Research and consulting firms

Hormone Replacement Therapy (HRT) Report Provide:Potential opportunities and challenges analysis in Hormone Replacement Therapy (HRT) market.Current and future market outlook in the developed and emerging regional markets.Detailed analysis of the segment that is expected to dominate the market.Regions that are expected to witness the fastest growth during the forecast period.Identify the latest developments, market shares, and strategies employed by the major market players.Comprehensive & in-depth research and after-sales warranty by Global Market Monitor.Analysis of Influences of COVID-19 to the present and future Hormone Replacement Therapy (HRT) market and related industry.

About Global Market MonitorGlobal Market Monitor is a professional modern consulting company, engaged in three major business categories such as market research services, business advisory, technology consulting.We always maintain the win-win spirit, reliable quality and the vision of keeping pace with The Times, to help enterprises achieve revenue growth, cost reduction, and efficiency improvement, and significantly avoid operational risks, to achieve lean growth. Global Market Monitor has provided professional market research, investment consulting, and competitive intelligence services to thousands of organizations, including start-ups, government agencies, banks, research institutes, industry associations, consulting firms, and investment firms.ContactGlobal Market MonitorOne Pierrepont Plaza, 300 Cadman Plaza W, Brooklyn,NY 11201, USAName: Rebecca HallPhone: + 1 (347) 467 7721Email: info@globalmarketmonitor.comWeb Site: https://www.globalmarketmonitor.com

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Hormone Replacement Therapy (HRT) Market to Eyewitness Stunning Growth by 2027 Covid-19 Analysis The Shotcaller - The Shotcaller

The Male Hypogonadism Market report by Persistence Market Research is focusing on the fact that healthcare providers are into collection of socioeconomic information of the patients, so that tracking at any point of time is possible. This on-the-go monitoring is amongst the ongoing trends in the healthcare industry.

According to Persistence Market Researchs new report,globalmale hypogonadism marketis slated to exhibit a steady expansion throughout the forecast period (2017-2026). Revenues from the global market for male hypogonadism are estimated to exceedUS$ 3,300 Mn by 2026-end.

Governments Taking Initiatives to Spread Awareness about Male Hypogonadism Therapeutics

Lack of sex hormones, usually referred to as male hypogonadism has resulted into many health risks that include osteoporosis, heart disease, and cardiovascular diseases on the back of thinning of bones. Global male hypogonadism market comprises several patented brands that currently have high market penetration. Proliferation in geriatric population in tandem with rising incidences related to rheumatoid arthritis and obesity have been primary factors affecting prevalence of male hypogonadism globally.

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Company Profiles

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Mounting incidences of testosterone deficiency in male population is a key factor that prevalence of male hypogonadism has surged worldwide. Several governments around the world have been taking initiatives to spread the awareness on hypogonadism treatment procedures, for example testosterone replacement therapy (TST), in order to relieve the painful burden on patients and their families.

As low testosterone levels are increasingly associated with exacerbation of chronic conditions, it further results into disorders apropos to hypothalamic-pituitary-gonadal axis. Advent of TST has however enabled reduction in cases of male hypogonadism considerably. With growing awareness related to its treatment among patients, the market is likely to gain an uptick during the forecast period.

Rising availability of the selective androgen receptor modulators (SARMs) has further sustained the market expansion. The development and high availability of SARMs has led toward the provision of improved treatment procedure to patients having androgen deficiencies, thereby influencing the market growth.

Access Full Report @https://www.persistencemarketresearch.com/checkout/22303

North America will continue to Dominate Global Male Hypogonadism Market

North America will continue to dominate the global male hypogonadism market, with more than one-third revenue share during the forecast period. In addition, revenues from the male hypogonadism market in North America will exhibit the fastest expansion through 2026, as compared to those from all the other regional segments comprised in the report. Europe and Asia-Pacific excluding Japan (APEJ) are also expected to remain lucrative for the male hypogonadism market. The market in APEJ will ride on a slightly higher CAGR than that in Europe through 2026.

Topical gels are expected to remain the most lucrative among drugs available for treatment of male hypogonadism globally, with sales projected to register the fastest expansion through 2026. Injectables will also remain a major revenue contributor to the market. Sales of injectable and transdermal patches are poised to reflect an equal CAGR through 2026.

Testosterone Replacement Therapy to Remain Preferred among Patients

Based on therapy, testosterone replacement therapy is expected to remain preferred among patients with male hypogonadism worldwide. Roughly 66% revenue share of the market is expected to be held by revenues from testosterone replacement therapy by 2026-end. Revenues from gonadotropin replacement therapy will remain slightly more than half revenues gained from testosterone replacement therapy throughout the forecast period.

Klinefelters syndrome is expected to remain the most prevalent disease type observed in the male hypogonadism market, and revenues from treatment of this disease will exceed US$ 1,800 Mn by 2026-end. Kallmann Syndrome and Pituitary Adenomas among disease types will also account for major revenue shares of the market by 2026-end.

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Persistence Market Research is here to provide companies a one-stop solution with regards to bettering customer experience. It does engage in gathering appropriate feedback after getting through personalized customer interactions for adding value to customers experience by acting as the missing link between customer relationships and business outcomes. The best possible returns are assured therein.

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Persistence Market ResearchAddress 305 Broadway, 7th Floor, New York City, NY 10007 United StatesU.S. Ph. +1-646-568-7751USA-Canada Toll-free +1 800-961-0353Salessales@persistencemarketresearch.comWebsite https://www.persistencemarketresearch.com

Original post:
The Male Hypogonadism Market To Witness Steadfast Growth In The Next 10 Years The Courier - The Courier

According to Persistence Market Researchs new report, globalmale hypogonadism marketis slated to exhibit a steady expansion throughout the forecast period (2017-2026). Revenues from the global market for male hypogonadism are estimated to exceed US$ 3,300 Mn by 2026-end.

Governments Taking Initiatives to Spread Awareness about Male Hypogonadism Therapeutics

Lack of sex hormones, usually referred to as male hypogonadism has resulted into many health risks that include osteoporosis, heart disease, and cardiovascular diseases on the back of thinning of bones. Global male hypogonadism market comprises several patented brands that currently have high market penetration. Proliferation in geriatric population in tandem with rising incidences related to rheumatoid arthritis and obesity have been primary factors affecting prevalence of male hypogonadism globally.

Strategizing The Moves For The Next Decade? See Through Sample Of Male Hypogonadism Market Report! https://www.persistencemarketresearch.co/samples/22303

Company Profiles

Starting With The New Decade On A Diligent Note In The Male Hypogonadism Market? https://www.persistencemarketresearch.co/methodology/22303

Mounting incidences of testosterone deficiency in male population is a key factor that prevalence of male hypogonadism has surged worldwide. Several governments around the world have been taking initiatives to spread the awareness on hypogonadism treatment procedures, for example testosterone replacement therapy (TST), in order to relieve the painful burden on patients and their families.

As low testosterone levels are increasingly associated with exacerbation of chronic conditions, it further results into disorders apropos to hypothalamic-pituitary-gonadal axis. Advent of TST has however enabled reduction in cases of male hypogonadism considerably. With growing awareness related to its treatment among patients, the market is likely to gain an uptick during the forecast period.

