Last January, I explained why a Phase 3 clinical trial involving an immunotherapy for head and neck cancer owned by the tiny biotech Cel-Sci (CVM) was doomed to deliver a negative outcome. Since then, Cel-Sci shares have soared threefold. The $3 stock now trades above $9.

Was I wrong? Not at all. The Cel-Sci immunotherapy in question, called Multikine, is still destined to fail. (In fact, it already has.) My only error last January was not appreciating the extent to which Cel-Sci was willing to issue a steady flow of misleading and erroneous information about the Multikine Phase 3 clinical trial.

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  • JP asked:

    JP
    OCTOBER 9, 2019 AT 5:26 PM
    “Does STAT checking writer, such as Adam Feuerstein, article before releasing it on the net?”

    JP from what I can see of all the inaccuracies the answer is no.

  • I really hate dealing with innuendoes and inaccuracies from someone who is supposed to be supplying non-biased information but in this case…

    2014 the trial was halted for only two weeks and the IDMC made a decision to continue treating several hundred more patients. There was no reason to announce this since the decision was made to continue. If it was decided to stopped due to issues there would have been an 8K. So what? Thats not even an issue.

    In 2016 the trial was halted and all 928 patients data was reviewed and the decision to continue was again made based on the IDMC recommendation. While it is true that CVM originally wanted to add more patients, by the time the clinical hold was lifted adding more patients would have delayed the trial so it was agreed to not add more. You fail to state anywhere that the trial data was COMPLETELY reviewed at that time and no issues found. No toxicity issues, no deaths. Nothing but data coming in.

    You also fail to mention that CVM had sued the former CRO for their misdeeds and WON. Show me another company that has done that.

    You like to say the trial has failed already and that the company just didn’t tell us. Since you dont have access to the trial data how could you possibly know that with certainty?

    The trial has not failed, it is still very much alive and still waiting on the 928th event which was anticipated last year. The IDMC in March of 2010 reviewed the data again and recommended continuing to wait for the final event. Here we are 6 months later, still no final event. That I can tell you with certainty.

    To imply that the company is keeping data from us is a real stretch. There is no merit at all and to think that 101 trial sites around the world, all those regulatory agencies, CRO and everyone else involved is somehow holding this trial up so the management can continue taking salary is ludicrous.
    But here, if you are saying that the company is just keeping this trial alive to personally benefit can you explain HOW ARE THEY KEEPING THE PATIENTS ALIVE TO PULL THIS OFF?

    And please do explain the above and how it is the CEO doesnt sell a single share, owns near 1.1 million shares is benefitting from this sham of all shams as you imply?

    Opdivo and Keytruda? SCCHN survival data is in the government database, not CVMs. That data includes patients treated with either of those drugs. The extension of life is only 3 months. 3 yr survival rates is 47% overall according to SEER. Keytruda was approved for H&N metastatic and/or unresectable recurring H&N cancer in June of 2019, nearly 3 years after the last patient in the Multikine trial was treated. But lets say I give you the beneift of the doubt that Keytruda has been around as long as Opdivo since 2016. 96 of the trial sites are in other countries. Go down the list and see which ones have Keytruda and Opdivo approved.

    Do tell us, how is it this trial has not reached 298 events? Use either drug for an example on how that would work in a trial that is 8 years old now. The math doesn’t work Adam. Where are the “events” Adam?

    I won’t even go into other bullet points right now. I’d like to see your answers on this comment first.

    As you stated on Twitter, you have been “writing” about CVM since 2009. 10 years Adam. Several times a year. The company keeps forging ahead, the stock price keeps going up. Every day that ticks by makes the results stronger.

    • Correction to the above

      “The trial has not failed, it is still very much alive and still waiting on the 928th event which was anticipated last year.”

      Should read “298th event”

    • All comments are posted, Kevin. However, as STAT’s comment policy states (https://www.statnews.com/comment-policy/):

      STAT reserves the right to remove comments that contain:
      Insults
      Threats or personal attacks
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      Pat Skerrett
      STAT

    • Dear Patrick Skerrett

      Where are the comments posted? Please provide a link? I do not see any comments on AF’s article.

      Thank you

      Kevin

    • Kevin, heres a copy of what I posted earlier.

      Joe
      OCTOBER 9, 2019 AT 12:36 PM
      I really hate dealing with innuendoes and inaccuracies from someone who is supposed to be supplying non-biased information but in this case…

      2014 the trial was halted for only two weeks and the IDMC made a decision to continue treating several hundred more patients. There was no reason to announce this since the decision was made to continue. If it was decided to stopped due to issues there would have been an 8K. So what? Thats not even an issue.

      In 2016 the trial was halted and all 928 patients data was reviewed and the decision to continue was again made based on the IDMC recommendation. While it is true that CVM originally wanted to add more patients, by the time the clinical hold was lifted adding more patients would have delayed the trial so it was agreed to not add more. You fail to state anywhere that the trial data was COMPLETELY reviewed at that time and no issues found. No toxicity issues, no deaths. Nothing but data coming in.

      You also fail to mention that CVM had sued the former CRO for their misdeeds and WON. Show me another company that has done that.

      You like to say the trial has failed already and that the company just didn’t tell us. Since you dont have access to the trial data how could you possibly know that with certainty?

      The trial has not failed, it is still very much alive and still waiting on the 928th event which was anticipated last year. The IDMC in March of 2010 reviewed the data again and recommended continuing to wait for the final event. Here we are 6 months later, still no final event. That I can tell you with certainty.

      To imply that the company is keeping data from us is a real stretch. There is no merit at all and to think that 101 trial sites around the world, all those regulatory agencies, CRO and everyone else involved is somehow holding this trial up so the management can continue taking salary is ludicrous.
      But here, if you are saying that the company is just keeping this trial alive to personally benefit can you explain HOW ARE THEY KEEPING THE PATIENTS ALIVE TO PULL THIS OFF?

      And please do explain the above and how it is the CEO doesnt sell a single share, owns near 1.1 million shares is benefitting from this sham of all shams as you imply?

      Opdivo and Keytruda? SCCHN survival data is in the government database, not CVMs. That data includes patients treated with either of those drugs. The extension of life is only 3 months. 3 yr survival rates is 47% overall according to SEER. Keytruda was approved for H&N metastatic and/or unresectable recurring H&N cancer in June of 2019, nearly 3 years after the last patient in the Multikine trial was treated. But lets say I give you the beneift of the doubt that Keytruda has been around as long as Opdivo since 2016. 96 of the trial sites are in other countries. Go down the list and see which ones have Keytruda and Opdivo approved.

      Do tell us, how is it this trial has not reached 298 events? Use either drug for an example on how that would work in a trial that is 8 years old now. The math doesn’t work Adam. Where are the “events” Adam?

      I won’t even go into other bullet points right now. I’d like to see your answers on this comment first.

      As you stated on Twitter, you have been “writing” about CVM since 2009. 10 years Adam. Several times a year. The company keeps forging ahead, the stock price keeps going up. Every day that ticks by makes the results stronger.

      Reply
      Joe
      OCTOBER 9, 2019 AT 12:39 PM
      Correction to the above

      “The trial has not failed, it is still very much alive and still waiting on the 928th event which was anticipated last year.”

      Should read “298th event”

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