A Phase 1/2, Open-Label, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of DT-DEC01 Therapy in Patients with Duchenne Muscular Dystrophy - DEC for DMD

开始日期2023-12-12

申办/合作机构-

CTRI/2014/02/004375 / Completed临床4期IIT

Efficacy and adverse reactions of single dose DEC of 100 mg, 200 mg and 300 mg strength in filariasis endemic community in Orissa

开始日期2006-06-01

申办/合作机构-

100 项与 Dystrophin expressing chimeric cells (Dystrogen Therapeutics) 相关的临床结果

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100 项与 Dystrophin expressing chimeric cells (Dystrogen Therapeutics) 相关的专利（医药）

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项与 Dystrophin expressing chimeric cells (Dystrogen Therapeutics) 相关的文献（医药）

2024-09-01·Medical & Biological Engineering & Computing

DEC-DRR: deep ensemble of classification model for diabetic retinopathy recognition

Article

作者: Lisha, L B ; Helen Sulochana, C

Most diabetes patients are liable to have diabetic retinopathy (DR); however, the majority of them might not be even aware of the ailment. Therefore, early detection and treatment of DR are necessary to prevent vision loss. But, avoiding DR is not a simple process. An ophthalmologist can typically identify DR through an optical evaluation of the fundus and through the evaluation of color pictures. However, due to the increased count of DR patients, this could not be possible as it consumes more time. To rectify this problem, a novel deep ensemble-based DR classification technique is developed in this work. Initially, a Wiener filter (WF) is applied for preprocessing the image. Then, the enhanced U-Net-based segmentation process is done. Subsequent to the segmentation process, features are extracted that include statistical features, inferior superior nasal temporal (ISNT), cup to disc ratio (CDR), and improved LGBP as well. Further, deep ensemble classifiers (DEC) like CNN, Bi-GRU, and DMN are used to recognize the disease. The outcomes from DMN, CNN, and Bi-GRU are then subjected to improved SLF. Additionally, the weights of DMN, CNN, and Bi-GRU are adjusted via pelican updated Tasmanian devil optimization (PU-TDO). Finally, outputs on DR (microaneurysms, hemorrhages, hard exudates, and soft exudates) are obtained. The performance of DEC + PU-TDO for diabetic retinopathy is computed over extant models with regard to different measures for four datasets. The results on accuracy using the DEC + PU-TDO scheme for the IDRID dataset is maximum around 0.975 at 90th LP while other models have less accuracy. The FPR of DEC + PU-TDO is less around 0.039 at the 90th LP for the SUSTech-SYSU dataset, while other extant models have maximum FPR.

2024-09-01·Diabetes, Obesity and Metabolism

Once‐weekly insulin icodec compared with daily basal insulin analogues in type 2 diabetes: Participant‐level meta‐analysis of the ONWARDS 1–5 trials

Article

作者: Ásbjörnsdóttir, Björg ; Bari, Tanvir J. ; Vilsbøll, Tina ; Bajaj, Harpreet S. ; Begtrup, Kamilla ; Rosenstock, Julio

AbstractAimTo perform a participant‐level post hoc meta‐analysis of Phase 3a trials in type 2 diabetes (T2D) to characterize the hypoglycaemia safety and glycaemic efficacy of once‐weekly insulin icodec (icodec).Materials and MethodsAll ONWARDS 1–5 randomized participants were pooled as overall T2D, insulin‐naive, an insulin‐experienced subgroups, and by once‐daily trial comparator (degludec or glargine U100). The main outcomes included incidence and rates of clinically significant and severe hypoglycaemia. Additional endpoints included change in glycated haemoglobin (HbA1c) from baseline and HbA1c target achievement without clinically significant or severe hypoglycaemia.ResultsThe meta‐analysis comprised 3765 participants (1882 icodec vs. 1883 comparators). In the overall T2D pool, clinically significant hypoglycaemia incidence was similar in the icodec group versus the comparator group (17.9% vs. 16.2%, odds ratio [OR] 1.14, 95% confidence interval [CI] 0.94, 1.38); however, rates were low but significantly higher in the icodec group (1.15 vs. 1.00 episodes/participant‐year of exposure, estimated rate ratio 1.51 [95% CI 1.24, 1.85]). Fewer severe hypoglycaemic episodes occurred with icodec than with comparators (8 vs. 18). A greater reduction in HbA1c occurred with icodec versus comparators, irrespective of subgroup (estimated treatment difference range [−0.10 to −0.29%]; all p < 0.05). Across subgroups, except for the insulin‐experienced subgroup, the odds of achieving HbA1c <53 mmol/mol (7.0%) without clinically significant or severe hypoglycaemia were greater with icodec than with comparators (OR range 1.30–1.55; all p < 0.05).ConclusionsIcodec was associated with a similar incidence but higher rates of clinically significant hypoglycaemia (equating to one additional hypoglycaemic episode every 6 years) and fewer severe hypoglycaemic episodes versus comparators. Our findings also confirmed the greater efficacy of icodec that was demonstrated in the ONWARDS trial programme.