Rising availability of the selective androgen receptor modulators (SARMs) has further sustained the market expansion. The development and high availability of SARMs has led toward the provision of improved treatment procedure to patients having androgen deficiencies, thereby influencing the market growth.

How About Obtaining Insights About The Region To Enter Concerning The Male Hypogonadism Market? Press The Purchase Now Button To Have Our Male Hypogonadism Market Report! https://www.persistencemarketresearch.com/checkout/22303

North America will continue to Dominate Global Male Hypogonadism Market

North America will continue to dominate the global male hypogonadism market, with more than one-third revenue share during the forecast period. In addition, revenues from the male hypogonadism market in North America will exhibit the fastest expansion through 2026, as compared to those from all the other regional segments comprised in the report. Europe and Asia-Pacific excluding Japan (APEJ) are also expected to remain lucrative for the male hypogonadism market. The market in APEJ will ride on a slightly higher CAGR than that in Europe through 2026.

Topical gels are expected to remain the most lucrative among drugs available for treatment of male hypogonadism globally, with sales projected to register the fastest expansion through 2026. Injectables will also remain a major revenue contributor to the market. Sales of injectable and transdermal patches are poised to reflect an equal CAGR through 2026.

Testosterone Replacement Therapy to Remain Preferred among Patients

Based on therapy, testosterone replacement therapy is expected to remain preferred among patients with male hypogonadism worldwide. Roughly 66% revenue share of the market is expected to be held by revenues from testosterone replacement therapy by 2026-end. Revenues from gonadotropin replacement therapy will remain slightly more than half revenues gained from testosterone replacement therapy throughout the forecast period.

Klinefelters syndrome is expected to remain the most prevalent disease type observed in the male hypogonadism market, and revenues from treatment of this disease will exceed US$ 1,800 Mn by 2026-end. Kallmann Syndrome and Pituitary Adenomas among disease types will also account for major revenue shares of the market by 2026-end.

About Us :-

Persistence Market Research is here to provide companies a one-stop solution with regards to bettering customer experience. It does engage in gathering appropriate feedback after getting through personalized customer interactions for adding value to customers experience by acting as the missing link between customer relationships and business outcomes. The best possible returns are assured therein.

Contact us:

Persistence Market ResearchAddress 305 Broadway, 7th FloorNew York City,NY 10007 United StatesU.S. Ph. +1-646-568-7751USA-Canada Toll-free +1 800-961-0353Salessales@persistencemarketresearch.comWebsite https://www.persistencemarketresearch.com

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The Male Hypogonadism Market To Ride On Innovations KSU | The Sentinel Newspaper - KSU | The Sentinel Newspaper

The latest research report on Hormone Replacement Therapy Market delivers a comprehensive study on current market trends. The outcome also includes revenue forecasts, statistics, market valuations which illustrate its growth trends and competitive landscape as well as the key players in the business.

Global Hormone Replacement Therapy Market is valued at USD 19.45 Billion in 2019 and expected to reach USD 33.77 Billion by 2026 with the CAGR of 8.2% overtheforecast period

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Hormone replacement therapy is a treatment used to release symptoms of the menopause. The main advantage is that it is a very effective method of controlling menopausal symptoms, and it can make an important difference to a womans quality of life and security. Hormone replacement therapy can also reduce a womans risk of developing osteoporosis and cancer of the colon and rectum. Additionally, hormones are secreted predominantly from the endocrine glands and absorbed into the bloodstream. The hormones that have been most commonly utilised in hormone replacement therapy are progesterone, estrogen, testosterone, adrenal hormones, DHEA, thyroid hormones, pregnenolone, melatonin, and human growth hormone. It is the most effective treatment for menopause symptoms. Systemic hormone replacement therapy helps in treating cancer, rheumatoid arthritis and other diseases. Moreover, this treatment is particularly favorable for patients with growth hormone deficiency, women nearing menopause and elderly people suffering from hypogonadism. It may also protect against osteoporosis.

Global Hormone Replacement Therapy market report is segmented on the basis of product, administration, disease and region & country level. Based upon product, global hormone replacement therapy market is classified into estrogen replacement therapy, human growth hormone replacement therapy, thyroid replacement therapy and testosterone replacement therapy. Based upon administration, the market is divided into oral, parenteral and transdermal. Based upon disease, global hormone replacement therapy market is classified into menopause, hypothyroidism, male hypothyroidism, growth hormone deficiency, cancer and other.

The regions covered in this Hormone Replacement Therapy market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, market of Hormone Replacement Therapy sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Afria, etc.

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Big Study Found No Rise in Death Risk among Women who Took Hormone Therapy

September 12th, 2017; after a massive study of hormone replacement therapy was halted due to higher rates of breast cancer, heart attack and stroke among women assigned to the drugs to treat menopausal symptoms, a new follow-up study has found those women had no higher risk of death as of 2014 than participants who took a placebo.

The Growing Awareness about Hormone Replacement is the Key Factor Influencing the Global Hormone Replacement Therapy Market Growth.

Increasing healthcare expenditure due to growing awareness about health related problems. For example, According to OECD, the US spent $10,209 on healthcare per capita, or per person, in 2017. Thats more than any other country in OECDs 36-country consortium, and over $2,000 more than Switzerland, the second-highest spending country. In addition, rising drug development and hormonal imbalance disorders with rising geriatric population are also boosting the hormone replacement therapy market growth. Additionally, the rising womens population between the age group of 45 to 60, which increases the range of menopausal window due to this factor the demand of hormonal replacement therapy, is also growing. However, the hormone replacement therapy has number of side effects which may hamper the market growth. For example, fluid retention, indigestion, headache, and depression, bloating, swelling, nausea, leg cramps. Combined hormone replacement therapy slightly increases the risk of developing breast cancer, womb cancer, ovarian cancer and stroke. For example, Women who take hormone replacement therapy for more than 1 year have a higher risk of breast cancer than women who never use hormone replacement therapy. The risk is linked to all types of hormone replacement therapy except vaginal oestrogen. In spite of that, technological advancements in this field may create the number of opportunities within the forecast period.

North America is expected to Dominate the Global Hormone Replacement Therapy Market

North America is expected to dominate the global hormone replacement therapy market due to the increasing awareness about the hormonal replacement therapy And Increasing number of womens which have menopause problems in this region. For example, National Center for Biotechnology Information, in the United States, approximately 1.3 million women become menopausal each year and, 1% of women experience premature menopause before the age of 40. The Asia Pacific is expected to experience surge of demand too, owing to the factors such as increased awareness levels among the end users and improving healthcare infrastructure. Rising geriatric population is one of the primary factors responsible for the growth of the hormonal replacement therapy marketin the Europe.

Key Benefits for Global Hormone Replacement Therapy Market Report-

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Global Hormone Replacement Therapy Market Segmentation:

By Product:

By Administration:

By Disease:

By Regional & Country Analysis:

North America, U.S., Mexico, Canada , Europe, UK, France, Germany, Italy , Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of Middle East and Africa

Table of Content

1.1. Research Process

1.2. Primary Research

1.3. Secondary Research

1.4. Market Size Estimates

1.5. Data Triangulation

1.6. Forecast Model

1.7. USPs of Report

1.8. Report Description

2.1. Market Introduction

2.2. Executive Summary

2.3. Global Hormone Replacement Therapy Market Classification

2.4. Market Drivers

2.5. Market Restraints

2.6. Market Opportunity

2.7. Hormone Replacement Therapy Market: Trends

2.8. Porters Five Forces Analysis

2.9. Market Attractiveness Analysis

Continued

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Originally posted here:
Hormone Replacement Therapy Market Global Industry Scope and Growth Analysis Report 2021: Opportunity Assessment, Business Boosting Strategies, and...

