Urinary Bladder Diseases

According to GlobalData, there will be 123,846 cervical cancer cases in the eight major markets (UK, US, France, Germany, Spain, Italy, Japan, and urban China) by 2030. Credit: Ground Picture via Shutterstock. Asieris Pharmaceuticals has announced positive data indicating the Phase III trial of its cold light photodynamic drug-device combination Cevira (APL-1702) achieved its primary endpoint in participants with cervical high-grade squamous intraepithelial lesions (HSIL). HSIL are precancerous lesions linked to human papillomavirus (HPV) that can lead to cervical cancer. The results were presented at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, US, which was held 16-18 March. Cevira also demonstrated a tolerable safety profile. The therapy stimulates the body’s production of the photosensitiser protoporphyrin IX (PPIX), which selectively accumulates in tumour tissue, and upon exposure to specific wavelengths, triggers tumour cell apoptosis. The primary endpoint, which evaluated the response rate six months after administering Cevira, showed a statistically significant improvement of 89.4% compared to the placebo group. See Also: Dr. Reddy’s Laboratories files patent for 6-substituted pyridazine compounds for treating diseases dependent on SMARCA2/SMARCA4 The drug also showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the Cevira group compared to placebo. Cevira was developed through Phase I and II clinical trials by Norway-based Photocure ASA, with Asieris gaining commercialisation rights in July 2019. The Phase III trial (NCT04484415) enrolled 402 HSIL patients, defining the primary endpoint of response as the conversion of cervical epithelial tissue pathology to normal, or the conversion to low-grade squamous intraepithelial lesion (LSIL) while achieving baseline HPV clearance. Long-lasting infection with certain types of HPV, a common sexually transmitted infection, is the main cause of cervical cancer. If left untreated, HPV can be linked to 95% of cervical cancer cases, according to the World Health Organization. The China-based biotech now plans to submit a new drug application for Cevira in Q2 2024, according to Asieris’ chief development officer Linda Wu. According to a report on GlobalData’s Pharma Intelligence Center, the number of cervical cancer cases in the eight major markets (UK, US, France, Germany, Spain, Italy, Japan, and urban China) will reach 123,846 by 2030. GlobalData is the parent company of Clinical Trials Arena. In the announcement accompanying the data, Linda Wu said: “The study not only demonstrates remarkable efficacy but also exhibits a favourable safety profile, offering a new powerful artillery for the national cervical cancer prevention and control system. “Additionally, we are making significant progress in product development overseas, aiming to bring this innovative treatment to more patients as soon as possible.” The company also has other cancer candidates in the pipeline. Earlier this year, a Phase II trial of its repurposed antibiotic drug APL-1202 achieved its primary endpoint in participants with muscular invasive bladder cancer (MIBC). The drug is already approved to treat oesophagal squamous cell carcinoma in China and is also being reviewed by the US Food and Drug Administration to treat the same type of cancer.

RESEARCH TRIANGLE PARK, N.C., March 18, 2024 /PRNewswire/ -- Dignify Therapeutics (Dignify), a pharmaceutical and medical device development company focused on restoring bowel and bladder control for elderly and neurologically impaired individuals, today announced that Anthony DiTonno has been named as Chief Executive Officer. This appointment expands Mr. DiTonno's duties as he will continue in his position as Executive Chairman. Continue Reading "This is a natural progression for Tony as he has been leading Dignify's business development effort as Executive Chairman" said company President Dr. Ed Burgard. "His extensive experience in building life sciences companies provides strong leadership as Dignify raises a Series A round and transitions into a clinical stage company". Addition significantly expands senior management team Post this "Dignify Therapeutics' product candidates represent a significant improvement in quality of life for patients who suffer from bowel and bladder problems. I look forward to working closely with the Dignify team to secure the capital we need to move our programs forward" DiTonno added. As a serial entrepreneur, Mr. DiTonno has more than 25 years of senior leadership experience spanning the pharmaceutical, biotechnology, and medical device industries. He has comprehensive experience in companies of all sizes and scopes, from small privately held companies to large public enterprises, to entities transitioning from private to public. His long record of success in launching startups in the pharmaceutical and medical technology industries, extensive experience in raising capital and securing commercial and corporate partnerships, and strong product launch background in some of the most competitive and strictly regulated markets will add tremendous value to Dignify Therapeutics as the company moves into this new stage of growth. About Dignify Therapeutics Founded by a team of serial entrepreneurs who are internationally-recognized scientists, Dignify Therapeutics' mission is to provide practical and convenient treatments for bladder and bowel voiding dysfunctions, primarily using a repositioning strategy of drug discovery that the team has successfully implemented multiple times over the last 20 years in the fields of urology and gastroenterology. The Company is funded by founders, venture capital (RA Capital Mgmt and Eshelman Ventures), the North Carolina Biotechnology Center, the One NC Small Business Program, and the NIH SBIR/STTR program (18 awards, approximately $18 million). Dignify Therapeutics is located in the First Flight Venture Center in Research Triangle Park, North Carolina. SOURCE Dignify Therapeutics

