{"id":8955,"date":"2024-05-30T05:00:56","date_gmt":"2024-05-30T09:00:56","guid":{"rendered":"https:\/\/www.bluerocktx.com\/?p=8955"},"modified":"2024-07-22T17:24:57","modified_gmt":"2024-07-22T21:24:57","slug":"bluerock-therapeutics-receives-fda-regenerative-medicine-advanced-therapy-designation-for-parkinsons-disease-cell-therapy-candidate-bemdaneprocel","status":"publish","type":"post","link":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-receives-fda-regenerative-medicine-advanced-therapy-designation-for-parkinsons-disease-cell-therapy-candidate-bemdaneprocel\/","title":{"rendered":"BlueRock Therapeutics receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson\u2019s disease cell therapy candidate bemdaneprocel"},"content":{"rendered":"<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:360,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Regenerative Medicine Advanced Therapy (RMAT) designation follows phase I clinical trial results demonstrating that bemdaneprocel is well tolerated with no major safety issues through 18 months<\/span><span data-ccp-props=\"{&quot;201341983&quot;:2,&quot;335559740&quot;:360}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:360,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson\u2019s disease<\/span><span data-ccp-props=\"{&quot;201341983&quot;:2,&quot;335559740&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><b><span data-contrast=\"auto\">Berlin, Germany and Cambridge, MA, USA, May 30, 2024 \u2013 <\/span><\/b><span data-contrast=\"auto\">Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced today that BlueRock\u2019s investigational cell therapy bemdaneprocel for the treatment of Parkinson\u2019s disease has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA).<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u201cWe are excited about the positive data from the bemdaneprocel phase I clinical trial and believe it has great potential to help patients living with Parkinson&#8217;s disease regain functions they have lost to the disease,\u201d said Seth Ettenberg, President and CEO of BlueRock Therapeutics. \u201cNow with this RMAT designation in hand, we look forward to closely collaborating with the FDA to ready this program for phase II clinical studies.\u201d\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating Parkinson\u2019s disease. Phase I clinical trial data announced in March demonstrated that at 18 months it was well tolerated with no major safety issues. In addition, an observed increase in the F-DOPA PET imaging signal after stopping immune suppression therapy at 12 months, as defined in the study\u2019s protocol, demonstrates that the transplanted cells survive and engraft in the brain.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Managed by the FDA\u2019s Center for Biologics, Evaluation and Research (CBER), the RMAT program is dedicated to investigational regenerative medicines, including cell therapies, intended to treat, modify, reverse, or cure serious diseases. Investigational therapies that receive RMAT designation are eligible to receive expedited development review and development planning guidance from senior CBER managers. RMAT also creates a pathway for early discussions about potential surrogate endpoints and ways to support accelerated approval and satisfy post approval requirements.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u201cThe RMAT designation for bemdaneprocel underscores the potential of this candidate to fundamentally change the way we think about Parkinson\u2019s disease care,\u201d said Christian Rommel, PhD, Head of Research and Development at Bayer\u2019s Pharmaceuticals Division. \u201cWe are driven by our commitment to deliver breakthrough innovation for patients and are proud and excited to see bemdaneprocel continuing to clear hurdles in the development process.\u201d<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">About bemdaneprocel <\/span><\/b><b><span data-contrast=\"none\">(BRT-DA01) and the Phase I Trial<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson\u2019s disease. These dopaminergic neuron precursors are derived from pluripotent stem cells that are human embryonic stem cells. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson\u2019s disease. When transplanted, they have the potential to reform neural networks that have been severely affected by Parkinson\u2019s and restore motor and non-motor function to patients. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">The phase I study is a multi-center, multi-site, open-label, non-randomized, non-controlled study. Twelve (12) subjects diagnosed with Parkinson\u2019s disease received surgical transplantation of 1 of 2 different dose levels of bemdaneprocel cells to the post-commissural putamen bilaterally, and administration of a 1-year immunosuppression regimen. Cohort A (5 subjects) received a dose of 0.9 million cells per putamen. Cohort B (7 subjects) received 2.7 million cells per putamen. Safety and tolerability were assessed at 1 year as the primary endpoint, along with evidence of cell survival and motor effects. The feasibility of transplantation was also assessed. Assessments were repeated at 18 months. All assessments will continue over 2 years.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">The transplant surgeries were performed by Dr. Viviane Tabar, MD, Chair of the Department of Neurosurgery at Memorial Sloan Kettering (MSK) Cancer Center and Dr. Andres Lozano, M.D., Ph.D., F.R.C.S.C., F.R.S.C., F.C.A.H.S., Neurosurgeon and Senior Scientist, Krembil Brain Institute, University Health Network (UHN), Alan &amp; Susan Hudson Cornerstone Chair in Neurosurgery, Toronto Western Hospital, University Health Network and Chairman of the Division of Neurosurgery at the University of Toronto (UoT). Participants were followed at clinical sites by Dr. Harini Sarva, M.D. at Weill Cornell Medicine, Dr. Claire Henchcliffe, M.D., D.Phil., F.A.A.N., F.A.N.A. at the University of California, Irvine, and Dr. Alfonso Fasano, M.D., PhD., Chair in Neuromodulation and Multi-Disciplinary Care at the University Health Network (UHN) and UoT.\u202f<\/span><span data-contrast=\"none\">\u202f<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><i><span data-contrast=\"auto\">Disclosure:\u202f\u00a0<\/span><\/i><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><i><span data-contrast=\"auto\">Memorial Sloan Kettering (MSK): Dr. Tabar has financial interests related to BlueRock. MSK has institutional financial interests related to BlueRock. Note the foregoing institutional disclosure language is included because the referenced study relates to MSK technology licensed to BlueRock.