PDAT clinical outcomes for infectious keratitis from Brazil and Mexico
KNOXVILLE, TN, May 14, 2024 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced that clinical and non-clinical data on rose bengal photodynamic antimicrobial therapy (“RB PDAT”) were presented at the annual meeting of the Association for Research in Vision and Ophthalmology (“ARVO”), held May 5-9, 2024 in Seattle, Washington. The ARVO annual meeting brings together approximately 10,000 vision researchers, clinicians, and scientists from around the world for scientific sessions, poster presentations, and invited speaker sessions.
Provectus entered into an exclusive worldwide license agreement with the University of Miami (the “University”) in April 2024 for its intellectual property related to RB PDAT for treating bacterial, fungal, and parasitic (acanthamoeba) eye infections. The Company and University plan to form a start-up biotechnology company (e.g., “Eyecare NewCo”), potentially in the third quarter of 2024, aimed at commercializing the University’s PDAT light source medical device in combination with a drug formulation of Provectus’s proprietary pharmaceutical-grade rose bengal active pharmaceutical ingredient (“RB API”). The Company would contribute the RB PDAT license to and have an exclusive RB API supply arrangement with Eyecare NewCo.
RB PDAT emerged under the leadership of Jean-Marie Parel, IngETS-G, Ph.D., FARVO, Director of Bascom Palmer Eye Institute’s (“BPEI’s”) Ophthalmic Biophysics Center at the University of Miami Miller School of Medicine. Dr. Parel and the OBC team have spent more than ten years advancing RB PDAT technology against different types of infectious keratitis.
ARVO 2024 RB PDAT presentations included:
Evaluating the Safety of Rose Bengal Photodynamic Therapy, Huang et al., BPEI (Poster no. B0448, Session: Cornea),
Rose Bengal Photodynamic Antimicrobial Therapy as an Adjuvant Treatment for Infectious Keratitis, Eskenazi-Betech et al., Instituto de Oftalmologia Fundacion Conde de Valenciana IAP (Mexico) (B0338, Cornea),
Assessment of photosensitizer concentration with a Singlet Oxygen luminescence dosimeter for Photodynamic Antimicrobial Therapy, Carrera et al., BPEI (B0570, Cornea),
Clinical outcome in patients with infectious keratitis treated with Rose Bengal Photodynamic Antimicrobial Therapy (RB-PDAT) at the Federal University of Sao Paulo (UNIFESP), Tabuse et al., Universidade Federal de São Paulo (Brazil) (B0575, Cornea),
Enhanced Fungal Inhibition with High-Dose Rose Bengal Photodynamic Antimiocrobial Therapy, Merikansky et al., BPEI (B0580, Cornea),
Inhibition of Fungal Isolates via Singlet Oxygen Generation from Erythrosin B and Rose Bengal Photodynamic Antimicrobial Therapy, Ahmed et al., BPEI (Paper no. 4917, Cornea),
Arginine-Mediated Enhancement of Photodynamic Antimicrobial Therapy to Target the Oxygen-Independent Pathway, Gonzalez et al., BPEI (B0005, Immunology/Microbiology), and
Preclinical/Poster: Exploring the Combination of Rose Bengal Photodynamic Antimicrobial Therapy and Existing Antifungals, Krishna et al., BPEI (B0010, Immunology/Microbiology).
RB PDAT is the subject of two international Phase 3 randomized controlled trials for acanthamoeba and fungal (NCT05110001) and bacterial (NCT06271772) keratitis, and has been used to treat infectious keratitis patients in four countries to date:
India: LV Prasad Eye Institute (Bagga et al. 2022) and Aravind Eye Care System (NCT05110001 data readout planned in Q4 2024),
Brazil: Universidade Federal de São Paulo (ARVO 2024), and
Mexico: Instituto de Oftalmología FAP (ARVO 2024).
About Bascom Palmer Eye Institute
Bascom Palmer Eye Institute serves as the Department of Ophthalmology for the University of Miami Miller School of Medicine. The mission of BPEI is to enhance the quality of life by improving sight, preventing blindness, and advancing ophthalmic knowledge through compassionate patient care and innovative research. For 2023-2024, U.S. News & World Report (“U.S. News”) ranked BPEI as the nation’s best in ophthalmology, marking the 22nd time and 20th consecutive year that BPEI has received the No. 1 ranking since U.S. News began surveying American physicians for its annual “Best Hospitals” rankings 34 years ago.
About Provectus
Provectus Biopharmaceuticals, Inc. is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes. Provectus’s lead HX molecule is named rose bengal sodium.
Provectus’s medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo development programs in oncology, hematology, full-thickness cutaneous wound healing, and canine cancers; and in vitro discovery programs in infectious diseases, tissue regeneration and repair, and proprietary targets.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, ClinicalTrials.gov. For additional information about Provectus, please visit the Company’s website at www.provectusbio.com.
FORWARD-LOOKING STATEMENTS: The information provided in this press release may include forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the business of Provectus and its affiliates, which are based on currently available information and current assumptions, expectations, and projections about future events and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Such statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are often, but not always, identified by the use of words such as “aim,” “likely,” “outlook,” “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “would,” “project,” “projection,” “predict,” “potential,” “targeting,” “intend,” “can,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of Provectus’s drug agents and/or their uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and the Company undertakes no obligation to update or revise any forward-looking statements, whether because of new information, future events, or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the Securities and Exchange Commission, including those described in Item 1A of:
