A Randomized Controlled Study Using Alpha Lipoic Acid and CoQ-10 to Determine if Vestibular Function Can be Improved or Maintained Over the Course of One Year

To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.

开始日期2024-01-01

申办/合作机构

University of Texas Health Science Center At San Antonio

[+1]

NCT05370508 / Active, not recruiting临床1/2期

A Phase 1/2 Dose Escalation and Expansion Study of Sonodynamic Therapy With SONALA-001 in Combination With Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound in Subjects With Progressive or Recurrent Glioblastoma Multiforme (rGBM)

The primary objectives of this trial are to evaluate the safety, dose-limiting toxicities, maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended Phase 2 dose (RP2D) for future study after a single treatment of SONALA-001 in combination with MRgFUS and to evaluate preliminary efficacy of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device in subjects with progressive or recurrent GBM.

开始日期2023-02-06

申办/合作机构

SonALAsense, Inc.初创企业

NCT05123534 / Recruiting临床2期

A Phase 2 Dose-escalation Study Examining the Safety, Pharmacokinetics, and Preliminary Efficacy of Ascending Drug and Energy Dose Combinations for Sonodynamic Therapy Using SONALA-001 in Combination With Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound in Subjects With Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG)

The primary objectives of this trial are to evaluate the safety and tolerability of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of MR-Guided Focused Ultrasound (MRgFUS) energy in combination with SONALA-001 in subjects with diffuse intrinsic pontine glioma
Funding Source - FDA OOPD

开始日期2022-08-12

申办/合作机构

SonALAsense, Inc.初创企业

100 项与 SONALA-001 相关的临床结果

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100 项与 SONALA-001 相关的转化医学

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100 项与 SONALA-001 相关的专利（医药）

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6,604

项与 SONALA-001 相关的文献（医药）

2024-05-01·Food chemistry

Comparison of interactions between alpha-lactalbumin and three protopanaxadiol ginsenosides: Impacts on the structure and antitumor properties

Article

作者: Feng, Sitong ; Diao, Mengxue ; Wang, Yingyi ; Liang, Yuan ; Zhang, Tiehua ; Lu, Yitong ; Zhao, Yueying

In this research, interactions between α-lactalbumin (ALA) and three protopanaxadiol ginsenosides [20(S)-Rg3, 20(S)-Rh2, and 20(S)-PPD] were compared to explore the effects of similar ligand on structure and cytotoxicity of ALA. Multi-spectroscopy revealed the binding between ALA and ginsenoside changed the conformation of ALA, which related to different structures and solubility of ligands. Scanning electron microscope illustrated that all ALA-ginsenoside complexes exhibited denser structures via hydrophobic interactions. Additionally, the cytotoxic experiments confirmed that the cytotoxicity of ginsenoside was enhanced after binding with ALA. Molecular docking showed all three ginsenosides were bound to the sulcus depression region of ALA via hydrogen bonding and hydrophobic interaction. Furthermore, molecular dynamics simulation elucidated the precise binding sites and pertinent system properties. Among all three composite systems, 20(S)-Rh2 had optimal binding affinity. These findings enhanced understanding of the synergistic utilization of ALA and ginsenosides as functional ingredients in food, medicine, and cosmetics.

2024-04-28·The British journal of nutrition

Effect of fatty acid-enriched black soldier fly larvae meal combined with chitinase on the metabolic processes of Nile tilapia

Article

作者: Lalèyè, Philippe A ; Tokpon, Nicole ; Cambier, Pierre ; Mandiki, Robert ; Kestemont, Patrick ; Agbohessou, Pamphile S ; Blanquer, Aude ; Mes, Wouter ; Lambert, Jérôme ; Gérardy, Mazarine ; Garigliany, Mutien-Marie

Abstract:

The aim of this study is to determine to what extent the addition of chitinase to black soldier fly (BSF) larval meal enriched or not with long-chain PUFA (LC-PUFA) could improve growth, protein digestion processes and gut microbial composition in Nile tilapia. Two different types of BSF meal were produced, in which larvae were reared on substrates formulated with vegetable culture substrate (VGS) or marine fish offal substrate (FOS). The BSF raised on VGS was enriched in α-linolenic acid (ALA), while that raised on FOS was enriched in ALA + EPA + DHA. Six BSF-based diets, enriched or not with chitinase, were formulated and compared with a control diet based on fishmeal and fish oil (FMFO). Two doses (D) of chitinase from Aspergillus niger (2 g and 5 g/kg feed) were added to the BSF larval diets (VGD0 and FOD0) to obtain four additional diets: VGD2, VGD5, FOD2 and FOD5. After 53 d of feeding, results showed that the BSF/FOS-based diets induced feed utilisation, protein efficiency and digestibility, as well as growth comparable to the FMFO control diet, but better than the BSF/VGS-based diets. The supplementation of chitinase to BSF/FOS increased in fish intestine the relative abundance of beneficial microbiota such as those of the Bacillaceae family. The results showed that LC-PUFA-enriched BSF meal associated with chitinase could be used as an effective alternative to fishmeal in order to improve protein digestion processes, beneficial microbiota and ultimately fish growth rate.

2024-03-27·Journal of experimental botany

A novel tetratricopeptide-repeat protein, TTP1, forms complexes with glutamyl-tRNA reductase and protochlorophyllide oxidoreductase during tetrapyrrole biosynthesis

Article

作者: Grimm, Bernhard ; Roling, Lena ; Pang, Xiaoqing ; Herbst, Josephine

Abstract:

The biosynthesis of the tetrapyrrole end-products chlorophyll and heme depends on a multifaceted control mechanism that acts primarily at the post-translational level upon the rate-limiting step of 5-aminolevulinic acid synthesis and upon light-dependent protochlorophyllide oxidoreductase (POR). These regulatory processes require auxiliary factors that modulate the activity, stability, complex formation, and subplastidal localization of the relevant proteins. Together, they ensure optimal metabolic flow during the day and at night. As an Arabidopsis homolog of the POR-interacting tetratricopeptide-repeat protein (Pitt) first reported in Synechocystis, we characterize tetrapyrrole biosynthesis-regulating tetratricopeptide-repeat protein1 (TTP1). TTP1 is a plastid-localized, membrane-bound factor that interacts with POR, the Mg protoporphyrin monomethylester cyclase CHL27, glutamyl-tRNA reductase (GluTR), GluTR-binding protein, and FLUORESCENCE IN BLUE LIGHT. Lack of TTP1 leads to accumulation of GluTR, enhanced 5-aminolevulinic acid synthesis and lower levels of POR. Knockout mutants show enhanced sensitivity to reactive oxygen species and a slower greening of etiolated seedlings. Based on our studies, the interaction of TTP1 with GluTR and POR does not directly inhibit their enzymatic activity and contribute to the control of 5-aminolevulinic acid synthesis. Instead, we propose that TTP1 sequesters a fraction of these proteins on the thylakoid membrane, and contributes to their stability.

项与 SONALA-001 相关的新闻（医药）

2024-06-03

·PRNewswire

Leading Cancer Researchers from NYU Langone's Perlmutter Cancer Center Present Latest Clinical Findings & Research at ASCO 2024 Annual Conference

