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Phase II PV-10 Trial Results
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Phase II PV-10 Trial Results

› Forums › General Melanoma Community › Phase II PV-10 Trial Results

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      • October 30, 2014 at 2:31 am
      RJoeyB
      Participant

        It's very interesting stuff and agreed that its biggest role (like with T-Vec) might be in combination with other systemic agents with the "abscopal effect".  What's bothered me, specifically with PV-10, is that they've been reporting on this same Phase II trial that was completed over two years ago, I think.  There was a dust-up in May just before ASCO with the FDA when they tried to get some kind of breakthrough designation based on the study results, but the FDA denied them (again, having done so multiple times already), telling them they needed to conduct more trials with more participants, and also essentially saying to stop asking for the same thing without more data.  I'll see if I can find the links.  Supposedly a larger Phase III trial is coming, but I think I've been reading that for over a year.  Like anything with new therapies, I so much want to hear about it as a success story, and I believe the results that they've published, but keep wondering what's really going on, and why all the delays in expanded trials.

          • October 30, 2014 at 2:53 am
          RJoeyB
          Participant

            Here's one take on on the trial history and interactions with the FDA, written back in January (granted from a financial site):

             
            This is the FDA's rejection letter from May:
             
             
            And the part that I now remember really bugging me was this:
             
            "FDA previously communicated concerns regarding the development program and provided advice regarding the type of data that should be systematically collected to investigate the clinical benefit(s) of an intratumoral treatment of a subset of individual lesions in a systemic disease (malignant melanoma), as previously discussed at the April 8, 2010, March 7, 2011, and October 18, 2011, end-of-Phase 2 meetings and the December 16, 2013 General Guidance teleconference."
             
            Four years of advice from the FDA about what they expected to move forward.  That could very well be the FDA being too obstructive, too, but at some point, Provectus needs to move this forward.
             
            • October 30, 2014 at 6:48 pm
            BrianP
            Participant

              Thanks Joe.  After I posted the article I googled "PV-10" and went to this link:

              https://www.pvct.com/pv10melanoma.html

              After reading it I was a little confused of the timeline because like you pointed out the Phase II results are about 2 years old.  Sounds like to me it's good science but bad execution by the company.  Hopefully things will start moving in the right direction.  Like Celeste I think this has huge niche potential.

              Brian

              • October 30, 2014 at 6:48 pm
              BrianP
              Participant

                Thanks Joe.  After I posted the article I googled "PV-10" and went to this link:

                https://www.pvct.com/pv10melanoma.html

                After reading it I was a little confused of the timeline because like you pointed out the Phase II results are about 2 years old.  Sounds like to me it's good science but bad execution by the company.  Hopefully things will start moving in the right direction.  Like Celeste I think this has huge niche potential.

                Brian

                • October 30, 2014 at 6:48 pm
                BrianP
                Participant

                  Thanks Joe.  After I posted the article I googled "PV-10" and went to this link:

                  https://www.pvct.com/pv10melanoma.html

                  After reading it I was a little confused of the timeline because like you pointed out the Phase II results are about 2 years old.  Sounds like to me it's good science but bad execution by the company.  Hopefully things will start moving in the right direction.  Like Celeste I think this has huge niche potential.

                  Brian

                  • October 30, 2014 at 2:53 am
                  RJoeyB
                  Participant

                    Here's one take on on the trial history and interactions with the FDA, written back in January (granted from a financial site):

                     
                    This is the FDA's rejection letter from May:
                     
                     
                    And the part that I now remember really bugging me was this:
                     
                    "FDA previously communicated concerns regarding the development program and provided advice regarding the type of data that should be systematically collected to investigate the clinical benefit(s) of an intratumoral treatment of a subset of individual lesions in a systemic disease (malignant melanoma), as previously discussed at the April 8, 2010, March 7, 2011, and October 18, 2011, end-of-Phase 2 meetings and the December 16, 2013 General Guidance teleconference."
                     
                    Four years of advice from the FDA about what they expected to move forward.  That could very well be the FDA being too obstructive, too, but at some point, Provectus needs to move this forward.
                     
                    • October 30, 2014 at 2:53 am
                    RJoeyB
                    Participant

                      Here's one take on on the trial history and interactions with the FDA, written back in January (granted from a financial site):

                       
                      This is the FDA's rejection letter from May:
                       
                       
                      And the part that I now remember really bugging me was this:
                       
                      "FDA previously communicated concerns regarding the development program and provided advice regarding the type of data that should be systematically collected to investigate the clinical benefit(s) of an intratumoral treatment of a subset of individual lesions in a systemic disease (malignant melanoma), as previously discussed at the April 8, 2010, March 7, 2011, and October 18, 2011, end-of-Phase 2 meetings and the December 16, 2013 General Guidance teleconference."
                       
                      Four years of advice from the FDA about what they expected to move forward.  That could very well be the FDA being too obstructive, too, but at some point, Provectus needs to move this forward.
                       
