{"id":13971,"date":"2021-11-08T19:12:27","date_gmt":"2021-11-08T13:42:27","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=13971"},"modified":"2023-06-21T11:14:24","modified_gmt":"2023-06-21T05:44:24","slug":"gene-therapy-for-hemophilia","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/gene-therapy-for-hemophilia","title":{"rendered":"The Evolved Gene Therapy for Hemophilia"},"content":{"rendered":"\n<p>Hemophilia is an inherited rare disorder where blood doesn\u2019t clot in the regular way because the person affected doesn\u2019t make enough blood-clotting proteins (clotting factors). Without these factors, patients cannot stop bleeding when they are injured. Patients with more severe forms of the disease can experience spontaneous bleeding around the joints. Small cuts are not much dangerous but internal bleeding is very harmful to hemophiliac patients. The main concern is internal bleeding in elbows, knees, ankles and other joints. Internal bleeding can damage the organs and tissues and can also be potentially life-threatening.<\/p>\n\n\n\n<p>Below mentioned are the <a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-market\"><strong>different types of Hemophilia&nbsp;<\/strong><\/a><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-a2030-market\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Hemophilia A<\/strong><\/a>: It is caused by a lack of blood clotting factor VIII; approximately 85% of Hemophiliacs have type A disease.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-b-market\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Hemophilia B<\/strong><\/a>: It is caused by a deficiency of factor IX.<\/li>\n\n\n\n<li><strong>Hemophilia C<\/strong>: Some doctors use this term to refer to a lack of clotting factor XI.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.delveinsight.com\/blog\/von-willebrand-disease-vwd-market\"><strong>Von Willebrand disease<\/strong><\/a>: A part of the factor VIII molecule known as von Willebrand factor or ristocetin cofactor is reduced. The von Willebrand factor involves helping the platelets (blood cells that control bleeding) attach to the lining of a vein or artery. This missing factor results in prolonged bleeding time because the platelets are unable to attach to the wall of the vessel and form a plug to stop the bleeding. This disease is similar to Hemophilia but is not usually called by this name. It is more common and usually milder than Hemophilia.<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Types of Hemophilia<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Deficient Factor&nbsp;<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Inheritance Type<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Hemophilia A<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>VIII<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>X-linked recessive<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Hemophilia B<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>IX<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>X-linked recessive<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Hemophilia C<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>XI<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Autosomal recessive<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>von Willebrand disease<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>VIII:vW<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Autosomal dominant<\/strong><\/td><\/tr><\/tbody><\/table><figcaption class=\"wp-element-caption\"><strong>Types of Hemophilia as per their Inheritance Type<\/strong><\/figcaption><\/figure>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-a-lifelong-genetic-disorder\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Hemophilia diagnosis<\/strong><\/a> includes <strong>screening tests <\/strong>such as<strong> <\/strong>Complete Blood Count (CBC), Activated Partial Thromboplastin Time (APTT) Test, Prothrombin Time (PT) Test, Fibrinogen Test and <strong>clotting factor tests<\/strong>. Screening tests are blood tests that show if the blood is clotting properly. Clotting factor tests, also called factor assays, are required to diagnose a bleeding disorder. This blood test shows the type of Hemophilia and the severity.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"594\" height=\"204\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205058\/Haemophilia-Sign-and-Symptoms.png\" alt=\"Haemophilia Sign and Symptoms\" class=\"wp-image-23673\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205058\/Haemophilia-Sign-and-Symptoms.png 594w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205058\/Haemophilia-Sign-and-Symptoms-300x103.