Global Market Monitor recently published a market research report on Hormone Replacement Therapy (HRT), which studied Hormone Replacement Therapy (HRT) industry outlook, competitive situation, regional market analysis, type & application segment analysis, and market trend forecast by 2027.

Get the complete sample, please click:https://www.globalmarketmonitor.com/request.php?type=1&rid=656651

Competition AnalysisMajor enterprises in the global market of Hormone Replacement Therapy (HRT) include:Amgen Novartis Novo Nordisk Wyeth Eli Lily Merck & Co. Abbott Laboratories Mylan Laboratories Bayer Genentech Pfizer

View the Comprehensive Analysis on Various Segment:https://www.globalmarketmonitor.com/reports/656651-hormone-replacement-therapyhrtmarket-report.html

Market Segments by Application:Menopause Hypothyroidism Male Hypogonadism Growth Hormone Deficiency Others

Market Segments by TypeOral Parenteral Transdermal Others

Table of Content1 Report Overview1.1 Product Definition and Scope1.2 PEST (Political, Economic, Social and Technological) Analysis of Hormone Replacement Therapy (HRT) Market2 Market Trends and Competitive Landscape3 Segmentation of Hormone Replacement Therapy (HRT) Market by Types4 Segmentation of Hormone Replacement Therapy (HRT) Market by End-Users5 Market Analysis by Major Regions6 Product Commodity of Hormone Replacement Therapy (HRT) Market in Major Countries7 North America Hormone Replacement Therapy (HRT) Landscape Analysis8 Europe Hormone Replacement Therapy (HRT) Landscape Analysis9 Asia Pacific Hormone Replacement Therapy (HRT) Landscape Analysis10 Latin America, Middle East & Africa Hormone Replacement Therapy (HRT) Landscape Analysis 11 Major Players Profile

Ask for a Report Sample at:https://www.globalmarketmonitor.com/request.php?type=3&rid=656651

Key Regions OverviewMajor countries of North America, Europe, Asia Pacific, and the rest of the world are all exhaustive analyzed in the report. Apart from this, policy mobilization, social dynamics, development trends, and economic development in these countries are also taken into consideration.

In-depth Hormone Replacement Therapy (HRT) Market Report: Intended AudienceHormone Replacement Therapy (HRT) manufacturersDownstream vendors and end-usersTraders, distributors, and resellers of Hormone Replacement Therapy (HRT)Hormone Replacement Therapy (HRT) industry associations and research organizationsProduct managers, Hormone Replacement Therapy (HRT) industry administrator, C-level executives of the industriesMarket Research and consulting firms

Key questions answered in the reportWhat will the market size and growth rate be in 2026?What segment or region will drive or lead market growth and what are the reasons?How will market drivers, constraints and future opportunities affect market dynamics and subsequent analysis of relevant trends?What key strategies are used by top vendors to increase revenue?

About Global Market MonitorGlobal Market Monitor is a professional modern consulting company, engaged in three major business categories such as market research services, business advisory, technology consulting.We always maintain the win-win spirit, reliable quality and the vision of keeping pace with The Times, to help enterprises achieve revenue growth, cost reduction, and efficiency improvement, and significantly avoid operational risks, to achieve lean growth. Global Market Monitor has provided professional market research, investment consulting, and competitive intelligence services to thousands of organizations, including start-ups, government agencies, banks, research institutes, industry associations, consulting firms, and investment firms.ContactGlobal Market MonitorOne Pierrepont Plaza, 300 Cadman Plaza W, Brooklyn,NY 11201, USAName: Rebecca HallPhone: + 1 (347) 467 7721Email: info@globalmarketmonitor.comWeb Site: https://www.globalmarketmonitor.com

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Global Hormone Replacement Therapy (HRT) Industry Market Report 2020, Forecast Till 2027 By Type, End-use, Geography and Player The Courier - The...

WEDNESDAY, May 12, 2021 (HealthDay News) -- Cora Oakley is a rough-and-tumble 4-year-old who loves gymnastics and outdoor activities, particularly if it involves bouncing on a trampoline.

It's hard to tell from looking at her that she was born without an immune system. Kids with this condition can acquire dangerous, life-threatening infections from day-to-day activities as simple as going to school or playing with friends.

"I remember asking the doctor if she was going to die, and he said to me, 'I hope not,'" remembers her mother, Chelsea Oakley, 38, of Morristown, N.J. "It was everything you didn't want to hear as a new mom."

Instead, Cora now has essentially a normal immune system, thanks to an experimental gene therapy that journeyed inside her newborn body and fixed the genetic defect that caused her immune deficiency.

The life-saving therapy utilizes a harmless, modified form of the AIDS-causing human immunodeficiency virus (HIV) to work its magic.

Cora is one of 48 out of 50 young children who were essentially cured of their severe combined immunodeficiency (SCID) using this new procedure, researchers reported May 11 in the New England Journal of Medicine.

"None of the 50 patients had any complications from the [therapy], and 48 out of the 50 restored their immunity to quite normal levels," said lead researcher Dr. Donald Kohn, a professor of microbiology, immunology and molecular genetics at University of California, Los Angeles (UCLA). "They're no longer patients. They're off all of their antibiotics. They're living normal lives."

The children all suffered from a form of immune deficiency called ADA-SCID, in which a faulty gene causes a buildup in the bloodstream of a naturally occurring biochemical called adenosine.

"Lymphocytes are particularly sensitive to adenosine, so you basically poison off the lymphocytes, and that's what results in SCID," Kohn said. Lymphocytes are the white blood cells that power the human immune system.

This particular genetic abnormality causes 10% to 15% of all cases of SCID, Kohn said.

Kids with this form of SCID are kept alive by receiving regular injections of the enzyme they cannot make that breaks down adenosine, along with a battery of other medications that take the place of their missing immune system.

Until now, the luckiest children receive a bone marrow transplant to replace their faulty immune system, but not everyone can find a donor and they have to take drugs to block rejection of the transplant. This therapy is effective in about 70% of kids with SCID, according to the U.S. National Institutes of Health.

In this new procedure, doctors remove some of a child's bone marrow and expose it to a genetically modified form of HIV into which has been cloned a normal copy of their broken gene, Kohn said.

The child undergoes chemotherapy to kill off their faulty bone marrow, and then the genetically modified cells are put back in as a replacement.

"We collect blood-forming stem cells from the bone marrow of these patients, bring them to the laboratory, use this lentiviral vector to insert this normal gene into their stem cells, and then they're given back to the patients by intravenous infusion," Kohn said.

Cora was the very last child to be treated in the clinical trial, her mom said. She had her bone marrow extracted in 2017 when she was 3 months old, and her newly corrected stem cells were reinserted into her about a month later.

As a newborn, Cora showed no signs of immune deficiency at all, Chelsea noted.