OSLO, Norway, March 18, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO) , the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has communicated today the Phase III clinical study results for its non-surgical treatment candidate for cervical high-grade squamous intraepithelial lesions (HSIL) Cevira® (APL-1702). The results were presented at two recent medical congresses and demonstrated highly statistically significant efficacy and a favorable safety profile for Cevira, with a significant clearance rate of high-risk HPV16 and/or HPV18 compared to placebo (p=0.0001). Key data from the international multicenter Phase III trial were presented for the first time last week, in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress, March 13-16 in Stockholm, Sweden, and at the 2024 SGO Annual Meeting on Women's Cancer of the Society of Gynecologic Oncology, March 16-18 in San Diego, CA, USA. Cevira (APL-1702) is a pioneering photodynamic drug-device combination product used as a non-invasive therapy for treating cervical high-grade squamous intraepithelial lesions (HSIL). This study is a large prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL over 12 months. The primary endpoint of the study is the proportion of responders at 6 months after the initial treatment. Between November 2020 and July 2022, 402 eligible patients from various countries including China, Germany, and the Netherlands were randomized and enrolled in this study. In terms of the primary efficacy endpoint, the response rate in the APL-1702 group was significantly higher than that in the control group, with an increase of 89.4% (41.1% vs. 21.7%, p = 0.0001), which is considered a highly clinically relevant effect. Additionally, APL-1702 showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the APL-1702 group compared to the control group (31.4% vs. 15.4%). The incidence of treatment-emergent adverse events (TEAEs) was comparable between the APL-1702 group and the control group, with the majority being mild and self-resolving without requiring intervention. The occurrence rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were low in both groups. The current progress involves ongoing communication with regulatory authorities in China and preparing for the submission of the new drug application for APL-1702. Additionally, active efforts are being made to advance development of the product outside of China. "We are very pleased to see the strong results of this randomized controlled Phase III clinical trial in which Cevira (APL-1702) demonstrated clear benefit in patients with HSIL. Based on the results, treatment with Cevira has the potential to fill an unmet clinical need as an alternative to conventional surgical therapies for HSIL", said Anders Neijber, Photocure's Chief Medical Officer. "At present, Photocure teams are supporting Asieris' to prepare the new drug application (NDA) for Cevira (APL-1702) in China, with the goal of bringing this innovative therapy to a larger number of patients as soon as possible." According to the press release, the main cause of cervical cancer is persistent infection with human papillomavirus (HPV), which leads to precancerous lesions of the cervix. Approximately 25% of individuals with HSIL may progress to invasive cervical cancer within 10 years. Read Asieris' full media release here: Cevira (APL-1702) has potential to become a breakthrough photodynamic drug-device combination product that can offer patients the option of non-surgical treatment of high-grade precancerous lesions of the cervix. Photocure developed Cevira through Phase 1 and Phase 2 trials, and the global rights for development and commercialization were out-licensed to Asieris Meditech Co., Ltd in 2019. Asieris is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. Note to editors: All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin. About Photocure ASA Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at , , For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl CFO Photocure ASA Tel: +4745055000 Email: [email protected] David Moskowitz Vice President, Investor Relations Photocure ASA Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] This information was brought to you by Cision The following files are available for download: