Sirnaomics Receives FDA Clearance to Initiate Phase 2 Study of STP705

Sirnaomics announced the U.S. Food and Drug Administration (FDA) has agreed to the company's proposed trial design for a Phase 2 clinical study to evaluate its lead product candidate, STP705, for the treatment of in situ Squamous Cell Carcinoma Nonmelanoma Skin Cancer (NMSC). The company expects to initiate the study in the first half of 2019.

STP705 is a siRNA (small interfering RNA) therapeutic that utilizes a proprietary polypeptide nanoparticle (PNP)-enhanced delivery system to inhibit expression of TGF-β1 and COX-2, which have been identified as major factors in promoting epithelial cell proliferation and regulating development and progression of NMSC in humans.

"FDA clearance to proceed with the NMSC trial represents an important step forward in demonstrating the broader clinical utility of our siRNA platform," said Sirnaomics' founder and CEO Patrick Y. Lu, PhD. "Building on our technology's potential against fibrotic disease, the drug target selection and tumor targeting delivery capabilities of our platform will help demonstrate the broader therapeutic potential of STP705 as a therapeutic candidate against cancer."

The Phase 2 trial, led by Brian Berman, MD, PhD, Professor Emeritus, Dermatology and Cutaneous Surgery at University of Miami Miller School of Medicine and one of the world's leading experts in NMSC, will evaluate the safety and potential therapeutic effect of STP705 in NMSC patients.

"There is a real clinical need for non-invasive, targeted therapy for in situ squamous cell carcinoma," Dr. Berman said.

"We are very pleased to have someone of Dr. Berman's caliber to lead this anti-cancer study," said Michael Molyneaux, MD, Sirnaomics' Chief Medical Officer. "Nonmelanoma skin cancer is the most common form of skin cancer and a growing public health problem due to its increasing incidence and associated medical costs. We hope to demonstrate the clinical utility of STP705 as a therapeutic alternative to surgery - the current standard of care for NMSC and which carries the risk of significant adverse effects."

NMSC is the most common form of cancer in the United States, affecting an estimated 3.5 million people with medical related costs reaching $650 million annually. The gold standard of treatment for high-risk NMSC is Mohs micrographic surgery (MMS) or radiotherapy. However, with surgery the patients are at a high risk of infection, hematoma and scar development. Nonmelanoma skin cancer (NMSC) is diagnosed more commonly and it is a growing public health problem due to its increasing incidence and medical care costs. NMSC consists of two major subtypes: basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). BCCs arise from the basal cell layer and constitute the majority of all diagnosed skin cancers (80%). They are able to damage the surrounding tissue, however, they are rarely life threatening or metastatic. SCCs arise from hair follicle stem cells and account for 16% of all skin cancers.

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