- Treatment with bemdaneprocel did not cause any serious adverse events related to cell therapy following discontinuation of immunosuppression after one year in the trial鈥檚 high and low dose cohorts.
- Bemdaneprocel is the first investigational allogeneic pluripotent stem cell-derived cell therapy for Parkinson鈥檚 disease and the most clinically advanced cell therapy being investigated for treating the disease.鈥赌�&苍产蝉辫;
- SA国际传媒 expects to initiate a Phase 3 clinical trial for bemdaneprocel in H1 2025.鈥赌�&苍产蝉辫;
Cambridge MA, USA, APRIL 16, 2025 – SA国际传媒, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced the publication of the 18-month data from its Phase 1 exPDite clinical trial for bemdaneprocel in the journal Nature.鈥赌�&苍产蝉辫;
鈥淭he concept of 鈥渞ebuilding鈥� brain networks that have been lost to disease is compelling,鈥� said Claire Henchcliffe, MD, chair of the UC Irvine School of Medicine鈥檚 Department of Neurology at the University of California, Irvine and one of the study鈥檚 Principal Investigators, 鈥淭he results of鈥痶his early phase clinical trial demonstrate鈥痶he promise of regenerative medicine and鈥痵hould provide hope for鈥疨arkinson鈥檚 disease鈥痯atients and their families.鈥濃��&苍产蝉辫;
The publication, which is available , confirms that 18 months following surgery, treatment with bemdaneprocel did not cause any serious adverse events related to cell therapy. In addition, positron emission tomography (PET) imaging techniques demonstrated sustained neuron cell engraftment in the trial鈥檚 high and low dose cohorts following discontinuation of immunosuppression after one year post-treatment. The publication also reports encouraging trends in secondary and exploratory subjective and objective endpoints related to motor function. These data were first presented in March 2024 at the Alzheimer鈥檚 and Parkinson鈥檚 Diseases Conference in Lisbon, Portugal.鈥��
鈥淐ell therapy is a potential new treatment option for individuals with Parkinson’s disease and our team is immensely proud of having bemdaneprocel鈥檚 18-month Phase 1 data published in such a prestigious journal as Nature,鈥� said Amit Rakhit, MD, MBA Head of Development and Chief Medical Officer at SA国际传媒 Therapeutics. 鈥淥ur efforts are now focused on maintaining our forward momentum to initiate and enroll the Phase 3 trial as we advance bemdaneprocel鈥檚 development to this exciting next stage.鈥濃��&苍产蝉辫;
The Phase 3 trial, called exPDite-2, is expected to be initiated in the first half of 2025.鈥赌�&苍产蝉辫;
About bemdaneprocel (BRT-DA01)鈥��鈥�&苍产蝉辫;
Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine-producing neurons that are lost in Parkinson鈥檚 disease. These dopaminergic neuron precursors are derived from human embryonic stem cells, developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson鈥檚 disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson鈥檚 disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track designation followed in 2024 by a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.鈥� Data from the Phase 1 trial鈥檚 12 participants presented at the 2024 International Congress of Parkinson鈥檚 Disease and Movement Disorders (MDS) demonstrated good tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. These participants remain in a long-term Continued Evaluation Study. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.鈥��赌�&苍产蝉辫;
About Parkinson鈥檚 disease鈥�鈥�&苍产蝉辫;
Parkinson鈥檚 disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person鈥檚 daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than 10 million people worldwide are estimated to be living with PD. This makes it the world鈥檚 second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options lack the holistic management of symptoms so new therapies are needed.鈥赌�&苍产蝉辫;
About SA国际传媒鈥���鈥�&苍产蝉辫;
SA国际传媒 is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological, ophthalmic, cardiovascular and immunological diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson鈥檚 disease and OpCT-001 for the treatment of primary photoreceptor disease are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is expected to begin a Phase 3 clinical trial in H1 2025. OpCT-001 is expected to begin Phase 1 clinical testing in H1 2025. SA国际传媒 was 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, SA国际传媒 became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell & 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 www.bluerocktx.com.鈥����赌�&苍产蝉辫;
About Bayer鈥�&苍产蝉辫;
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 鈥淗ealth for all, Hunger for none,鈥� the company鈥檚 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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to .鈥�&苍产蝉辫;
Contact for media inquiries:鈥�鈥�&苍产蝉辫;
Jeff Lockwood, phone +1 (617) 510 6997鈥�赌�&苍产蝉辫;
Email: jlockwood@bluerocktx.com鈥�赌�&苍产蝉辫;
Find information at www.bluerocktx.com鈥赌�&苍产蝉辫;
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Forward-Looking Statements鈥��
Certain statements in this press release are forward-looking which may be identified by the use of forward-looking words such as 鈥渁nticipate,鈥� 鈥渆xpect鈥�, 鈥渂elieve,鈥� 鈥渇orecast,鈥� 鈥渆stimate鈥� and 鈥渋ntend,鈥� among others. These forward-looking statements are based on SA国际传媒鈥檚 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 outcomes from our clinical trials and ongoing FDA and other regulatory requirements, and interpretation of data by the FDA. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products, and uncertainty in the outcome of clinical trials cannot be avoided. Except as expressly required by law, SA国际传媒 does not undertake an obligation to update or revise any forward-looking statement. All of SA国际传媒鈥檚 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.鈥�&苍产蝉辫;