                    • October 30, 2014 at 2:31 am
                    RJoeyB
                    Participant

                      It's very interesting stuff and agreed that its biggest role (like with T-Vec) might be in combination with other systemic agents with the "abscopal effect".  What's bothered me, specifically with PV-10, is that they've been reporting on this same Phase II trial that was completed over two years ago, I think.  There was a dust-up in May just before ASCO with the FDA when they tried to get some kind of breakthrough designation based on the study results, but the FDA denied them (again, having done so multiple times already), telling them they needed to conduct more trials with more participants, and also essentially saying to stop asking for the same thing without more data.  I'll see if I can find the links.  Supposedly a larger Phase III trial is coming, but I think I've been reading that for over a year.  Like anything with new therapies, I so much want to hear about it as a success story, and I believe the results that they've published, but keep wondering what's really going on, and why all the delays in expanded trials.

                      • October 30, 2014 at 2:31 am
                      RJoeyB
                      Participant

                        It's very interesting stuff and agreed that its biggest role (like with T-Vec) might be in combination with other systemic agents with the "abscopal effect".  What's bothered me, specifically with PV-10, is that they've been reporting on this same Phase II trial that was completed over two years ago, I think.  There was a dust-up in May just before ASCO with the FDA when they tried to get some kind of breakthrough designation based on the study results, but the FDA denied them (again, having done so multiple times already), telling them they needed to conduct more trials with more participants, and also essentially saying to stop asking for the same thing without more data.  I'll see if I can find the links.  Supposedly a larger Phase III trial is coming, but I think I've been reading that for over a year.  Like anything with new therapies, I so much want to hear about it as a success story, and I believe the results that they've published, but keep wondering what's really going on, and why all the delays in expanded trials.

                        • October 30, 2014 at 1:49 pm
                        rjr11273
                        Participant

                          This clearly looks like a penny stock scam. I wouldn't expect anything else to come of this

                          • October 30, 2014 at 1:49 pm
                          rjr11273
                          Participant

                            This clearly looks like a penny stock scam. I wouldn't expect anything else to come of this

                            • October 30, 2014 at 1:49 pm
                            rjr11273
                            Participant

                              This clearly looks like a penny stock scam. I wouldn't expect anything else to come of this

                              • October 30, 2014 at 2:47 pm
                              Bubbles
                              Participant

                                I'm with Brian on this one…as were many of the researchers at ASCO.  Intralesional therapy (PV-10, IL-2, T-VEC, and others) are being spoken very well of by many of the top dogs in melanoma world today.  No one is saying they will rid us all of melanoma…but for those with a persistent non-responsive accessible lesion, intralesional therapy may be a real boon…and if there is death of an additional by-stander lesion or two….as more and more data is demonstrating….all the better!!!  To quote Weber on how researchers are looking at these drugs:  "Injectable therapies are making a comeback.….eons ago we were injecting BCG, interferon, and IL-2 into local-regional melanoma metastasis….now there are some interesting drugs, and T-VEC is one of them.  I see this as a niche drug that would be best used to prime the immune system and follow up with a drug such as pembrolizumab, nivolumab, ipi, or a combination of those….that's where I see intralesional therapy going."  Certainly something I would be willing to try should I have the need.  Low risk to health.  Potential death to a tumor.  Hopefully, they will prove helpful to more folks as time goes by.  Celeste

                                  • October 30, 2014 at 6:31 pm
                                  RJoeyB
                                  Participant

                                    Agreed on the intralesionals, I wasn't trying to discount them.  I've actually posted elsewhere about them with a positive view, whether as a monotherapy for someone with low but unresectable tumor burden, in combination with immunotherapy with perhaps some abscopal effect, or as a way to reduce a specific unresectable tumor (I was hoping it would be an option for Shane who has posted here about a troublesome tumor that is preventing him from beginning his TIL treatment).  I think these injectionables are another opportunity for another "tool in the toolbox":  T-Vec, PV-10, injectionable IL-2, electroporated IL-12 (OncoSec ImmunoPulse).  I'm just a little leery right now about PV-10, because of the trial and FDA issues I wrote about above — I've been hearing about it for perhaps two years now, and I periodically see a "new" news story in my research, get excited, then go read about it and it's just a new report about the same trial, which is frustrating.  I hope I didn't give the impression that I've completely discounted either PV-10 or certainly not the entire category of intralesionals/injectionables.