2024-08-01·Journal of Lipid Research

The DNA methyltransferase inhibitor decitabine blunts the response to a high-animal fat and protein diet in mice

Article

作者: de la Rocha, Carmen ; Rodríguez-Ríos, Dalia ; Ramírez-Chávez, Enrique ; Trejo-Saavedra, Diana Lilia ; Romo-Morales, Gloria Del Carmen ; Winkler, Robert ; Molina-Torres, Jorge ; Flores-Sierra, José de Jesús ; Pérez-Vázquez, Victoriano ; Muciño-Arellano, Magaly Del Rosario ; Rivera-Bustamante, Rafael ; Lund, Gertrud ; Correa-Navarro, Viridiana Abigail ; García-Rojas, Nancy Shyrley ; Sánchez-Palafox, Jaime Eduardo ; Zaina, Silvio ; Colín-Castelán, Dannia ; Rangel-Salazar, Rubén

Increasing evidence hints that DNA hypermethylation may mediate the pathogenic response to cardiovascular risk factors. Here, we tested a corollary of that hypothesis, that is, that the DNA methyltransferase inhibitor decitabine (Dec) ameliorates the metabolic profile of mice fed a moderately high-animal fat and protein diet (HAFPD), a proxy of cardiovascular risk-associated Western-type diet. HAFPD-fed mice were exposed to Dec or vehicle for eight weeks (8W set, 4-32/group). To assess any memory of past exposure to Dec, we surveyed a second mice set treated as 8W but HAFPD-fed for further eight weeks without any Dec (16W set, 4-20/group). In 8W, Dec markedly reduced HAFPD-induced body weight gain in females, but marginally in males. Characterization of females revealed that Dec augmented skeletal muscle lipid content, while decreasing liver fat content and increasing plasma nonesterified fatty acids, adipose insulin resistance, and-although marginally-whole blood acylcarnitines, compared to HAFPD alone. Skeletal muscle mitochondrial DNA copy number was higher in 8W mice exposed to HAFPD and Dec, or in 16W mice fed HAFPD only, relative to 8W mice fed HAFPD only, but Dec induced a transcriptional profile indicative of ameliorated mitochondrial function. Memory of past Dec exposure was tissue-specific and sensitive to both duration of exposure to HAFPD and age. In conclusion, Dec redirected HAFPD-induced lipid accumulation toward the skeletal muscle, likely due to augmented mitochondrial functionality and increased lipid demand. As caveat, Dec induced adipose insulin resistance. Our findings may help identifying strategies for prevention and treatment of lipid dysmetabolism.

