Provectus Biopharmaceuticals Announces Exclusive License Option Agreement with Ophthalmic Biophysics Center of Bascom Palmer Eye Institute at University of Miami for Treatment of Eye Infections

Rhea-AI Summary

Provectus (OTCQB: PVCT) announced an exclusive worldwide license agreement with the University of Miami for a photodynamic antimicrobial therapy (PDAT) device. This collaboration will use Provectus’ rose bengal for treating bacterial, fungal, and viral infections of the eye. The company has also initiated a sponsored research program with the Ophthalmic Biophysics Center to explore rose bengal's efficacy against infectious keratitis. OBC has established its clinical proof-of-concept in treating microbial keratitis, including drug-resistant strains.

Positive

• Exclusive license agreement with University of Miami for PDAT device.
• Sponsored research program initiated for treating infectious keratitis.
• Demonstrated clinical proof-of-concept for treatment of microbial keratitis.

Negative

• None.

KNOXVILLE, TN, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company has entered into an option agreement with the University of Miami (UM) for an exclusive worldwide license of intellectual property developed by the Ophthalmic Biophysics Center (OBC) of Bascom Palmer Eye Institute (BPEI), which is part of the UM Health System, for the use of OBC’s photodynamic antimicrobial therapy (PDAT) medical device in combination with Provectus’ proprietary pharmaceutical-grade rose bengal for the treatment of bacterial, fungal, and viral infections of the eye. The Company also initiated a sponsored research program with OBC to investigate Provectus’ rose bengal for the treatment of infectious keratitis.

Established in 1970 by BPEI founding director Edward W.D. Norton, MD and Jean-Marie Parel, IngETS-G, PhD, FARVO, OBC performs translational eye care research in all areas of ophthalmology, from the retina and vitreous to the cornea, glaucoma, cataracts, neuro-ophthalmology, and ocular oncology. OBC has developed more than 350 surgical instruments and clinical devices to date.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors said, “Provectus is pleased to advance its collaboration with OBC director Dr. Parel, Dr. Guillermo Amescua, MD, a board-certified ophthalmologist and director of Bascom Palmer’s Ocular Surface Center, and the entire OBC team to now include this important option-to-license step. OBC’s innovative and comprehensive work on rose bengal PDAT has, among other things, shown in vitro activity against multiple etiologies of microbial keratitis^1,2,3,4,5, including drug-resistant strains^3,6, established in vivo safety⁷, demonstrated in vitro superiority over riboflavin PDAT^8,9, and achieved clinical proof-of-concept for the treatment of infectious keratitis^10,11.”

Mr. Rodrigues added, “OBC’s clinical work in ophthalmology, Provectus’ clinical trials in oncology and dermatology, and the Company’s wide-ranging preclinical work in hematology, infectious diseases, animal health, tissue regeneration and repair, and other disease areas support a key component of Provectus’ business strategy, which is to demonstrate the broad spectrum therapeutic platform potential of the Company’s proprietary pharmaceutical-grade halogenated xanthene small molecule rose bengal.”

About Bascom Palmer Eye Institute

BPEI serves as the Department of Ophthalmology for the UM Miller School of Medicine in Miami, Florida. Its mission is to enhance the quality of life by improving sight, preventing blindness, and advancing ophthalmic knowledge through compassionate patient care and innovative research. For 2022-2023, U.S. News & World Report (U.S. News) ranked BPEI as the nation’s best in ophthalmology, marking the 21^st time and 19^th consecutive year that BPEI has received the No. 1 ranking since U.S. News began surveying American physicians for its annual “Best Hospitals” rankings 33 years ago.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a class of small molecules called halogenated xanthenes (HXs). The Company’s lead molecule is rose bengal sodium. A second HX molecule has been synthesized.

Provectus’ drug discovery and development programs include investigational drugs and drug targets in oncology (clinical-stage), dermatology (clinical-stage), hematology, infectious diseases, ophthalmology (clinical-stage), animal health, and tissue regeneration and repair, and use multiple routes of administration, such as intralesional (IL), topical (.top), oral (P.O.), inhaled (.inh), intranasal (IN), and intravenous (IV).

Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at www.provectusbio.com.

References

1. Arboleda A, Miller D, Cabot F, et al. Assessment of rose bengal versus riboflavin photodynamic therapy for inhibition of fungal keratitis isolates. Am J Ophthalmol. 2014;158:64–70.
2. Durkee H, Arboleda A, Aguilar MC, et al. Rose bengal photodynamic antimicrobial therapy to inhibit Pseudomonas aeruginosa keratitis isolates. Lasers Med Sci. 2019;35:861–866.
3. Halili F, Arboleda A, Durkee H, et al. Rose bengaland riboflavin-mediated photodynamic therapy to inhibit methicillin-resistant Staphylococcus aureus keratitis isolates. Am J Ophthalmol. 2016;166:194–202.
4. Schrier A, Greebel G, Attia H, Trokel S, Smith EF. In vitro antimicrobial efficacy of riboflavin and ultraviolet light on Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, and Pseudomonas aeruginosa. J Refract Surg. 2009;25:S799–S802.
5. Naranjo A, Pelaez D, Arrieta E, et al. Cellular and molecular assessment of rose bengal photodynamic antimicrobial therapy on keratocytes, corneal endothelium and limbal stem cell niche. Exp Eye Res. 2019;188:107808.
6. Amescua G, Arboleda A, Nikpoor N, et al. Rose rengal photodynamic antimicrobial therapy: a novel treatment for resistant Fusarium keratitis. Cornea. 2017;36:1141–1144.
7. Martinez JD, Arrieta E, Naranjo A, Monsalve P, Mintz KJ, Peterson J, Arboleda A, Durkee H, Aguilar MC, Pelaez D, Dubovy SR, Miller D, Leblanc R, Amescua G, Parel JM. Rose Bengal Photodynamic Antimicrobial Therapy: A Pilot Safety Study. Cornea. 2021 Aug 1;40(8):1036-1043.
8. Arboleda A, Miller D, Cabot F, Taneja M, Aguilar MC, Alawa K, Amescua G, Yoo SH, Parel JM. Assessment of rose bengal versus riboflavin photodynamic therapy for inhibition of fungal keratitis isolates. Am J Ophthalmol. 2014 Jul;158(1):64-70.e2.
9. Adre E, Durkee H, Arboleda A, Alawa K, Maestre J, Mintz KJ, Leblanc RM, Amescua G, Parel JM, Miller D. Rose Bengal and Riboflavin Mediated Photodynamic Antimicrobial Therapy Against Selected South Florida Nocardia Keratitis Isolates. Transl Vis Sci Technol. 2022 Jan 3;11(1):29.
10. Naranjo A, Arboleda A, Martinez JD, Durkee H, Aguilar MC, Relhan N, Nikpoor N, Galor A, Dubovy SR, Leblanc R, Flynn HW Jr, Miller D, Parel JM, Amescua G. Rose Bengal Photodynamic Antimicrobial Therapy for Patients With Progressive Infectious Keratitis: A Pilot Clinical Study. Am J Ophthalmol. 2019 Dec;208:387-396.
11. Sepulveda-Beltran PA, Levine H, Altamirano DS, Martinez JD, Durkee H, Mintz K, Leblanc R, Tóthová JD, Miller D, Parel JM, Amescua G. Rose Bengal Photodynamic Antimicrobial Therapy: A Review of the Intermediate-Term Clinical and Surgical Outcomes. Am J Ophthalmol. 2022 Aug 8;243:125-134.
    

FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management 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. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or 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 particular 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 Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result 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 SEC, including those described in Item 1A of:

• the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, and
• Provectus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2022.

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Contact:

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

FAQ

What is Provectus' agreement with the University of Miami?

Provectus has an option agreement for an exclusive license of a photodynamic antimicrobial therapy device developed by the University of Miami for treating eye infections.

What is the significance of the sponsored research program with OBC?

The program aims to investigate the efficacy of Provectus' rose bengal in treating infectious keratitis.

What are the potential benefits of using rose bengal in PDAT?

Rose bengal has shown in vitro activity against several microbial strains, including drug-resistant ones, and has demonstrated safety in previous studies.

What is the stock symbol for Provectus?

The stock symbol for Provectus is PVCT.