A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)

SDP-4-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID.

开始日期2020-08-14

申办/合作机构

Silk Technologies Ltd.

NCT03889886 / Completed临床2期

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Dose-Response Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)

SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups via topical ocular instillation BID.

开始日期2019-04-16

申办/合作机构

Silk Technologies Ltd.

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149

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2024-03-28·Journal of Microbiology and Biotechnology

Change in the Gut Microbiota of Lactating Sows and Their Piglets by Inclusion of Dietary Spray-Dried Plasma in Sow Diets

Article

作者: Song, Minho ; Kim, Yonghee ; Cho, Jin Ho ; Kyoung, Hyunjin ; Kim, Younghoon ; Choe, Jeehwan ; Kim, Hyeun Bum ; Park, Kyeong Il ; Ahn, Jinmu ; Lee, Jeong Jae

This study aimed to investigate the effects of dietary spray-dried plasma (SDP) on the gut microbiota of lactating sows and their piglets. A total of 12 sows were randomly assigned to one of two dietary treatment groups in a completely randomized design. The treatments were a sow diet based on corn and soybean meal (CON), and a CON diet with an added 1% SDP. The sows were fed the dietary treatments from d 30 before farrowing to weaning (d 28). The fecal samples of three sows from each treatment and two of their randomly selected piglets were collected to verify their fecal microbiota. There were no differences in the alpha diversity and distinct clustering of the microbial communities in the sows and their piglets when SDP was added to the sow diets from late gestation to weaning. The fecal microbiota of the lactating sows and their piglets showed a higher relative abundance of the phylum Bacteroidota and genus Lactobacillus and Ruminococcus and showed a lower relative abundance of the phylum Bacillota and genus Bacteroides, Escherichia/Shigella, and Clostridium in the sows fed the SDP diet than those fed the CON diet. Overall, these results show that the addition of SDP to the sow diet during lactation altered the gut environment with positive microbial composition changes. These results were similar in the nursing piglets, suggesting that the control of the sow diets during lactation may contribute to the intestinal health and growth in piglets after weaning.

2023-12-15·The Journal of Maternal-Fetal & Neonatal Medicine

Interaction between smoking during pregnancy and gestational diabetes mellitus and the risk of cesarean delivery: evidence from the National Vital Statistics System 2019

Article

作者: Song, Jie ; Cai, Ruiyu

OBJECTIVETo explore the interaction between smoking during pregnancy (SDP) and gestational diabetes mellitus (GDM) on the risk of cesarean delivery.METHODSThis retrospective cohort study utilized data from the National Vital Statistics System (NVSS) 2019. The NVSS database provides data on births and deaths as well as maternal characteristics in the United States. The duration of follow-up was 38.74 ± 2.12 weeks. The outcome was the method of delivery, including vaginal and cesarean delivery. The multivariate logistic regression model was adopted to assess the associations of SDP and GDM with the method of delivery. The interaction between SDP and GDM was examined via calculating the relative excess risk of interaction (RERI), the attributable proportion of interaction (API) and the synergy index (S). Subgroup analyses were conducted based on age, race, prepregnancy body mass index (BMI), and primiparity.RESULTSThe study included 3352615 puerperae. Compared with women who did not smoke during pregnancy, those who smoked during pregnancy had a significantly higher risk of cesarean delivery [odds ratio (OR)=1.07, 95% confidence intervals (CI): 1.05-1.10, p < 0.001]; women with GDM had a significantly greater risk of cesarean delivery than those without (OR = 1.31, 95%CI: 1.30-1.33, p < 0.001). In contrast to women who did not smoke during pregnancy and did not have GDM, those who smoked during pregnancy and had GDM exhibited an increased risk of a cesarean section (OR = 1.47, 95%CI: 1.40-1.54, p < 0.001). RERI was 0.08 (95%CI: 0.01-0.15), API was 0.06 (95%CI: 0.01-0.10), and S was 1.21 (95%CI: 1.04-1.40) suggested that there was an interaction between SDP and GDM, and it was a synergistic effect. There was a synergism between SDP and GDM in women of non-advanced age (RERI = 0.07, 95%CI: 0.001-0.15; API = 0.05, 95%CI: 0.003-0.10; S = 1.17, 95%CI: 1.001-1.36), in white women (RERI = 0.08, 95%CI: 0.004-0.16; API = 0.05, 95%CI: 0.01-0.10; S = 1.19, 95%CI: 1.02-1.39), in women who were overweight before pregnancy (RERI = 0.13, 95%CI: 0.05-0.21; API = 0.08, 95%CI: 0.04-0.13; S = 1.33, 95%CI: 1.14-1.55), and in primiparae (RERI = 0.20, 95%CI: 0.08-0.31; API = 0.12, 95%CI: 0.06-0.19; S = 1.50, 95%CI: 1.23-1.84).CONCLUSIONSDP and GDM were associated with an increased risk of cesarean delivery, and a synergistic effect existed between SDP and GDM on the risk of cesarean delivery, especially in women of non-advanced age, white women, women who were overweight before pregnancy, and primiparae.