The family got a call from her pediatrician seven days after her birth, asking her to go to a pediatric hospital because her blood work came back abnormal. Further tests confirmed that she had ADA-SCID.

Following the gene therapy, Cora and her family spent a month in the bone marrow transplant unit of Boston Children's Hospital, which was closer to her home than the UCLA center that's pioneering the treatment.

"I was seeing all these little kids who have had heavy rounds of chemo, who've had bone marrow transplants and were taking all of these anti-rejection meds. Until then, I really didn't understand how incredibly fortunate we were, and how much this changed the course of Cora's life," Chelsea said.

"She didn't have to go through all of these extra steps and have all this hardship because of this gene therapy. I remember breaking down in tears and being so thankful and so sad for all these other kids, because no child should have to go through that," Chelsea continued.

The results of this clinical trial are "exciting," said Dr. Jordan Orange, chair of pediatrics at Columbia University College of Physicians and Surgeons, in New York City.

"I think this will be a platform to see cures brought to a variety of immune deficiencies not all, but certainly more than this one," Orange said. "It's my hope that many immune diseases can be cured through these types of approaches."

However, the procedure didn't have a perfect track record, which shows there is room for improvement, Orange noted.

"When you look at the 50 patients in the study, two were not cured," Orange said. "That's pretty good, that 48 out of 50 were cured, but when you're the one in 25 it didn't work for, you're still looking for a solution."

For Cora, the therapy represents a miracle, her mother said.

"She's doing great. She doesn't get any extra treatments, not anything. She's not on any prophylactic drugs. She's fully vaccinated," Chelsea said. "To this day, she has no idea. She's too young yet to know what all of this meant."

This experimental gene treatment has been licensed to Orchard Therapeutics, a London-based biopharmaceutical company, Kohn said. It will need to be approved by the U.S. Food and Drug Administration.

More information

The U.S. National Institutes of Health has more about SCID and ADA-SCID.

SOURCES: Donald Kohn, MD, professor, microbiology, immunology and molecular genetics, New York City; Jordan Orange, MD, PhD, chair, pediatrics, Columbia University College of Physicians and Surgeons, New York City; Chelsea Oakley, 38, Morristown, N.J.; New England Journal of Medicine, May 11, 2021, online

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Gene Therapy Uses HIV to Rescue Kids Born Without Immune System - HealthDay News

By Morgan C. Fitzgerald

California has one of the weakest laws in place to protect patients against the onerous and potentially dangerous practice of step therapy, according to a new study published by the Global Healthy Living Foundation.

Step therapy, also known as a fail-first requirement, can be a profit-generating treatment protocol enforced by health insurance companies under which patients must fail medications in defined tiers before receiving approval to step up to the medications prescribed by their doctors.

Insurance companies promote this requirement under the guise of ensuring that patients receive the most effective and reasonably priced drugs when in reality this practice forces patients to compromise treatment decisions and blocks access to essential medications.

Furthermore, each time patients change insurance coverage or start a new treatment, the process can start all over again. Step therapy causes immense, unnecessary patient suffering and gravely weakens individuals ability to receive the medicines prescribed to them.

In California, the current step therapy law fails to cover any of the six most common reasons for requesting an exemption to this process, such as a doctor believing that the first-step medication will be ineffective or even detrimental to their patient, among other provisions.

Im one of those people caught in the step therapy loop, having lived more than half my life with debilitating migraine.

Migraine is a complex neurological disease affecting more than 12% of the U.S. population. Symptoms commonly interfere with daily activities and can be so severe as to be disabling.

Between the ages of 12 and 21 I tried countless medications to manage migraine, but there were no migraine-specific preventative medications at the time so I was limited to off-label use of a multitude of drugs.

This included antidepressants, anxiolytics, antiepileptics, high blood pressure pills, and even a drug designed to treat dementia.

Unfortunately, these medications were not harmless. The side effects were numerous and almost as hard to manage as the disease I was trying to treat.

When I turned 21 my health took a turn for the worse, chronic migraine snowballed into a never-ending migraine attack, called intractable or refractory migraine, and I had to drop out of college and move back home.

Hunkering down in my childhood bedroom, I worked tirelessly with my doctors to try and improve my health while constantly battling with maddening insurance protocols.

In 2018, two years into my refractory migraine, a new class of medications developed specifically for migraine, calcitonin gene-related peptide (CGRP) monoclonal antibodies, hit the market.

It was exciting to have migraine-specific medications available and the listed side effects were far fewer and less severe than the medications historically prescribed to migraine patients.

However, despite the fact that I had the same insurance coverage, meaning the insurance company had documentation of every medication and treatment I had ever tried, they denied coverage.

It took numerous medical necessity forms, appeal letters, and phone calls over a six-month period to finally gain insurance coverage. It was only on this new, more expensive medication that I was able to return to being a contributing force in society, finishing school and securing a job at a major research institution.

Without access to the newest therapies, I would still be unable to work and likely on disability.

Happy ending not so fast. Over the last three years, I have changed insurance companies, tried two other CGRP medications, added treatment for a comorbid condition, and tried to add noninvasive device therapy.

With each of these events, the insurance company reset the step protocol and repeatedly delayed or entirely blocked access to the treatments that my doctors determined to be the best course of disease management.

My doctors and I are forced to repeatedly fill out reams of paperwork and spend countless hours on the phone while I suffer from disrupted, fractured treatment. This effort is daunting, costly and a risk to my health.

Most chronically ill patients do not have the stamina or resources to push for the coverage they need.

Step therapy takes medical decision-making away from patients and doctors and puts it in the hands of insurance companies.

In California, we can help chronic disease patients access the medications deemed necessary by their doctors by reforming step therapy legislation.

Thats why I am urging my community to support Assembly Bill 347. For more information about step therapy, visit the Global Healthy Living Foundations 50StateNetwork at http://www.50statenetwork.org

Morgan Fitzgerald is an Encinitas resident and volunteer patient advocate with the Global Healthy Living Foundation.

Read more from the original source:
Commentary: California is last when it comes to protecting patients' rights - Coast News

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SOUTH SAN FRANCISCO, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Amunix Pharmaceuticals, Inc. (Amunix), an immuno-oncology company leveraging its proprietary, clinically validated Pro-XTEN technology platform to discover and develop transformative T cell engagers and cytokine therapies for patients with cancer, today announced the appointment of Ciara Kennedy, Ph.D., M.B.A. to its board of directors. Dr. Kennedy brings to Amunix a wealth of strategic and operational experience across multiple therapeutic areas and stages of development in the biopharmaceutical industry.

We are excited to welcome Ciara, a leader in the biotech industry, to Amunix, said Angie You, chief executive officer of Amunix. Ciaras strategic, transactional and operational expertise will be invaluable as we plan to initiate a Phase 1/2 clinical trial for our lead program AMX-818, a masked HER2-targeted T cell engager, in early 2022 and transition into a clinical stage company. In addition, her visionary leadership will contribute to our strategic focus of building out our pipeline of masked T cell engagers and cytokines.

Dr. Kennedy added, I am delighted to join Amunixs board and am excited about the potential of its proprietary Pro-XTEN technology to harness the untapped potential of T-cell engagers and cytokines. I look forward to working closely with the experienced team as the company matures and grows its pipeline of promising therapeutics that has the potential to change the landscape of potent options for solid tumors.

Most recently, Dr. Kennedy was the President and Chief Executive Officer of Amplyx Pharmaceuticals, Inc., a clinical-stage company developing innovative drug therapies for debilitating and life-threatening diseases in patients with compromised immune systems, where she led the company through a successful acquisition by Pfizer Inc. Prior to Amplyx, she was chief operating officer of Lumena Pharmaceuticals Inc. where she oversaw operations including clinical development and helped lead its successful acquisition by Shire plc. Earlier in her career, Dr. Kennedy also held various roles at Cypress Bioscience, Inc. and Biogen Idec Ltd.. Dr. Kennedy has a strong track record of building companies through to later stages of clinical development with a unique breadth of experience across business development, finance, program management, and clinical/regulatory strategy.

In addition to Amunix, Dr. Kennedy is on the boards of Otonomy, Inc. and Aristea Therapeutics, Inc. She holds a Ph.D. from Queens University of Belfast, Northern Ireland and an M.B.A. from the Rady School of Management University of California, San Diego and B.S. from University of Cork, Ireland.

About Amunixs Pro-XTEN Technology

Amunixs Pro-XTEN technology aims to mitigate the toxicity of T cell engagers (TCEs) and cytokines by creating drugs that are preferentially activated in the tumor microenvironment, thus driving tumor cell killing while minimizing on-target, off-tumor toxicity that can damage healthy tissues and/or cause cytokine release syndrome. Amunixs Pro-XTEN technology leverages the intrinsically high protease activity in the tumor microenvironment to preferentially unmask and activate our drugs in the tumor microenvironment. The two proprietary components of this technology are as follows: 1) an XTEN Mask, a polypeptide that serves a dual purpose of acting as a universal spatial shield mask and providing half-life extension, and 2) a protease-cleavable linker which enables preferential unmasking and drug activation in the tumor microenvironment.

About Amunix Pharmaceuticals

Amunix Pharmaceuticals, based in South San Francisco, California, is an immuno-oncology company leveraging its proprietary, clinically validated Pro-XTEN technology platform to discover and develop transformative T cell engagers and cytokine therapies for patients with cancer. Amunix aims to expand the therapeutic index of TCEs and cytokines, which have demonstrated anti-tumor clinical activity, but have not realized their potential due to dose-limiting on-target, off-tumor toxicity. Amunix addresses this challenge by using its universal, protease-releasable masking technology, or Pro-XTEN, to create next generation, conditionally active T cell engagers, or XPATs, and cytokines, or XPACs, that are preferentially activated in tumors as compared to healthy tissues. Amunixs most advanced product candidate, AMX-818, is a masked HER2-targeted TCE for the treatment of HER2-expressing solid tumors, which is currently in IND-enabling studies. Along with other T cell engager programs, Amunix is also applying its proprietary masking technology to its first masked, protease-activated cytokine program, IL12-XPAC, which is in discovery stage.

For additional information about the company, please visit http://www.amunix.com.

Contacts

Company Contact:Jen Herbach Director, Corporate DevelopmentBD@amunix.com

Media Contact:Sylvia Wheelermedia@amunix.com

Investor Contact:Zeeshan MerchantChief Financial Officerinvestors@amunix.com

Link:
Amunix Expands its Board of Directors with the Appointment of Industry Veteran, Ciara Kennedy, Ph.D., MBA - StreetInsider.com

Solid tumor-specific scaffold protein ligands from Navigo combined with MDimunes BioDrone technology to create novel targeted extracellular vesicle-based therapeutics

Halle/Saale, Germany and Seoul, Korea, May 11th, 2021. Navigo Proteins, a protein engineering biotech company generating scaffold protein-based affinity ligands, and MDimune, a biotech company developing an innovative drug delivery platform based on exosome-like, nanosized cell-derived vesicles (CDVs), today announced a technology collaboration to achieve tissue-targeting of extracellular vesicles (EVs). The ongoing research combines Navigos target-binding Affilin molecules with MDimunes CDV technology, to enable Affilin-mediated delivery of CDVs specifically to solid tumor targets.

For the current collaboration, Navigo Proteins will contribute its existing solid tumor-specific Affilin molecules to decorate the surface of the exosome-like CDVs from MDimunes BioDrone technology, thereby pioneering next-generation, targeted extracellular vesicle-based therapeutics (See Figure 1).

Figure 1: Affilin-mediated tumor targeting of CDVs

Dr. Ulrich Haupts, Chief Scientific Officer of Navigo Proteins commented: We are looking forward to combining our selectivity-conferring Affilin molecules with MDimunes extracellular vesicles manufacturing platform, since this opens up an exciting new application for our scaffold protein-based Affilin molecules in the upcoming field of exosome-based therapeutics. The modular and highly engineerable Affilin technology can be a very attractive solution for the precise, targeted delivery of exosome-like vesicles, carrying different payloads to different target tissues.

Recently, we have invested significant efforts and resources to expedite effective steering of our vesicles, CDVs, to tumors or other resistant tissues. The current collaboration with Navigo Proteins is one of them highlighting our recent focus. Navigo Proteins demonstrated expertise in generating highly tissue-specific ligands will be key to enable this goal and ultimately build a foundation for our BioDrone platform technology, said Dr. Seung Wook Oh, Chief Scientific Officer of MDimune.

Affilin Affinity Ligands

Navigos Affilin molecules are target-specific, small, stable, highly engineerable, single-chain affinity ligands and are based on human Ubiquitin as a protein scaffold. Since Ubiquitin is an evolutionarily conserved natural human protein, also present in plasma, Affilin molecules have low immunogenic potential in humans and can also be directly used in various pre-clinical animal models.

Affilin molecules are currently being developed as antibody-alternatives in protein-drug conjugates, radio conjugates, CAR-T cell therapy, and as bi/multi-specific molecules by combining them with antibodies. With this collaboration, Navigo aims to extend the applicability of Affilin molecules to direct exosomes and extracellular vesicles to the target tissues of interest.

BioDrone Platform Technology

MDimunes BioDrone platform facilitates the production of CDVs, exosome-like, nanosized vesicles, in large quantities from various cell types by a proprietary extrusion method. CDVs are similar to exosomes in size, properties, and functions, but exhibit substantial advantages in yield that is more suitable for large-scale production and versatility to allow highly sophisticated engineering, starting from virtually any cell type. BioDrone technology is emerging as a highly versatile and scalable delivery system to address many human diseases, including cancer, neurodegeneration, and more.

While the current project is aimed at Affilin-CDV-mediated payload delivery to solid tumors, this technological advance will not only be limited to cancer but could be expanded to other tissues and diseases.

About Navigo Proteins GmbH

Navigo Proteins is a premier protein engineering company developing affinity ligands, based on its proprietary platform of selected, small, and stable, yet highly engineerable scaffold proteins. These ligands serve as target-binding proteins in biotherapeutic molecules (PRECISION TARGETING) or for commercial custom affinity purification of biologics (PRECISION CAPTURING).

