A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Study to Explore the Safety and Efficacy of ALS-L1023 in Patients With Non-alcoholic Steatohepatitis (NASH)

The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis

开始日期2019-12-04

申办/合作机构

AngioLab, Inc.

NCT03725501

/ Completed临床2期

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Three-arm Parallel-Group, 12-Month Study to Evaluate the Safety and Efficacy of ALS-L1023 Administered in Combination With Ranibizumab in Patients With Wet-AMD

The objective of this phase 2 study is to determine the optimal dose of ALS-L1023 by evaluating the safety and efficacy of ALS-L1023 comparing with placebo when used in combination with Ranibizumab for the treatment of wet age-related macular degeneration(AMD).
The study is designed as multicenter, randomized, placebo-controlled, double-blind, three-arm parallel-group phase 2 study in patients with neovascular age-related macular degeneration.
This study consists of two separate phases: a loading phase and a PRN(pro re nata) phase.
Once the subject provides a written informed consent, subject information including demographics, medical history, and concomitant medications will be collected, and only those who meet the inclusion/exclusion criteria will participate in the study.
All subjects who are enrolled in the study will be randomized into three groups Group A (Ranibizumab 0.5mg & ALS-L1023 600mg) or Group B (Ranibizumab 0.5mg & ALS-L1023 1200mg) or Group C (Ranibizumab & placebo) in a 1:1:1 ratio. Randomization will be stratified by whether or not the subject has PCV(polypoidal choroidal vasculopathy) confirmed at Screening test.
During the 3-month loading phase, all subjects will receive a Ranibizumab 0.5mg injection into the vitreous every month and take either the placebo or ALS-L1023 orally twice a day. During the following 3-12 month PRN phase, subjects will continue to take the placebo or ALS-L1023 in the same frequency as above but receive Ranibizumab injection only when it meets retreatment criteria. Subjects must instill antibacterial eye drops three times a day for three days after Ranibizumab injection.
Subjects will visit the study site monthly during the 12 month study period in order to receive scheduled assessments and evaluate safety and efficacy of treatment. Image interpretation will be performed by a central reading center. The central reading center will confirm eligibility for enrollment and the discrimination of Polypoidal Choroidal Vasculopathy(PCV) at screening and play a role in interpreting whole images of all subjects after the end of the study.

开始日期2018-12-07

申办/合作机构

AngioLab, Inc.

KCT0003361

/ Not yet recruiting临床2期

开始日期2018-11-19

申办/合作机构

AngioLab, Inc.

100 项与 Ethyl acetate extract 相关的临床结果

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100 项与 Ethyl acetate extract 相关的转化医学

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100 项与 Ethyl acetate extract 相关的专利（医药）

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项与 Ethyl acetate extract 相关的文献（医药）

2023-04-20·Pharmaceuticals (Basel, Switzerland)

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ALS-L1023 in Non-Alcoholic Fatty Liver Disease.

Article

作者: Yoon, Eileen L ; Jung, Seungwon ; Jeong, Soung Won ; Hwang, Jungwook ; Kang, Bo-Kyeong ; Jun, Dae Won ; Kim, Gi-Ae ; Cho, Hyun Chin ; Kim, Mimi

Preclinical data have shown that the herbal extract, ALS-L1023, from Melissa officinalis reduces visceral fat and hepatic steatosis. We aimed to assess the safety and efficacy of ALS-L1023 as the treatment of non-alcoholic fatty liver disease (NAFLD). We conducted a 24-week randomized, double-blind, placebo-controlled 2a study in patients with NAFLD (MRI-proton density fat fraction [MRI-PDFF] ≥ 8% and liver fibrosis ≥ 2.5 kPa on MR elastography [MRE]) in Korea. Patients were randomly assigned to 1800 mg ALS-L1023 (n = 19), 1200 mg ALS-L1023 (n = 21), or placebo (n = 17) groups. Efficacy endpoints included changes in liver fat on MRI-PDFF, liver stiffness on MRE, and liver enzymes. For the full analysis set, a relative hepatic fat reduction from baseline was significant in the 1800 mg ALS-L1023 group (-15.0%, p = 0.03). There was a significant reduction in liver stiffness from baseline in the 1200 mg ALS-L1023 group (-10.7%, p = 0.03). Serum alanine aminotransferase decreased by -12.4% in the 1800 mg ALS-L1023 group, -29.8% in the 1200 mg ALS-L1023 group, and -4.9% in the placebo group. ALS-L1023 was well tolerated and there were no differences in the incidence of adverse events among the study groups. ALS-L1023 could reduce hepatic fat content in patients with NAFLD.

