Gelonghui Reports CMS' Successful Phase III Study of Methylthioninium Chloride Enteric-coated Sustained-release Tablets
SHENZHEN, CHINA, Dec 19, 2022 - (ACN Newswire) - Gelonghui released a Press Release on "China Medical System Holdings Limited's innovative product Methylthioninium Chloride Enteric-coated Sustained-release Tablets ('the Product') has obtained positive results for its Phase III clinical trial in China."
This is another breakthrough for the Product after China Medical System Holdings Limited ("CMS" or the "Group") had efficiently completed the enrollment of all 1,802 subjects for its China Phase III Clinical Trial in July this year, of which only 6 months (including the Spring Festival Holiday) was taken. The Group will actively move forward the Product's new drug application (NDA) in China.
In this China Phase III clinical trial, Methylthioninium Chloride Enteric-coated Sustained-release Tablets was compared to placebo with the purpose of assessing its safety and efficacy in the improvement of histologically confirmed non-polypoid colorectal lesions in subjects undergoing screening or surveillance colonoscopy for colorectal cancer. The research was led by Beijing Friendship Hospital, Capital Medical University and conducted in 22 sites nationwide. In total, 1802 subjects were randomized, 897 in the Product arm and 905 in the placebo arm. Of those, 872 in the product arm and 879 in the placebo arm were in the primary efficacy population (FAS: Full Analysis Set).
The study met the primary endpoint with very high statistical significance:
In the overall FAS, the proportion of patients with at least one histologically confirmed non-polypoid colorectal lesion was significantly higher in the Product group (445/872 subjects; 51.0%) as compared with placebo (362/879, 41.2%); (adjusted OR [95% CI]: 1.55 [1.27, 1.89]; P< 0.0001).
The study also confirmed the superiority of the Product versus placebo in several clinically meaningful endpoints:
a) Number of histologically confirmed non-polypoid colorectal lesions per patient In the FAS, the per patient number of histologically confirmed non-polypoid colorectal lesions in the Product group was 0.9, as compared to 0.7 in the placebo group (difference between groups [95%CI]: 0.18 [0.07, 0.30] P=0.0022).
b) Number of histologically confirmed non-polypoid adenomas or cancers per patient In the FAS, the per patient number of histologically confirmed non-polypoid adenomas or cancers in the Product group was 0.6 as compared to 0.5 in the placebo group (difference between groups [95%CI]: 0.12 ([0.03, 0.22] P=0.0125).
c) Detection rate of non-polypoid adenoma or cancer (NP-ADR) In the FAS, 341 out of 872 patients (39.1%) were detected with at least one histologically confirmed non-polypoid adenoma in the Product arm. as compared with 274 out of 879 patients in the placebo group (31.2%) (OR [95%CI]: 1.43 [1.17, 1.75] P=0.0004).
d) Proportion of patients with at least one histologically confirmed <10 mm non-polypoid colorectal lesion Non-polypoid histologically confirmed colorectal lesions less than <10 mm were found in 415 out of 872 patients (47.6%) in the Product group versus 350 out of 879 patients (39.8%) in the placebo group (OR [95%CI] 1.43 [1.17, 1.74] P= 0.0003).
e) Number of histologically confirmed <10 mm non-polypoid colorectal lesions per patient In the FAS, the per patient number of histologically confirmed non-polypoid colorectal lesions < 10 mm was 0.9 in the Product group versus 0.7 in the placebo group (difference between groups [95%CI]: 0.15 [0.03, 0.26] P=0.0110).
f) Number of histologically confirmed non-polypoid adenomas or cancers <10 mm per patient Overall, the per patient number of histologically confirmed non-polypoid adenomas or cancers <10 mm was 0.6 in the Product test group versus 0.5 in the placebo group (difference between groups 95 %CI]: 0.11 [0.02, 0.20] P=0.0199).
No serious adverse events related to the drug were reported in this clinical study, and the product is well-tolerated with good safety.
Alessandro Della Cha, CEO of Cosmo Pharma, said: "We are very thankful to our partner CMS for this great clinical outcome, which is in line with our expectations and further confirms the data coming from our prior trial. The Product has proven once again its capacity of helping in particular the detection of the <10mm flat lesions, which are the most dangerous. We are thus very much looking forward to bring the Product in the Chinese market, which is the largest colonoscopy market of all".