Navigos PRECISION TARGETING unit creates proprietary Affilin molecules based on the human Ubiquitin scaffold a highly conserved, small (8.5kDa) and stable natural human protein. A major strength of the Precision Targeting toolbox is its modular engineerability. The target-specific Affilin molecules can be combined with a variety of carrier units for site-specific payload coupling as well as half-life extension moieties and function-conferring effector modules to convert them into different biopharmaceutical modalities. Navigos ligands are currently being developed as Affilin-drug conjugates, Affilin-radio conjugates, Affilin CAR-T cell therapy and can also be fused to antibodies to create robustly-to-produce bi-/multi-specific molecules (MabfilinTM/FabfilinTM).

For more information visit https://www.navigo-proteins.com/ and follow Navigo Proteins on LinkedIn.

About MDimune Inc.

MDimune, a South Korean biotech founded in 2015, has been committed to the development and implementation of state-of-the-art BioDrone platform technology. BioDrone is an innovative technology that relies on human-sourced CDVs, nanosized vesicles obtained from various cells by using a proprietary extrusion method to achieve target-specific drug delivery. With superior productivity compared to exosomes, BioDrone is emerging as a highly versatile and scalable delivery system to combat diverse debilitating human diseases, including cancer, neurodegeneration, and rare diseases.

MDimune is expanding its global network to harness effective tissue targeting strategies to achieve highly tissue-specific delivery of various cargos such as miRNA, siRNA, mRNA, and proteins. The company envisions applying this novel BioDrone platform to address various needs of pharmaceutical clients who are looking for effective drug carriers.

For more information visit http://www.mdimune.com/en/.

Navigo Proteins Contact

Dr. Oliver Schub

Director Business Development

oliver.schub@navigo-proteins.com

Tel.: +49 (0)345 27996330

MDimune Contact

Brin Choi

Manager, Business Development

jychoi@mdimune.com

Tel.: +82 (0)70+7826

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Navigo Proteins and MDimune Enter into a Research Collaboration on Affilin-Mediated Targeting of Extracellular Vesicles - BioSpace

May 9, 2021 (Reports and Markets) Nuclear Plant Life Extension Market

Reports And Markets recently added a research report on the Nuclear Plant Life Extension Market, which represents a study for the period from 2021 to 2027. The research study provides a near look at the market scenario and dynamics impacting its growth. This report highlights the crucial developments along with other events happening in the market which are marking the growth and opening doors for future growth in the coming years. Additionally, the report is built on the basis of the macro- and micro-economic factors and historical data that can influence the growth.

The report offers valuable insight into the Nuclear Plant Life Extension Market progress and approaches related to the Nuclear Plant Life Extension market with an analysis of each region. The report goes on to talk about the dominant aspects of the market and examine each segment.

Key Players: Areva,CNNC,Rosatom,Westinghouse Electric Company,CGN,Hitachi GE Nuclear Energy,Mitsubishi Heavy Industries,KHNP,Kansai Electric Power,Japan Atomic Power,Alstom,Hitachi

Get a Free Sample @ https://www.reportsandmarkets.com/sample-request/global-nuclear-plant-life-extension-market-size-status-and-forecast-2020-2026?utm_source=beveragemanager&utm_medium=60

The global Nuclear Plant Life Extension Market segmented by company, region (country), by Type, and by Application. Players, stakeholders, and other participants in the global Nuclear Plant Life Extension market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by region (country), by Type, and by Application for the period 2021-2027.

Market Segment by Regions, regional analysis covers

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, Colombia etc.)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Key Points of the Geographical Analysis:

Data and information related to the consumption rate in each region

The estimated increase in the consumption rate

The expected growth rate of the regional markets

Proposed growth of the market share of each region

Geographical contribution to market revenue

Research objectives:

To study and analyze the global Nuclear Plant Life Extension Market size by key regions/countries, product type and application, history data from 2013 to 2017, and forecast to 2027.

To understand the structure of the Nuclear Plant Life Extension Market by identifying its various sub segments.

Focuses on the key global Nuclear Plant Life Extension players, to define, describe and analyze the value, market share, market competition landscape, SWOT analysis and development plans in next few years.

To analyze the Nuclear Plant Life Extension with respect to individual growth trends, future prospects, and their contribution to the total market.

To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).

To project the size of Nuclear Plant Life Extension sub markets, with respect to key regions (along with their respective key countries).

To analyze competitive developments such as expansions, agreements, new product launches and acquisitions in the market.

To strategically profile the key players and comprehensively analyze their growth strategies.

The report lists the major players in the regions and their respective market share on the basis of global revenue. It also explains their strategic moves in the past few years, investments in product innovation, and changes in leadership to stay ahead in the competition. This will give the reader an edge over others as a well-informed decision can be made looking at the holistic picture of the market.

Table of Contents: Nuclear Plant Life Extension Market

Chapter 1: Overview of Nuclear Plant Life Extension Market

Chapter 2: Global Market Status and Forecast by Regions

Chapter 3: Global Market Status and Forecast by Types

Chapter 4: Global Market Status and Forecast by Downstream Industry

Chapter 5: Market Driving Factor Analysis

Chapter 6: Market Competition Status by Major Manufacturers

Chapter 7: Major Manufacturers Introduction and Market Data

Chapter 8: Upstream and Downstream Market Analysis

Chapter 9: Cost and Gross Margin Analysis

Chapter 10: Marketing Status Analysis

Chapter 11: Market Report Conclusion

Chapter 12: Research Methodology and Reference

Get complete Report: https://www.reportsandmarkets.com/enquiry/global-nuclear-plant-life-extension-market-size-status-and-forecast-2020-2026?utm_source=beveragemanager&utm_medium=60

Key questions answered in this report

What will the market size be in 2027 and what will the growth rate be?

What are the key market trends?

What is driving this market?

What are the challenges to market growth?

Who are the key vendors in this market space?

What are the market opportunities and threats faced by the key vendors?

What are the strengths and weaknesses of the key vendors?

About Us:

Reports and Markets is not just another company in this domain but is a part of a veteran group called Algoro Research Consultants Pvt. Ltd. It offers premium progressive statistical surveying, market research reports, analysis & forecast data for a wide range of sectors both for the government and private agencies all across the world. The database of the company is updated on a daily basis. Our database contains a variety of industry verticals that include: Food Beverage, Automotive, Chemicals and Energy, IT & Telecom, Consumer, Healthcare, and many more. Each and every report goes through the appropriate research methodology, Checked from the professionals and analysts.

Contact Us:

Sanjay Jain

Manager Partner Relations & International Marketing

http://www.reportsandmarkets.com

Ph: +1-352-353-0818 (US)

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Global Nuclear Plant Life Extension Market Insights 2021 Industry Overview, Competitive Players & Forecast 2027| Areva,CNNC,Rosatom,Westinghouse...

PRESS RELEASE

INTESA SANPAOLO SUPPORTS THE DEVELOPMENT OF THE CAMPUS BIO-MEDICO UNIVERSITY OF ROME WITH A LOAN OF 50 MILLION EURO. THE PROJECT FEATURES INNOVATIVE SUSTAINABILITY CHARACTERISTICS

Milan, 13 May 2021 - Intesa Sanpaolo and Campus Bio-Medico S.p.A., the organizations set up to promote the Campus Bio-Medico University of Rome, have signed a 50 million euro loan agreement for investments with innovative sustainability characteristics.