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205058\/Haemophilia-Sign-and-Symptoms-150x52.png 150w\" sizes=\"(max-width: 594px) 100vw, 594px\" \/><figcaption class=\"wp-element-caption\"><strong>Major Sign and Symptoms of Haemophilia<\/strong><\/figcaption><\/figure>\n\n\n\n<p>Hemophilia symptoms depend on the level of clotting factors. If the clotting-factor level is mildly reduced, it might bleed only after surgery or trauma. If the deficiency is severe, one can bleed easily for seemingly no reason. <a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-market\"><strong>Hemophilia symptoms<\/strong><\/a> include unexplained and excessive bleeding from cuts or injuries, or after surgery or dental work, large and deep bruises, abnormal bleeding after vaccinations, pain, swelling, tightness in joints, blood in your urine or stool, nosebleeds and at times unexplained irritability in infants. <a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-market\"><strong>Hemophilia risk factors<\/strong><\/a><strong> <\/strong>include having a family member who also has the disorder. Males are much more likely to have Hemophilia than are females.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"730\" height=\"400\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205151\/Hemophilia-A-Market-Outlook-and-Trends.png\" alt=\"Hemophilia A Market Outlook and Trends\" class=\"wp-image-23677\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205151\/Hemophilia-A-Market-Outlook-and-Trends.png 730w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205151\/Hemophilia-A-Market-Outlook-and-Trends-300x164.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205151\/Hemophilia-A-Market-Outlook-and-Trends-150x82.png 150w\" sizes=\"(max-width: 730px) 100vw, 730px\" \/><figcaption class=\"wp-element-caption\">Hemophilia A Market Outlook and Trends<\/figcaption><\/figure>\n\n\n\n<p>According to DelveInsight, the<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/infographics\/hemophilia-a2030-market\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Hemophilia A market<\/strong><\/a> size in seven major markets (7MM) is estimated to be <strong>USD 5,760 million<\/strong> in 2017. Many key pharmaceuticals are proactively involved in producing Hemophilia A therapies including companies like <strong>Spark Therapeutics, Sigilon Therapeutics, ASC Therapeutics, Pfizer, Sanofi Genzyme,&nbsp; Novo Nordisk,<\/strong> and many others.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"696\" height=\"358\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205259\/Hemophilia-B-Market-Outlook-and-Trends.png\" alt=\"Hemophilia B Market Outlook and Trends\" class=\"wp-image-23680\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205259\/Hemophilia-B-Market-Outlook-and-Trends.png 696w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205259\/Hemophilia-B-Market-Outlook-and-Trends-300x154.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205259\/Hemophilia-B-Market-Outlook-and-Trends-150x77.png 150w\" sizes=\"(max-width: 696px) 100vw, 696px\" \/><figcaption class=\"wp-element-caption\"><strong>Hemophilia B Market Outlook and Trends<\/strong><\/figcaption><\/figure>\n\n\n\n<p>DelveInsight estimates that the<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-b-market\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Hemophilia B market<\/strong><\/a><strong> <\/strong>size in the 7MM is expected to change at a<strong> CAGR of 8.9% <\/strong>by 2030 and the total number of<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-b-epidemiology-forecast\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>prevalent cases of Hemophilia B <\/strong><\/a>was observed to be <strong>10,739 cases <\/strong>in the 7MM in the year 2020. Many key pharmaceuticals are proactively involved in producing Hemophilia B therapies including companies like<strong> UniQure Biopharma B.V.\/CSL Behring, Sangamo Therapeutics, Pfizer, Spark Therapeutics, Genzyme, Novo Nordisk, Sanofi, ApcinteX Ltd, Freeline Therapeutics, <\/strong>and others.<\/p>\n\n\n\n<p>As per DelveInsight, <a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-market\"><strong>Hemophilia C<\/strong><\/a> occurs with an estimated <strong>prevalence of 1 case per 100,000 population<\/strong> in the United States, a rate that makes Hemophilia A approximately 10 times more common than Hemophilia C.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"803\" height=\"205\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205355\/von-Willebrand-disease-VWD-Market-Outlook-and-Trends.png\" alt=\"von Willebrand disease (VWD) Market Outlook and Trends\" class=\"wp-image-23683\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205355\/von-Willebrand-disease-VWD-Market-Outlook-and-Trends.png 803w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205355\/von-Willebrand-disease-VWD-Market-Outlook-and-Trends-300x77.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205355\/von-Willebrand-disease-VWD-Market-Outlook-and-Trends-150x38.