KNOXVILLE, Tenn., June 7 /PRNewswire-FirstCall/ -- Provectus Pharmaceuticals, Inc. (OTC Bulletin Board: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has announced additional positive data from its Phase 2 clinical trial of PV-10 for metastatic melanoma. The data, on changes in visceral and nodal metastases following chemoablation of cutaneous melanoma lesions with PV-10, was presented by Dr. Sanjiv Agarwala at the American Society of Clinical Oncology 2010 Annual Meeting, on Sunday, June 6, 2010, in the General Poster Session on Melanoma/Skin Cancers, Abstract #8534. Positive improvement observed in these remote, untreated lesions, including metastases to the lungs, liver and brain, illustrate a potential systemic effect in visceral organs to which melanoma has spread. Dr. Agarwala's updated information included data from both the initial 40 subjects and the final 40 subjects enrolled in the Phase 2 trial.
A multi-media news release containing video is available at the following link: http://multivu.prnewswire.com/mnr/pvct/43978/.
Summary data on 20 subjects, including initial data on 4 subjects from the final 40 subjects in the study, who had evidence of macroscopic metastases of the lung, liver, brain or lymph nodes at screening, were presented. Among the first 40 study participants, 7 of the 16 subjects (44%) with visceral or macroscopic nodal metastases at screening exhibited stasis or regression of their lesions, including complete regression of multiple pulmonary metastases measuring up to 1.1 cm in one subject. Detailed data were presented on one Stage IV subject who experienced complete regression of multiple lung metastases and partial regression of multiple brain metastases over the study interval.
Dr. Agarwala, Chief of Medical Oncology and Hematology at St. Luke's Hospital and Health Network in Bethlehem, PA, and Principal Investigator for Provectus's Phase 2 PV-10 trial site at St. Luke's, noted, "I believe these data on visceral lesions that have not been injected with PV-10 are an additional positive indicator of the apparent immunologic response that PV-10 chemoablation can elicit against untreated lesions. With a single exception, these outcomes were associated with a positive response to PV-10 in these subjects' injected lesions, a correlation that is consistent with an immunologic-based process. Together with the similar correlation that has been observed between successful PV-10 chemoablation and resolution of uninjected cutaneous bystander lesions, this 'remote bystander response' is a very exciting development that illustrates the potential of PV-10 to trigger a beneficial systemic response."
Agarwala continued, "I look forward to being part of a research team being assembled to begin investigating the immunologic mechanism of action underlying these results through an anticipated Phase 2B clinical study. By looking at potential immune markers in peripheral blood and tumor tissue, we expect to learn how PV-10 chemoablation recruits and sensitizes immune cells to exposed tumor antigens. This should provide crucial confirmation of our clinical results, and more importantly allow us to fully understand and apply PV-10's potential in oncology."
Agarwala further noted, "Half of the initial 'N=40' cohort were Stage IIIB (in transit metastatic disease) upon enrollment, while a quarter had demonstrated visceral disease of the lungs, liver or brain (Stage IV M1b or M1c). Interestingly, outcome of these subjects' injected target lesions was not clearly dependent on disease stage, and there was no obvious evidence of a dependence of outcome on prior treatment history. I believe this highlights a potentially broad role PV-10 could play in management of melanoma, since it has now been employed early and late in the treatment of patients."
Craig Dees, PhD, CEO of Provectus said, "The additional information that Dr. Agarwala presented at ASCO is very exciting and meaningful, underscoring the importance of immunology in the fight against cancer, and the potential that PV-10 has in battling the disease. This new information deepens our confidence that PV-10 will be a viable treatment for metastatic melanoma, and that its immunological potential is significant. To my knowledge, this is the first time that local therapy with a small molecule drug has shown repeatable activation of the immune system against non-treated tumors. As we follow the guidance that we received from the FDA during our End-of-Phase 2 meeting, we are designing a protocol for a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment, and look forward to our next steps that will bring us closer to commercialization of PV-10. We also look forward to commencing our proposed Phase 2B clinical trial to examine the immunologic markers behind the fascinating data presented by Dr. Agarwala."
The supplemental data presented at ASCO is in addition to data announced on May 21, 2010, which included 52-week data on the first 40 subjects enrolled in the study:
- Objective Response of PV-10 injected lesions was achieved in 60% of subjects, with a Complete Response ("CR") in 33% of subjects and locoregional disease control (Stable Disease, "SD", or better) in 80% of subjects;
- An OR was achieved in untreated bystander lesions in 43% of subjects having an evaluable bystander lesion at baseline;
- Mean Progression Free Survival ("PFS") was 8.5 months for all subjects, while the OR cohort had a significantly longer PFS estimated to be at least 11.1 months vs. 3.0 months for SD and Progressive Disease ("PD") subjects; and
- PV-10 was well tolerated, with Adverse Experiences ("AEs") that were generally mild to moderate, locoregional and transient, with no deaths or life-threatening experiences attributable to PV-10.
Key conclusions from the poster were that:
- A majority of subjects exhibited a robust response in their injected lesions;
- Response appeared to be unrelated to disease stage or prior treatment history;
- Locoregional treatment with PV-10 may elicit systemic benefit in untreated visceral lesions; and
- The overall safety and efficacy profile of PV-10 compares favorably with available and emerging options for metastatic melanoma patients.
Provectus expects to announce complete final study results at Melanoma 2010 in Sydney, Australia, November 4-7, 2010.
The poster presentation can be accessed by the following link:
PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal is a small molecule agent with an established safety history, a short half-life in the bloodstream, and is excreted unmetabolized via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.
About Provectus Pharmaceuticals, Inc. (www.pvct.com)
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment and final follow-up in three Phase 2 trials -- PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial of PV-10 for liver cancer. Information about these and the Company's other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company's website at www.pvct.com or contact Porter, LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.
SOURCE Provectus Pharmaceuticals, Inc.