The financed investment plan involves the creation of new spaces and infrastructures for university education, training and scientific research all with characteristics of environmental sustainability and energy efficiency.

For Intesa Sanpaolo, this marks the conclusion of one more transaction that is part of the 6- billion-euro earmarked for the circular economy as envisaged by the 2018-2021 Business Plan. 200 Projects have already received funding within this context. The transaction was concluded by the Intesa Sanpaolo IMI Corporate and Investment Banking Division, headed by Mauro Micillo with the support of the Intesa Sanpaolo Innovation Center Circular Economy Desk, the company of the Group dedicated to innovating and spreading the circular economy.

"Supporting Italian excellence such as the Campus Bio-Medico University of Rome in its development projects gives Intesa Sanpaolo great pride and satisfaction," said Richard Zatta, Head of Global Corporate of the IMI Corporate & Investment Banking Division of Intesa Sanpaolo. At a time like the present, which is profoundly marked by the effects of the pandemic, providing support to the healthcare sector, universities and scientific research is even more crucial. The funded project will further expand the areas for university education with eco-sustainable and low environmental impact structures".

"A great crisis like the current one has uncovered how fragile our socio-economic system is, but it has also revealed the great opportunities for universities, as they find themselves spearheading the change towards greater technological, social, scientific knowledge and reflection on the fundamental values of our civic life, social organisation and commitment to the service of others - stated Giuseppe Garofano, Chairman of Campus Bio-MedicoSpA

The transaction includes a tranche of around 30 million euro for the creation of green and mobility infrastructures and innovative spaces dedicated to university education, informal learning and campus life that will host university students as early as the 2022-23 academic year. The project envisages a significant improvement in energy efficiency both in new spaces and in the various related systems, which will make it possible to optimise solar radiation, regulate air renewal and also produce the heat required for heating, thus avoiding the use of natural gas.

A second tranche of 20 million euro will be used to extend the maturity and thus refinance the remainder of a previous mortgage granted to allow the construction of the hospital and university complex which today constitutes one of the country's medical, scientific and academic centres of excellence.

The Campus Bio-Medico University is composed of the Department of Medicine and Surgery (with degree courses in Italian and English, and 24 specialised schools), the Department of Engineering (offering the Chemical Engineering for Sustainable Development course, among others) and the Department of Science and Technology for humans and the environment (with a course specifically focused on the circular economy) attended by over 2,200 students. Its research laboratories host 50 research units, with around 400 researchers.

The Campus Bio-Medico University Hospital has 400 beds, 18 operating rooms, 70 outpatient clinics and a first-level emergency room (currently reconverted into a Covid Center with 100 dedicated beds). It is equipped with all the latest technological equipment for diagnosis and treatment.

To boost and support the Circular and Green Economy, Intesa Sanpaolo has developed a wide and diversified range of financing and advisory products, dedicated to all types of customers, in Italy and abroad. Projects receiving Intesa Sanpaolo loans for the circular economy must meet a number of criteria, including product life extension, renewable energy, resource

optimisation, recyclable products and technologies that enable and foster this economic model. This allows the Bank to disburse loans at increasingly advantageous terms for customers, subject to verifying the achievement of the circular economy objectives.

***

Press information

Intesa Sanpaolo

Media Relations, Corporate & Investment Banking and Governance Areas stampa@intesasanpaolo.com https://group.intesasanpaolo.com/it/sala-stampa/news

Intesa Sanpaolo

Intesa Sanpaolo is the leading Bank in Italy and one of the soundest and most profitable banks in Europe. It offers commercial, corporate investment banking, asset management and insurance services. The Intesa Sanpaolo Group has approximately 14.7 million customers in Italy who are assisted through both digital and traditional channels. It also has

7.1 million international customers which it serves through its commercial banking subsidiaries present in 12 countries in Central-Eastern Europe, the Middle East and North Africa, and through an international network dedicated to corporate customers in 26 countries. Intesa Sanpaolo is considered one of the most sustainable banks in the world. For the Group, creating value means being a driver for growth, for the benefit of both society and the economy. As regards the environment, the Group has set up a 6-billion-euro fund for the circular economy. Intesa Sanpaolo supports major economic inclusion and poverty reduction projects, including an impact fund of 1.5 billion euro for loans available to social groups who struggle to access credit. Intesa Sanpaolo has a high level of involvement in cultural initiatives, organised by the Bank or in collaboration with other entities in Italy and further afield. These include permanent and temporary exhibitions showcasing the Bank's impressive artistic heritage at the Gallerie d'Italia, the Group's museums located in Milan, Naples, Vicenza and soon Turin.

Website: group.intesasanpaolo.com | News: https://group.intesasanpaolo.com/it/sala-stampa/news | Twitter:

@intesasanpaolo | Facebook: @intesasanpaolo | LinkedIn: https://www.linkedin.com/company/intesa-sanpaolo |

Instagram: @intesasanpaolo

Press information

Campus Bio-Medico SpA

Executive Director Domenico Mastrolitto info@cbm-spa.it

Media Relations Manager info@italcommunications.it https://italcommunications.it

Campus Bio-Medico SpA

Campus Bio-Medico S.p.A. is one of the two promoters of the Campus Bio-Medico University of Rome and the company that owns the university campus building and the land on which it is situated. It manages a 90,000 square metre building complex, which includes the 400-bed university hospital and 90 hectares of land, part of which is located within the Decima Malafede Natural Reserve in Rome. Campus Bio-Medico SpA ensures that the institutional goals of the University are pursued and handles the development of new projects for university growth, including through its own managerial and business resources. Its shareholders are non-profit entities, entrepreneurs and private and institutional investors. The university promoters are the Campus Bio-Medico Association and Campus Bio-Medico SpA. They guarantee the pursuit of the institutional aims set out in the Articles of Association and in the Charter of Purposes of the Campus Bio-Medico University of Rome, including through the appointment of some members of the university Board of Directors.

Website: campusbiomedicospa.it - futureunicampus.co m - unicampus.it | News: https://campusbiomedicospa .it/cbm-

media - https://unicampus.it/news-blog | LinkedIn: https://www.linkedin.com/company/campusbiomedicospa

Disclaimer

Intesa Sanpaolo S.p.A. published this content on 13 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 May 2021 10:23:07 UTC.

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Intesa Sanpaolo S p A : supports the development of the Campus Bio-Medico University of Rome with a loan of 50 million euro. The project features...

News Release

Tuesday, May 11, 2021

An investigational gene therapy can safely restore the immune systems of infants and children who have a rare, life-threatening inherited immunodeficiency disorder, according to research supported in part by the National Institutes of Health. The researchers found that 48 of 50 children who received the gene therapy retained their replenished immune system function two to three years later and did not require additional treatments for their condition, known as severe combined immunodeficiency due to adenosine deaminase deficiency, or ADA-SCID. The findings were published today inthe New England Journal of Medicine.

ADA-SCID, which is estimated to occur in approximately 1 in 200,000 to 1,000,000 newborns worldwide, is caused by mutations in theADAgene that impair the activity of the adenosine deaminase enzyme needed for healthy immune system function. This impairment leaves children with the condition highly susceptible to severe infections. If untreated, the disease is fatal, usually within the first two years of life.