2023-11-01·Food science and biotechnology

Comparison of physicochemical properties and oxidative stability of microencapsulated perilla oil powder prepared by freeze-drying and spray-drying

Article

作者: Lee, JaeHwan ; Koo, HeeWon ; Kim, SungHwa

Perilla oil is vulnerable to lipid oxidation owing to its high linolenic acid content.Microencapsulation using freeze- and spray-drying methods was applied to enhance the oxidative stability and change the physicochem. properties of perilla oil.Freeze-dried powder (FDP) possessed 11.77 to 38.48% oil content, whereas spray-dried powder (SDP) had 8.90-27.83% oil content.Encapsulation efficiency ranged from 51.22 to 85.71% by freeze-drying and from 77.38 to 90.74% by spray-drying.The oxidative stability of powders depends on the oil content and production methods.Generally, FDP had higher oxidative stability and water solubility, and lower moisture content and water activity than SDP.The particle size of FDP (154.00-192.00μm) in volume-weight mean diameter was 2.56-24.49 times larger than that of SDP (7.84-72.03μm).SDP had a lower volatile content at the initial time of storage than FDP, while more volatiles were observed in SDP as storage time increased.The microencapsulation method should be selected appropriately depending on the target property or usage in food applications.

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2023-12-20

·PRNewswire

SciTech Development Announces First Patient Dosed in Phase 1 Clinical Trial of ST-001

This study is designed to evaluate ST-001 for the treatment of T-cell non-Hodgkin's lymphoma (NHL). GROSSE POINTE, Mich., Dec. 20, 2023 /PRNewswire/ -- SciTech Development ("SciTech" or the "Company"), a clinical-stage pharmaceutical company with a novel and patented drug delivery platform, today announced that the company has dosed the first patient in its Phase 1 clinical trial with lead cancer drug candidate, ST-001 nanoFenretinide. ------------------------ Join us here to learn more about the Company and our science: ------------------------ "There have been relatively few new cancer breakthroughs for T-cell lymphoma in several years, so we are excited to announce this milestone for patients suffering from this rare disease." said Earle Holsapple, SciTech's President, and CEO. "Our scientific team has worked extremely hard to bring this new drug to the people that need it most. We currently have four active trial sites with world-renowned medical institutions in New York, California, Pennsylvania, and Michigan, with more sites coming onboard in early 2024 as the trials expand. SciTech is proud to be on the forefront of helping cancer patients and we thank everyone who has supported our journey." The active drug fenretinide has been clinically tested and deemed safe in over 3,000+ patients in previous clinical trials. However, due to bioavailability issues of past fenretinide formulations, high concentrations of the drug could not reach and kill the target cancer cells. SciTech led the effort to find the solution with its patented methods for phospholipids and nanoparticalization to enhance fenretinide's bioavailability, thus developing ST-001 nanoFenretinide. SciTech's Phase 1 clinical trials are targeting patients with T-cell non-Hodgkin's lymphoma, including Cutaneous T-cell Lymphoma (CTCL), Mycosis Fungoides, Sézary Syndrome, and non-Cutaneous T-cell Lymphoma subtypes. The initial study will determine the Maximum Tolerated Dose (MTD) of ST-001 nanoFenretinide (IV infusion) in patients with CTCL and other T-cell non-Hodgkin's lymphoma. For more detailed trial information, please visit ClinicalTrials.gov; Identifier: NCT04234048. About SciTech Development SciTech Development, LLC is a clinical-stage pharmaceutical company that has developed a patented nanoparticle drug delivery platform (SDP) that maximizes the bioavailability of water-insoluble therapeutics. SciTech's lead drug candidate, ST-001 nanoFenretinide, combines SDP and the drug fenretinide as a broadly applicable anticancer drug. For more information about the Company, please visit: Contact Information: David Schaffer Director; Business Development and Investor Relations [email protected] Safe Harbor – Forward-Looking Statement: This document contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding attempts to identify new products, services or strategic opportunities which may include a strategic transaction, plans regarding partnering activities, service pricing or financial forecasts. Such statements are only predictions, and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that the Company may not be able to identify acceptable strategic opportunities or conclude any identified strategic transaction, the risk that products or services that appeared promising in early use do not demonstrate the same utility in larger-scale uses or trials, the risks associated with the Company's reliance on outside financing to meet its capital requirements, and the risks associated with the Company's reliance on forward-looking contracts. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted, or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underly the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, political, environmental, competitive, and/or other material risks. SOURCE SciTech Development

