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Associated Press
03-06-2025
- Business
- Associated Press
Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange Book
WOBURN, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication 'Approved Drug Products with Therapeutic Equivalence Evaluations' (commonly known as the Orange Book). The Orange Book is a key reference for healthcare providers, pharmacists, and payers and is the definitive source for identifying FDA-approved drug products. Inclusion of a drug in the Orange Book confirms that the FDA recognizes that the drug meets their rigorous standards for safety, efficacy, and quality. In addition, patents listed confer intellectual property protections which may include the drug's composition, formulation, or specific uses. Listing of the patent for the propylene glycol-free formulation of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043. The revised formulation, which eliminates propylene glycol—a well-known allergen for some patients1—demonstrates Biofrontera's continued commitment to innovation and patient-centric development. It offers a significant improvement for individuals who are sensitive to this excipient without compromising the treatment's effectiveness. The patent for the revised formulation of Ameluz® was issued on April 22, 2025, and lasts until December 8, 2043. The formulation itself was accepted by the FDA and has been in use since 2024. 'We are proud to announce the inclusion of the patent for our propylene glycol-free formula in the Orange Book,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'This recognition validates the differentiated profile of our propylene glycol-free formulation, offering physicians and patients a formulation that reduces the potential for allergic reactions while maintaining the efficacy of Ameluz® RhodoLED PDT.' References: About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact: Investor Relations Andrew Barwicki 1-516-662-9461 [email protected]
Yahoo
01-06-2025
- Business
- Yahoo
ImPact Biotech Presents Interim Analysis from Phase 3 ENLIGHTED Study of Padeliporfin VTP in LG UTUC at ASCO 2025
– Complete response (CR) observed in 73% (27/37) of evaluable patients with low-grade upper tract urothelial cancer (UTUC) who completed the Induction Treatment Phase (ITP) – – Padeliporfin VTP treatment continues to be safe and well-tolerated, establishing profile consistent with prior results alongside additional follow-up in Maintenance Treatment Phase (MTP) – – Interim analysis follows evaluation of 50% of target enrollment in study; completion of enrollment anticipated in 2H25 with topline data by year end – – Selected for late-breaking podium presentation today at 1:15 PM CT – TEL AVIV, Israel, May 31, 2025 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin vascular targeted photodynamic (VTP) therapy to treat a range of solid tumors, today announced updated interim results from ENLIGHTED, the Company's ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial cancer (UTUC). These data will be presented in a late-breaking podium session at the at the American Society of Clinical Oncology Annual Meeting taking place May 30 – June 3, 2025, in Chicago, Illinois. 'We are pleased to share this interim analysis, now capturing 50% of target enrollment in ENLIGHTED, which continues to reinforce Padeliporfin VTP's best-in-class potential in low-grade UTUC,' said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. 'We believe the emerging profile – a non-invasive treatment option delivering robust and sustained surgery-like efficacy, but without the associated risk of organ injury or loss – presents clear advantages over the standard of care. We are urgently progressing development to bring underserved UTUC patients this paradigm-shifting treatment and look forward to announcing potentially registrational topline data, including a view into durability, in UTUC within the year.' Key results from the interim analysis of the Phase 3 ENLIGHTED study of Padeliporfin VTP: As of November 5, 2024, the data cut-off for the poster presentation at ASCO, 43 patients had begun treatment, of which 37 had completed ITP and were evaluable for efficacy. Clinical Profile: 27 of the 37 (73%) response-evaluable patients achieved a CR at the end of ITP. 5 of the 37 (13.5%) response-evaluable patients achieved a partial response (PR) at the end of ITP. Safety and Tolerability Profile: Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results. Adverse events (AEs): the majority of treatment-emergent adverse events (TEAEs) were mild or moderate and were primarily URS related, resolving within a few days. The most common Grade 3 serious adverse events related to VTP treatment were hematuria, dysuria and flank pain, which resolved within a few days. No TEAEs of special interest were reported and no TEAE led to discontinuation of the study treatment. ImPact continues to recruit for the ENLIGHTED study and expects to complete enrollment in the second half of 2025. The company anticipates the presentation of topline ENLIGHTED data in 2025. Podium Presentation Details: Poster Title: Interim results of efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) in the treatment of low-grade upper tract urothelial cancer (LG UTUC): ENLIGHTED phase 3 studyPresenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical CenterPoster Number: LBA4513Session Title: Bladder Cancer: Upper Tract Transitional Cell CarcinomaSession Date & Time: May 31, 2025, 1:15 PM CT About ENLIGHTEDThe Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an outpatient endoscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care follow-up visits every three months with optional VTP therapy administered on each visit for up to 12 months. The study's primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response. About ImPact BiotechImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of unresectable solid tumors. The novel VTP platform delivers non-thermal laser light via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Padeliporfin VTP is currently being evaluated in a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: and the ENLIGHTED clinical trial website (for the US): Contacts Global Head of Business DevelopmentGuy Precision AQJohn in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
