[Translation] An open, single-arm, multicenter, phase II clinical trial to evaluate the efficacy, safety, and pharmacodynamics of orbitazine fumarate enteric-coated micropellets (SM-1) in the treatment of advanced small intestinal adenocarcinoma (SBA)

1、主要目的：评价富马酸奥比特嗪肠溶微丸胶囊（SM-1）治疗晚期小肠腺癌的有效性。 2、次要目的：（1）评价富马酸奥比特嗪肠溶微丸胶囊（SM-1）治疗晚期小肠腺癌的安全性；（2）评价富马酸奥比特嗪肠溶微丸胶囊（SM-1）治疗晚期小肠腺癌的PK、PD特征。

[Translation]

1. Primary objective: To evaluate the efficacy of Orbitazine fumarate enteric-coated micropellets (SM-1) in the treatment of advanced small intestinal adenocarcinoma. 2. Secondary objectives: (1) To evaluate the safety of Orbitazine fumarate enteric-coated micropellets (SM-1) in the treatment of advanced small intestinal adenocarcinoma; (2) To evaluate the PK and PD characteristics of Orbitazine fumarate enteric-coated micropellets (SM-1) in the treatment of advanced small intestinal adenocarcinoma.

Start Date03 Jan 2023

Sponsor / Collaborator

Shenzhen Zhenxing Pharmaceutical Technology Co Ltd

CTR20221641 / Active, not recruitingPhase 1

富马酸奥比特嗪肠溶微丸胶囊（SM-1）联合替莫唑胺在难治或复发胶质母细胞瘤受试者中的安全性、药代动力学 I 期临床研究

[Translation] Phase I clinical study on the safety and pharmacokinetics of orbitazine fumarate enteric-coated micropellets (SM-1) combined with temozolomide in subjects with refractory or recurrent glioblastoma

主要目的：确定富马酸奥比特嗪肠溶微丸胶囊（SM-1）联合替莫唑胺在复发高级别胶质瘤患者的安全性和耐受性，包括剂量限制性毒性（DLT）和最大耐受剂量（MTD）/II 期推荐剂量（RP2D）。次要目的： 1）确定富马酸奥比特嗪肠溶微丸胶囊（SM-1）联合替莫唑胺在复发高级别胶质瘤患者中口服给药的药代动力学特性； 2）初步评估富马酸奥比特嗪肠溶微丸胶囊（SM-1）在中国复发高级别胶质瘤患者中的有效性。

[Translation]

Primary objective: To determine the safety and tolerability of oral SM-1 combined with temozolomide in patients with recurrent high-grade glioma, including dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)/phase II recommended dose (RP2D). Secondary objectives: 1) To determine the pharmacokinetic properties of oral SM-1 combined with temozolomide in patients with recurrent high-grade glioma; 2) To preliminarily evaluate the efficacy of SM-1 in Chinese patients with recurrent high-grade glioma.

Start Date19 Sep 2022

Sponsor / Collaborator

Shenzhen Zhenxing Pharmaceutical Technology Co Ltd

CTR20200351 / CompletedPhase 1

富马酸奥比特嗪肠溶微丸胶囊（SM-1）在晚期实体瘤及复发难治性淋巴瘤患者的安全性、药代动力学I期临床研究

[Translation] Phase I clinical study on the safety and pharmacokinetics of Orbitazine Fumarate Enteric-coated Micropellets (SM-1) in patients with advanced solid tumors and relapsed and refractory lymphoma

1.主要目的确定富马酸奥比特嗪肠溶微丸胶囊（SM-1）在晚期实体瘤及复发难治性淋巴瘤患者的安全性和耐受性，包括剂量限制性毒性（DLT）和最大耐受剂量（MTD）/II 期推荐剂量（RP2D）。 2. 次要目的确定富马酸奥比特嗪肠溶微丸胶囊（SM-1）单次、多次口服给药的药代动力学特征。初步评估富马酸奥比特嗪肠溶微丸胶囊（SM-1）的抗肿瘤活性。

[Translation]

1. Primary Objective To determine the safety and tolerability of Orbitazine Fumarate Enteric-Coated Micropellets Capsules (SM-1) in patients with advanced solid tumors and relapsed refractory lymphoma, including dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)/Phase II recommended dose (RP2D). 2. Secondary Objective To determine the pharmacokinetic characteristics of Orbitazine Fumarate Enteric-Coated Micropellets Capsules (SM-1) after single and multiple oral administration. To preliminarily evaluate the antitumor activity of Orbitazine Fumarate Enteric-Coated Micropellets Capsules (SM-1).

