Trending...
- Cancer Survivor Roslyn Franken Marks 30-Year Milestone with Empowering Gift for Women Survivors
- New Article Reveals Common Pricing Pitfalls in Flooring Projects — And How to Avoid Them
- The Easy Way to Collect Every Wedding Photo from Your Guests - No App Needed
GAITHERSBURG, Md. and SUZHOU BIOBAY, China, Jan. 17, 2021 /PRNewswire/ -- Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2a clinical study of the company's lead drug candidate, STP705, for the treatment of cutaneous basal cell carcinoma.
The open label, dose escalation study is designed to evaluate the efficacy and safety of intralesional injection of STP705 in adult patients with cutaneous basal cell carcinoma confirmed with biopsy samples. The objective is to determine the safe and effective recommended dose of STP705 for the treatment of basal cell carcinoma (BCC), as well as analysis of biomarkers common to BCC formation pathway including TGF-β1 and COX-2. The trial is comprised of three dose escalation cohorts ranging from 30 μg to 90 μg with five patients in each group, and a total of 15 patients will be enrolled in the trial. Participants will receive injections of STP705 once a week for up to six weeks.
The primary endpoint of this trial is to evaluate patients for complete histological clearance of the tumor cells within the treated BCC lesion with secondary endpoints, evaluating subjects for investigational product treatment related adverse events, as well as serious adverse events, and cutaneous skin reactions.
"This marks another significant milestone as we continue to leverage our polypeptide nano-particle technology for siRNA drug delivery to advance our pipeline of oncology therapeutic candidates," said Patrick Lu, Ph.D., the founder, President and CEO of Sirnaomics. "We look forward to obtaining important clinical readouts in this trial and increasing the probability of success, while continuing to demonstrate our leadership in RNAi therapeutic development for skin cancers."
"This is an important study and milestone for Sirnaomics, the STP705 program, and potentially for patients with BCC, as it could offer an alternative to surgical excision of these lesions," said Michael Molyneaux M.D., Chief Medical Officer. "The company recognizes that there is a high unmet need for non-surgical treatments for various types of nonmelanoma skin cancers that reduce scarring and achieve high rates of histological clearance."
More on Marylandian
The Company expects to report initial clinical data from the trial in 2021.
Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04669808.
About Basal Cell Carcinoma
Basal cell carcinoma (BCC) is a type of nonmelanoma skin cancer that occurs most often on areas that are exposed to the sun, such as head and neck. The most commonly found clinical feature of BCC is an elevated tumor with a pearly and translucent margin and telangiectasia. The color may vary widely from nearly normal skin color to erythematous to violaceous and may also be pigmented. BCC may also resemble noncancerous skin conditions such as eczema or psoriasis. The majority of these cancers occur on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation. It is believed that development of BCC is linked closely to overexpression of TGF-β1 and COX-2.
Surgery is the currently the most common treatment option for the treatment of nonmelanoma cancer. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection and bleeding. Surgery can also have a significant recurrence rate. As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective.
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-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of cholangiocarcinoma, nonmelanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma and primary sclerosing cholangitis. Preclinical animal models using STP705 have demonstrated a dramatic improvement in T-cell penetration into tumors in the liver with single agent action as well as improvement in the efficacy of an anti-PD-L1 antibody checkpoint inhibitor in an HCC model. This effect may improve other immune checkpoint inhibitor efficacies in addition to those targeting the PD-1/PD-L1 axis.
More on Marylandian
About Sirnaomics, Inc.
Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The company's mission is to develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need. The guiding principles of the company are: Innovation, Global Vision with a Patient Centered focus. Members of the senior management team have a combined experience in the biopharmaceutical industry, spanning clinical development, regulatory, financial and business management in both the USA and China. The company is supported by funding from institutional investors, corporate partnerships and government grants. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of focus include oncology, anti-fibrotic, anti-viral and metabolic therapeutics. Learn more at www.sirnaomics.com.
Contact:
Sirnaomics:
Michael Molyneaux, MD, MBA
Chief Medical Officer
Email: [email protected]
Investors:
Stephanie Carrington
Tel: +1 646 277 1282
Email : [email protected]
Media:
Mark Corbae
Tel: +1 203 682 8288
Email: [email protected]
SOURCE Sirnaomics, Inc.
Related Links
http://www.sirnaomics.com
The open label, dose escalation study is designed to evaluate the efficacy and safety of intralesional injection of STP705 in adult patients with cutaneous basal cell carcinoma confirmed with biopsy samples. The objective is to determine the safe and effective recommended dose of STP705 for the treatment of basal cell carcinoma (BCC), as well as analysis of biomarkers common to BCC formation pathway including TGF-β1 and COX-2. The trial is comprised of three dose escalation cohorts ranging from 30 μg to 90 μg with five patients in each group, and a total of 15 patients will be enrolled in the trial. Participants will receive injections of STP705 once a week for up to six weeks.
The primary endpoint of this trial is to evaluate patients for complete histological clearance of the tumor cells within the treated BCC lesion with secondary endpoints, evaluating subjects for investigational product treatment related adverse events, as well as serious adverse events, and cutaneous skin reactions.
"This marks another significant milestone as we continue to leverage our polypeptide nano-particle technology for siRNA drug delivery to advance our pipeline of oncology therapeutic candidates," said Patrick Lu, Ph.D., the founder, President and CEO of Sirnaomics. "We look forward to obtaining important clinical readouts in this trial and increasing the probability of success, while continuing to demonstrate our leadership in RNAi therapeutic development for skin cancers."