2022-11-02·Journal of agricultural and food chemistry

Evaluation of the Perceptual Interaction among Ester Odorants and Nonvolatile Organic Acids in Baijiu by GC-MS, GC-O, Odor Threshold, and Sensory Analysis

Article

作者: Zheng, Fuping ; Li, Hehe ; Sun, Baoguo ; Li, Zexia ; Wang, Guangnan ; Wang, Xinlei ; Jing, Si

By applying the aroma extract dilution analysis, 13 esters were found to have high FD factors in the Laobaigan flavor type of Baijiu. These were then quantified using GC-MS. In addition, 35 nonvolatile organic acids were quantified by a derivatization method combined with GC-MS. The perceptual interactions of lactic acid and ethyl lactate and that of lactic acid and ethyl acetate were studied through the olfactory threshold. The S curve was used to evaluate the changes in the olfactory thresholds. After adding lactic acid (1142, 20 000, and 53 703 mg/L), the olfactory thresholds of ethyl lactate (1000, 724, and 295 mg/L) and ethyl acetate (398, 324, and 257 mg/L) decreased obviously, which revealed that lactic acid gave additive or synergistic odor effects for the two esters. Furthermore, it was discovered that as the concentrations of lactic acid increased, the extent of the interaction among these compounds was also greater in the mixture.

2022-02-01·Reproductive sciences (Thousand Oaks, Calif.)3区 · 医学

Effects of Solvents, Emulsions, Cosolvents, and Complexions on Ex Vivo Mouse Myometrial Contractility

3区 · 医学

Article

作者: Boatwright, Naoko ; Hansen, Christopher J ; Siricilla, Shajila ; Herington, Jennifer ; Rogers, Jackson H ; Kumi, Melissa E

Abstract:

A great need exists to develop tocolytic and uterotonic drugs that combat poor, labor-related maternal and fetal outcomes. A widely utilized method to assess novel compounds for their tocolytic and uterotonic efficacy is the isometric organ bath contractility assay. Unfortunately, water-insoluble compounds can be difficult to test using the physiological, buffer-based, organ bath assay. Common methods for overcoming solubility issues include solvent variation, cosolvency, surfactant or complexion use, and emulsification. However, these options for drug delivery or formulation can impact tissue function. Therefore, the goal of this study was to evaluate the ability of common solvents, surfactants, cosolvents, and emulsions to adequately solubilize compounds in the organ bath assay without affecting mouse myometrial contractility. We found that acetone, acetonitrile, and ethanol had the least effect, while dimethylacetamide, ethyl acetate, and isopropanol displayed the greatest inhibition of myometrial contractility based on area under the contractile curve analyses. The minimum concentration of surfactants, cosolvents, and human serum albumin required to solubilize nifedipine, a current tocolytic drug, resulted in extensive bubbling in the organ bath assay, precluding their use. Finally, we report that an oil-in-water base emulsion containing no drug has no statistical effect beyond the control (water), while the drug emulsion yielded the same potency and efficacy as the freely solubilized drug.