In an interview with Gelonghui, Mr. Yin, Director of Medical Department of CMS, said: "These excellent results showed that Product could enhance visualization of the colorectal lesions in subjects undergoing screening or surveillance colonoscopy, thus to help improve the detection rate of non-polypoid lesions, in order to reduce the mortality of colorectal cancer indirectly. We expect the Product will be marketed in the China soon, to potentially benefit tens of millions of people who get colonoscopies in China."
About Methylthioninium Chloride Enteric-coated Sustained-release Tablets
Methylthioninium Chloride Enteric-coated Sustained-release Tablets is a novel oral formulation of the existing liquid colon staining dye methylene blues. Formulated by the proprietary MMX sustained-release technology of the Group's partner Cosmo, it delivers the dye in a delayed and controlled way, distributing evenly through the full length of the colon, which enhances visualization of the colorectal lesions in subjects undergoing screening or surveillance colonoscopy, thus to help improve the detection rate of colorectal cancer/precancerous lesions.
About Gelonghui
Founded in 2014, Gelonghui is a leading global investment research platform in China. For the first time in China, it put forward the investment concept of "global vision, betting on China", integrating financial media, research, investment banks, databases and other roles.
Media Contact Address: Dachong International Center, Yuehai Street, Nanshan District, Shenzhen Business Team, Gelonghui Email: business@gelonghui.com Tele: +86 (0755) 86533750 Website: https://www.gelonghui.com/
SOURCE: Gelonghui
Source: Gelonghui Sectors: Healthcare & Pharm, MedTech
Copyright ©2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
Latest Release
Mazda Production and Sales Results for August 2024 Sep 27, 2024 17:20 JST
| Honda Issues Integrated Report - "Honda Report 2024" Sep 27, 2024 15:37 JST
| Hitachi Becomes First Oracle Partner in Japan to Win Regional Best in Class Award in the Customer Success Category in the 2024 Oracle Partner Awards Sep 27, 2024 14:19 JST
| Mitsubishi Corporation Strengthens the Partnership with PETRONAS, Reinforcing Confidence in LNG Operations in the Region Sep 27, 2024 13:39 JST
| MHI Completes Production of the Core Stage of the Final H-IIA Launch Vehicle (No. 50) Sep 26, 2024 12:00 JST
| A2Z and Nayax Capital Sign Framework Agreements to Enable Global Financing for the Sale or Lease of Cust2Mate Smart Carts Integrated with Nayax's Solutions Sep 25, 2024 22:00 JST
| Osaka Gas and MHI to Implement the CO2NNEX Digital Platform for Managing and Transferring the Environmental Value of e-Methane at Expo 2025 Osaka, Kansai, Japan Sep 25, 2024 15:11 JST
| Hitachi Rail Unveils the 'HMAX' AI Solution, Accelerated by NVIDIA, to Optimize Trains, Signaling and Infrastructure Sep 25, 2024 13:05 JST
| Overview of Honda Exhibits at JAPAN MOBILITY SHOW BIZWEEK 2024 Sep 24, 2024 18:32 JST
| Tosha Schareina Wins FIM E-Xplorer World Cup Men's Category Sep 24, 2024 18:16 JST
| Mazda to open new R&D office in Azabudai Hills in early summer 2025 Sep 24, 2024 16:25 JST
| Rozebalamin(R) for Injection 25 mg (Mecobalamin) Approved in Japan for Amyotrophic Lateral Sclerosis Sep 24, 2024 16:06 JST
| Valuufy CEO to present at the UN Science Summit (SSUNGA79) Sep 24, 2024 16:00 JST
| Anticancer Agent "Tasfygo(R) Tablets 35mg" (Tasurgratinib Succinate) Approved in Japan for Biliary Tract Cancer with FGFR2 Gene Fusions or Rearrangements Sep 24, 2024 15:01 JST
| Mitsubishi Corporation, KDDI CORPORATION, Lawson, Inc. Launching an Initiative to Transform into "Next-generation Convenience Store" Sep 20, 2024 18:02 JST
| Hitachi Rail is innovating and delivering transformative 5G digital signalling Sep 20, 2024 16:47 JST
| Olympus Launches New 4K Camera Head for Urological Endoscopy Sep 20, 2024 15:00 JST
| Honda to Relocate the Base of its Rugby Team Activities Sep 19, 2024 15:05 JST
| Renewal of Compact CO2 Capture System "CO2MPACT(TM)" Series Sep 19, 2024 14:35 JST
| The world's first commercial copper die-cast rotor for railway traction motors Sep 19, 2024 13:57 JST
|
More Latest Release >>
|