Provectus Biopharmaceuticals Announces Presentation of Meta-Analysis Results of Single-Agent PV-10® in Stage III Cutaneous Melanoma at Society for Melanoma Research (SMR) 2021

Rhea-AI Summary

Provectus has revealed promising results from a meta-analysis of its Phase 2 and 3 clinical trials involving PV-10 for treating Stage III cutaneous melanoma. The analysis included 184 patients, boasting a median overall survival of 44.9 months. PV-10 demonstrated a 56% complete response rate across 774 injected lesions. Data from the expanded access program showed a rapid treatment response with favorable safety profiles. This substantial data set spans 12 years and over 1,200 lesions, indicating the drug’s effectiveness against locoregional melanoma, positioning it favorably against standard therapies.

Positive

• Median overall survival of 44.9 months in 184 patients.
• 56% complete response rate in injected lesions.
• Favorable safety profile with predominantly mild-to-moderate adverse events.

Negative

• None.

• 184 patients: 44.9 months median overall survival
• 774 PV-10-injected lesions (121 patients): 56% complete response

KNOXVILLE, TN, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that results from a meta-analysis of response, survival, and safety data from the Company’s Phase 2 and 3 clinical trials (NCT00521053 and NCT02288897, respectively) and expanded access program (EAP) (NCT01260779) of single-agent cancer immunotherapy PV-10 (rose bengal disodium) for the treatment of Stage III cutaneous melanoma was presented at the SMR 2021 Virtual Congress (the Society for Melanoma Research annual meeting), which was held online from October 28^th to 31^st.

A copy of the poster presentation is available on Provectus’ website at https://www.provectusbio.com/media/docs/publications/SMR-2021-PV-10-in-Stage-III-Melanoma.21Oct2021.pdf.

Highlights of the SMR 2021 presentation:

• Baseline characteristics
  • Efficacy evaluable population (EEP)
    • 121 clinical trial and EAP patients; 88% in-transit melanoma
    • 55% male; median age of 71 years (range 33-97)
    • 744 PV-10-injected lesions
  • Clinical evaluable population (CEP)
    • 57 EAP patients
    • 422 PV-10-injected lesions
• Safety (104 patients)
  • Adverse events were predominantly transient, locoregional to the PV-10-injection site, and mild-to-moderate grade
• Injected-lesion response
  • Efficacy evaluable population
    • 56% complete response (CR), 64% objective response rate (ORR), 78% disease control rate (DCR)
  • Clinical evaluable population
    • 56% CR, 65% ORR, 91% DCR
• Time-to-event metrics (EEP)
  • Time-to-response (TTR): median 2.4 months, mean 2.6, range 0.7-12
  • Time-to-progression (TTP): median not reached
  • Time-to-treatment failure (TTF): median not reached
• Survival (184 patients)
  • Overall survival (OS): median 44.9 months
  • Disease-specific survival (DSS): median 53.8 months

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, “For a Stage III cutaneous melanoma patient population with unique locoregional disease characteristics having a serious condition and facing an unmet medical need, these PV-10 data unequivocally display a positive risk-benefit profile: rapid response to PV-10 treatment, a high injected-lesion complete response rate, and an attractive safety profile.”

Mr. Rodrigues added, “This meta-analysis represents approximately 12 years, 185 patients, and 1,200 lesions worth of PV-10 data. The results categorically quantify a robust response of Stage III melanoma lesions to intralesional PV-10 treatment that is temporally consistent and reproducible across multiple different countries, sites, principal investigators, and study protocols. The data compare very favorably with those reported for drug products approved for Stage III melanoma, such as oncolytic virus and immune checkpoint blockade therapies.”

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 is the significance of the 44.9 months median overall survival reported by Provectus (PVCT)?

The 44.9 months median overall survival indicates a promising treatment outcome for Stage III cutaneous melanoma patients receiving PV-10.

What were the findings regarding the complete response rate in Provectus's clinical trials?

The trials reported a 56% complete response rate in 774 PV-10 injected lesions, emphasizing the treatment's efficacy.

How does the safety profile of PV-10 compare in the treatment of melanoma?

PV-10 exhibited a favorable safety profile, with mostly mild-to-moderate adverse events primarily localized to the injection sites.

How long has the data regarding PV-10 treatment been collected?

The meta-analysis represents approximately 12 years of data involving 185 patients and 1,200 lesions.

What does the term 'locoregional disease characteristics' refer to in relation to the melanoma study?

Locoregional disease characteristics refer to the specific patterns of melanoma that are confined to local areas rather than being widespread, which affects treatment strategies.