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Galena Biopharma, Inc. Message Board

  • mofisher22 mofisher22 Dec 5, 2012 4:00 PM Flag

    Kaplan, A Yahoo, other knowlegible longs, Question?

    Much has been written and discussed re. Nuevax, and the trials that have been done. I understand the final completed phase one and two will be disclosed Friday. Since they are already in phase 3, were they allowed to proceed to phade 3 before phase 2 was complete? Was it based on partial phase 2 results? What exactly is the difference of opinion re the results and/or trial makeup/setup? I know Adam F. has tried to tear the results and prospects apart. Others have put forth compelling points with an opposing view to his. I know that Dr. Peoples in San Antonio Air Force hospital is the lead Dr on these trials. I understand that if successful, Nuevax is supposed to complement the Roche drug and basically treat what it can not treat. I have heard there may be problems with the size of the trials, is this true? I have seen stories and videio that seems to give positive statements from patients who have received the treatment. Wasn'y yhere some concrete numbers that are already known as to results from phase one and two. and I recall those being good. The presentation is on Friday, after market close, so I imagine many people will be somewhat anxious to see what is presented. What might be presented at the presentation that might be negative for Nuevax? So, I am asking you knowlegible longs to address these questions and also to add all documantation that you know about Nuevax and the trials that will help me and other less informed investors to more fully understand the complete story of Nuevax. Please do not respond with any comments such as go do your own dd, because many of us would prob not be able to decipher all the medical nuances of the trials. Thanks in advance. glta

    Sentiment: Strong Buy

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    • mo, your question is alot of d.d. ..........but the short end ; i read ph II started in 2001? there has been a few trials with different mixes of nuevax. the best combo with a final "booster' . low to interm subjects are going to be the best results for prevention of reoccurrence in ph III as they can prove from previous trials.............which they are going to show us friday. a 5 year follow up to ph II.hopefully close to 0% reoccurence and the pps hits the roof.JMHO

      Sentiment: Hold

    • I'll do my best to address some of your questions.

      "Since they are already in phase 3, were they allowed to proceed to phade 3 before phase 2 was complete? Was it based on partial phase 2 results? What exactly is the difference of opinion re the results and/or trial makeup/setup?"

      Phase 2 was a 2-3 year study which is now over. Phase 3 was launched based on the positive results from this completed trial with the FDA's blessing. After Phase 2 GALE essentially extended the trial in order to continue to monitor the progress of the patients over a 5 year time-frame. The data we see on Friday will not effect the phase 3 trial in anyway (barring some devastating safety concern).

      For the purposes of this breast cancer patients can be divided into 2 groups, node-negative and node-positive, and further based on the expression of HER2 can be HER2 1+, 2+ or 3+ (low, intermediate or high). The Phase 2 study had all of these types of patients. Analysis of the 3 year data showed that patients who were node-positive with low or intermediate HER2 showed the most benefit from NeuVax, this is the population which is targeted for the phase 3 study.

      AF et al have argued that the neuvax arm of the phase 2 trial had benefits that the control arm didn't which would skew the results. The major benefit is that more patients in the neuvax group were treated with herceptin which is known to decrease recurrence rates. What AF fails to mention is that even if this difference is taken into account the vaccinated group still shows statistically significant improvement over the control arm.

      AF has also argued that if neuvax works with low-intermediate HER2 expression it should work with high levels, since it didn't, this is proof that the vaccine doesn't work at all. This argument is a perfect example of a complete lack of knowledge about immunology and oncology. High HER2 is associated with extremely aggressive cancers which are known to not respond as well to vaccination. In addition, extremely high levels of antigens have been shown to have a neutralizing effect on the immune system in which the normal kinds of immune functions do not operate in the same way as would be expected. A difference in efficacy of a vaccine on low/intermediate HER2 patients and High HER2 patients is not evidence of anything other than a difference in biology between these types of cancer, which is already known.

      • 1 Reply to A Yahoo! User
      • "I have heard there may be problems with the size of the trials, is this true?"

        I wouldn't say it's a problem. The sample size is small, but this is not unusual for a phase 2 trial, that's why we have phase 3 and don't approve drugs with only phase 2 data. Phase 2 accomplished exactly what it was supposed to accomplish. It examined any possible safety issues with the vaccine and it identified which populations of patients the drug was most appropriate for and showed the most efficacy. The phase 3 trial is launched to examine on a large scale the efficacy of the drug.

        It's also worth noting that although the phase 2 sample size is small the fact that the results remain statistically significant over the long term makes this less of a problem.