临床1期

2023-10-26

·PRNewswire

SciTech Development Announces The Formation of a Distinguished Medical Advisory Board With Top Oncology Specialists

GROSSE POINTE FARMS, Mich., Oct. 26, 2023 /PRNewswire/ -- SciTech Development, LLC, today announced the formation of a distinguished and independent medical advisory board (MAB) comprised of key opinion leaders and world-renowned experts in T-Cell Lymphomas and hematological malignancies. The board will provide strategic and clinical advice for SciTech's outreach and education initiatives within the oncology community. Continue Reading SciTech Medical Advisory Board "SciTech is excited and incredibly proud that this world-class group of medical experts will assist us with innovative insights that enable us to bring ST-001 to patients who have limited options in their cancer treatments," said President and Managing Partner Earle Holsapple. "The clarity they bring in understanding the clinical needs of patients will serve to guide us through the commencement of our phase 1 clinical trial and through our subsequent expedited clinical program." The three medical advisors appointed to the board are Madeleine Duvic, M.D., Larisa Geskin, M.D., and Ajay Gopal, M.D. Madeleine Duvic, MD – "The development of ST-100 is exciting because this new drug holds the promise of improved bioavailability, leading to increased efficacy with low toxicity." Dr. Duvic is a Professor of Medicine and Dermatology practices in Houston, Texas, and holds the Blanche Bender Endowed Chair of Research. Her clinical research includes translational/molecular studies leading to improved therapies for cutaneous T-cell lymphomas. She has written over 500 peer-reviewed papers and a book on Retinoids. She participated in the development of topical and oral tazarotene and bexarotene which both received FDA approval. Larisa J. Geskin, MD, FAAD - "I am thrilled to support SciTech's innovative approach to cancer therapeutics. SciTech's patented nanoparticle platform, SDP, enhances the effectiveness and safety of fenretinide, which has shown promise in treating patients with incurable cutaneous lymphomas in preliminary studies. SciTech's flagship product, ST-001, stands out for its ability to deliver therapeutic doses without toxic side effects, greatly benefiting our patients." Dr. Geskin is a Professor of Dermatology (in Medicine, Division of Hematology-Oncology) at Columbia University Medical Center and the Director of the Comprehensive Cutaneous Oncology Center at the Columbia University Department of Dermatology. Dr. Geskin serves as the Immediate Past-President of the International Society for Cutaneous Lymphomas (ISCL), the Secretary-Treasurer of the US Cutaneous Lymphomas Consortium (USCLC), and the Founding Chair of the New York Cutaneous Lymphoma Consortium (NYCLC), among her many other responsibilities. Ajay K. Gopal, MD - "Based on the encouraging preclinical data from a variety of laboratories, our observed tolerability of fenretinide, and the unmet need in a spectrum of malignancies novel formulations such as ST-001 nanoFenretinide are certainly worthy of further investigation." Dr. Gopal received his undergraduate degree from Duke University and his MD from Emory University. He completed his internal medicine training at Duke University School of Medicine and his oncology training at the University of Washington and Fred Hutchinson Cancer Center, where he currently holds an endowed chair and serves as a Professor and Clinical Research Director for Hematologic Malignancies. Dr. Gopal has over 2 decades of experience in the development of novel therapies for lymphoma, as reflected by over 200 publications in the field, including the first translational and clinical trial data evaluating fenretinide in lymphoma. Contact: Earle Holsapple Email: [email protected] About SciTech Development SciTech Development, LLC is a clinical-stage pharmaceutical company that has developed a patented nanoparticle drug delivery platform (SDP) that maximizes the bioavailability of water-insoluble therapeutics. SciTech's lead drug candidate, ST-001 nanoFenretinide, combines SDP and the drug fenretinide as a new drug product with potentially broad effectiveness in many cancers. For more information about the Company, please visit: SOURCE SciTech Development