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/20205355\/von-Willebrand-disease-VWD-Market-Outlook-and-Trends-768x196.png 768w\" sizes=\"(max-width: 803px) 100vw, 803px\" \/><figcaption class=\"wp-element-caption\"><strong>von Willebrand Disease (VWD) Market Outlook and Trends<\/strong><\/figcaption><\/figure>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/blog\/von-willebrand-disease-vwd-market\"><strong>von Willebrand disease (VWD)<\/strong><\/a><strong> <\/strong>affects up to 1% of the population in the United States, as analyzed by Delveinsight. <a href=\"https:\/\/www.delveinsight.com\/report-store\/von-willebrand-disease-vwd-market\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>von Willebrand disease market size<\/strong><\/a> in the US is anticipated to increase with a <strong>CAGR of 1.23%<\/strong> by 2030 and the total diagnosed <a href=\"https:\/\/www.delveinsight.com\/report-store\/von-willebrand-disease-epidemiology-forecast\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>von Willebrand disease prevalent cases<\/strong><\/a> were found to be <strong>12,505 cases<\/strong> in the US in the year 2020. The leading companies working proactively to improve the VWD treatment landscape include <strong>CSL Behring GmbH, Sanofi-Aventis, Octapharma, Grifols, Takeda,<\/strong> and others.<\/p>\n\n\n\n<p>Historically, there has been no cure for Hemophilia. <a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-pipeline-insight\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Hemophilia treatment<\/strong><\/a><strong> <\/strong>involves replacing the missing blood clotting factor so that the blood can clot properly, called replacement therapy. This is typically done by injecting treatment products, called <strong>clotting factor concentrates,<\/strong> into a person\u2019s vein. Clinicians typically prescribe treatment products for <strong>episodic care <\/strong>or <strong>prophylactic care<\/strong>. Episodic care is used to stop a patient\u2019s bleeding episodes; prophylactic care is used to prevent bleeding episodes from occurring.&nbsp;<\/p>\n\n\n\n<p>Conceptually, clotting factors can help restore normal blood clotting in a patient, and this aspect can be achieved through gene therapy. Gene therapy for Hemophilia is touted as the most advanced and revolutionary treatment. A single dose of experimental gene therapy can boost the production of a missing blood-clotting factor in individuals with Hemophilia, giving patients a long-term solution for preventing dangerous bleeding episodes.<\/p>\n\n\n\n<p><strong>How can Gene Therapy be used in <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-pipeline-insight\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Hemophilia treatment&nbsp;<\/strong><\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/blog\/delveinsights-hematological-disorders-based-gene-therapy-reports\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Gene therapy for Hemophilia<\/strong><\/a> involves inducing a modified virus (disease-free) in the hemophiliac patient to introduce a copy of the gene which encodes for the clotting factor that has been missing in patients. Following the gene therapy treatment with the virus, it is expected that the patients shall begin producing their own clotting factors. Human clinical trials have commenced in order to test potential gene therapies for Hemophilia.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/blog\/a-crispr-cas9-approach-for-gene-therapy-the-hot-new-rd-field\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>CRISPR\/Cas9<\/strong><\/a> is another strategy that could allow a patient\u2019s body to produce its own blood clotting factor. It uses a piece of genetic material and an enzyme that acts like molecular scissors to repair the genetic fault that causes clotting factor deficiency.<\/p>\n\n\n\n<p>Gene therapy offers the potential for a cure for patients with Hemophilia by establishing continuous endogenous expression of factor VIII or factor IX (FIX) following the transfer of a functional gene to replace the hemophilic patient&#8217;s own defective gene.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Experimental Gene Therapies in Hemophilia&nbsp;<\/strong><\/h2>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-b-market\"><strong>UniQure<\/strong><\/a> is developing two investigational gene therapies for Hemophilia <a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-b-market\"><strong>AMT-060<\/strong><\/a><strong> <\/strong>and <a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-b-market\"><strong>AMT-061<\/strong><\/a><strong>. AMT-060<\/strong> is an ongoing two-cohort Phase 1\/2, non-randomized, open-label, multi-centre clinical trial<strong> (NCT02396342). <\/strong>There are 10 patients in the clinical study experiencing severe to moderately severe Hemophilia B. After administration of the AMT-060 gene therapy, clinical demonstration indicated a significant and sustained increase in factor IX activity, a substantial reduction in factor IX replacement therapy usage, and a complete cessation of spontaneous bleeding episodes. Now, <strong>AMT-061 <\/strong>is being developed to deliver a variant of the <a href=\"https:\/\/ghr.nlm.nih.gov\/gene\/F9\"><em>F9<\/em><\/a><em> <\/em>gene that encodes for clotting factor IX called FIX-Padua. This variant carries the instructions to make factor IX protein that is eight times more active than the normal protein. A harmless virus vector is used to direct the delivery of FIX-Padua to the patient\u2019s body. Interim results of an ongoing Phase 2B study <strong>(NCT03489291)<\/strong> testing the safety and efficacy of AMT-061 in three patients with severe to moderately severe Hemophilia B showed increased factor IX activity, reduced risk of bleeding, and no adverse events. A multicenter Phase 3 study <strong>(NCT03569891)<\/strong> evaluating the safety, efficacy, and tolerability of AMT-061 in Hemophilia B patients is also underway.