项与 Ethyl acetate extract 相关的新闻（医药）

2023-12-11

·PRNewswire

Viridis Chemical Wins at S&P Global Commodity Insights' 25th Annual Platts Global Energy Awards for Sustainable Chemicals Best Product

Viridis biobased ethyl acetate (ETAC) was named a winner as a renewable, low-carbon, and scalable solution that increases sustainability and benefits the environment Winners Hailed from Belgium, Germany, India, Saudi Arabia, Singapore, Thailand, UK, Ukraine, United Arab Emirates and US HOUSTON, Dec. 11, 2023 /PRNewswire/ -- Viridis Chemical, a manufacturer of renewable, biobased, low-carbon chemicals, announced that its commercial-scale ethyl acetate has been named a winner at the 25th Annual Platts Global Energy Awards in the Sustainable Chemicals Best Product category. S&P Global Commodity Insights, the leading global independent provider of data, insights, analysis and benchmark prices for the commodities, energy and energy transition markets, honored industry excellence in 21 performance categories and winners from nearly a dozen countries at the Platts Global Energy Awards gala. The Awards program, now in its 25th year and often described as the "Oscars of the energy industry", recognizes corporate and individual innovation, leadership, and performance in the energy and petrochemicals sectors, and bestowed honors on companies from Belgium, Germany, India, Singapore, Thailand, UK, Ukraine, United Arab Emirates and US. "We are honored to be named a winner of the esteemed Platts Global Energy Award," said Carl V Rush, Jr., CEO and co-founder of Viridis Chemical. "It is exciting to see the chemical industry's stewardship, advances, and focus on circular economy, climate protection, carbon mitigation and management, and environmental protection. With our proprietary catalytic process, Viridis is delivering high-quality, industrial-scale ETAC to many industries and pushing boundaries with a 40–80% lower carbon footprint than the next best fossil fuel-based manufacturing technology." Since its launch in February 2021, Viridis Chemical has gone from a start-up chemical company to a world-class manufacturer of renewable, 100% biobased, low-carbon ethyl acetate with growing sales throughout North America and Europe. Saugata Saha, President of S&P Global Commodity Insights, said: "At this celebratory quarter-of-a-century milestone for the Platts Global Energy Awards, we are particularly honored by the industry's continued recognition of the program as the energy industry's longstanding premier awards event and welcome the opportunity to congratulate not only the finalists and winners of 2023 but those across the history of the event. Each has contributed not only to a better energy future, but in recent years, has demonstrated an enhanced commitment to greater community service, energy security and a more sustainable energy transition." An independent panel of judges chose the winners of the 2023 Platts Global Energy Awards from finalists selected from nominations that represented 33 different countries. Viridis' 100% biobased ETAC is marketed worldwide by HELM AG, one of the world's largest chemical distribution companies. This partnership with HELM AG gives Viridis access to an international sales force, introducing Viridis' high-quality, low-carbon, sustainability ethyl acetate story to customers and prospects across the globe in various industries, including paints and coatings, adhesives, packaging, personal care, food and beverage, and pharmaceuticals. "We are delighted to see our long-term partner Viridis recognized with this prestigious award. Our customers have been providing positive feedback on the quality of Viridis's ethyl acetate product and the reliability of our service to markets. With the severely reduced carbon footprint, we are excited to continue to help customers deliver a game-changing impact in their markets," said Björn Steckel, President of Chemicals Americas of HELM. Viridis Chemical's ethyl acetate is a United States Department of Agriculture (USDA)-certified, biobased product meeting all requirements under the USDA BioPreferred® Program. Traditionally, ethyl acetate has been manufactured from fossil fuel-based resources. Earlier this year, Viridis received International Sustainability & Carbon Certification PLUS (ISCC PLUS) for its manufacturing facility in Columbus, Nebraska. Products certified to the ISCC PLUS standard assure companies, brand owners, and consumers that high sustainability requirements have been met. Additionally, in June 2023, Viridis received the Independent Commodity Intelligence Services (ICIS) 2023 Product Innovation Award in the Small and Medium-sized Business category. To learn more visit . For more details about other Award winners of this year's Platts Global Energy Awards, access the December issue of the S&P Global Commodity Insights Magazine or visit the Platts Global Energy Awards website. About Viridis Chemical Headquartered in Houston, Texas, Viridis Chemical, LLC, is a world-class manufacturer of renewable, biobased, low-carbon chemicals and the only industrial-scale manufacturer of 100 percent biobased ethyl acetate in North America. Viridis is committed to the safe, environmentally sound, and economically viable conversion of bio-ethanol into circular, sustainable products previously derived from fossil fuel-based resources. Viridis is a member of the American Chemistry Council (ACC), holds International Sustainability & Carbon PLUS Certification (ISCC PLUS) for its manufacturing facility in Columbus, Nebraska, and has a USDA-certified, biobased product meeting all requirements under the USDA BioPreferred® program. For more information, please visit . About HELM AG HELM is a Hamburg, Germany-based family-owned company established in 1900. HELM is one of the world's largest chemicals marketing companies and is committed to providing solutions to its partners that support a successful transformation to a sustainable economy and society. The company secures access to the world's key markets through its specific regional knowledge and its multinational presence in more than 30 countries. As a multifunctional marketing organization, HELM is active in the chemicals industry, in the agricultural industry, in energy materials, and in pharmaceuticals, generating global revenues of EUR 8 billion per year. Learn more at . About S&P Global Commodity Insights At S&P Global Commodity Insights, our complete view of global energy and commodity markets enables our customers to make decisions with conviction and create long-term, sustainable value.  We're a trusted connector that brings together thought leaders, market participants, governments, and regulators and we create solutions that lead to progress. Vital to navigating commodity markets, our coverage includes oil and gas, power, chemicals, metals, agriculture, shipping and energy transition. Platts® products and services, including leading benchmark price assessments in the physical commodity markets, are offered through S&P Global Commodity Insights. S&P Global Commodity Insights maintains clear structural and operational separation between its price assessment activities and the other activities carried out by S&P Global Commodity Insights and the other business divisions of S&P Global. S&P Global Commodity Insights is a division of S&P Global (NYSE: SPGI). S&P Global is the world's foremost provider of credit ratings, benchmarks, analytics and workﬂow solutions in the global capital, commodity and automotive markets. With every one of our offerings, we help many of the world's leading organizations navigate the economic landscape so they can plan for tomorrow, today. For more information visit . MEDIA CONTACTS Viridis Chemical: Kathleen Van Gorden | [email protected] | 401-480-1840 SOURCE Viridis Chemical

