Provectus Biopharmaceuticals Provides Update on Research into Oral Administration of PV-10® Immunotherapy for Treatments of Hematology, Oncology, and Virology

Rhea-AI Summary

Provectus (OTCQB: PVCT) has updated its research on the systemic administration of PV-10, an investigational immunotherapy, focusing on hematology, oncology, and virology. The Company announced new patent applications published by the USPTO, showcasing in vivo data from studies on leukemia and solid tumors that demonstrated increased survival rates in mice. Provectus plans to publish findings from these studies in peer-reviewed journals in 2022. The Company continues to seek patent protection globally and emphasizes the significance of its immune system research.

Positive

• New patent applications published by the USPTO for PV-10, indicating active development.
• In vivo studies show increased survival rates in mice with acute lymphoblastic leukemia and colorectal tumors.
• Plans to publish data in peer-reviewed journals, enhancing credibility and visibility.

Negative

• None.

KNOXVILLE, TN, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided an update on the Company’s research into the systemic administration of Provectus’ investigational immunotherapy, PV-10 (rose bengal disodium, a halogenated xanthene molecule), for the treatments of hematology, oncology, and virology indications, in conjunction with the Company’s efforts to expand its intellectual property.

Hematology: On August 5, 2021, the U.S. Patent and Trademark Office (USPTO) published Provectus’ patent application entitled “Composition and Method for Oral Treatment of Leukemia” (publication no. US 2021/0236418 A1), containing:

• In vivo data of mice with acute lymphoblastic leukemia that received oral PV-10 and displayed increased survival.
  

Provectus expects these and other related data from the hematology program to be published in a peer-reviewed medical journal in 2022.

Oncology: On September 30, the USPTO published the Company’s patent application entitled “Treatment of Solid Cancerous Tumors by Oral Administration of a Halogenated Xanthene” (US 2021/0299055 A1), containing:

• In vivo data of mice with adenomatous polyposis coli multiple intestinal neoplasia (a colorectal tumor model that continuously promotes abnormal cell proliferation and transformation into cancer) that received oral rose bengal and displayed increased survival in both prophylactic and therapeutic settings.

Virology: On September 30, the USPTO also published Provectus’ patent application entitled “Novel Uses of Halogenated Xanthenes in Oncology and Virology” (US 2021/0299083 A1), containing:

• In silico data of rose bengal’s docking-based binding affinity to the main protease of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus’ spike protein, and different variants of the spike protein, and
  
• In vitro data of PV-10’s activity against SARS-CoV-2 in African green monkey kidney cell (Vero) and human lung epithelial cell (Calu-3) models, and of PV-10’s synergistic activity with remdesivir in a Vero cell model.
  

Provectus expects that data from the oncology and virology programs would be published when appropriate.

The Company routinely files for patent protection in key countries in Asia, Europe, and North America.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, “Cancer and virology are related fields that intersect at the innate and adaptive immune systems of the human body. This convergence provides the scientific rationale for applying discoveries about PV-10 in one field to others.”

Mr. Rodrigues added, “Provectus and its collaborators have successfully characterized the multifaceted, specific, and consistent immune system response to intratumoral PV-10 treatment in a variety of clinical studies and supporting preclinical research. The aims of our newer hematology, oncology, and virology development programs, among others, have been to illuminate the expansiveness of our immunogenic small molecule science, and to support the advancement of oral PV-10 immunotherapy drug product candidates into the clinic.”

About PV-10

Intralesional (IL) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days. This PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB). In CB-refractory advanced cutaneous melanoma, PV-10 may restore disease-specific T cell function. IL PV-10 has been administered to over 450 patients with cancers of the skin and of the liver. It is administered under visual, tactile, or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to visceral hepatic tumors. IL PV-10 is also undergoing preclinical study for pediatric solid tumor cancers (including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma).

Systemic administration of PV-10 is undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers, and as a treatment for relapsed and refractory blood cancers.

Different formulations and routes of administration of PV-10 and rose bengal disodium are also undergoing clinical and/or preclinical study in virology, microbiology, ophthalmology, dermatology, and animal health.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on an entire and wholly-owned family of small molecules called halogenated xanthenes. 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.

Trademark

PV-10^® is registered trademark of Provectus Pharmatech, Knoxville, Tennessee, U.S.A.

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, 2020 and Provectus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.

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Contact:

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

FAQ

What did Provectus announce on October 4, 2021?

Provectus announced updates on its research of PV-10, including new patent applications and promising in vivo study results.

What are the indications being researched by Provectus for PV-10?

Provectus is researching PV-10 for hematology, oncology, and virology indications.

What were the findings from the studies on leukemia and solid tumors?

The studies showed increased survival rates in mice treated with oral PV-10, highlighting its potential effectiveness.

When does Provectus expect to publish its research data?

Provectus anticipates publishing findings from its hematology program in a peer-reviewed journal in 2022.

What is the significance of the new patent applications for PV-10?

The patent applications indicate Provectus's commitment to protecting its intellectual property and advancing its research.