PV-10 is a proprietary compound used to assess damage to the eye, as well as an agent used as an intravenous diagnostic to detect liver ailments. Dr. Sanjiv Agarwala, chief of medical oncology and hematology at St. Luke’s Hospital and Health Network in Pennsylvania, is the principal investigator for Provectus’ phase 2 trial for PV-10.
Provectus said data from the clinical trial showed positive improvement in remote, untreated lesions, including metastases to the lungs, liver and brain, resulting in a potential systemic effect in visceral organs affected by melanoma. Dr. Agarwala recently presented the data at the American Society of Clinical Oncology 2010 Annual Meeting in the General Poster Session on Melanoma/Skin Cancers, Abstract #8534.
“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,” Dr. Agarwala stated in the press release. “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.”
Dr. Agarwala said his research team will further investigate PV-10 through a phase 2B clinical study in hopes of confirming clinical results to allow the company to fully understand and apply PV-10’s potential in oncology.
Craig Dees, PhD, CEO of Provectus, said the data reflects PV-10’s potential in the market and sets up the design for further trials.
“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,” Dees stated. “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.”
Provectus expects to announce complete final study results at Melanoma 2010 in Sydney, Australia, November 4-7, 2010.
For more information visit: http://www.pvct.com