We are delighted to announce completion of all nine patient injections for our phase one trial of Eyecyte-RPE? to treat Geographic Atrophy secondary to Dry Age related Macular Degeneration. Interim results show promise and will be explored further in our upcoming phase two trial in India and the US. Key takeaways: 1. No Serious Adverse Events reported in any of the nine patients. 2. Average improvement of 14.9 letters in ETDRS standard vision tests reported in six patients over a 3-6 month follow up. 3. Signs of disease reversal observed in some patients. 4. Structural/anatomical changes corresponding to vision rescue identified in almost all patients post 3 months. About Eyecyte-RPE? Eyecyte-RPE?, derived from induced pluripotent stem cells (hiPSCs) is a proprietary retinal cell therapy product with a novel composition, developed and patented by Eyestem Research. The product can help replace the damaged or lost retinal pigment epithelium (RPE) cells and provide crucial support to the adjoining photoreceptor layer. This unique formulation is allogeneic, scalable and can be stored as a frozen vial for long periods of time. For more information, please visit https://lnkd.in/gkReKH7d
Eyestem Research
生物技术
Bangalore,KARNATAKA 3,447 位关注者
Developing Scalable Cell Replacement therapies for the world !
关于我们
Current cell and gene therapy products are estimated to cost >$250k per injection. This is unsustainable. Our vision is to democratize access to cell therapy and provide benefits to a larger section of humanity We intend to disrupt the global cell therapy ecosystem and set a new benchmark for quality and affordability in this sector. Eyecyte-RPE-our flagship project to treat incurable macular degeneration has excellent efficacy results and will be in FIM trials in 2021.
- 所属行业
- 生物技术
- 规模
- 2-10 人
- 总部
- Bangalore,KARNATAKA
- 类型
- 私人持股
地点
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主要
Centre for Cellular and Molecular Platforms
GKVK Post, Bellary Road
IN,KARNATAKA,Bangalore,560065
Eyestem Research员工
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Dr. Ramesh Byrapaneni
Managing Director, Endiya Partners
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Ramaswamy Subramanian
Professor/ Gerald and Edna Mann Director, Purdue University.
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Vijay Konala, Ph.D.
Head: Product Development & Compliance
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Rajarshi Pal, Ph.D.
Co-Founder & Chief Scientist, Eyestem Research, Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru
动态
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We are delighted to announce approval from our Drug Safety Monitoring Board (DSMB) to move forward with the third cohort of patients for our phase one trial to treat Geographic Atrophy secondary to Dry AMD. So far, the first two cohorts have had no Serious Adverse Events (SAEs) and some mild Treatment Emergent Adverse Events (TEAEs) thus reinforcing the safety profile of Eyecyte-RPE. We now move forward with the third and final cohort of the phase one trial. Exciting times !
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We are delighted to announce interim results for our first in human trial for Geographic Atrophy secondary to Dry AMD. 1. Eyecyte-RPE was well tolerated across the first two doses with no serious adverse events (SAEs) and minimal Treatment Emergent Adverse Events (TEAEs). 2. Five out of Six patients had a improvement in vision (3-31 letters). At this time, improvement has been sustained at five months for the first two enrolled patients. 3. Noticeable decrease in RPE defect area and Photoreceptor defect area was observed in the injected eye vs. the uninjected eye. 4. Structural changes in OCT observed at the area of injection corroborated the functional improvements. The excellent safety profile, along with promising signs of efficacy, will be further explored in our phase two study. Taken together, this data represents a large and critical inflection point for Eyestem in bringing this therapy to patients who need it the most !
