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Recent popular reports from Yimaike ★ AAV-delivered microRNA gene therapy enters clinical research Yimai Meng broke the news ★ The field of mRNA technology is blooming, how to optimize the next generation delivery vector Yimai Meng broke the news on April 27, 2021 / Yimai Ke News eMedClub News/ --Sirnaomics, a leader in the creation of new nucleic acid drugs, announced yesterday that it has initiated a phase 2b clinical trial study of its main drug candidate STP705 for the treatment of skin squamous cell carcinoma in situ (isSCC).
STP705 is a siRNA (small interfering RNA) therapeutic drug, consisting of two siRNA oligonucleotides that target the mRNA expression of transforming growth factor-β1 (TGF-β1) and cyclooxygenase (COX-2) respectively.
Molecular composition, using histidine-lysine copolypeptide (HKP) as the introduction system (adjuvant) to prepare nanoparticle preparations.
The Phase 2a clinical study of STP705 for the treatment of isSCC has announced positive results on December 21, 2020.
The Phase 2a study set up 5 different dose groups ranging from 10 ug to 120 ug, aiming to determine the safe and effective recommended dose of STP705 for the treatment of skin squamous cell carcinoma in situ.
A total of 25 patients were enrolled in the phase 2a study and received local administration of STP705 once a week.
After repeated injections for six weeks, a clear dose-dependent curative effect curve was observed; 76% of the patients achieved complete histological clearance of tumor cells, two 90% of patients in the optimal dose groups (30 ug and 60 ug) achieved histological complete removal of tumor cells.
In terms of safety, there were no adverse events related to drug treatment and no serious adverse events.
More importantly, no obvious skin adverse reactions were found in all treatment groups, and a clear dose window was able to be determined.
Based on the success of this Phase 2a study, this randomized, double-blind, placebo-controlled Phase 2b study will enroll 100 adult patients with isSCC, aiming to further evaluate the safety and effectiveness of local injection of STP705.
This study is a two-part dose escalation study.
The run-in part of the study will evaluate a new dose level and the 30 ug and 60 ug dosing regimens of the STP705 Phase 2a study; subsequently, the second part of the study will The two most effective dose levels of these three regimens were further evaluated.
Dr.
Lu Yang, the founder, president and CEO of Sanno Pharmaceuticals, said: "In the recently completed phase 2a clinical trial of STP705 for the treatment of isSCC, a high proportion of patients achieved histological clearance (of tumor cells) in a dose-dependent manner.
This is the gold standard for skin cancer.
With the initiation of phase 2b clinical trials, we hope to learn more about this non-surgical, non-invasive treatment, its potential in the treatment of common non-melanoma skin cancer, and understand nucleic acid Interfering with the treatment prospects of drugs in a wider range of tumor types.
"The 2021 nucleic acid drug development forum will kick off in Nanjing from May 7th to 8th, 2021, to welcome the "new era of super drugs".
STP705 is a siRNA (small interfering RNA) therapeutic drug, consisting of two siRNA oligonucleotides that target the mRNA expression of transforming growth factor-β1 (TGF-β1) and cyclooxygenase (COX-2) respectively.
Molecular composition, using histidine-lysine copolypeptide (HKP) as the introduction system (adjuvant) to prepare nanoparticle preparations.
The Phase 2a clinical study of STP705 for the treatment of isSCC has announced positive results on December 21, 2020.
The Phase 2a study set up 5 different dose groups ranging from 10 ug to 120 ug, aiming to determine the safe and effective recommended dose of STP705 for the treatment of skin squamous cell carcinoma in situ.
A total of 25 patients were enrolled in the phase 2a study and received local administration of STP705 once a week.
After repeated injections for six weeks, a clear dose-dependent curative effect curve was observed; 76% of the patients achieved complete histological clearance of tumor cells, two 90% of patients in the optimal dose groups (30 ug and 60 ug) achieved histological complete removal of tumor cells.
In terms of safety, there were no adverse events related to drug treatment and no serious adverse events.
More importantly, no obvious skin adverse reactions were found in all treatment groups, and a clear dose window was able to be determined.
Based on the success of this Phase 2a study, this randomized, double-blind, placebo-controlled Phase 2b study will enroll 100 adult patients with isSCC, aiming to further evaluate the safety and effectiveness of local injection of STP705.
This study is a two-part dose escalation study.
The run-in part of the study will evaluate a new dose level and the 30 ug and 60 ug dosing regimens of the STP705 Phase 2a study; subsequently, the second part of the study will The two most effective dose levels of these three regimens were further evaluated.
Dr.
Lu Yang, the founder, president and CEO of Sanno Pharmaceuticals, said: "In the recently completed phase 2a clinical trial of STP705 for the treatment of isSCC, a high proportion of patients achieved histological clearance (of tumor cells) in a dose-dependent manner.
This is the gold standard for skin cancer.
With the initiation of phase 2b clinical trials, we hope to learn more about this non-surgical, non-invasive treatment, its potential in the treatment of common non-melanoma skin cancer, and understand nucleic acid Interfering with the treatment prospects of drugs in a wider range of tumor types.
"The 2021 nucleic acid drug development forum will kick off in Nanjing from May 7th to 8th, 2021, to welcome the "new era of super drugs".