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-b-market\"><strong>FLT180a<\/strong><\/a> is a gene therapy being developed by <a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-b-market\"><strong>Freeline<\/strong><\/a><strong>.<\/strong> A Phase 1 clinical trial<strong> (NCT03369444)<\/strong> is currently recruiting patients with Hemophilia B in the U.K. to test FLT180a. A second Phase 2\/3 study <strong>(NCT03641703)<\/strong> is also recruiting participants in the same location to investigate the long-term safety and durability of factor IX activity in participants who have been treated with FLT180a gene therapy.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-b-market\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Sangamo Therapeutics<\/strong><\/a> is developing a genome editing therapy for Hemophilia B called <a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-b-market\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>SB-FIX<\/strong><\/a><strong>.<\/strong> A Phase 1\/2 clinical trial <strong>(NCT02695160)<\/strong> is currently recruiting participants at several sites in the U.S. and the U.K. <strong>SB-525<\/strong> is another gene therapy for Hemophilia A developed by<strong> Sangamo Therapeutics<\/strong>. A Phase 1\/2 clinical trial <strong>(NCT03061201) <\/strong>is currently recruiting about 20 adults with Hemophilia A to evaluate the safety, efficacy and tolerability of the treatment across many sites in the United States.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"821\" height=\"243\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/21111400\/Key-Players-Developing-Gene-Therapy-for-the-Treatment-of-Hemophilia.png\" alt=\"Key Players Developing Gene Therapy for the Treatment of Hemophilia\" class=\"wp-image-23689\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/21111400\/Key-Players-Developing-Gene-Therapy-for-the-Treatment-of-Hemophilia.png 821w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/21111400\/Key-Players-Developing-Gene-Therapy-for-the-Treatment-of-Hemophilia-300x89.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/21111400\/Key-Players-Developing-Gene-Therapy-for-the-Treatment-of-Hemophilia-150x44.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/06\/21111400\/Key-Players-Developing-Gene-Therapy-for-the-Treatment-of-Hemophilia-768x227.png 768w\" sizes=\"(max-width: 821px) 100vw, 821px\" \/><figcaption class=\"wp-element-caption\"><strong>Key Players Developing Gene Therapy for the Treatment of Hemophilia<\/strong><\/figcaption><\/figure>\n\n\n\n<p><strong>Fidanacogene elaparvovec <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-b-market\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>(SPK-9001)<\/strong><\/a> is a gene therapy for Hemophilia B being developed in a partnership between <strong>Spark Therapeutics<\/strong> and <strong>Pfizer.<\/strong> This therapy is currently being investigated in a Phase II clinical trial <strong>(NCT02484092)<\/strong>.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/report-store\/spk-8011-emerging-drug-insight-and-market-forecast\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>SPK-8011<\/strong><\/a> is another gene therapy for Hemophilia A being developed by <a href=\"https:\/\/www.delveinsight.com\/report-store\/spk-8011-emerging-drug-insight-and-market-forecast\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Spark Therapeutics<\/strong><\/a><strong>. <\/strong>Preliminary results from Phase 1\/2 clinical trials<strong> (NCT03003533)<\/strong> indicated that all five participants in the first two dose cohorts have shown persistent, stable clotting factor levels in their blood. <strong>Spark Therapeutics<\/strong> is developing another gene therapy called <a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-a-pipeline-insight\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>SPK-8016<\/strong><\/a><strong>, <\/strong>which is designed to help Hemophilia A patients who have developed inhibitors against their own clotting factors. Patients are currently being recruited for a Phase 1\/2 clinical trial <strong>(NCT03734588<\/strong>) in the U.S. to determine the effective dosage of the treatment.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/report-store\/valrox-valoctocogene-roxaparvovec-emerging-drug-insight-and-market-forecast\"><strong>Valrox<\/strong> <\/a>(valoctocogene roxaparvovec or BMN 270) is a gene therapy for Hemophilia A being developed by <a href=\"https:\/\/www.delveinsight.com\/report-store\/valrox-valoctocogene-roxaparvovec-emerging-drug-insight-and-market-forecast\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Biomarin<\/strong><\/a>. The therapy is currently being tested in two Phase III clinical trials <strong>(NCT03392974 and NCT03370913).