{"id":7238,"date":"2021-04-07T18:03:04","date_gmt":"2021-04-08T01:03:04","guid":{"rendered":"https:\/\/www.bluerocktx.com\/?p=7238"},"modified":"2023-06-26T14:32:31","modified_gmt":"2023-06-26T18:32:31","slug":"bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease","status":"publish","type":"post","link":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/","title":{"rendered":"BlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson\u2019s Disease"},"content":{"rendered":"

CAMBRIDGE, Mass.,\u00a0April 7, 2021\u00a0\/PRNewswire\/<\/strong> \u2014 BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer\u00a0AG, announced that Health Canada has given permission to initiate \u201cPhase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson\u2019s Disease (PD).\u201d\u00a0This is the first trial in\u00a0Canada\u00a0to study pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson\u2019s disease.<\/p>\n

\u201cWe\u2019re excited to initiate this study with our expert collaborators at University Health Network in\u00a0Toronto\u00a0as we believe this trial could shift the treatment paradigm for PD patients in\u00a0Canada\u00a0and around the world,\u201d states Emile\u00a0Nuwaysir, Ph.D., President and Chief Executive Officer of BlueRock. \u201cOur therapy is intended to replace the midbrain dopaminergic neurons lost in the degenerative condition to rebuild the neural circuit, and thereby restore motor control\u00a0to Parkinson\u2019s patients. If successful, this could demonstrate for the first time that the effects of degenerative disease are, in principle, reversible.\u201d<\/p>\n

\u201cWe are thrilled to be the first national trial site bringing leading-edge clinical research with life-changing potential to the nearly 8 million patients world-wide who are affected by Parkinson\u2019s,\u201d says\u00a0Brad Wouters, Ph.D., Executive Vice-President, Science and Research, University Health Network (UHN). \u201cAs the largest hospital-based research institution in\u00a0Canada, UHN is uniquely positioned with both talent and clinical trial infrastructure to support this important research.\u201d<\/p>\n

\u201cExploring the potential for a cell therapy that could improve Parkinson\u2019s rather than simply slowing its progress is a monumental step \u2013 few therapeutic approaches to date have been designed to truly restore function,\u201d says the trial\u2019s lead investigator\u00a0Andres Lozano, M.D., Ph.D., Senior Scientist, Krembil Research Institute and RR Tasker Chair in Stereotactic and Functional Neurosurgery, University Health Network. \u201cThis is an important step to advance treatment using a novel strategy for a disease that does not yet have a cure and could change lives for many patients.\u201d<\/p>\n

The trial will enroll ten patients in\u00a0the United States\u00a0and\u00a0Canada, with the Canadian trial site at University Health Network,\u00a0Canada\u2019s\u00a0largest research and teaching hospital network, located in\u00a0Toronto, Ontario. The primary objective of the\u00a0Ph1\u00a0study is to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. The secondary objectives of the study are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant, to evaluate continued safety and tolerability at two years, and to assess feasibility of transplantation.<\/p>\n

More information about this trial is available at\u00a0clinicaltrials.gov<\/span><\/a>\u00a0(NCT#04802733).<\/p>\n

About Parkinson\u2019s Disease
\n<\/strong>Parkinson\u2019s disease is a progressive neurodegenerative disorder caused by nerve cell damage in the brain, leading to decreased dopamine levels. The worsening of motor and non-motor symptoms is caused by the loss of dopamine-producing neurons. At diagnosis, it is estimated\u202fthat\u202fpatients have\u202falready\u202flost 60-80 percent of their dopaminergic neurons. Parkinson\u2019s disease often starts with a tremor in one hand. Other symptoms are rigidity, cramping and slowness of movement (bradykinesia).\u202fParkinson\u2019s disease is the second most common neurodegenerative disorder, impacting\u202fmore than\u202f7.5 million people, including 1.3 million in North America.<\/p>\n