项与 Dystrophin expressing chimeric cells (Dystrogen Therapeutics) 相关的新闻（医药）

2023-10-24

·PRNewswire

Rising R&D Investment and Government Support Fuel Expansion of Global Duchenne Muscular Dystrophy Drugs Market

DUBLIN, Oct. 24, 2023 /PRNewswire/ -- The "Duchenne Muscular Dystrophy Drugs - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. The global market for Duchenne Muscular Dystrophy Drugs, valued at US$2 billion in 2022, is projected to grow to US$27.4 billion by 2030, with a remarkable compound annual growth rate (CAGR) of 39.1% during the analysis period of 2022-2030. Among the segments analyzed in the report, Exon Skipping is expected to lead the growth with a CAGR of 44.9%, reaching US$18.1 billion by the end of the forecast period. The Steroid Therapy segment is estimated to grow at a CAGR of 27.7% over the next 8 years. Key Market Insights: The U.S. Duchenne Muscular Dystrophy Drugs market is estimated at US$843.1 million in 2022. China, the world's second-largest economy, is forecasted to reach a market size of US$2.4 billion by 2030, with a CAGR of 46%. Japan and Canada are also noteworthy markets, expected to grow at 32.6% and 31.7% respectively from 2022 to 2030. Within Europe, Germany is forecasted to grow at approximately 34.8% CAGR. Select Competitors: Key players in the Duchenne Muscular Dystrophy Drugs market include: Acceleron Pharma, Inc. Akashi Therapeutics, Inc. BioMarin Pharmaceutical, Inc. Bristol-Myers Squibb Company Eli Lilly and Company Janssen Pharmaceuticals, Inc. Lexicon Pharmaceuticals, Inc. Nippon Shokubai Co., Ltd. Nobelpharma Co., Ltd. Pfizer, Inc. PTC Therapeutics, Inc. Sarepta Therapeutics Inc. Taiho Pharmaceutical Co., Ltd. Economic Outlook: The global economic outlook is showing signs of improvement, with growth recovery expected in the near term. While challenges such as slower-than-expected decline in global headline inflation, food and fuel inflation in developing countries, and high retail inflation persist, countries and governments are taking measures to address these issues. The rise of new technologies, including generative AI, applied AI, machine learning, next-generation software development, Web3, cloud and edge computing, quantum technologies, electrification, renewables, and climate technologies, is expected to open up new opportunities in the global investment landscape. These technologies have the potential to drive incremental growth and value to global GDP. The short-term economic landscape is expected to be a mix of challenges and opportunities, requiring resilience and adaptability from businesses and their leaders. For more detailed insights into the Duchenne Muscular Dystrophy Drugs market and global economic trends, please refer to the full report. What`s New? Special discussions on the global economic climate and market sentiment Coverage on global competitiveness and key competitor percentage market shares Market presence analysis across multiple geographies - Strong/Active/Niche/Trivial Online interactive peer-to-peer collaborative bespoke updates Access to digital archives and research platform Complimentary updates for one year Access to curated