Start Date27 Apr 2020

Sponsor / Collaborator

Shenzhen Zhenxing Pharmaceutical Technology Co Ltd

100 Clinical Results associated with Orbitazine fumarate

100 Translational Medicine associated with Orbitazine fumarate

100 Patents (Medical) associated with Orbitazine fumarate

Literatures (Medical) associated with Orbitazine fumarate

01 Sep 2024·The Journal of Prosthetic Dentistry

Cameo and intaglio surface stability and variability of additively, subtractively, and conventionally manufactured occlusal devices after long-term storage

Article

Author: Cakmak, Gulce ; Orgev, Ahmet ; Donmez, Mustafa Borga ; Yilmaz, Burak ; Marques, Vinicius Rizzo ; Almogbel, Lolowh ; Kahveci, Cigdem

STATEMENT OF PROBLEMAdditive and subtractive manufacturing have become alternative technologies for fabricating occlusal devices. However, knowledge of the long-term stability of occlusal devices fabricated using these recent technologies is limited.PURPOSEThe purpose of this in vitro study was to evaluate the cameo and intaglio surface stability and variability of additively, subtractively, and conventionally manufactured occlusal devices after 18 months of storage.MATERIAL AND METHODSA standard tessellation language (STL) file of a dentate maxillary typodont was used to design a master occlusal device. The STL file of this design was used to fabricate occlusal devices additively either with a digital light processing (AM-1) or a continuous liquid interface production (AM-2) printer, subtractively with 2 different 5-axis milling units (SM-1 and SM-2), and conventionally (TM-HP) (n=10). STL files of each device's cameo and intaglio surfaces were generated using a laboratory scanner after fabrication and after 18 months of storage in a moist environment. These generated files were imported into an analysis software program (Geomagic Control X) to analyze the dimensional stability of tested devices by using the root mean square method. The average deviation values defined the variability of measured changes over time. Cameo and intaglio surface deviations were analyzed using the Kruskal-Wallis and Dunn tests, while the variability of measured deviations was analyzed with 1-way analysis of variance and the Tukey HSD tests (α=.05).RESULTSSignificant differences were observed among tested devices when the intaglio surface deviations and the cameo surface variability were considered (P<.001). SM-2 had significantly higher intaglio surface deviations than AM-1, SM-1, and AM-2 (P≤.036). Among the test groups, AM-1 had the greatest cameo surface variability (P≤.004).CONCLUSIONSSM-2 resulted in lower intaglio surface stability than the additive and the other subtractive manufacturing technologies, while AM-1 led to the highest cameo surface variability among the test groups.

06 Aug 2024·Microbiology Spectrum

Immunogenicity and vaccine potential of clinical isolate Mycobacterium kansasii strain against Mycobacterium tuberculosis infection

Article

Author: Shin, Sung Jae ; Kim, Hongmin

ABSTRACTMycobacterium kansasii is a bacterium included in non-tuberculous mycobacteria (NTM) that can cause lung disease. It shares a significant number of antigens with Mycobacterium tuberculosis (Mtb), suggesting that it has the potential to be used as a tuberculosis (TB) vaccine. Therefore, we subcutaneously vaccinated mice with reference strain, M. kansasii -ATCC12478 [ M. kansasii -American Type Culture Collection (ATCC)], and clinically isolated strain, M. kansasii -SM-1 to evaluate potential as a TB vaccine by comparing with bacille Calmette-Guerin (BCG) vaccine. Ten weeks after vaccination, we evaluated immunogenicity of M. kansasii -ATCC and M. kansasii -SM-1, and M. kansasii -SM-1 immunization induces potent Mtb antigen-specific IFN-γ-producing CD4 + T cells than M. kansasii -ATCC. Upon Mtb infection, M. kansasii -SM-1 provided better protection than M. kansasii -ATCC, which was comparable to the efficacy of BCG. These results showed that the clinical strain M. kansasii -SM-1, which exhibits an enhanced Mtb antigen-specific Th1 response, shows greater vaccine efficacy compared to M. kansasii -ATCC. In this study, we demonstrated that vaccine efficacy can vary depending on the strain of M. kansasii and that its efficacy can be comparable to BCG. This suggests that M. kansasii has the potential to be a live TB vaccine candidate. IMPORTANCEMycobacterium kansasii , a non-tuberculous mycobacteria (NTM) species causing lung disease, shares key antigens with Mycobacterium tuberculosis (Mtb), indicating its potential for TB vaccine development. Subcutaneous vaccination of mice with M. kansasii strains reference strain M. kansasii -ATCC12478 [( M. kansasii -American Type Culture Collection (ATCC)] and clinically isolated strain M. kansasii -SM-1 revealed differences in immunogenicity. M. kansasii -SM-1 induced a robust Mtb antigen-specific IFN-γ-producing CD4 + T cell response compared to M. kansasii -ATCC. Additionally, M. kansasii -SM-1 conferred better protection against Mtb infection than M. kansasii -ATCC, which is comparable to bacille Calmette-Guerin (BCG). These findings underscore the variable vaccine efficacy among M. kansasii strains, with M. kansasii -SM-1 exhibiting promising potential as a live TB vaccine candidate, suggesting its comparative effectiveness to BCG.

01 Jan 2022·Sleep and Biological Rhythms

Efficacy of the triple-combination SM-1 in a 5-h phase advance transient insomnia model

Article

Author: Chen, Lan Bo ; Zammit, Gary ; Rosenberg, Russell ; Dahl, Thomas ; Roth, Thomas ; Ahmad, Maha

Thomas Dahl, PO Box 404, Guilford, CT 06437 USA. Email: tadahl@outlook.com. The objectives of the study were to demonstrate the efficacy and safety of SM-1 in a circadian challenge model of transient insomnia. Randomized, double-blind, placebo-controlled cross-over study utilizing a 5-h phase advance model of transient insomnia. Subjects were 85 healthy adults reporting a history of transient insomnia, with an average age of 38.9 years. Both SM-1 and placebo were administered to all subjects in a randomly assigned sequence, with at least 1 week between treatments. The primary endpoint was total sleep time determined by polysomnography. Secondary endpoints included wakefulness after sleep onset, latency to persistent sleep, number of awakenings, subjective total sleep time and subjective sleep onset latency, total sleep time by quarters of the night, subjective number of awakenings, and sleep quality. Safety endpoints included adverse events, Karolinska Sleepiness Scale, Digit Symbol Substitution Test, and predischarge evaluation (tandem gait and Romberg tests). SM-1 provided an increase of 94.4 min in total sleep time over placebo (p < 0.0001). Wakefulness after sleep onset, subjective total sleep time, subjective sleep onset latency, and total sleep time in the first quarter of the night also showed significant improvement. SM-1 was well-tolerated with both type and frequency of adverse events being comparable to placebo, and no residual sleepiness upon awakening (i.e., after 8 h). SM-1 provided a robust and statistically significant increase in total sleep time compared to placebo in a circadian model of transient insomnia, without evidence of next-day impairment.

100 Deals associated with Orbitazine fumarate

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
High grade glioma	Phase 2	CN	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	23 Aug 2024
Advanced Triple-Negative Breast Carcinoma	Phase 2	CN	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	21 Apr 2023
Adenocarcinoma of small intestine	Phase 2	CN	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	03 Jan 2023
Colonic Cancer	Phase 2	-	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	-
Glioma	Phase 2	-	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	-
Rectal Cancer	Phase 2	-	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	-
Head and Neck Neoplasms	Phase 1	CN	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	-
Advanced Malignant Solid Neoplasm	Preclinical	CN	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	27 Apr 2020
Recurrent Lymphoma	Preclinical	CN	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	27 Apr 2020
Refractory Lymphoma	Preclinical	CN	Shenzhen Zhenxing Pharmaceutical Technology Co Ltd	27 Apr 2020

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