Provectus Biopharmaceuticals Announces Eight Presentations of Rose Bengal Photodynamic Antimicrobial Therapy at ARVO 2024 Annual Meeting

Rhea-AI Summary

Provectus Biopharmaceuticals (OTCQB: PVCT) announced clinical and non-clinical data presentations on rose bengal photodynamic antimicrobial therapy (RB PDAT) at the ARVO 2024 Annual Meeting held May 5-9 in Seattle. The company has entered an exclusive worldwide license agreement with the University of Miami to commercialize RB PDAT for treating various eye infections. They plan to form a start-up, Eyecare NewCo, by Q3 2024. Presentations covered diverse aspects of RB PDAT, including safety and effectiveness. RB PDAT is currently in two Phase 3 trials and has been used in the U.S., India, Brazil, and Mexico.

Positive

• Provectus presented robust clinical and non-clinical data on RB PDAT at ARVO 2024, enhancing the therapy's visibility.
• Exclusive worldwide license agreement with the University of Miami for RB PDAT intellectual property.
• Plan to form Eyecare NewCo in Q3 2024 to commercialize RB PDAT technology.
• Eight presentations at ARVO 2024 highlighting the safety and efficacy of RB PDAT.
• RB PDAT is in two international Phase 3 trials for various types of keratitis.
• RB PDAT has been used clinically in four countries, indicating global reach and potential market acceptance.

Negative

• No immediate revenue increase or financial gain announced from the ARVO 2024 presentations.
• Formation of Eyecare NewCo and commercialization plans are still in the early stages and subject to potential delays.
• Ongoing Phase 3 trials mean RB PDAT is not yet market-approved, posing a risk to investors.
• Dependence on successful trial outcomes and regulatory approvals before realizing any financial benefit.

• 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:

1. Evaluating the Safety of Rose Bengal Photodynamic Therapy, Huang et al., BPEI (Poster no. B0448, Session: Cornea),
   
2. 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),
   
3. Assessment of photosensitizer concentration with a Singlet Oxygen luminescence dosimeter for Photodynamic Antimicrobial Therapy, Carrera et al., BPEI (B0570, Cornea),
   
4. 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),
   
5. Enhanced Fungal Inhibition with High-Dose Rose Bengal Photodynamic Antimiocrobial Therapy, Merikansky et al., BPEI (B0580, Cornea),
   
6. 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),
   
7. Arginine-Mediated Enhancement of Photodynamic Antimicrobial Therapy to Target the Oxygen-Independent Pathway, Gonzalez et al., BPEI (B0005, Immunology/Microbiology), and
   
8. 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:

• U.S.: BPEI (first clinical reporting: Naranjo et al. 2019),
• 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:

• The Company’s Annual Report on Form 10-K for the period ended December 31, 2023.
  

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Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999

FAQ

What is the significance of Provectus's presentations at ARVO 2024?

Provectus's data presentations at ARVO 2024 highlighted the safety and effectiveness of RB PDAT, enhancing its scientific credibility and market potential.

What is RB PDAT and what does it treat?

RB PDAT is a rose bengal photodynamic antimicrobial therapy used to treat various eye infections including bacterial, fungal, and parasitic keratitis.

What is the recent agreement between Provectus and the University of Miami?

Provectus has entered an exclusive worldwide license agreement with the University of Miami to commercialize RB PDAT for treating eye infections.

When is Eyecare NewCo expected to form?

Eyecare NewCo is targeted to be formed in the third quarter of 2024 to commercialize RB PDAT technology.

What are the current trials involving RB PDAT?

RB PDAT is involved in two international Phase 3 randomized controlled trials for acanthamoeba, fungal, and bacterial keratitis.

In which countries has RB PDAT been used clinically?

RB PDAT has been used in the United States, India, Brazil, and Mexico.