Provectus News Provectus Biopharmaceuticals Op
Post# of 23098
Posted On: 04/15/2015 8:32:13 PM
Provectus News
Provectus Biopharmaceuticals Opens Patient Enrollment; Begins Phase 3 International FDA Comparative Clinical Trial of PV-10 for Melanoma
Interim Data Expected When 50% of Events Achieved
Wednesday April 15, 2015
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus"
, enters phase 3 and has opened enrollment of patients for its phase 3 international FDA comparative clinical trial of PV-10 for melanoma. The Company is seeking 225 patients and enrollment has begun at St. Luke's University Hospital and Health Network, Bethlehem, PA, the first study site to be opened, with additional sites to be added in the coming weeks and months.
The study is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600 wild-type and have failed or are not otherwise candidates for ipilimumab or another immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms. The Primary Outcome Measure is progression-free survival (PFS) to be assessed every 12 weeks up to 18 months
The Secondary Outcome Measures include complete response rate (CRR) and its duration (to be assessed every 12 weeks up to 18 months); and Overall survival (OS) to be assessed every 12 weeks up to 18 months.
Safety and tolerability will be assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs. For more details on the study, please visit https://www.clinicaltrials.gov/ct2/show/NCT02288897 Top-line results from the phase 2 trial have been posted on clinicaltrials.gov, for the study entitled "Phase 2 study of Intralesional PV-10 for Metastatic Melanoma," [NCT00521053]. https://clinicaltrials.gov/ct2/show/NCT00521053.
For a complete history of Provectus' research into PV-10 as a treatment for melanoma, visit https://www.pvct.com/pv10melanoma.html
The complete press release is available at www.pvct.com/pressrelease.html?article=20140415.1 on the Provectus website.
Provectus Biopharmaceuticals Opens Patient Enrollment; Begins Phase 3 International FDA Comparative Clinical Trial of PV-10 for Melanoma
Interim Data Expected When 50% of Events Achieved
Wednesday April 15, 2015
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus"
, enters phase 3 and has opened enrollment of patients for its phase 3 international FDA comparative clinical trial of PV-10 for melanoma. The Company is seeking 225 patients and enrollment has begun at St. Luke's University Hospital and Health Network, Bethlehem, PA, the first study site to be opened, with additional sites to be added in the coming weeks and months. The study is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600 wild-type and have failed or are not otherwise candidates for ipilimumab or another immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms. The Primary Outcome Measure is progression-free survival (PFS) to be assessed every 12 weeks up to 18 months
The Secondary Outcome Measures include complete response rate (CRR) and its duration (to be assessed every 12 weeks up to 18 months); and Overall survival (OS) to be assessed every 12 weeks up to 18 months.
Safety and tolerability will be assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs. For more details on the study, please visit https://www.clinicaltrials.gov/ct2/show/NCT02288897 Top-line results from the phase 2 trial have been posted on clinicaltrials.gov, for the study entitled "Phase 2 study of Intralesional PV-10 for Metastatic Melanoma," [NCT00521053]. https://clinicaltrials.gov/ct2/show/NCT00521053.
For a complete history of Provectus' research into PV-10 as a treatment for melanoma, visit https://www.pvct.com/pv10melanoma.html
The complete press release is available at www.pvct.com/pressrelease.html?article=20140415.1 on the Provectus website.
(0)
(0)
I'm in it to win it!
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'