<\/strong><\/p>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<figure class=\"wp-block-table is-style-stripes\"><table class=\"has-black-color has-green-to-yellow-gradient-background has-text-color has-background\"><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Company Name&nbsp;<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Gene Therapy<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Clinical Trial Phase<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Biomarin<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Valrox<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Phase III<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Spark Therapeutics<\/strong> and <strong>Pfizer<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>SPK-9001<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Phase II<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>UniQure<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>AMT-061<\/strong><strong>AMT-060<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Phase II<\/strong><strong>Phase I\/II<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Spark Therapeutics<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>SPK-8011<\/strong>&nbsp;<strong>SPK-8016<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Phase I\/II<\/strong><strong>Phase I\/II<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Sangamo Therapeutics<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>SB-FIX<\/strong><strong>SB-525<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Phase I\/II<\/strong><strong>Phase I\/II<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Freeline<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>FLT180a<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Phase I<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><\/p>\n<\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-gene-therapy-for-hemophilia-progress-and-setbacks\"><strong>Gene Therapy for Hemophilia: Progress and Setbacks<\/strong><\/h2>\n\n\n\n<p>Using <a href=\"https:\/\/www.delveinsight.com\/blog\/delveinsights-hematological-disorders-based-gene-therapy-reports\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>gene therapy for Hemophilia<\/strong><\/a> treatment is in many ways a promising option, but it also has some drawbacks. Few of the progressive factors that gene therapy benefits in Hemophilia are:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Hemophilia is considered to be an ideal genetic disorder to treat involving the gene therapy mechanism, as it occurs because of a single genetic defect i.e. a monogenic disease. This type of treatment can be considered immensely successful even if only a minimal increase in clotting factors is observed after the treatment. A little increase can lead to massive benefits for the patients.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Another major advantage in gene therapy for Hemophilia is the way of disease occurrence in terms of a genetic disorder. It is very simple, caused by one known genetic defect that decreases the body&#8217;s ability to produce sufficient clotting factors in the blood. Unlike other genetic diseases, which at times involve numerous genetic defects, Hemophilia is comparatively a much easier target for gene therapy.<\/li>\n\n\n\n<li>One more basic reason for <a href=\"https:\/\/www.delveinsight.com\/blog\/delveinsights-hematological-disorders-based-gene-therapy-reports\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>gene therapy for Hemophilia<\/strong><\/a> being so encouraging is that even minimal success from the gene therapy procedure can mean a significant improvement in quality of life for patients. In some peculiar tests, this therapy has led to a marginal improvement in clotting factors in the blood, and also the time it took for the subject&#8217;s blood to clot reduced remarkably. People who experience such kind of improvements after gene therapy may be able to go for longer time durations without supplemental clotting factors infusions.<\/li>\n<\/ul>\n\n\n\n<p>However, gene therapy for Hemophilia is not completely positive, given the lack of people participating in clinical studies. Some of the essential setbacks include<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The results of gene therapy for Hemophilia treatment are proven to be inconsistent. Many studies that are conducted on animals have procured good results often, but that still hasn\u2019t managed to translate similar results in human beings.<\/li>\n\n\n\n<li>Another con is the factor that there is a severe risk to the patient&#8217;s body while undergoing gene therapy for<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/blog\/delveinsights-hematological-disorders-based-gene-therapy-reports\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Hemophilia treatment<\/strong><\/a>. It is observed that the patient will develop antibodies to the viral vectors used to deliver the genetic material to the cells.