    • I'll do my best to address some of your questions.

      "Since they are already in phase 3, were they allowed to proceed to phade 3 before phase 2 was complete? Was it based on partial phase 2 results? What exactly is the difference of opinion re the results and/or trial makeup/setup?"

      Phase 2 was a 2-3 year study which is now over. Phase 3 was launched based on the positive results from this completed trial with the FDA's blessing. After Phase 2 GALE essentially extended the trial in order to continue to monitor the progress of the patients over a 5 year time-frame. The data we see on Friday will not effect the phase 3 trial in anyway (barring some devastating safety concern).

      For the purposes of this breast cancer patients can be divided into 2 groups, node-negative and node-positive, and further based on the expression of HER2 can be HER2 1+, 2+ or 3+ (low, intermediate or high). The Phase 2 study had all of these types of patients. Analysis of the 3 year data showed that patients who were node-positive with low or intermediate HER2 showed the most benefit from NeuVax, this is the population which is targeted for the phase 3 study.

      AF et al have argued that the neuvax arm of the phase 2 trial had benefits that the control arm didn't which would skew the results. The major benefit is that more patients in the neuvax group were treated with herceptin which is known to decrease recurrence rates. What AF fails to mention is that even if this difference is taken into account the vaccinated group still shows statistically significant improvement over the control arm.

      AF has also argued that if neuvax works with low-intermediate HER2 expression it should work with high levels, since it didn't, this is proof that the vaccine doesn't work at all. This argument is a perfect example of a complete lack of knowledge about immunology and oncology. High HER2 is associated with extremely aggressive cancers which are known to not respond as well to vaccination. In addition, extremely high levels of antigens have been shown to have a neutralizing effect on the immune system in which the normal kinds of immune functions do not operate in the same way as would be expected. A difference in efficacy of a vaccine on low/intermediate HER2 patients and High HER2 patients is not evidence of anything other than a difference in biology between these types of cancer, which is already known.

      "I have heard there may be problems with the size of the trials, is this true?"

      I wouldn't say it's a problem. The sample size is small, but this is not unusual for a phase 2 trial, that's why we have phase 3 and don't approve drugs with only phase 2 data. Phase 2 accomplished exactly what it was supposed to accomplish. It examined any possible safety issues with the vaccine and it identified which populations of patients the drug was most appropriate for and showed the most efficacy. The phase 3 trial is launched to examine on a large scale the efficacy of the drug.

      It's also worth noting that although the phase 2 sample size is small the fact that the results remain statistically significant over the long term makes this less of a problem.

      " What might be presented at the presentation that might be negative for Nuevax?"

      Friday's presentation will not effect the phase 3 trial. What we can expect is an update on the presentation given in june. It will be 5 year follow-up data on the patients in the phase 2 trial. I expect the results to show that reoccurrence rates in the vaccinated patients continue to remain statistically lower than the control arm. If they show that the enough reoccurrences have shown up in the vaccinated group compared to the control group this would be negative but not devastating in the long run. The vaccine has already been proven effective over at least 3 years, and still offers benefit to breast cancer patients. That being said, we have already seen partial 5 year data which has been positive and I expect Friday will just be confirmation that the vaccine is effective over the long term.

      I can't post links here, but for DD check out the company website. As well, several SA articles have been written which give exact numbers as well as interviews with Ahn and Peoples regarding the make up of the trials and various criticisms.

      I'd like to reitterate that Neuvax is still a risky investment. Phase 2 data was promising, but nothing short of solid long-term large-scale phase 3 data will make this a success. AF's arguments are illogical and in some cases completely false, but there are still risks in investing in a early stage company, nothing is risk free.

      Also, I wouldn't read too much into the TEVA deal. It's nice, but TEVA is essentially saying that IF phase 3 data is positive, THEN we will provide money for commercialization. Basically, if galena has a successful drug they will put up some cash to make sure they get a piece of the pie.

      Hope this helps a bit.

      //Deaux

    • I'll do my best to address some of your questions.

      "Since they are already in phase 3, were they allowed to proceed to phade 3 before phase 2 was complete? Was it based on partial phase 2 results? What exactly is the difference of opinion re the results and/or trial makeup/setup?"

      Phase 2 was a 2-3 year study which is now over. Phase 3 was launched based on the positive results from this completed trial with the FDA's blessing. After Phase 2 GALE essentially extended the trial in order to continue to monitor the progress of the patients over a 5 year time-frame. The data we see on Friday will not effect the phase 3 trial in anyway (barring some devastating safety concern).