About BlueRock Therapeutics
\n<\/strong>BlueRock Therapeutics is a leading engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. BlueRock Therapeutics\u2019\u00a0cell+gene<\/em>\u00a0platform harnesses the power of cells to create new medicines for neurology, cardiology, and immunology indications. BlueRock Therapeutics\u2019 cell differentiation technology recapitulates the cell\u2019s developmental biology to produce authentic cell therapies, which are further engineered for additional function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore or regenerate lost function. BlueRock Therapeutics was founded in 2016 by Versant Ventures and Bayer AG and capitalized with one of the largest-ever Series A financings in biotech history by Bayer AG (through its Leaps by Bayer unit) and Versant Ventures. The company was fully acquired by Bayer in 2019. BlueRock Therapeutics\u2019 culture is defined by scientific innovation, the highest ethical standards, and an urgency to bring transformative treatments to all who would benefit. For more information, visit\u00a0bluerocktx.com<\/span><\/a>.<\/p>\n

About Bayer
\n<\/strong>Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help\u00a0people and planet thrive by supporting efforts to master\u00a0the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The\u00a0Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4\u00a0billion euros. R&D expenses before special items\u00a0amounted to\u00a04.9 billion euros.\u00a0For more information, go to\u00a0www.bayer.com<\/span><\/a>.<\/p>\n

Forward-Looking Statements
\n<\/em><\/strong>Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201cforecast,\u201d \u201cestimate\u201d and \u201cintend,\u201d among others. These forward-looking statements are based on BlueRock\u2019s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing of our clinical trial for DA01; our results regarding the safety, tolerance and efficacy of DA01 cell transplantation for patients with Parkinson\u2019s disease; and ongoing FDA, Health Canada and other regulatory requirements regarding the development of DA01. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, BlueRock does not undertake an obligation to update or revise any forward-looking statement. All of the Company\u2019s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

