{"id":7258,"date":"2022-05-31T18:21:24","date_gmt":"2022-06-01T01:21:24","guid":{"rendered":"https:\/\/www.bluerocktx.com\/?p=7258"},"modified":"2023-06-26T14:30:55","modified_gmt":"2023-06-26T18:30:55","slug":"bluerock-therapeutics-announces-completion-of-enrollment-of-phase-1-trial-in-patients-with-parkinsons-disease","status":"publish","type":"post","link":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-announces-completion-of-enrollment-of-phase-1-trial-in-patients-with-parkinsons-disease\/","title":{"rendered":"BlueRock Therapeutics Announces Completion of Enrollment of Phase 1 Trial in Patients with Parkinson\u2019s Disease"},"content":{"rendered":"<ul>\n<li><strong>Initiation of global non-interventional study for patients with Parkinson\u2019s planned for the second half of 2022 as next step<\/strong><\/li>\n<\/ul>\n<p><strong>CAMBRIDGE, Mass., May 31, 2022<\/strong>\u00a0\u2013 BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer\u202fAG, announced\u202fthe completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson\u2019s disease (PD). The purpose of the\u202fPh1 clinical trial is to evaluate the safety, tolerability, and\u202fpreliminary\u202fefficacy\u202fof BRT-DA01 in patients with Parkinson\u2019s disease.<\/p>\n<p>\u201cPatients with Parkinson\u2019s disease are faced with life changing challenges and uncertainties that are not addressed by current treatments,\u201d said Ahmed Enayetallah, M.D., Ph.D., Senior Vice President, Clinical Development, BlueRock Therapeutics. \u201cWe are excited that our Phase 1 clinical trial has completed enrollment and believe it is a critical next step toward the development of a novel cell therapy that has the potential to transform the treatment landscape for this devastating disease.\u201d<\/p>\n<p><strong>About the BRT-DA01 Phase 1 Trial<\/strong><\/p>\n<p>The primary objective of the\u00a0Ph1\u00a0trial is to assess the safety and tolerability of BRT-DA01 transplantation at one-year post-transplant. The secondary objectives of the trial 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<p>In the United States, the trial was initiated at Weill Cornell Medicine with Dr. Harini Sarva, M.D. as the Principal Investigator (PI) and first surgeries being performed by Dr. Viviane Tabar, Chair of the Department of Neurosurgery at Memorial Sloan Kettering Cancer Center. Additional Neurology sites were added at the University of California, Irvine, under the guidance of Dr. Claire Henchcliffe, M.D., D.Phil., F.A.A.N., F.A.N.A. (PI), and at the University Health Network (UHN), under the guidance of Dr. Lozano, O.C., M.D., Ph.D., F.R.C.S.C., F.R.S.C., F.C.A.H.S. (PI) and Dr. Alfonso Fasano, M.D., PhD., Chair in Neuromodulation and Multi-Disciplinary Care, UHN and UoT.<\/p>\n<p>More information about the Phase 1 trial is available at\u00a0<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04802733?term=04802733&amp;draw=2&amp;rank=1\" target=\"_blank\" rel=\"noopener\">clinicaltrials.gov<\/a>\u00a0(NCT#04802733)<\/p>\n<p>As a next step, BlueRock Therapeutics plans to initiate a global non-interventional study in the second half of 2022.<\/p>\n<p>More information about the non-interventional study is available at\u00a0<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05363046?term=05363046&amp;draw=2&amp;rank=1\" target=\"_blank\" rel=\"noopener\">clinicaltrials<\/a><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04802733?term=04802733&amp;draw=2&amp;rank=1\">.gov<\/a>\u00a0(NCT#05363046)<\/p>\n<p><strong>About Parkinson\u2019s Disease<\/strong><\/p>\n<p>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 that patients have already lost 60-80% 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). According to the Parkinson\u2019s Foundation, more than 10 million people worldwide suffer from Parkinson\u2019s disease, with one million living in the United States. BRT-DA01 is being clinically evaluated in a subset of patients with Parkinson\u2019s disease, where regular medications are no longer fully effective.<\/p>\n<p><strong>About BlueRock Therapeutics<\/strong><\/p>\n<p>BlueRock Therapeutics is a leading engineered cell therapy company with a mission to create authentic cellular medicines to reverse devastating diseases, with the vision of improving the human condition. The Company\u2019s\u00a0<strong><em>cell+gene<\/em><\/strong>\u00a0platform harnesses the power of cells to create new medicines for neurology, cardiology, immunology, and ophthalmology indications. BlueRock Therapeutics\u2019 cell differentiation technology recapitulates the cells\u2019 developmental biology to produce authentic cells, some of which are engineered for additional therapeutic function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore 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 the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit\u00a0<a href=\"http:\/\/www.bluerocktx.com\/\">www.bluerocktx.com<\/a>.<\/p>\n<p><strong>About Bayer<\/strong><\/p>\n<p>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 people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating 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 Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&amp;D expenses before special items amounted to 5.3 billion euros. For more information, go to\u00a0<a href=\"http:\/\/www.bayer.com\/\" target=\"_blank\" rel=\"noopener\">www.bayer.com<\/a>.<\/p>\n<p><strong><em>Forward-Looking Statements\u202f<\/em><\/strong><\/p>\n<p><em>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 the Company\u2019s current expectations of BlueRock, 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 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<p><em>This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer\u2019s public reports which are available on the Bayer website at\u00a0<\/em><a href=\"http:\/\/www.bayer.com\/\" target=\"_blank\" rel=\"noopener\"><em>www.bayer.com<\/em><\/a><em>. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.\u00a0<\/em><\/p>\n<p><strong>CONTACT:\u00a0\u00a0<\/strong><\/p>\n<p>BlueRock Therapeutics<br \/>\nJeff Lockwood<br \/>\nVice President, Corporate Communications<br \/>\n(617) 510-6997<br \/>\n<a href=\"mailto:jlockwood@bluerocktx.com\">jlockwood@bluerocktx.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Initiation of global non-interventional study for patients with Parkinson\u2019s planned for the second half of 2022 as next step CAMBRIDGE, Mass., May 31, 2022\u00a0\u2013 BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer\u202fAG, announced\u202fthe completion of enrollment of its Phase [&hellip;]<\/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],"class_list":["post-7258","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-releases","tag-neurology","tag-clinical-trials"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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