|
| Friday, 19 August 2022, 11:30 HKT/SGT | |
| |
|
|
|
|
| Data results will be available in Q1 2023 |
Gaithersburg, MD, USA and Suzhou BioBay, China, Aug 19, 2022 - (ACN Newswire) - Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that the Company has dosed the first patient in a Phase I/II clinical study of STP705, the Company's leading siRNA (small interfering RNA) drug candidate, for the treatment of patients with facial squamous cell skin cancer in situ (isSCC).
The open label, dose escalation study is designed to evaluate the safety, tolerability, and efficacy of various doses of STP705 administered by intralesional injection and to determine the recommended dose. The study will also analyze biomarkers common to isSCC formation pathways, including TGF-beta1 and COX-2. The primary endpoint is to determine the number of patients with histological clearance (HC) of facial isSCC lesions at the end of treatment with STP705. HC is defined as the absence of detectable evidence of the isSCC tumor cell nests as determined by central pathology review. A total of 30 patients, divided into three cohorts of 10 patients each, will receive a given dose once per week for six weeks. Cohort A will receive a 30 ug dose, Cohort B a 60 ug dose, and Cohort C a 90 ug dose.
"We expect that the study of STP705 as a treatment for facial isSCC to yield positive results given previous studies of STP705 that have shown to be safe and effective as a cancer treatment," said Dr. Patrick Lu, founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Our drug has the potential to offer millions of patients with these non-melanoma facial lesions a non-surgical, non-invasive alternative to traditional lesion removal."
"With surgical removal being the only available treatment for isSCC currently, patients have normally found the results to be painful and aesthetically unpleasing on the face. By dosing our first patient in this Phase I/II study, we can begin to evaluate the safety and effectiveness of STP705 in eradicating these cancerous lesions," said Michael Molyneaux M.D., Executive Director and Chief Medical Officer of Sirnaomics. "Formulating this clinical trial as a dose escalation study also gives us the opportunity to determine which dose is the best suited in removing the cancer without adverse events."
The study started in the United States in August 2022, and is expected to be completed in Q1 2023. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05421013.
About STP705
Sirnaomics' leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-beta1 and COX2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in seven clinical trials for different indications: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), a Phase I/II for facial isSCC, a Phase I for liver cancer (basket), and a Phase I for medical cosmetology treatment.
About Sirnaomics
Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutic for its core product, STP705. Learn more at www.sirnaomics.com.
CONTACT:
Michael Molyneaux, MD, MBA
Executive Director and Chief Medical Officer, Sirnaomics
Email: MichaelMolyneaux@sirnaomics.com
Investor Relations:
Nigel Yip
Chief Financial Officer, China, Sirnaomics
Email: NigelYip@sirnaomics.com
US Media Contact:
Alexis Feinberg
Tel: +1 203 939 2225
Email: Alexis.Feinberg@westwicke.com
Asia Media Contact:
Bunny Lee
Tel: +852 3150 6707
Email: sirnaomics.hk@pordahavas.com
Topic: Press release summary
Sectors: BioTech, Healthcare & Pharm
https://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2025 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| |
Latest Press Releases
Wear the Speed, Live the Convenience: Tappy Technologies Powers the Launch of High Performance Payment Bands in Collaboration with First Abu Dhabi Bank and Mastercard
Dec 5, 2025 18:53 HKT/SGT
|
|
|
Leapfrog Acquisition Corp Announces Pricing of $125,000,000 Initial Public Offering
Dec 5, 2025 17:50 HKT/SGT
|
|
|
Bank Indonesia Unveils Five-Point Strategy to Boost Indonesia's Economic Resilience
Dec 5, 2025 16:00 HKT/SGT
|
|
|
Business of IP Asia (BIP Asia) Forum and Entrepreneur Day open today
Dec 5, 2025 15:41 HKT/SGT
|
|
|
Immortal Dragons Backs Etheros Pharmaceuticals: Targeting Aging-Related Disease with Breakthrough Catalytic Antioxidants
Dec 5, 2025 15:00 HKT/SGT
|
|
|
Doubleview Extends High-Grade Domains at Hat: H099 Returns 438m of 0.40% CuEq Including 52m of 1.02% CuEq, Expanding Mineralization Envelope Around Conceptual Pit Vertically and Laterally
Dec 4, 2025 21:59 HKT/SGT
|
|
|
CaoCao Unveils '100 Cities, 100 Billion in 10 Years' Robotaxi Strategy, Officially Launches World's First 'Green Intelligent Mobility Hub'
Dec 4, 2025 21:00 HKT/SGT
|
|
|
The Gourmet's Guide: Using Your TravelKon eSIM to Hunt for Japan's Best Ramen, Sushi, and Street Food
Dec 4, 2025 17:45 HKT/SGT
|
|
|
Spritzer Celebrates Global and Regional Brand Excellence 2025
Dec 4, 2025 12:45 HKT/SGT
|
|
|
Oman's 10-Year Golden Residency Program Attracts Global Investors Seeking Stability and Long-Term Access
Dec 4, 2025 07:00 HKT/SGT
|
|
|
|
|
More Press release >> |
|
|
|