These findings suggest that this experimental gene therapy could serve as a potential treatment option for infants and older children with ADA-SCID, said Anthony S. Fauci, M.D., director of NIHs National Institute of Allergy and Infectious Diseases (NIAID). Importantly, gene therapy is a one-time procedure that offers patients the hope of developing a completely functional immune system and the chance to live a full, healthy life.

People with ADA-SCID can be treated with enzyme replacement therapy, but this treatment does not fully reconstitute immune function and must be taken for life, usually once or twice weekly. Transplants of blood-forming stem cells, ideally from a genetically matched sibling donor, can provide a more lasting solution. However, most people lack such a donor. Additionally, stem cell transplants carry risks such asgraft-versus-host disease and side effects from chemotherapy medications given to help the donor stem cells establish themselves in the patients bone marrow.

The new research evaluated an experimental lentiviral gene therapy designed to be safer and more effective than previously tested gene-therapy strategies for ADA-SCID. This gene therapy involves inserting a normal copy of theADAgene into the patients own blood-forming stem cells. First, stem cells are collected from the patients bone marrow or peripheral blood. Next, a harmless virus is used as a vector, or carrier, to deliver the normalADAgene to these cells in the laboratory. The genetically corrected stem cells then are infused back into the patient, who has received a low dose of the chemotherapy medication busulfan to help the cells establish themselves in the bone marrow and begin producing new immune cells.

The experimental gene therapy, developed by researchers from the University of California, Los Angeles (UCLA) and Great Ormond Street Hospital (GOSH) in London, uses a modified lentivirus to deliver the ADA gene to cells. Previous gene-therapy approaches for ADA-SCID have relied on a different type of virus called a gamma retrovirus. Some people who have received gamma retroviral gene therapies have later developed leukemia, which scientists suspect is due to the vector causing activation of genes that control cell growth.The lentiviral vector is designed to avoid this outcome and to enhance the effectiveness of gene delivery into cells.

The results come from three separate Phase 1/2 clinical trials, two conducted in the United States and one in the United Kingdom. The U.S. trials, led by principal investigator Donald Kohn, M.D., of UCLA, enrolled 30 participants with ADA-SCID ranging in age from 4 months to 4 years at UCLA Mattel Childrens Hospital and the NIH Clinical Center in Bethesda, Maryland. The U.K. study, conducted at GOSH and led by principal investigator Claire Booth, M.B.B.S., Ph.D., enrolled 20 participants ranging in age from 4 months to 16 years. Most participants acquired and retained robust immune function following gene therapy 96.7% after two years in the U.S. studies and 95% after three years in the U.K. study and were able to stop enzyme replacement therapy and other medications. Of the two participants for whom gene therapy did not restore lasting immune function, one restarted enzyme replacement therapy and later received a successful stem cell transplant from a donor, and the other restarted enzyme replacement therapy. The lentiviral gene therapy appeared safe overall, although all participants experienced some side effects. Most of these were mild or moderate and attributable to the chemotherapy that the participants received.

Researchers observed similar outcomes in all three trials, although there were some differences between the studies. Stem cells were collected from bone marrow in the U.S. trials and from peripheral blood in the U.K. trial. In one of the U.S. trials, 10 children were treated with genetically corrected stem cells that had been frozen and later thawed. The two other trials used fresh stem cell preparations. In the future, the freezing procedure known as cryopreservation may allow stem cells to be more easily transported and processed at a manufacturing facility far from the patients home and shipped back to a local hospital, reducing the need for patients to travel long distances to specialized medical centers to receive gene therapy. A trial of the cryopreserved treatment is now underway at the Zayed Centre for Research into Rare Diseases in Children in London, in partnership with GOSH.

For more information about the trials described in the New England Journal of Medicine paper, visit ClinicalTrials.gov under identifiers NCT01852071, NCT02999984 and NCT01380990. The investigational lentiviral gene therapy, which is licensed to Orchard Therapeutics, has not been approved for use by any regulatory authority.

The research was funded in part by three NIH Institutes: NIAID; the National Heart, Lung and Blood Institute; and the National Human Genome Research Institute. Additional funding was provided by the California Institute for Regenerative Medicine, the Medical Research Council, the National Institute for Health Research Biomedical Research Centre at Great Ormond Street Hospital for Children National Health Service Foundation Trust and University College London, and Orchard Therapeutics.

NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

DB Kohn, C Boothet al. Autologousex vivolentiviral gene therapy for adenosine deaminase deficiency.New England Journal of MedicineDOI: 10.1056/NEJMoa2027675 (2021).

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Read more:
Gene therapy restores immune function in children with rare immunodeficiency - National Institutes of Health

Jesse Owens

Making waves in the fight against disease at the University of Hawaii is the Institute for Biogenesis Researchs (IBR) youngest full-time faculty member, 36-year-old Jesse Owens. Owens, who also earned his PhD in cell and molecular biology from UH Mnoa, was awarded $2.3 million from the National Institutes of Health (NIH) over the next five years to develop a new, safer and more efficient approach to gene therapy. He leads a team of collaborators from UH Mnoas John A. Burns School of Medicine (JABSOM), MIT and UC Davis.

The $2.3 million grant is significant because it was a first-time submission and received a score in the 1st percentile, higher than 99% of grants submitted from institutions across all 50 states in the U.S.

Directed evolution of a sequence-specific targeting technology for therapeutic gene delivery to the human genome, Owens grant addresses drawbacks to current genome editing technologies that randomly insert a therapeutic gene, which can disrupt important host genes and potentially cause cancer. Methods like CRISPR (clustered regularly interspaced short palindromic repeats), a family of DNA sequences in genomes of organisms, are inefficient in non-dividing cells and delivering large DNA cargos. However, the technology that Owens is developing can direct large pieces of DNA to a safe location in the genome that can be used in all body tissues, both dividing and non-dividing, which will allow us to cure more types of diseases.

This is an R01, which is the coveted personal grant that people get to do researchits bringing absolutely state-of-the-art technology that hes inventing to do new gene therapy in Hawaii and this is why were very proud of him, said IBR Director Steven Ward.

I think the schools here in Hawaii are underestimated Owens

Not only is he faculty here, he got his PhD here, he was trained here, he was raised on the Big Island, added Ward. Hes the product of that and it just shows you that Hawaii can do some of the worlds greatest biomedical research.

In addition to the NIH funding, Owens recently signed a sponsored-research agreement with a private company specializing in non-viral gene therapies called SalioGen Therapeutics. The goal of this collaboration is to advance the tools he is developing in the lab into clinical-stage gene therapy candidates.

Born on Hawaii Island, Owens shares his Hilo High School alma mater with renowned Nobel Prize winner Jennifer Doudna, who developed CRISPR gene therapy. He hopes to inspire other children from Hawaii to pursue a career in science.

I think the schools here in Hawaii are underestimated really, but you can succeed coming out of Hawaii, for sure, Owens said.

Read more on the JABSOM website.

This research is an example of UH Mnoas goal of Excellence in Research: Advancing the Research and Creative Work Enterprise (PDF), one of four goals identified in the 201525 Strategic Plan (PDF), updated in December 2020.

Continue reading here:
$2.3M boost puts Hawaii gene therapy research on the map | University of Hawaii System News - UH System Current News