NEW YORK , June 3, 2024 /PRNewswire/ -- Researchers from NYU Langone Health's Perlmutter Cancer Center are presenting their latest findings and research at the 2024 American Society of Clinical Oncology (ASCO) Annual Conference, held May 31 to June 4 at Chicago's McCormick Place. Among these presentations: a three-year update on the long-term efficacy of an mRNA vaccine for use in patients being treated for metastatic melanoma a retrospective look at treatment patterns and outcomes in patients with advanced endometrial cancer a look at the safety and efficacy of a noninvasive combination treatment for patients with recurrent glioblastoma "This year's crop of presentations is a showcase of the Perlmutter Cancer Center's commitment to delivering the highest level of research and clinical care," said Alec Kimmelman, MD, PhD, the center's director. Late-Breaker Rapid Oral Abstract: Three-year update on the long-term efficacy of an mRNA vaccine for use in patients being treated for metastatic melanoma Monday, June 3, 10:15AM CT In a follow-up presentation at ASCO to the recently published clinical trial describing the effectiveness of combining the immunotherapy drug pembrolizumab with V940—an investigational individualized neoantigen mRNA vaccine for people with high-risk, surgically removed melanoma—this three-year update looks at the longer-term recurrence rates of treated patients. The primary analysis of the phase 2 trial, led by Jeffrey S. Weber, MD, PhD, deputy director of Perlmutter Cancer Center, and sponsored by Moderna and Merck, assessed patients who received the vaccine, called mRNA-4157/V940, and the immunotherapy drug pembrolizumab, comparing their risk of recurrence and development of distant metastases to those who had received only pembrolizumab. This three-year follow-up analysis showed a higher percentage of durable and meaningful long-term recurrence-free survival or survival without distant spread of cancer in patients who received both treatments (74.8 percent) compared to those who received only pembrolizumab (55.6 percent). The patients' overall survival also improved with combination treatment, at 96.0 percent compared to 90.2 percent with pembrolizumab alone. "This additional information continues to support the potential of mRNA-4156/V940 in combination with pembrolizumab for patients with metastatic melanoma," said Dr. Weber. "We have followed up this work with a randomized phase 3 trial in more than a thousand patients, which we hope will provide a definitive assessment of the efficacy of the combination of V940 and pembrolizumab compared to pembrolizumab alone." Poster: A retrospective look at treatment patterns and outcomes in patients with advanced endometrial cancer Monday, June 3, 9AM This retrospective study, led by Bhavana Pothuri, MD, director of gynecologic oncology research at Perlmutter Cancer Center and a professor in the Department of Obstetrics and Gynecology, assesses testing for treatment options, treatment patterns, and outcomes among patients with advanced endometrial cancer. In the past decade, newer therapies have been introduced for advanced endometrial cancer. Molecular profiling of mismatch repair/microsatellite instability (MMR/MSI) status has become an important testing tool to determine treatment, but real-world data on the prevalence of its use is limited. Researchers looked at 1,441 deidentified patients with advanced endometrial cancer who started therapy between January 2018 and June 2023, analyzing patient characteristics, treatment patterns, and testing patterns. While MMR/MSI testing was common, less than 50 percent of patients were receiving new therapies, and further study with implementation science may aid in increased adoption. "Advanced endometrial cancer is the fourth most common cancer affecting women in the United States, and it is the only gynecologic malignancy with increasing incidence—and increasing mortality that is soon expected to surpass that of ovarian cancer," said Dr. Pothuri. "Despite increasing trends, there may be outstanding barriers to the adoption of new therapies. We need further studies to assess these changes in outcomes over a longer time frame, along with continued education to increase awareness and access to newer FDA-approved treatments." Poster: The safety and efficacy of a noninvasive combination treatment for patients with recurrent glioblastoma Saturday, June 1, 9AM Dimitris G. Placantonakis, MD, PhD, an associate professor in the Department of Neurosurgery, is presenting an ongoing, multicenter phase1/2 study that explores if sonodynamic therapy is safe and can help patients with recurrent or progressive glioblastoma live longer. Recurrent glioblastoma is a lethal brain tumor that has an extremely poor prognosis and no effective therapies. Sonodynamic therapy is a noninvasive combination treatment that uses a drug, aminolevulinic acid HCL (SONALA-001), and a device, the Exablate 4000 Type 2.0, to deliver focused ultrasound to target glioblastoma cells. This has been shown in previous studies to lead to tumor cell death and improved survival in animal models. People enrolled in this trial are receiving different dosage levels in order to determine the maximum tolerable dose for further study. The phase 2 portion will further characterize safety, along with evaluation of the efficacy of this treatment, with other key endpoints, including overall survival and recurrence rate. "We are very excited about this study because, as a new therapy, it offers hope for people with this disease," said Dr. Placantonakis. "This is also exciting because it offers a noninvasive treatment approach that pulses ultrasound waves from a device that is outside the head, so there is no need to surgically remove the tumor, and it eliminates the risk of side effects that are inherent in conventional brain surgery." Media Inquiries Marlene Naanes Phone: 646-754-5016 [email protected] SOURCE NYU Langone Health

临床2期ASCO会议临床3期临床结果疫苗

2023-11-14

·BioSpace

FDA Grants Fast Track Designation to SonALAsense’s SONALA-001 in Combination with the INSIGHTEC Transcranial Ultrasound Device for Sonodynamic Therapy of DIPG, a Rare Pediatric Brain Cancer

Encouraging preliminary data from the ongoing DIPG clinical study to be presented at the 2023 Society for Neuro-Oncology Annual Meeting in Vancouver OAKLAND, Calif.--(BUSINESS WIRE)-- Sonalasense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the development program of SONALA-001 in combination with the INSIGHTEC Exablate 4000 Type-2 Device for the treatment of patients with diffuse intrinsic pontine glioma (DIPG). This builds upon SONALA-001 also having received orphan drug designation in 2021 for malignant gliomas. The FDA’s Fast Track is a process designed to facilitate the development, and expedited review, of drugs to treat serious conditions and fill an unmet medical need. The program allows eligibility for more frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval, more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers, and accelerated approval. “Receiving Fast Track Designation underscores the immediate and urgent need to bring new therapy options for DIPG patients,” said Ely Benaim, M.D., SonALAsense’s Chief Medical Officer and Executive Vice President of Development. “We are committed to working as efficiently as possible to bring SONALA-001 SDT to patients with this universally fatal disease.” DIPG is a rare, aggressive, and deadly pediatric brain tumor that strikes the pons, which links the brain to the spinal cord and helps control breathing, blood pressure, heart rate and other vital functions. It diffuses through the pons in a way that makes surgery impossible. Approximately 300 children are diagnosed with DIPG each year in the US, usually between the ages of 5 and 9. The median survival is 7-11 months after diagnosis with no effective treatments available beyond radiation. The current standard of care with fractionated radiotherapy and supportive care show significant side effects and limited efficacy. SONALA-001 is SonALAsense’s proprietary intravenous aminolevulinic acid HCl (ALA) formulation. SonALAsense’s SDT uses the energy of ultrasound to produce light within the brain to activate protoporphyrin IX, a metabolite of ALA. SONALA-001 SDT is currently being evaluated for safety and preliminary efficacy in clinical study SDT-201, an open label drug and energy dose ranging and expansion study (NCT 05123534). Preliminary data generated from the dose ranging cohort will be presented at a SonALAsense-hosted symposium at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada, November 16-19. “We are excited for the opportunity to present promising results generated from our DIPG study to date,” said Mark de Souza, SonALAsense CEO. We are fully committed in our efforts to provide hope to this group of patients of the utmost medical need, and to bring this novel treatment to patients as quickly as possible.” About SonALAsense SonALAsense is a clinical-stage company, developing a proprietary form of sonodynamic therapy (SDT) as a first-in-class, noninvasive drug-device combination to treat recurrent glioblastoma, diffuse intrinsic pontine glioma, and other life-threatening cancers. SDT uses SONALA-001 in combination with MR-guided focused ultrasound to selectively target and kill tumor cells. SONALA-001 has received Orphan Drug Designation for Malignant Gliomas. SONALA-001 in combination with the INSIGHTEC Exablate 4000 Type-2 ultrasound device has received Fast Track Designation for the treatment of patients with DIPG. Follow SonALAsense on Twitter and LinkedIn and visit our website at sonalasense.com.

快速通道孤儿药

2023-05-09

·Business Wire

SonALAsense Welcomes Dr. Ely Benaim as Chief Medical Officer and Executive Vice President of Development

OAKLAND, Calif.--( BUSINESS WIRE )--SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 in combination with Insightec’s MR-guided focused ultrasound (MRgFUS), has appointed Ely Benaim, M.D., as Chief Medical Officer and Executive Vice President of Development. As a new member of the SonALAsense team, Dr. Benaim will play a crucial role in gaining FDA approval and commercializing SDT to treat aggressive brain tumors, such as diffuse intrinsic pontine glioma (DIPG) and recurrent glioblastoma multiforme (rGBM); both of which have ongoing trials. “ Dr. Benaim brings decades of clinical and industry experience and incredible insights to SonALAsense,” said Mark de Souza, PhD, Chief Executive Officer at SonALAsense. “ With his extensive history in oncology practice, bench research, drug and device development, and biopharmaceutical management, he will help us advance sonodynamic therapy through clinical trials and ultimately regulatory approval.” Dr. Benaim began his career as a pediatric oncologist at St. Jude Children’s Research Hospital. Later, he moved into drug development, taking high-profile positions at Amgen, Sangamo BioSciences, Millennium Pharmaceuticals, Rexahn Pharmaceuticals and others. Prior to joining SonALAsense, he was Chief Medical Officer for Novocure, where he managed several pivotal clinical trials. “ I’ve always been attracted to challenging conditions, such as orphan diseases, and driven to accelerate approvals because there were no therapies,” said Dr. Benaim. “ When people say something cannot be done, that’s when I really start getting interested. Both DIPG and glioblastoma are incredibly challenging conditions, and I wanted to be part of the solution.” SonALAsense’s SDT uses SONALA-001, a proprietary formulation of aminolevulinic acid (ALA), to disrupt heme metabolism in tumor cells, increasing production of protoporphyrin, a heme precursor. From there, energy from focused ultrasound excites protoporphyrin molecules, which produce reactive oxygen species that destroy cancer cells. Recently, Dr. Hasan Syed at Children’s National Hospital published a peer-reviewed paper on the first DIPG patient treated with SONALA-001 in the Journal of Neuro-Oncology; a major milestone for this deadly and understudied childhood disease. “ There’s early evidence of activity in patients,” said Dr. Benaim. “ We need to get more patients into clinical trials, gather more data and move as quickly, and as safely, as possible through the regulatory process.” At SonALAsense, Dr. Benaim will work to accelerate this process to get SDT rapidly to patients. He will lead clinical operations, data management, and safety, and play a major role in regulatory filings. He will also be an ambassador for the company, sharing information about this novel therapy with the oncology community. “ We are pleased and honored to have Dr. Benaim join our team,” said company founder and Chief Scientific Officer, Stuart Marcus, M.D., Ph.D. “ He will give us tremendous energy as we advance sonodynamic therapy through clinical trials.” About SonALAsense SonALAsense is a clinical-stage company, developing sonodynamic therapy (SDT) as a first-in-class, noninvasive drug-device combination to treat recurrent glioblastoma, diffuse intrinsic pontine glioma, and other life-threatening cancers. SDT uses SONALA-001 (a drug) in combination with MR-guided focused ultrasound (a device) to selectively target and kill tumor cells. Follow SonALAsense on Twitter and LinkedIn and visit our website at sonalasense.com

高管变更

100 项与 SONALA-001 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
多形性胶质母细胞瘤	临床2期	美国	SonALAsense, Inc.初创企业	2023-02-06
复发性胶质母细胞瘤	临床2期	美国	SonALAsense, Inc.初创企业	2023-02-06
弥漫内生性脑桥神经胶质瘤	临床2期	美国	SonALAsense, Inc.初创企业	2022-08-12
弥漫性中线胶质瘤	临床2期	美国	SonALAsense, Inc.初创企业	2022-08-12
寻常痤疮	临床2期	中国	上海复旦张江生物医药股份有限公司	2019-07-11
高级别胶质瘤	临床1期	美国	SonALAsense, Inc.初创企业	2021-03-15

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临床结果

适应症

分期

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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


NCT05123534 (SDT-201, ASCO2024)	临床2期	弥漫内生性脑桥神经胶质瘤 ALA metabolite \| protoporphyrin IX (PpIX)	6	SONALA-001 5mg/kg	餘糧夢選鑰範鬱獵艱築(網壓選蓋壓築醖繭鑰範) = 鹽簾鹹觸餘選網艱醖觸夢製醖繭壓獵廠襯齋顧 (膚範夢願齋製膚鏇顧鹹 ) 更多	积极	2024-05-24
NCT00237718 (CTgov)	临床2期	终末期肾脏病	385	Alpha lipoic acid+delta (mixed) tocopherols (ALA and Vitamin E)	觸廠壓築窪顧選憲糧廠(膚觸構網網齋鬱網憲築) = 襯築選網鏇構鑰憲鏇築憲餘淵鏇鑰簾餘網鑰艱 (醖簾憲願鹽簾衊齋選衊, 築願積艱鏇衊糧淵觸鹹 ~ 觸憲顧鏇觸淵鑰選鹹範) 更多	-	2011-10-05
NCT00237718 (CTgov)	临床2期	终末期肾脏病	385	Placebo (Placebo)	觸廠壓築窪顧選憲糧廠(膚觸構網網齋鬱網憲築) = 構範製衊鹽鹽網淵鹽艱憲餘淵鏇鑰簾餘網鑰艱 (醖簾憲願鹽簾衊齋選衊, 觸簾範壓齋糧願製夢鬱 ~ 觸夢鹹壓齋憲鑰製遞鬱) 更多	-	2011-10-05