"This is an important study and milestone for Sirnaomics, the STP705 program, and potentially for patients with BCC, as it could offer an alternative to surgical excision of these lesions," said Michael Molyneaux M.D., Chief Medical Officer. "The company recognizes that there is a high unmet need for non-surgical treatments for various types of nonmelanoma skin cancers that reduce scarring and achieve high rates of histological clearance."
More on Marylandian
- Why Philadelphia Homeowners Should Ditch Oil for Natural Gas
- JudyMaids Launches "Clean Homes, Full Plates" Fall Food Drive to Support Manna Food Center
- Zero-Trust Architecture: NJTRX Addresses 60% of U.S. Investors' Custody Security Concerns
- Sub-Millisecond Trading Platform: HNZLLQ Introduces Unified Gateway for Philippine Digital Asset Traders
- $2.1B Theft Losses: Bitquore Launches 1M+ TPS Platform with 95% Offline Asset Protection for U.S. Traders
The Company expects to report initial clinical data from the trial in 2021.
Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04669808.
About Basal Cell Carcinoma
Basal cell carcinoma (BCC) is a type of nonmelanoma skin cancer that occurs most often on areas that are exposed to the sun, such as head and neck. The most commonly found clinical feature of BCC is an elevated tumor with a pearly and translucent margin and telangiectasia. The color may vary widely from nearly normal skin color to erythematous to violaceous and may also be pigmented. BCC may also resemble noncancerous skin conditions such as eczema or psoriasis. The majority of these cancers occur on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation. It is believed that development of BCC is linked closely to overexpression of TGF-β1 and COX-2.
Surgery is the currently the most common treatment option for the treatment of nonmelanoma cancer. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection and bleeding. Surgery can also have a significant recurrence rate. As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective.
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-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of cholangiocarcinoma, nonmelanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma and primary sclerosing cholangitis. Preclinical animal models using STP705 have demonstrated a dramatic improvement in T-cell penetration into tumors in the liver with single agent action as well as improvement in the efficacy of an anti-PD-L1 antibody checkpoint inhibitor in an HCC model. This effect may improve other immune checkpoint inhibitor efficacies in addition to those targeting the PD-1/PD-L1 axis.
More on Marylandian
- America Anesthesia Partners Unveils New User-Friendly Website
- Hiclean Tools Releases HCX2100 Electric Pressure Washer
- Bùng Nổ Ra Mắt, AALIVE Tung Gói Thưởng 68% và Dàn Game Thuần Việt Hấp Dẫn
- ARCH Dental + Aesthetics Offers Free Consultations for New Patients
- Maisano Brothers Inc. Expands National Paving Division Into Tampa, Florida
About Sirnaomics, Inc.
Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The company's mission is to develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need. The guiding principles of the company are: Innovation, Global Vision with a Patient Centered focus. Members of the senior management team have a combined experience in the biopharmaceutical industry, spanning clinical development, regulatory, financial and business management in both the USA and China. The company is supported by funding from institutional investors, corporate partnerships and government grants. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of focus include oncology, anti-fibrotic, anti-viral and metabolic therapeutics. Learn more at www.sirnaomics.com.
Contact:
Sirnaomics:
Michael Molyneaux, MD, MBA
Chief Medical Officer
Email: [email protected]
Investors:
Stephanie Carrington
Tel: +1 646 277 1282
Email : [email protected]
Media:
Mark Corbae
Tel: +1 203 682 8288
Email: [email protected]
SOURCE Sirnaomics, Inc.
Related Links
http://www.sirnaomics.com
Filed Under: Business
0 Comments
Latest on Marylandian
- LSC Destruction Launches Cutting-Edge Cryptocurrency Scanning to Hard Drive Destruction Services
- $150 Million Financing Initiates N A S D A Q's First Tether Gold Treasury Combining the Stability of Physical Gold with Blockchain $AURE
- Tamla Olivier Named Technologist of the Year at 30th Annual Women of Color STEM Conference in Baltimore
- Podcast for Midlife Women Entrepreneurs Celebrates 100th Episode with Rhea Lana's Founder and CEO
- What If Help Could Come Before the Fall?
- New Book by Pastor Miguel Bustillos Inspires Believers to Deepen Their Prayer Life
- OddsTrader Examines the NHL Presidents Trophy Curse: Why Regular-Season Success Rarely Leads to Playoff Glory
- Bookmakers Review Launches Betting Insights on NBC's "The Voice: Battle of Champions"
- Coming Up this Weekend on CNBC Mike Milligan Joins Tom Hegna on "Financial Freedom with Tom Hegna"
- Parker Stone Unleashes the Highly Anticipated Dark Romance, "The Reluctant Heir," Out Today
- UK Website Launches "Toy Time Machine" — Find Your Childhood Christmas Toy in One Click
- $73.6M Pipeline, $10M Crypto Play & Legal Firepower: Why Investors Are Watching Cycurion (N A S D A Q: CYCU) Like a Hawk
- Grammy award-winning Cuban-Canadian artist Alex Cuba releases his 11th studio album, "Indole"
- Thread Advisory Group Launches to Help Retailers Turn Strategy Into Lasting Results
- QView Medical and Eve Wellness Announce Partnership to Advance Direct-to-Consumer Breast Cancer Screening With FDA-Approved AI
- New Article Reveals Common Pricing Pitfalls in Flooring Projects — And How to Avoid Them
- CRG Named One of OrangeSlices' 2026 Elev8 GovCon Honorees
- Airbus Defence and Space and Omnitronics Sign MoU to Advance Interoperability in Critical Communications
- Prince George's County MWA Hosts Historian Jean Burgess for Free Workshop
- White Glove Restoration Sends "Help in Boxes" to Support Communities in Ghana