YouTube video transcripts of market sentiments shared by CEOs, domain experts and market influencers via interviews, podcasts, press statements and event keynotes Key Topics Covered: I. METHODOLOGY II. EXECUTIVE SUMMARY 1. MARKET OVERVIEW A Prelude to Duchenne Muscular Dystrophy Global Economic Update From Pandemic to War & Inflation: "Gloomy Outlook for 2023 Despite Signs of Easing Inflationary Conditions Here's How Inflationary Pressures Affect the Economy Here's What's Causing Inflationary Pressures in the Global Market Although Past Peak in 2023, Efforts to Solve the Inflation Puzzle Should Continue Global Economy Faces a Tough Climb Towards Recovery Made Rockier by the War, Anti-Inflation Fiscal Policies & Slower Than Desirable Easing of Inflationary Pressures: World Economic Growth Projections (Real GDP, Annual % Change) for the Years 2020 Through 2024 Impact of COVID-19 on Duchenne Muscular Dystrophy Drugs Market Competition Product Development as Hallmark of Global Duchenne Muscular Dystrophy Market Duchenne Muscular Dystrophy Drugs - Global Key Competitors Percentage Market Share in 2023 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2023 (E) Global Market Overview and Prospects Global Duchenne Muscular Dystrophy Drugs Market Set for a Rapid Growth, Driven by Rising Prevalence A Review of the Approved DMD Drugs North America and Europe to Remain Lucrative Markets Molecular Therapy, Hospital/Clinic & Hospital Pharmacy: Hale & Hearty Segments of Duchenne Muscular Dystrophy Market Dynamic Factors Keeping Duchenne Muscular Dystrophy Market Growing Market Drivers Rising Incidence of DMD to Catalyze Growth DMD Prevalence (in 100,000 Population) in Select Countries: 2020 High Uptake of Novel Therapies & Drugs Market Restraints & Challenges Lack of Standardization for Clinical Efficacy Stringent Regulatory Regime Market Opportunities Product Developments & Rising Awareness Surge in Clinical Trials to Launch Novel Options Recent Market Activity 2. FOCUS ON SELECT PLAYERS 3. MARKET TRENDS & DRIVERS Rising R&D Investment to Boost DMD Market Select Therapy Candidates Under Development for Treating DMD Growing Government Support Propels Market Expansion Biologics - The Most Dynamic Segment of the Market Blossoming of Gene Therapy in Duchenne Muscular Dystrophy Treatment Domain Gene Therapy for DMD Treatment Elevidys, The First Ground-breaking Gene Therapy for Treatment of Duchenne Muscular Dystrophy (DMD) Children's National Hospital Starts Offering Newly Approved Gene Therapy for DMD Promising Gene Therapies Potential Side-Effects & Risks of Gene Therapies Vamorolon Holds Potential to Lessen Health Risks Linked with Extended Use of Steriods DT-DEC01 Offers Promise to Stabilize or Improve Motor Function AOC 1044 Receives Orphan Drug Status for DMD44 Italfarmaco Group Announces NDA Acceptance for Givinostat Targeting Duchenne Muscular Dystrophy Uptrend in Healthcare Expenditure Creates Substantial Opportunities World Healthcare Expenditure (In US$ Trillion) for the Years 2019, 2021 & 2023 4. GLOBAL MARKET PERSPECTIVE III. MARKET ANALYSIS IV. COMPETITION For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