&nbsp;<\/li>\n\n\n\n<li>The method of treatment is another setback when it comes to <a href=\"https:\/\/www.delveinsight.com\/blog\/delveinsights-hematological-disorders-based-gene-therapy-reports\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>gene therapy for Hemophilia<\/strong><\/a>. For the genetic material to go inside the cellular structure, it is essential to attach it to viruses, which are then injected inside the body where they can invade those cells. In some cases, an immune response or reaction can be triggered due to this. The patient\u2019s body in return can produce antibodies that can destroy the particular viruses, stopping the treatment from happening in the first place.<\/li>\n\n\n\n<li>Taking the decision of whether to undergo gene therapy or not can be extremely difficult. Apart from the insurance questions, the biggest barrier is that gene therapy results aren\u2019t guaranteed and if it doesn\u2019t work in the favour, patients will never get another chance for using the same therapy or a similar vector for re-treatment.&nbsp;<\/li>\n<\/ul>\n\n\n\n<p>In conclusion, gene therapy has an excellent safety profile, but the fact that only around 100 people with Hemophilia have undergone treatment whose results were taken under consideration. Many adverse reactions are expected to occur when several thousands of people may actually undergo this gene therapy treatment. Unfortunately, scientists are still not able to predict whether the transmitted gene copy or the expressing cells will be stable and the results will persist, or if they may be inactivated which means a patient is back to square one.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.delveinsight.com\/blog\/hemophilia-market\"><strong>What Does the Future Hold for Gene Therapy for Hemophilia<\/strong><\/a><\/h2>\n\n\n\n<p>FDA has promised to accelerate the reviews of gene therapies for Hemophilia A and B. DelveInsight analysts anticipate that these therapies could have a quoted price of $2.5 to $3 million, making them the most expensive drugs ever to reach the market. With vigorous research, inclusion parameters can be broadened and gene therapy can be available to people with less severe diseases. Scientists are looking at other viral vectors, including &#8211; <em>lentivirus<\/em>, which can open up gates of gene therapy to people who have antibodies associated with Adeno-Associated Virus (AAV).<\/p>\n\n\n\n<p>For more than a decade now, gene therapy is considered to be one of the most sought-after treatments for Hemophilia. A one-shot targeted process that can fix the inherited condition at its source and operates on replacement of a defective gene with a functional one to produce sufficient clotting factor. Now that this revolutionary treatment is assured to become very much of a reality, several significant pharmaceutical companies and drug giants are expected to receive US Food and Drug Administration approval to market gene therapy for Hemophilia in the subsequent years.<\/p>\n\n\n\n<p><strong>Frequently Asked Questions<\/strong><\/p>\n\n\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1636376743389\"><strong class=\"schema-faq-question\"><strong>What will the factor levels be after gene therapy?<\/strong><\/strong> <p class=\"schema-faq-answer\">Yes, they may vary as a response to gene therapy. Solely based on the clinical trials, factors may be moderate, mild or normal Hemophilia range and may fluctuate over time. Whether there is a requirement of factors if you have an accident, injury or require surgery will depend on the factor level.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1636376754641\"><strong class=\"schema-faq-question\"><strong>Can gene therapy be stopped or turned off?<\/strong><\/strong> <p class=\"schema-faq-answer\">No, it is not possible to reverse or undo the one-time intravenous infusion used for gene therapy.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1636376762368\"><strong class=\"schema-faq-question\"><strong>Can the effects of gene therapy be passed to children?<\/strong><\/strong> <p class=\"schema-faq-answer\">No, gene therapy for Hemophilia corrects the genetic defect only in the person who receives it. It does not correct the genes that are passed onto the next generation.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1636376770421\"><strong class=\"schema-faq-question\"><strong>What are some of the key companies working in the field of gene therapy for Hemophilia?<\/strong><\/strong> <p class=\"schema-faq-answer\">Some of the major pharmaceuticals working proactively in the field of gene therapy for Hemophilia include names like<strong> Spark Therapeutics, Sigilon Therapeutics, ASC Therapeutics, Pfizer, Sanofi Genzyme,\u00a0 Novo Nordisk, UniQure Biopharma B.V.\/ CSL Behring, Sangamo Therapeutics, Pfizer, Genzyme,\u00a0 ApcinteX Ltd, <\/strong>and <strong>Freeline Therapeutics.