CAMBRIDGE, Mass.,\u00a0April 7, 2021\u00a0\/PRNewswire\/ \u2014 BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer\u00a0AG, announced that Health Canada has given permission to initiate \u201cPhase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson\u2019s Disease (PD).\u201d\u00a0This is the […]<\/p>\n","protected":false},"author":2,"featured_media":7708,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[56,57],"acf":[],"yoast_head":"\nBlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson\u2019s Disease - BlueRock Therapeutics LP<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson\u2019s Disease - BlueRock Therapeutics LP\" \/>\n<meta property=\"og:description\" content=\"CAMBRIDGE, Mass.,\u00a0April 7, 2021\u00a0\/PRNewswire\/ \u2014 BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer\u00a0AG, announced that Health Canada has given permission to initiate \u201cPhase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson\u2019s Disease (PD).\u201d\u00a0This is the […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/\" \/>\n<meta property=\"og:site_name\" content=\"BlueRock Therapeutics LP\" \/>\n<meta property=\"article:published_time\" content=\"2021-04-08T01:03:04+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-06-26T18:32:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.bluerocktx.com\/wp-content\/uploads\/2023\/06\/BR-Logo-Card.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"900\" \/>\n\t<meta property=\"og:image:height\" content=\"1000\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"BlueRock Therapeutics\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"BlueRock Therapeutics\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/\",\"url\":\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/\",\"name\":\"BlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson\u2019s Disease - BlueRock Therapeutics LP\",\"isPartOf\":{\"@id\":\"https:\/\/www.bluerocktx.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.bluerocktx.com\/wp-content\/uploads\/2023\/06\/BR-Logo-Card.jpg\",\"datePublished\":\"2021-04-08T01:03:04+00:00\",\"dateModified\":\"2023-06-26T18:32:31+00:00\",\"author\":{\"@id\":\"https:\/\/www.bluerocktx.com\/#\/schema\/person\/7bce67a9ee8dcf888329288a28761057\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#primaryimage\",\"url\":\"https:\/\/www.bluerocktx.com\/wp-content\/uploads\/2023\/06\/BR-Logo-Card.jpg\",\"contentUrl\":\"https:\/\/www.bluerocktx.com\/wp-content\/uploads\/2023\/06\/BR-Logo-Card.jpg\",\"width\":900,\"height\":1000,\"caption\":\"BlueRock Therapeutics Logo Card\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.bluerocktx.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"BlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson\u2019s Disease\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.bluerocktx.com\/#website\",\"url\":\"https:\/\/www.bluerocktx.com\/\",\"name\":\"BlueRock Therapeutics LP\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.bluerocktx.com\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.bluerocktx.com\/#\/schema\/person\/7bce67a9ee8dcf888329288a28761057\",\"name\":\"BlueRock Therapeutics\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.bluerocktx.com\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/154b53ac9f1feafa6f14d0efa17a4fdb?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/154b53ac9f1feafa6f14d0efa17a4fdb?s=96&d=mm&r=g\",\"caption\":\"BlueRock Therapeutics\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"BlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson\u2019s Disease - BlueRock Therapeutics LP","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/","og_locale":"en_US","og_type":"article","og_title":"BlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson\u2019s Disease - BlueRock Therapeutics LP","og_description":"CAMBRIDGE, Mass.,\u00a0April 7, 2021\u00a0\/PRNewswire\/ \u2014 BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer\u00a0AG, announced that Health Canada has given permission to initiate \u201cPhase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson\u2019s Disease (PD).\u201d\u00a0This is the […]","og_url":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/","og_site_name":"BlueRock Therapeutics LP","article_published_time":"2021-04-08T01:03:04+00:00","article_modified_time":"2023-06-26T18:32:31+00:00","og_image":[{"width":900,"height":1000,"url":"https:\/\/www.bluerocktx.com\/wp-content\/uploads\/2023\/06\/BR-Logo-Card.jpg","type":"image\/jpeg"}],"author":"BlueRock Therapeutics","twitter_card":"summary_large_image","twitter_misc":{"Written by":"BlueRock Therapeutics","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/","url":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/","name":"BlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson\u2019s Disease - BlueRock Therapeutics LP","isPartOf":{"@id":"https:\/\/www.bluerocktx.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#primaryimage"},"image":{"@id":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#primaryimage"},"thumbnailUrl":"https:\/\/www.bluerocktx.com\/wp-content\/uploads\/2023\/06\/BR-Logo-Card.jpg","datePublished":"2021-04-08T01:03:04+00:00","dateModified":"2023-06-26T18:32:31+00:00","author":{"@id":"https:\/\/www.bluerocktx.com\/#\/schema\/person\/7bce67a9ee8dcf888329288a28761057"},"breadcrumb":{"@id":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#primaryimage","url":"https:\/\/www.bluerocktx.com\/wp-content\/uploads\/2023\/06\/BR-Logo-Card.jpg","contentUrl":"https:\/\/www.bluerocktx.com\/wp-content\/uploads\/2023\/06\/BR-Logo-Card.jpg","width":900,"height":1000,"caption":"BlueRock Therapeutics Logo Card"},{"@type":"BreadcrumbList","@id":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-permission-from-health-canada-for-da01-trial-in-parkinsons-disease\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.bluerocktx.com\/"},{"@type":"ListItem","position":2,"name":"BlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson\u2019s Disease"}]},{"@type":"WebSite","@id":"https:\/\/www.bluerocktx.com\/#website","url":"https:\/\/www.bluerocktx.com\/","name":"BlueRock Therapeutics LP","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.bluerocktx.com\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.bluerocktx.com\/#\/schema\/person\/7bce67a9ee8dcf888329288a28761057","name":"BlueRock Therapeutics","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.bluerocktx.com\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/154b53ac9f1feafa6f14d0efa17a4fdb?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/154b53ac9f1feafa6f14d0efa17a4fdb?s=96&d=mm&r=g","caption":"BlueRock Therapeutics"}}]}},"_links":{"self":[{"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/posts\/7238"}],"collection":[{"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/comments?post=7238"}],"version-history":[{"count":3,"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/posts\/7238\/revisions"}],"predecessor-version":[{"id":7636,"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/posts\/7238\/revisions\/7636"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/media\/7708"}],"wp:attachment":[{"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/media?parent=7238"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/categories?post=7238"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bluerocktx.com\/wp-json\/wp\/v2\/tags?post=7238"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}