Aminolevulinic Acid Hydrochloride

The article, published in the prestigious journal Neurosurgery, which targets neurosurgeons, is entitled “Novel uPAR-targeting optical imaging agent ICG-Glu-Glu-AE105 (FG001) for visualization of malignant glioma during surgery: First-in-human study in 35 brain cancer patients” and identified with doi:10 1227/neu.0000000000003542, available here: link. “We are very pleased with the publication of the results from this first-in-human study that shows FG001 not only enables safe and targeted tumor identification including in the transition zone, being the tissue between the cancer and normal tissue which constitutesthe biggest challenge for the surgeon treating high-grade glioma – where the agent continued to produce visible fluorescence.” said Morten Albrechtsen, CEO of FluoGuide; “FG001 has the potential to redefine how surgeons approach brain tumor resection” Next clinical step and regulatory path Following the successful completion of this phase I study, FluoGuide is obtaining FDA regulatory advice prior to initiate the U.S. clinical trial supporting approval of FG001 guiding surgery of patients with High Grade Glioma. FluoGuide anticipates feedback from ongoing regulatory interactions over the summer. “I am pleased to see the first result of FG001 in patients with malignant glioma published” says Jane Skjøth-Rasmussen, MD, PhD, Chief Physician in the Department of Neurosurgery at Rigshospitalet, Copenhagen, Denmark and Principal Investigator of the trial and the author of the publication, and continues: “The data demonstrates FG001 to be well tolerated and shows a promise for guiding surgery of malignant glioma.” In an editorial comment published together with the article Professor Pierre A. Robe, Chair of Neurosurgical Oncology at the University Medical Center (UMC) concludes: “Altogether, the results reported here are a welcome and exciting addition to the brain tumor neurosurgical community.” Please refer to the published article for the full commentary. Glioblastoma is among the most aggressive and lethal forms of brain cancer, with a crucial need for tools that enable maximal tumor resection while preserving healthy brain tissue. FG001 lights up cancer, enabling surgeons to perform more precise surgeries. It is an novel imaging agent that targets the urokinase-type plasminogen activator receptor (uPAR), a protein highly expressed in tumor tissue but largely absent from normal brain cells. Key results from the phase I study The result is from the first clinical trial with FG001 in patients with High Grade Glioma and is an open-label, single-center phase I trial involving 35 patients, and FG001 was administered intravenously prior to brain surgery. A dose of 36 mg administered 12-19 hours before surgery provided optimal tumor visualization. The tumor-to-background fluorescence ratio (TBR) was relevant for all image system tested (>1.5) and up to 2.7 (TBR mean) and 3.6 (TBR max). Notably, FG001 achieved a sensitivity of 79% and a specificity of 100% in identifying malignant tissue confirmed by histopathology. Compared with the imaging agent 5-ALA, FG001 was observed to provide clearer delineation in deeper tissue layers due to its NIR fluorescence properties, with no observed false positives. FG001's safety profile was equally promising, with only few (4) mild drug-related adverse events linked to the drug. It was observed that unlike 5-ALA, no FG001-related nausea or vomiting was reported in patients receiving evening doses, underscoring FG001s favorable tolerability. High precision in the transition zone The transition zone, being the tissue between the tumor and the normal tissue, is of special attention to neurosurgeons as it is where they must make the difficult decisions between removing tissue that may be cancer and risking disabling patients by removing more brain tissue than necessary. FG001 worked well in the transition zone where all 7 samples were correctly classified by FG001 whereas 5-ALA had 2 false negative. When the efficacy was calculated for transition zone only, then specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) were all 100% for FG001, whereas the numbers were 100%, 60%, 100%, and 50% for 5-ALA, respectively.

Biofrontera received patent approval for the revised formulation of Ameluz ® in April 2025, extending patent protection through to December 2043. The Orange Book is published by the U.S. Food and Drug Administration (FDA) and lists all approved prescription drug products, along with patent and exclusivity information. Inclusion signifies FDA recognition of the revised formulation's approved status and its intellectual property protection. 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 patients 1 —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: Jacob SE, et al. “Contact Allergy to Propylene Glycol: A Review.” Dermatitis. 2008;19(3):157–163. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/18569104 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 www.biofrontera-us.com 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 www.sec.gov. 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 ir@bfri.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.