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This is a fantastic exhaustive list of all iPSC derived clinical trials. Glad to see us on the list of course ! Thanks to the authors for creating such a valuable resource Agnete Kirkeby Heather Main Melissa Carpenter
A review published in Cell Stem Cell uncovers that more than 1200 patients have been treated with human pluripotent stem cell-derived products as part of clinical trials ? Human pluripotent stem cells can self-renew indefinitely in culture while maintaining the ability to become any cell type in the human body. Over the last decade, a growing number of clinical trials using human pluripotent stem cells to develop novel cellular treatments for diseases, such as Parkinson’s Disease, blindness, diabetes and cancer, have been initiated in various parts of the world. ? Now, a review paper that systematically categorizes and summarizes all completed and ongoing clinical trials with human pluripotent stem cells has been published in the journal Cell Press by co-authors Associate Professor Agnete Kirkeby, Dr Heather Main and Dr Melissa Carpenter. ? “Dr Main is a consultant from Australia and Dr Carpenter is a consultant based on the West Coast of the US, while I myself is based in Copenhagen. Collectively, we've therefore been in a good position to cover activities around the world, ” said Associate Professor Agnete Kirkeby. ? The 116 different clinical trials analysed are targeting 34 different indications, the majority of which are eye diseases, brain diseases and cancer. Despite concerns about tumor formation, no cases of tumor formation have been reported in the controlled clinical trials so far. Overall, the review thereby concludes that there does not appear to be any generalizable safety concerns for these kinds of novel cellular therapies. ? The review is the first of its kind to provide compiled information on immunosuppression used in the different pluripotent cell therapy clinical trials. Immunosuppression inhibits the body's immune system and prevents rejection of the transplanted cells and it is therefore an important part of designing and developing safe stem cell trials. ?? “When contacting the responsible clinical trial sponsors, we found them to be very helpful in providing additional trial information, and sensed a great deal of excitement around getting this review out as a resource to the field,”?said Associate Professor Kirkeby. ? It is the hope that this review on the landscape of human pluripotent stem cells in clinical use will be an invaluable resource to stem cell scientists all over the world. The authors have plans to update the review on a regular basis, as the field is rapidly progressing with new therapies and new clinical trials each year.
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Super proud to have our Founder and CEO, Jogin Desai, feted with the "Entrepreneur of the Year" Award at the BioSpectrum Asia Excellence Awards in Singapore !
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Excited to announce our recent patent filing for a customized Sub-retinal injection delivery technique which can be used, among others, to safely deliver Eyecyte-RPE into the area of interest for treatment of Geographic Atrophy (GA). The USP of this technique is its ability to harness readily available instruments used frequently in the operating room and integrate them together in a sometimes counter intuitive yet effective way ! With this invention, we move one step closer to create a safe, effective therapy for GA which can be adapted by surgeons worldwide with relative ease.
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We are delighted to announce approval from our Drug Safety Monitoring Board (DSMB) to move forward with the second cohort of patients for our phase one trial to treat Geographic Atrophy secondary to Dry AMD. In the words of our Principal Investigators "We are truly excited to see the excellent safety profile of Eyecyte-RPE and early indications of efficacy lead us to believe that this therapy has the potential to be transformational for patients. We look forward to recruiting the second cohort of patients and are excited to be part of the team that brings such innovative therapies closer to patients that need it most.” Download the press release for more details
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Today is a high water mark for all of us working at Eyestem Research. With the first three patient injections, we are one crucial step closer to our long term vision of creating a scalable cell therapy platform for incurable diseases-starting with the largest cause of incurable blindness for people over 50 globally. While it is early days, we are hoping Eyecyte-RPE can transform lives of patients suffering from this terrible disease- both in India and abroad. Taslimarif Saiyed, PhD Dr. Ramesh Byrapaneni Ashish Ranjan, Ph.DGert Hoogland Oppel Greeff Gillian Corken Suresh Ramu Raja Narayanan Raghu Gullapalli
We are beyond thrilled to announce completion of the first round of patient injections for our first in human trials to treat Geographic Atrophy, secondary to Dry Age-related Macular Degeneration. For those tuning in recently, Eyecyte-RPE is a patented RPE cell suspension designed to arrest and potentially reverse vision loss due to Dry AMD- the largest cause of incurable blindness for people above 50 globally. Completing the first 3 patient injections represents a critical milestone for our quest to find a cure. A special thanks to our exceptionally skilled surgeons at participating sites, whose dedication and attention to detail make all the difference ! Endiya Partners Centre for Cellular and Molecular Platforms (C-CAMP) DBT BIRAC Kotak Alternate Asset Managers Limited L V Prasad Eye Institute (LVPEI) https://lnkd.in/e7yH_RaU
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We are beyond thrilled to announce completion of the first round of patient injections for our first in human trials to treat Geographic Atrophy, secondary to Dry Age-related Macular Degeneration. For those tuning in recently, Eyecyte-RPE is a patented RPE cell suspension designed to arrest and potentially reverse vision loss due to Dry AMD- the largest cause of incurable blindness for people above 50 globally. Completing the first 3 patient injections represents a critical milestone for our quest to find a cure. A special thanks to our exceptionally skilled surgeons at participating sites, whose dedication and attention to detail make all the difference ! Endiya Partners Centre for Cellular and Molecular Platforms (C-CAMP) DBT BIRAC Kotak Alternate Asset Managers Limited L V Prasad Eye Institute (LVPEI) https://lnkd.in/e7yH_RaU