                                    Joe

                                    • October 30, 2014 at 6:31 pm
                                    RJoeyB
                                    Participant

                                      Agreed on the intralesionals, I wasn't trying to discount them.  I've actually posted elsewhere about them with a positive view, whether as a monotherapy for someone with low but unresectable tumor burden, in combination with immunotherapy with perhaps some abscopal effect, or as a way to reduce a specific unresectable tumor (I was hoping it would be an option for Shane who has posted here about a troublesome tumor that is preventing him from beginning his TIL treatment).  I think these injectionables are another opportunity for another "tool in the toolbox":  T-Vec, PV-10, injectionable IL-2, electroporated IL-12 (OncoSec ImmunoPulse).  I'm just a little leery right now about PV-10, because of the trial and FDA issues I wrote about above — I've been hearing about it for perhaps two years now, and I periodically see a "new" news story in my research, get excited, then go read about it and it's just a new report about the same trial, which is frustrating.  I hope I didn't give the impression that I've completely discounted either PV-10 or certainly not the entire category of intralesionals/injectionables.

                                      Joe

                                      • October 31, 2014 at 8:47 am
                                      rick1981
                                      Participant

                                        The forbes article just got updated, with some critical response from an oncologist:

                                        http://www.forbes.com/sites/jonfortenbury/2014/10/29/a-new-cancer-drug-worked-in-over-50-of-patients-in-a-phase-ii-trial/

                                        • October 31, 2014 at 8:47 am
                                        rick1981
                                        Participant

                                          The forbes article just got updated, with some critical response from an oncologist:

                                          http://www.forbes.com/sites/jonfortenbury/2014/10/29/a-new-cancer-drug-worked-in-over-50-of-patients-in-a-phase-ii-trial/

                                          • October 31, 2014 at 8:47 am
                                          rick1981
                                          Participant

                                            The forbes article just got updated, with some critical response from an oncologist:

                                            http://www.forbes.com/sites/jonfortenbury/2014/10/29/a-new-cancer-drug-worked-in-over-50-of-patients-in-a-phase-ii-trial/

                                            • October 30, 2014 at 6:31 pm
                                            RJoeyB
                                            Participant

                                              Agreed on the intralesionals, I wasn't trying to discount them.  I've actually posted elsewhere about them with a positive view, whether as a monotherapy for someone with low but unresectable tumor burden, in combination with immunotherapy with perhaps some abscopal effect, or as a way to reduce a specific unresectable tumor (I was hoping it would be an option for Shane who has posted here about a troublesome tumor that is preventing him from beginning his TIL treatment).  I think these injectionables are another opportunity for another "tool in the toolbox":  T-Vec, PV-10, injectionable IL-2, electroporated IL-12 (OncoSec ImmunoPulse).  I'm just a little leery right now about PV-10, because of the trial and FDA issues I wrote about above — I've been hearing about it for perhaps two years now, and I periodically see a "new" news story in my research, get excited, then go read about it and it's just a new report about the same trial, which is frustrating.  I hope I didn't give the impression that I've completely discounted either PV-10 or certainly not the entire category of intralesionals/injectionables.

                                              Joe

                                            • October 30, 2014 at 2:47 pm
                                            Bubbles
                                            Participant

                                              I'm with Brian on this one…as were many of the researchers at ASCO.  Intralesional therapy (PV-10, IL-2, T-VEC, and others) are being spoken very well of by many of the top dogs in melanoma world today.  No one is saying they will rid us all of melanoma…but for those with a persistent non-responsive accessible lesion, intralesional therapy may be a real boon…and if there is death of an additional by-stander lesion or two….as more and more data is demonstrating….all the better!!!  To quote Weber on how researchers are looking at these drugs:  "Injectable therapies are making a comeback.….eons ago we were injecting BCG, interferon, and IL-2 into local-regional melanoma metastasis….now there are some interesting drugs, and T-VEC is one of them.  I see this as a niche drug that would be best used to prime the immune system and follow up with a drug such as pembrolizumab, nivolumab, ipi, or a combination of those….that's where I see intralesional therapy going."  Certainly something I would be willing to try should I have the need.  Low risk to health.  Potential death to a tumor.  Hopefully, they will prove helpful to more folks as time goes by.  Celeste

                                              • October 30, 2014 at 2:47 pm
                                              Bubbles
                                              Participant

                                                I'm with Brian on this one…as were many of the researchers at ASCO.  Intralesional therapy (PV-10, IL-2, T-VEC, and others) are being spoken very well of by many of the top dogs in melanoma world today.  No one is saying they will rid us all of melanoma…but for those with a persistent non-responsive accessible lesion, intralesional therapy may be a real boon…and if there is death of an additional by-stander lesion or two….as more and more data is demonstrating….all the better!!!  To quote Weber on how researchers are looking at these drugs:  "Injectable therapies are making a comeback.….eons ago we were injecting BCG, interferon, and IL-2 into local-regional melanoma metastasis….now there are some interesting drugs, and T-VEC is one of them.  I see this as a niche drug that would be best used to prime the immune system and follow up with a drug such as pembrolizumab, nivolumab, ipi, or a combination of those….that's where I see intralesional therapy going."  Certainly something I would be willing to try should I have the need.  Low risk to health.  Potential death to a tumor.  Hopefully, they will prove helpful to more folks as time goes by.  Celeste

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