Gelonghui 16 April, San Nuo Medicine-B (02257BillykingcasinoHK) announced that the group has received information from the US Food and Drug Administration to further develop a company for the treatment of squamous cell carcinoma in situ (isSCC).BillykingcasinoSpecific guidance recommendations for the new siRNA therapy STP705.
The company has received a written reply from the U.S. Food and Drug Administration (FDA) about the Class C meeting requested by STP705 for further development of a new siRNA therapy for the treatment of squamous cell carcinoma in situ (isSCC).
The purpose of the requested category C meeting is to obtain FDA's advice and comments on the proposed non-clinical and clinical development plan in preparation for phase III and III clinical studies of II/ for the treatment of isSCC. In response to the Company's recommendations and issues related to non-clinical studies and clinical study design, FDA has provided clear and specific guidance for non-clinical and clinical studies, the revision of the proposed phase III and III clinical studies of II/, and the further demonstration required for the use of the two active ingredients in drug candidate STP705. At present, the company has been launched according to the guidance and advice of FDABillykingcasinoThe required preclinical studies were obtained.
Lu Yang, founder, Chairman, Executive Director, President and CEO of Sirnaomics, said: "the company is very grateful to FDA for its specific guidance and advice at the trial detail level, which will make the company's new siRNA therapy platform more efficient in the late clinical research and development stage. He believes that preclinical studies related to clinical dose regimens, several revisions to the proposed phase II/III study, and other related work will lay a solid foundation for follow-up phase III clinical studies of STP705 in the treatment of non-melanoma skin cancer. "
The main candidate for Sirnaomics, STP705, is a siRNA (small interfering nucleic acid) therapy, which uses dual targeting inhibition and enhanced peptide nanoparticles (PNP) delivery to directly knock down TGF- β 1 and COX-2 gene expression. The candidate has received several IND approvals from FDA and China's State Drug Administration (NMPA), including for the treatment of cholangiocarcinoma (CCA), non-melanoma skin cancer and hypertrophic scars. Currently, STP705 has three priority product lines: the first for isSCC, a completed phase II clinical trial for the treatment of basal cell carcinoma (BCC), and a phase I clinical trial for focal fat remodeling. In addition, in terms of other indications, STP705 has obtained an orphan drug qualification from FDA for the treatment of CCA and primary sclerosing cholangitis (PSC).
The group cannot guarantee that the STP705 drug will eventually be successfully marketed. Shareholders and potential investors should exercise caution when buying and selling shares in the company.