      For the purposes of this breast cancer patients can be divided into 2 groups, node-negative and node-positive, and further based on the expression of HER2 can be HER2 1+, 2+ or 3+ (low, intermediate or high). The Phase 2 study had all of these types of patients. Analysis of the 3 year data showed that patients who were node-positive with low or intermediate HER2 showed the most benefit from NeuVax, this is the population which is targeted for the phase 3 study.

      AF et al have argued that the neuvax arm of the phase 2 trial had benefits that the control arm didn't which would skew the results. The major benefit is that more patients in the neuvax group were treated with herceptin which is known to decrease recurrence rates. What AF fails to mention is that even if this difference is taken into account the vaccinated group still shows statistically significant improvement over the control arm.

      AF has also argued that if neuvax works with low-intermediate HER2 expression it should work with high levels, since it didn't, this is proof that the vaccine doesn't work at all. This argument is a perfect example of a complete lack of knowledge about immunology and oncology. High HER2 is associated with extremely aggressive cancers which are known to not respond as well to vaccination. In addition, extremely high levels of antigens have been shown to have a neutralizing effect on the immune system in which the normal kinds of immune functions do not operate in the same way as would be expected. A difference in efficacy of a vaccine on low/intermediate HER2 patients and High HER2 patients is not evidence of anything other than a difference in biology between these types of cancer, which is already known.

      "I have heard there may be problems with the size of the trials, is this true?"

      I wouldn't say it's a problem. The sample size is small, but this is not unusual for a phase 2 trial, that's why we have phase 3 and don't approve drugs with only phase 2 data. Phase 2 accomplished exactly what it was supposed to accomplish. It examined any possible safety issues with the vaccine and it identified which populations of patients the drug was most appropriate for and showed the most efficacy. The phase 3 trial is launched to examine on a large scale the efficacy of the drug.

      It's also worth noting that although the phase 2 sample size is small the fact that the results remain statistically significant over the long term makes this less of a problem.

      " What might be presented at the presentation that might be negative for Nuevax?"

      Friday's presentation will not effect the phase 3 trial. What we can expect is an update on the presentation given in june. It will be 5 year follow-up data on the patients in the phase 2 trial. I expect the results to show that reoccurrence rates in the vaccinated patients continue to remain statistically lower than the control arm. If they show that the enough reoccurrences have shown up in the vaccinated group compared to the control group this would be negative but not devastating in the long run. The vaccine has already been proven effective over at least 3 years, and still offers benefit to breast cancer patients. That being said, we have already seen partial 5 year data which has been positive and I expect Friday will just be confirmation that the vaccine is effective over the long term.

      I can't post links here, but for DD check out the company website. As well, several SA articles have been written which give exact numbers as well as interviews with Ahn and Peoples regarding the make up of the trials and various criticisms.

      I'd like to reitterate that Neuvax is still a risky investment. Phase 2 data was promising, but nothing short of solid long-term large-scale phase 3 data will make this a success. AF's arguments are illogical and in some cases completely false, but there are still risks in investing in a early stage company, nothing is risk free.

      Also, I wouldn't read too much into the TEVA deal. It's nice, but TEVA is essentially saying that IF phase 3 data is positive, THEN we will provide money for commercialization. Basically, if galena has a successful drug they will put up some cash to make sure they get a piece of the pie.

      Hope this helps a bit.

      //Deaux

    • Question is: Why would Teva entered into an agreement with GALE when the end results PI/II should beĀ negative? :)

      Sentiment: Buy

      • 1 Reply to apricusbio.eu33
      • nick and apricus, yes, I tend to think the way re TEVA. Also, by them presenting at the conference, makes no sense they would present failure, if no good, I would think they would just announce it and go away. However, I have been burned by several stocks for various reasons, and I know there are people out there who make it their business to try to bring down stocks, such as the prop think article that cratered GALE last month. Also, Adam F. has caused negative impact on GALE with his articles. I just want more affirmation as regards refuting those negative articles and comments. I got hammered last month by the DVAX adcom result, when all signs had pointed to a positive vote, it got voted down on safty, even though many people thought the vote unjust. So, I am trying to learn all I can before Friday.

        Sentiment: Buy

    • Hello Mo: drop me a line using the same name and two digits as appear (for me) within the context of this Board - the suffix to my email is the standard suffix associated with the email service of this host. If i receive your communications i'll be happy to follow through with substantial data. Dan

      Sentiment: Buy

    • all you need to know for now is that TEVA did the deal and they would not have done so if the science is bogus.

      friday is a few days away, no biggy to wait.

      more upside than downside is probable.

 
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