孤儿药基因疗法

2022-09-29

·BioSpace

Clinical Catch-Up: NASH, DMD Spaces Continue to Accelerate

New data from Axcella, PepGen, Dystrogen and Galecto are showing promise in challenging diseases, including NASH, Duchenne muscular dystrophy and myelofibrosis. Axcella's NASH Candidate Impresses In Phase IIb Axcella Therapeutics posted interim data Thursday from its Phase IIb EMMPACT study of AXA1125 in nonalcoholic steatohepatitis (NASH) confirming the candidate's ability to target multiple pathways simultaneously during disease treatment. Data from weeks 12 and 24 showed all participants experienced significantly greater changes from baseline in MRI-PDFF compared to the placebo group. The positive trend continued into the 24th week, though researchers noted they needed a larger group of subjects for it to be considered statistically significant. For this data set, around 30% of the target 270 participants were available, all with biopsy-confirmed stage II and stage III NASH. At week 12, the trial had 82 subjects, and 58 by week 24. Around 50% of the subjects have type II diabetes mellitus. They were randomized 1:1:1 to receive either 22.6 g or 33.9 g of AXA1125 twice a day or a placebo. Axcella expects to share topline, 48-week biopsy results in the first half of 2024. This news comes on the heels of a positive update from another company seeking to develop the next treatment for NASH. Oramed Pharmaceuticals recently shared promising mid-stage trial results from its oral insulin candidate ORMD-0801, showing a clinically meaningful reduction in liver fat from baseline at 12 weeks. The company is expected to share full details about this trial soon. PepGen Preps for Phase IIa DMD Study PepGen announced its Phase I trial of Duchenne muscular dystrophy treatment PGN-EDO51 in healthy adult males met the primary safety endpoint, enabling a move to Phase II. PepGen's lead clinical candidate, PGN-EDO51 uses its proprietary enhanced delivery oligonucleotide technology to deliver a therapeutic component designed to target the root cause of DMD. It is given intravenously and works by skipping exon 51 of the dystrophin transcript to restore the open reading frame and enable the production of a truncated dystrophin protein. PGN-EDO51 was tested in various doses on 32 healthy adult males, who were assessed for safety and tolerability, as well as oligonucleotide tissue concentration and exon skipping. The participants were given either 1, 5, 10 or 15 mg/kg of PGN-EDO51 or a placebo over the course of 28 days. PepGen is now preparing to launch a Phase IIa multiple ascending dose study in the first half of 2023. Full results from the Phase I study will be presented at an upcoming medical meeting. Dsytrogen's DMD Hopeful Shows Promise at 6 Months In other DMD news, Dystrogen Therapeutics shared positive initial results from the ongoing clinical trial of investigational engineered cell therapy DT-DEC01. Six months' worth of data demonstrated promising safety, functional and biomarker outcomes from the three subjects under the first low-dose cohort. The participants, aged six, seven and 15, showed improved duration and amplitude of motor unit potentials on EMG versus the pretreatment baseline. They were also observed to have improved grip strength and better 6MWD, NSAA, PODCI and PUL scores, among others. DC-DEC01 is an engineered chimeric cell that engrafts in cardiac and skeletal muscle to deliver full-length dystrophin gene and other healthy muscle cell components. The drug does not require immunosuppression. There was no evidence of immune reaction on blood assays during the six-month period in any of the patients. OncoNano's Fluorescence Imaging Agent Demonstrates Significant Detection OncoNano Medicine's ongoing Phase II clinical trial of pegsitacianine for the detection of residual disease after cytoreductive surgery delivered positive interim results from 27 participants. Data showed 55% of the participants demonstrated a significant detection of pathology-confirmed residual disease while being well-tolerated and without any serious adverse events. Pegsitacianine is a micellar fluorescence agent that can detect residual malignancies post-CRS and act as an adjunct to tactile and visual cues. The patients were given 1 mg/kg of the drug and underwent surgery with intra-operative imaging done between 24 and 72 hours post-dose. These findings could offer surgeons real-time optics to enhance their ability to detect cancerous tissues that might be left behind if only standard-of-care processes are implemented after CRS. The initial results were shared at an oral presentation at the World Molecular Imaging Congress in Florida. The study is still open to enrollment. Galecto's Myelofibrosis Drug Demonstrates Robust Collagen Fibrosis Reduction Galecto announced its ongoing Phase IIa MYLOX-1 study of GB2064 for the treatment of myelofibrosis delivered reduction in collagen fibrosis of the bone marrow equal to or greater than 1-grade in four out of five patients who received the drug for at least six months. All four participants demonstrated stable hemoglobin, thrombocyte and white blood cell count numbers and a stable spleen volume. None required transfusion. Two participants have already advanced into the extension phase since GB2064 maintained an acceptable tolerability profile. The trial started with 16 patients, of which eight have either continued to receive or completed the treatment. The other eight have discontinued due to either disease progression or adverse events. The most common AEs observed were gastrointestinal-related and manageable with standard therapy.

财报寡核苷酸细胞疗法

2022-09-27

·PRNewswire

Dystrogen Therapeutics Investigational Chimeric Cell Therapy DT-DEC01 for Duchenne Muscular Dystrophy Demonstrates Clinically Significant Functional and Biomarker Improvements