\u202fUniversity Health Network (UHN): UHN has institutional financial interests related to BlueRock.<\/span><\/i><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">More information about the Phase I trial is available at <\/span><a href=\"https:\/\/clinicaltrials.gov\/\"><span data-contrast=\"none\">clinicaltrials.gov<\/span><\/a><span data-contrast=\"auto\"> (<\/span><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04802733?term=NCT%2304802733&amp;draw=2&amp;rank=1\"><span data-contrast=\"none\">NCT04802733<\/span><\/a><span data-contrast=\"auto\">).\u202f<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">About Parkinson\u2019s disease<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Parkinson\u2019s disease is a progressive neurodegenerative disorder caused by the death of nerve cells in the brain, leading to decreased dopamine levels. At diagnosis, it is estimated that patients have already lost 50-80% of their dopaminergic neurons. The loss of these neurons leads to a progressive loss of motor function and symptoms such as tremors, muscle rigidity, and slowness of movement. Even with medication, the symptoms of Parkinson\u2019s disease can fluctuate during the course of the day. According to the Parkinson\u2019s Foundation, more than 10 million people worldwide suffer from Parkinson\u2019s disease, with approximately one million living in the United States. There is no cure, and the effectiveness of current treatments decreases over time.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">About BlueRock Therapeutics LP<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating cellular medicines to reverse devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for patients suffering from neurological, cardiovascular, immunological, and ophthalmic diseases. Our lead clinical program, bemdaneprocel, (BRT-DA01) is in Phase I clinical trials for Parkinson\u2019s disease. We were founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell &amp; Gene Therapy Platform. Our 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 <\/span><a href=\"https:\/\/www.bluerocktx.com\/\"><span data-contrast=\"none\">www.bluerocktx.com<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">About Bayer<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, \u201cHealth for all, Hunger for none,\u201d the company\u2019s 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&amp;D expenses before special items amounted to 5.8 billion euros. For more information, go to <\/span><a href=\"http:\/\/www.bayer.com\/\"><span data-contrast=\"auto\">www.bayer.com<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">BlueRock Therapeutics Media Contact:<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><b><span data-contrast=\"auto\">Jeff Lockwood, phone +1 617.510.6997<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">Email: <\/span><a href=\"mailto:jlockwood@bluerocktx.com\"><span data-contrast=\"none\">jlockwood@bluerocktx.com<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Bayer Media Contact:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><b><span data-contrast=\"auto\">Dr. <\/span><\/b><b><span data-contrast=\"auto\">Nuria Aiguabella Font, phone +49 1732329691<\/span><\/b><br \/>\n<span data-contrast=\"auto\">Email: <\/span><a href=\"mailto:nuria.aiguabellafont@bayer.com\"><span data-contrast=\"none\">nuria.aiguabellafont@bayer.com<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Bayer U.S. Media Contact:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><b><span data-contrast=\"auto\">Carolyn Nagle, phone +1 2014190337<\/span><\/b><br \/>\n<span data-contrast=\"auto\">Email: <\/span><a href=\"mailto:carolyn.nagle@bayer.com\"><span data-contrast=\"none\">carolyn.nagle@bayer.com<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Contact for investor inquiries:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><b><span data-contrast=\"auto\">Bayer Investor Relations Team, phone +49 214 30-72704<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\"><br \/>\n<\/span><span data-contrast=\"auto\">Email: <\/span><a href=\"mailto:ir@bayer.com\"><span data-contrast=\"none\">ir@bayer.com<\/span><\/a><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\"><br \/>\n<\/span><a href=\"https:\/\/www.bayer.com\/en\/investors\/ir-team\"><span data-contrast=\"none\">www.bayer.com\/en\/investors\/ir-team<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Find more information at <\/span><a href=\"https:\/\/www.bluerocktx.com\/\"><span data-contrast=\"none\">www.bluerocktx.com<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">Follow us on <\/span><a href=\"https:\/\/www.linkedin.com\/company\/bluerocktx\/\"><span data-contrast=\"none\">LinkedIn<\/span><\/a><span data-contrast=\"none\">\/bluerocktx<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Find more information at <\/span><a href=\"https:\/\/pharma.bayer.com\/\"><span data-contrast=\"none\">https:\/\/pharma.bayer.com\/<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Forward-Looking Statements<\/span><\/b><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">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 <\/span><a href=\"http:\/\/www.bayer.com\/\"><span data-contrast=\"auto\">www.bayer.com<\/span><\/a><span data-contrast=\"auto\">. The company assumes no liability whatsoever to update these forward-looking statements or to conform<\/span> <span data-contrast=\"auto\">them to future events or developments.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regenerative Medicine Advanced Therapy (RMAT) designation follows phase I clinical trial results demonstrating that bemdaneprocel is well tolerated with no major safety issues through 18 months\u00a0 Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson\u2019s [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7775,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[52,56,61],"class_list":["post-8955","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-releases","tag-announcement","tag-neurology","tag-parkinsons-disease"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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