2023-11-07

·PRNewswire

REGENATIVE LABS AND DR. ROBERT PARKER ANNOUNCE NEW CARE ADVANCEMENTS USING WHARTON'S JELLY ALLOGRAFTS IN ACHILLES TENDON DEFECTS

Improvement of patient-reported pain and functionality warrants future research. The homologous-use application validated by Dr. Parker sets a precedent for non-surgical allograft application. PENSACOLA, Fla., Nov. 7, 2023 /PRNewswire/ -- Regenative Labs (Regenative), a leading HCT/P manufacturer, announces a retrospective case report demonstrating new care advancements using its Wharton's Jelly allografts in the supplementation of Achilles tendon defects. Board-certified in foot and ankle surgery and lower extremity nerve specialist, Dr. Robert Parker of Parker Foot and Ankle in Texas, has presented for publication a novel case study of Wharton's Jelly, an umbilical cord connective tissue, applied to the structural tissue defect of the Achilles tendon in tandem with shock wave and laser therapy. The homologous use application validated by Dr. Parker sets a precedent for non-surgical allograft application. "As practitioners, we all share the knowledge that long-acting steroids, the acetates, are not only detrimental to tendons, they are in my opinion, contraindicated. This is especially true around larger tendons such as the Achilles. We also know the effect of short-acting steroids, the phosphates, though not as destructive, may give some pain relief but do absolutely nothing to help tissues heal themselves. I am very encouraged and optimistic about utilizing umbilical cord connective tissue as a structural allograft which helps my patient's own tissues heal themself even at multiple sites besides the Achille's tendon," shared Dr. Parker. The patient represented in this case report suffered with chronic Achilles tendinosis from chronic enthesopathy at the Achilles tendon insertion with a retrocalcaneal exostosis for three years and has failed standard-of-care practices for over two years. After application of Wharton's Jelly allografts, such as those provided by Regenative, in addition to extracorporeal pulsed-activated therapy (EPAT) and class IV laser therapy treatments, the patient's pain had improved from a 10/10 VAS to a 0/10 VAS in 13 weeks. While Achilles tendonitis and related tendon damage, also known as enthesopathies, is rampant among athletes, it does not exclusively affect athletes. Approximately 65 percent of Achilles injuries diagnosed in general practice are not sport related. Standard care practices for Achilles tendinosis vary from over-the-counter anti-inflammatories or corticosteroid injections with functional rehabilitation therapy to surgical intervention in severe cases. These costs can range upwards of $15k for a surgical repair and do not guarantee complete pain relief. The rising annual number of surgeries is enough to implement conservative protocols alternative to invasive surgical repair of the Achilles tendon. To advance the necessary research and fill the need for non-surgical alternatives, Regenative has been tracking data in its comprehensive retrospective data repository in which physicians across specialties submit patient data as they track patient outcomes up to 120 days after the patient receives an application of Regenative's products, like its Wharton's Jelly allografts. Regenative has collected data from clinics nationwide on Wharton's Jelly applications for Achilles tendon defects and is excited to highlight Dr. Parker's unique procedures in the first of many publications on regenerative podiatric medicine. "Given the high incidence rate and few effective treatment options for defects in the Achilles tendon, this study aims to provide a new, promising alternative intervention for patients who have failed all other standard-of-care treatments. This is just one of many homologous-use applications in regenerative medicine to improve patient outcomes," shared Regenative Labs CEO Tyler Barrett. Barrett is committed to providing patients with alternative options and, through what may be revealed in these studies, offers proven protocols to better address the root cause of their pain. Barrett and his team hope to enlist physicians to take part in studies regarding uncovered uses. Physicians will have their outcomes highlighted, furthering the understanding of regenerative medicine and uncovering new applications for this groundbreaking field of medicine. "We're doing the research at Regenative, and the results are very promising. We are calling on all physicians across the country to engage with us and advance the field of regenerative medicine," Barrett concluded. Contact Regenative to get your practice involved today. About Regenative Labs: Regenative Labs produces regenerative medicine products to address the root cause of a patient's conditions using Wharton's Jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with the daily challenges of innovations in healthcare, the company provides non-addictive, non-invasive options for patients. Regenative Labs' expert product research and development team complies with FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at Regenative's website: About Dr. Robert Parker: Dr. Robert G. Parker is a native Houstonian practicing in Houston, Texas. He graduated from the Ohio College of Podiatric Medicine (currently Kent State University) and was the first board-certified podiatric surgeon recognized by the American Board of Foot and Ankle Surgery in Houston. Dr. Parker is a faculty instructor of the advanced and fundamental Didactic and Cadaver courses for the Association of Extremity Nerve Surgeons. Additionally, he is a Founding Member and fellow of the Association of Extremity of Nerve Surgeons and served as the organization's president in 2013. Dr. Parker served on the American Board of Podiatric Medicine as an examiner for over a decade and was one of two cofounders of The Harris County Podiatric Residency program. He was also the President of the SW division of the American College of Foot Surgeons and has received numerous awards spanning his decades-long career. Learn more at Parker Foot and Ankle's website: SOURCE Regenative Labs