MIAMI and WARSAW, Poland, Sept. 26, 2022 /PRNewswire/ -- Dystrogen Therapeutics, Corp. the leader in chimeric cell therapies, today announced positive 6-month results from an ongoing clinical study conducted in Poland under a hospital exemption protocol of DT-DEC01, the Company's investigational engineered cell therapy for Duchenne muscular dystrophy (DMD). Results include 6-month safety, functional, and biomarker data from three clinical trial participants in the first, low-dose cohort. All patients, independent of their genetic mutation, demonstrated both clinical and biomarker improvements when compared to baseline. During this period, no adverse events (AEs and SAEs) associated with DEC therapy were observed. DT-DEC01 is in development for the treatment of DMD, a devastating neuromuscular disease associated with a lack of dystrophin protein. DT-DEC01 is an engineered chimeric cell that engrafts in skeletal and cardiac muscle, delivering a full-length dystrophin gene and related components of a healthy muscle cell, the absence of which is closely associated with the progressive degeneration and a shortened lifespan characteristic of the disease. DT-DEC01 requires no immunosuppression and there was no evidence of an immune reaction to the therapy on blood assays at 6 months post treatment, in any of the patients to date. "There are currently no approved treatments for boys and young men with DMD that result in a cure or significant attenuation of the disease. It is very encouraging that we continue to see consistent positive clinical and biomarker data from our investigational DT-DEC01 engineered cell therapy, even at this low dose, and that the benefit of the therapy is sustained at 6 months," said Kris Siemionow, M.D. Ph.D., CEO Dystrogen Therapeutics. "The improvements in functional and biomarker measures at 6 months in participants from the low dose cohorts who received DT-DEC01 are distinctly different from what an age-matched, natural history group would predict with DMD. When coupled with strong and sustained dystrophin expression in preclinical studies and encouraging clinical safety profile at 6 months, today's results increase our confidence in DT-DEC01 and provide additional supportive evidence for this approach." Cohort 1 (low dose) at 6 months: Patient #1. (7-year-old ambulatory with deletion of Exon 3-12) Improved duration and amplitude of motor unit potentials (up to 108% of baseline) on EMG (biomarker) when compared to pretreatment baseline. Improved 6MWD (430m --> 469m) and NSAA (31-->34) total score; improved 10-meter walk/run time (14%) and grip strength (5kg-->6.6kg); improved PODCI (90-->95) and others. Statistically and clinically significant increase in step count via activity tracker. Patient #2. (15-year-old non-ambulatory with deletion of Exon 48-50). Improved duration and amplitude of motor unit potentials (up to 287% of baseline) on EMG when compared to pretreatment baseline. Improved grip strength (8kg-->9.7kg); improved PUL (20-->23). Statistically and clinically significant increase in activity via activity tracker. Patient #3. (6-year-old ambulatory with nonsense mutation). Improved duration and amplitude of motor unit potentials (up to 124% of baseline) on EMG when compared to pretreatment baseline. Improved 6MWD (339m --> 390m) and NSAA (26-->28), improved supine to stand (5%); improved PODCI (89-->93), PUL (32-->39) and others. Statistically and clinically significant increase in step count via activity tracker. About DT-DEC01 DT-DEC01 is a chimeric cell therapy and constitutes an advanced therapeutic medicinal product (ATMP). DT-DEC01, which is made using Dystrogen's proprietary cell engineering technology, expresses favorable HLA characteristics which carry multiple immunological advantages. In preclinical studies, DT-DEC01 has been shown to express clinically significant levels of dystrophin when compared to controls. DT-DEC01 demonstrated significant functional improvement in cardiac, diaphragm, and other skeletal muscle strength and associated function in preclinical trials. Because DT-DEC01 is designed to prevent triggering an immune system response, a major advantage is that it does not require immunosuppression. The therapy is not associated with any genetic manipulation and therefore involves no risk of off target mutation, does not use viral vectors, and its use is not dependent on the genetic mutation of the DMD patient, thus making DT-DEC01 a universal therapy for all DMD patients. About Dystrogen Therapeutics Corp Dystrogen Therapeutics is a clinical-stage life sciences company committed to developing therapies for rare genetic diseases and disorders associated with aging. Dystrogen has developed a patented cell engineering technology platform, which has been shown to improve function in both clinical and pre-clinical trials. SOURCE Dystrogen Therapeutics Corporation

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适应症	最高研发状态	国家/地区	公司	日期
杜氏肌营养不良症	临床1期	美国	Dystrogen Therapeutics Corp.初创企业	2021-11-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AACR2023	N/A	急性髓性白血病	53	Venetoclax + AZA	築襯獵襯範糧遞糧製夢(願醖襯憲鹽糧蓋簾壓簾) = 蓋蓋淵膚構選夢範製鹽廠廠憲築夢衊網夢蓋壓 (鏇夢淵鑰衊蓋壓獵鹽鹽 ) 更多	-	2023-04-04
				Venetoclax + DEC	築襯獵襯範糧遞糧製夢(願醖襯憲鹽糧蓋簾壓簾) = 繭製網鑰願鹹淵醖範製廠廠憲築夢衊網夢蓋壓 (鏇夢淵鑰衊蓋壓獵鹽鹽 ) 更多