临床1期高管变更

2023-09-14

·BioSpace

SciTech Development Announces IRB Approval for Human Clinical Trials

Lead cancer drug candidate, ST-001 nanoFenretinide, has received Institutional Review Board ("IRB") approval for its upcoming clinical trials for T-Cell Lymphomas. GROSSE POINTE FARMS, MI / ACCESSWIRE / September 14, 2023 / SciTech Development ("SciTech" or the "Company"), a clinical-stage pharmaceutical company with a novel and patented drug delivery platform, today announced that the company has received IRB approval for its clinical trial protocol for their lead cancer drug candidate, ST-001 nanoFenretinide. SciTech Development ------------------------ Join us here to follow the Company: ------------------------ SciTech is pleased to announce that it has received central IRB approval from WCG to enter the clinic at the University of Pittsburgh Medical Center. USC Keck Medicine also granted SciTech local IRB approval to enter the clinic. Additional clinical sites will be added as the trials expand. ST-001 has FDA Investigational New Drug (IND) approval, orphan drug designation, and is Phase 1 clinical trial ready. An Institutional Review Board (IRB) is an FDA-registered consortium that has been formally designated to review and monitor biomedical research involving human subjects. IRB approval is a critical and necessary prerequisite to commencing human clinical trials and serves an important role in the protection of the rights and welfare of human research subjects. WCG is the world's largest independent centralized Institutional Review Board with over 200 IRB experts, servicing more than 800 institutions, with hundreds of active sites around the world. "The IRB approval of our accelerated T-Cell Lymphoma trial protocol is an important step that allows us to move forward with recruitment for our Phase 1 clinical trial," commented Earle Holsapple, SciTech's President and CEO. "We are excited to initiate this important study as there have been relatively few new cancer breakthroughs for T-Cell Lymphomas in several years." About SciTech Development SciTech Development, LLC is a clinical-stage pharmaceutical company that has developed a patented nanoparticle drug delivery platform (SDP) that maximizes the bioavailability of water-insoluble therapeutics. SciTech's lead drug candidate, ST-001 nanoFenretinide, combines SDP and the drug fenretinide as a broadly applicable anticancer drug. For more information about the Company, please visit: Safe Harbor - Forward-Looking Statement: This document contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding attempts to identify new products, services or strategic opportunities which may include a strategic transaction, plans regarding partnering activities, service pricing or financial forecasts. Such statements are only predictions, and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that the Company may not be able to identify acceptable strategic opportunities or conclude any identified strategic transaction, the risk that products or services that appeared promising in early use do not demonstrate the same utility in larger-scale uses or trials, the risks associated with the Company's reliance on outside financing to meet its capital requirements, and the risks associated with the Company's reliance on forward-looking contracts. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted, or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underly the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, political, environmental, competitive, and/or other material risks. Contact Information David Schaffer Director Investor Relations drs@scitechdevelopment.com SOURCE: SciTech Development View source version on accesswire.com:

孤儿药临床申请临床1期临床研究细胞疗法

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适应症	最高研发状态	国家/地区	公司	日期
干眼症	临床2期	-	Silk Technologies, Inc.初创企业	-
干眼综合征	临床前	美国	Silk Technologies Ltd.	2019-04-16

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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


NCT03889886 (CTgov)	临床2期	干眼综合征	305	Vehicle (Vehicle)	觸鹽築遞夢遞鹽窪蓋衊(鏇積鹹鹹選製鏇壓鹹顧) = 衊構顧鹽鑰獵衊鬱糧顧鑰淵齋繭衊鹹膚夢膚顧 (蓋糧願夢願衊繭夢憲觸, 觸觸膚選遞願窪簾糧襯 ~ 觸願壓鬱壓淵糧膚蓋淵) 更多	-	2022-09-02
				SDP-4 Ophthalmic Solution (0.1%) (SDP-4 Ophthalmic Solution (0.1%))	觸鹽築遞夢遞鹽窪蓋衊(鏇積鹹鹹選製鏇壓鹹顧) = 淵顧顧範構夢廠鹹網鑰鑰淵齋繭衊鹹膚夢膚顧 (蓋糧願夢願衊繭夢憲觸, 鬱範構鬱繭鑰夢鹽淵醖 ~ 繭壓顧鏇蓋繭鏇顧願膚) 更多
NCT04535947 (CTgov)	临床2期	干眼综合征	153	Vehicle (Vehicle)	壓淵壓衊鹹鬱鹽夢築壓(淵網膚壓積願糧餘鹽廠) = 鑰鑰鹽願構築積憲艱繭鹽餘襯鹹鹽積鹽憲齋願 (獵夢繭廠壓鑰築艱繭簾, 鑰鏇鑰艱簾觸顧艱範窪 ~ 窪築構積積衊襯糧鬱簾) 更多	-	2022-09-01
				SDP-4 Ophthalmic Solution (1.0%) (SDP-4 Ophthalmic Solution (1.0%))	壓淵壓衊鹹鬱鹽夢築壓(淵網膚壓積願糧餘鹽廠) = 獵願觸艱憲鬱網獵壓糧鹽餘襯鹹鹽積鹽憲齋願 (獵夢繭廠壓鑰築艱繭簾, 壓憲網夢選網蓋膚夢鏇 ~ 鑰繭獵鹹壓構選壓顧鏇) 更多