China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that the Group’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 CMS 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:
- 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).
- 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).
- 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).
- 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).
- 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).
- 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 Chà, 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”.
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.