Showing posts with label Provectus Pharma. Show all posts
Showing posts with label Provectus Pharma. Show all posts

Provectus Pharmaceuticals' PV-10 Phase 2 Final Data To Be Presented At 2nd European PostASCO Melanoma Meeting 2012 on June 22, 2012



Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com ), a development-stage oncology and dermatology biopharmaceutical company, announces that Phase 2 final data on PV-10 for metastatic melanoma will be presented at the 2nd European PostASCO Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanoma, on June 22, 2012, in Munich, Germany. 

Dr. Sanjiv Agarwala, M.D., Principal Investigator for the PV-10 Phase 2 trial, and Chief of Medical Oncology and Hematology at St. Luke's Hospital and Health Network in Bethlehem, PA, will be presenting the final Phase 2 PV-10 data at 9:24 a.m. (Munich time) that day. 

Dr. Craig Dees, PhD, CEO of Provectus said, "This will be the first time that final Phase 2 data on PV-10 for metastatic melanoma will be publicly announced. Dr. Agarwala is expected to present a detailed analysis of PV-10's impact upon Progression Free Survival ("PFS"), which is also the suggested primary endpoint for the proposed Phase 3 clinical trial protocol to qualify for Special Protocol Assessment with the Food and Drug Administration (FDA). This conference is an important venue for Provectus as the data will be presented to members of the global scientific and medical community, including important leading investigators from Europe. The presentation of the final Phase 2 data will also be a significant milestone for the company as we continue in our path towards regulatory approval for our novel oncology drug." 

Provectus Pharmaceuticals also expects PV-10 Phase 2 data will be featured in a peer-reviewed publication in upcoming months. 

About the 2nd European PostASCO Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanoma, http://melanomaglobal2012.org/ 

This conference is expected to attract interdisciplinary participants from all continents and offer a comprehensive overview on all new developments in melanoma therapy. The aim of this conference is to grant a deep overall insight into the development of new drugs for melanoma. The lively interaction of clinicians, as well as experts in translational and basic research, and representatives of the pharmaceutical industry, guarantees a successful outcome for every participant.

Provectus Pharmaceuticals gaining momentum

Provectus Pharmaceuticals, Inc.(OTC: PVCT) is a small-cap pharmaceutical company focused on developing treatments for oncology and dermatology. Shares of PVCT have started to gain some momentum the past few weeks in anticipation of clinical data that is being presented in November.

The data comes from its Phase 2 study of PV-10 in metastatic melanoma. This will be presented at the 7th International Melanoma Research Congress in Sydney, Australia, on November 4, 2010 at 4:30 p.m.


PVCT will be presenting efficacy data on the full study population, which will include response rate, progression-free-survival and overall survival. These are very important numbers for the future of PVCT and PV-10. At ASCO 2010, they presented data on the “first 40 subjects in its Phase 2 clinical trial of PV-10 for metastatic melanoma, with an objective response ("OR") observed in 61% of subjects and a mean Progression Free Survival ("PFS") of at least 11.1 months among those subjects achieving an OR.” Agarwala has previously said that PV-10 could play an important part in the management/treatment of melanoma because of the efficacy it has shown in early and late stages of melanoma. It's also noteworthy that PV-10 has demonstrated a very benign safety profile, with no serious adverse events either.
PV-10 is an interesting molecule whose immunological mechanism will be studied in a Phase 2 study to provide additional evidence of PV-10’s bystander effect. It is currently a part of the FDA’s Compassionate Use Program which provides experimental therapeutics to patients prior to final FDA approval. Provectus is also exploring the use of PV-10 in liver(currently in Phase 1) and breast cancer(completed Phase 1). Provectus is planning for a Phase 2 study of PV-10 for recurrent breast cancer.

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