<\/strong><\/p> <\/div> <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Hemophilia is an inherited rare disorder where blood doesn\u2019t clot in the regular way because the person affected doesn\u2019t make enough blood-clotting proteins (clotting factors). Without these factors, patients cannot stop bleeding when they are injured. Patients with more severe forms of the disease can experience spontaneous bleeding around the joints. Small cuts are not [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":13987,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":10,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[283,284,285,18878,604],"industry":[17225],"therapeutic_areas":[17235,17238,17233,17227,17234],"class_list":["post-13971","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-hemophilia","tag-hemophilia-a","tag-hemophilia-b","tag-hemophilia-c","tag-von-willebrand-disease","industry-pharmaceutical","therapeutic_areas-cell-and-gene-therapy","therapeutic_areas-genetic-disorders","therapeutic_areas-hematological-disorders","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-rare-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - 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Solely based on the clinical trials, factors may be moderate, mild or normal Hemophilia range and may fluctuate over time. Whether there is a requirement of factors if you have an accident, injury or require surgery will depend on the factor level.","inLanguage":"en-US"},"inLanguage":"en-US"},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/gene-therapy-for-hemophilia#faq-question-1636376754641","position":2,"url":"https:\/\/www.delveinsight.com\/blog\/gene-therapy-for-hemophilia#faq-question-1636376754641","name":"Can gene therapy be stopped or turned off?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"No, it is not possible to reverse or undo the one-time intravenous infusion used for gene therapy.","inLanguage":"en-US"},"inLanguage":"en-US"},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/gene-therapy-for-hemophilia#faq-question-1636376762368","position":3,"url":"https:\/\/www.delveinsight.com\/blog\/gene-therapy-for-hemophilia#faq-question-1636376762368","name":"Can the effects of gene therapy be passed to children?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"No, gene therapy for Hemophilia corrects the genetic defect only in the person who receives it. It does not correct the genes that are passed onto the next generation.","inLanguage":"en-US"},"inLanguage":"en-US"},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/gene-therapy-for-hemophilia#faq-question-1636376770421","position":4,"url":"https:\/\/www.delveinsight.com\/blog\/gene-therapy-for-hemophilia#faq-question-1636376770421","name":"What are some of the key companies working in the field of gene therapy for Hemophilia?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Some of the major pharmaceuticals working proactively in the field of gene therapy for Hemophilia include names like<strong> Spark Therapeutics, Sigilon Therapeutics, ASC Therapeutics, Pfizer, Sanofi Genzyme,\u00a0 Novo Nordisk, UniQure Biopharma B.V.\/ CSL Behring, Sangamo Therapeutics, Pfizer, Genzyme,\u00a0 ApcinteX Ltd, <\/strong>and <strong>Freeline Therapeutics.<\/strong>","inLanguage":"en-US"},"inLanguage":"en-US"}]}},"author_meta":{"display_name":"DelveInsight","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/arawat"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2021\/11\/08192011\/Gene-Therapy-for-Hemophilia-What-Does-the-Future-Hold-300x187.jpg","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Articles<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Articles<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">hemophilia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">hemophilia A<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">hemophilia B<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Hemophilia C<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Von Willebrand disease<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">hemophilia<\/span>","<span class=\"advgb-post-tax-term\">hemophilia A<\/span>","<span class=\"advgb-post-tax-term\">hemophilia B<\/span>","<span class=\"advgb-post-tax-term\">Hemophilia C<\/span>","<span class=\"advgb-post-tax-term\">Von Willebrand disease<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 4 years ago","modified":"Updated 3 years ago"},"absolute_dates":{"created":"Posted on Nov 8, 2021","modified":"Updated on Jun 21, 2023"},"absolute_dates_time":{"created":"Posted on Nov 8, 2021 7:12 pm","modified":"Updated on Jun 21, 2023 11:14 am"},"featured_img_caption":"Gene-Therapy-for-Hemophilia","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/13971","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=13971"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/13971\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/13987"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=13971"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=13971"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=13971"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=13971"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=13971"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}