临床结果

2023-06-19

·康龙化成

康 · 学术 | Reaction of the Day No. 1027

Regio and enantioselective remote dioxygenation of internal alkenesXiaonan Li1,3, Tilong Yang2,3, Jiayuan Li1, Xiang Li1, Pinhong Chen1, Zhenyang Lin 2 & Guosheng Liu11State Key Laboratory of Organometallic Chemistry and Shanghai Hongkong Joint Laboratory in Chemical Synthesis, Center for Excellence in Molecular Synthesis, Shanghai Institute of Organic Chemistry, University of Chinese Academy of Sciences, Chinese Academy of Sciences, Shanghai, China.2Department of Chemistry, The Hong Kong University of Science and Technology, Clear Water Bay, Kowloon, Hong Kong, China.3These authors contributed equally: Xiaonan Li, Tilong Yang.—Nat. Chem., https://doi-org.libproxy1.nus.edu.sg/10.1038/s41557-023-01192-3Recommended by Murong Xu_ MC3KEYWORDS: enantioselective, dioxygenation, internal alkenes, palladium-catalyzed, Pyox ligandsABSTRACT: Methods for the enantioselective direct oxygenation of internal alkenes have provided chemists with versatile and powerful toolboxes for the synthesis of optically pure alcohols, one of the most privileged structural motifs. Regioselectivity, however, remains a formidable challenge in the functionalization of internal alkenes. Here we report a palladium-catalyzed highly regio- and enantioselective remote 1,n-dioxygenation (n ≥ 4) of internal alkenes with engineered pyridine-oxazoline (Pyox) ligands. The reactions proceed efficiently and exhibit a broad substrate scope with excellent regio- and enantioselectivity, affording optically pure 1,n-diol acetates as the key synthons for important bioactive molecules. Experimental studies and density functional theory calculations provide evidence that the regioselectivity is governed by the reactivity disparity of two allylic C–H bonds, where the oxypalladation is reversible and the first palladium migration step proves to be the regioselectivity-determining step, enabled by the modified phenyl-substituted Pyox ligands.Regio- and enantioselective 1,n-dioxygenation of internal alkenesThe catalytic reactions and challenges of design in catalytic remote dioxygenationRegioselective ARD reaction and ligand screening (*ARD: asymmetric remote dioxygenation)Scope of Pd-catalysed remote dioxygenation of internal alkenesSynthetic applicationsSummary and CommentsProf. Guosheng Liu and Zhenyang Lin et al have developed a palladium-catalysed method for the highly regioselective ARD reaction of internal alkenes. Described herein represents a powerful tool for the efficient synthesis of chiral 1,n-diols from simple alkenes. The concept for tuning the regioselectivity of unactivated internal alkenes was demonstrated by altering the rate-determining step, enabled by the modified Pyox ligand, which lays the groundwork for further exploration of other regioselective functionalization reactions.

临床研究临床结果

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适应症	最高研发状态	国家/地区	公司	日期
腹型肥胖及代谢综合征	临床3期	韩国	Hanmi Pharmaceutical Co., Ltd.	2013-05-01
腹部肥胖	临床3期	韩国	Hanmi Pharmaceutical Co., Ltd.	2013-05-01
非酒精性脂肪性肝炎	临床2期	韩国	AngioLab, Inc.	2019-12-04
湿性黄斑变性	临床2期	韩国	AngioLab, Inc.	2018-12-07
代谢功能障碍相关的脂肪肝病	临床2期	韩国	AngioLab, Inc.	-
渗出性中耳炎	临床2期	韩国	AngioLab, Inc.	-
湿性年龄相关性黄斑变性	临床2期	韩国	AngioLab, Inc.	-
玫瑰痤疮	临床1期	韩国	AngioLab, Inc.	-

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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


AASLD2023	临床2期	代谢功能障碍相关的脂肪肝病	-	1800 mg ALS-L1023	築觸鏇網繭獵醖築築憲(襯繭憲壓遞齋製餘糧製) = 壓膚夢製簾選夢願壓製夢糧廠網觸衊願齋夢憲 (襯夢鹽壓衊構齋艱壓膚 ) 更多	-	2023-11-10
				1200 mg ALS-L1023	築觸鏇網繭獵醖築築憲(襯繭憲壓遞齋製餘糧製) = 窪醖積網築膚夢鏇壓製夢糧廠網觸衊願齋夢憲 (襯夢鹽壓衊構齋艱壓膚 ) 更多
ARVO2014	N/A	脉络膜新生血管	32	ALS-L1023 50 mg/kg	齋簾構鑰齋襯齋憲壓鹽(夢糧選構廠繭獵壓築構) = 獵製顧窪鹹襯鹹顧糧築繭構憲觸齋齋網壓範鬱 (廠繭願壓獵窪鏇夢鏇醖 )	-	2014-04-01
				ALS-L1023 100 mg/kg	齋簾構鑰齋襯齋憲壓鹽(夢糧選構廠繭獵壓築構) = 範衊製齋遞鑰範蓋構醖繭構憲觸齋齋網壓範鬱 (廠繭願壓獵窪鏇夢鏇醖 )