Nymox claims “success” in Phase II trial of NX-1207 in low-risk prostate cancer


According to a media release issued today by Nymox Pharmaceutical Corp., their investigational drug NX-1207 (now properly known by the generic name fexapotide triflutate) successfully met the designated endpoints for a Phase II clinical trial of this drug in treatment of men with low-grade, localized prostate cancer.

Now, as we have indicated all along, there are very serious questions about whether any of these patients actually needed treatment at all at the time that they were initially entered into this study, so it is difficult to ascertain exactly what the real benefit is (or is not) from this form of treatment. However, here is what Nymox is now reporting in their media statement:

  • The trial enrolled 147 patients with low-risk prostate cancer (specifically, clinical stage T1c, a Gleason score of 6 or less, a PSA level of ≤ 10 ng/ml, and a single positive prostate biopsy core with ≤ 50 percent cancer)
  • Patients were managed in one of three ways:
    • With active surveillance alone (and no active treatment), i.e., “control” patients
    • With a single, intraprostatic injection of fexapotide trifluate at a dose of 2.5 mg “followed by active surveillance” or
    • With a single, intraprostatic injection of fexapotide trifluate at a dose of 15 mg, “followed by active surveillance.”
  • The primary study endpoint was absence of tumor post-treatment in the region of the prostate where the baseline cancer was detected.
  • All patients were followed for a minimum of 18 months.

Post-treatment outcomes are said to be that

  • Absence of tumors “controlled for size in baseline area” was
    • Superior in men treated with fexapotide 15 mg as opposed to the control patients (p = 0.035)
    • Superior in men crossed over to fexapotide 15 mg as opposed to the control patients (p = 0.002)
    • Superior in men crossed over to fexapotide overall as opposed to the control patients (p = 0.014)
    • However, there is no mention of any cross-over design in  the actual study protocol
  • After at least 18 months of follow-up, there was
    • A 75.5 percent reduction in biopsy-proven prostate cancer Gleason upgrades (pathological progression) in patients treated with fexapotide 15 mg compared to control patients (p = 0.0055)
    • A 71.7 percent reduction in prostate cancer Gleason upgrades in fexapotide-treated patients overall compared to control patients (p = 0.0045)
    • An 84.8 percent reduction in surgery or radiotherapy in patients with biopsy-proven Gleason upgrades treated with fexapotide overall compared to control group patients (p = 0.014).
    • A 54.8 percent reduction in surgery or radiotherapy instituted for all causes in patients with or without prostate cancer Gleason upgrade treated with fexapotide 15 mg compared to control patients (p = 0.026).
  • In addition there were improvements for fexapotide patients compared to controls in all four of the secondary study endpoints.
  • There were no significant drug-related adverse events and no significant related sexual adverse events reported.
  • Overall superior results for the fexapotide 15 mg dose compared to the 2.5 mg dose.

Nymox’s CEO is quoted as follows in the company’s media release:

These results demonstrate that a single targeted office injection of fexapotide has led to statistically significant improvement in outcomes with much less surgery or radiotherapy required after 18 months. This means a reduction in patient discomfort, and a reduction in permanent side effects and life changes when the more invasive treatments are required.

He continues by stating that

Based on these outcomes, we believe there are exciting potential patient benefits from one or more painless fexapotide office injections for this common and distressing condition.

The company also implies that it will be presenting data from this study at upcoming medical meetings.

Frankly, The “New” Prostate Cancer InfoLink has no idea what to make of these data. You take a group of men who show no indication that they need treatment. You treat many of them (although it is unclear from the media release or the study summary on ClinicalTrials.gov whether the patients were randomized to one or other of the three study arms or how many patients were enrolled in each of the three arms), and then you claim success without providing any data on the numbers of patients who are said not to need surgery or radiation therapy … and all this with a drug that has no side effects.

Now if these were results in men with even favorable, intermediate-risk prostate cancer (i.e., clinical stage T1c or T2a, PSA ≤ 10, a Gleason score of 3 + 4 = 7), then one might be able to see what the fuss was about, but the patients enrolled in this trial were so low risk that giving them the drug might have had nothing to do with the actual outcomes described!

We should be clear that, at this time, there is no randomized Phase III clinical trial in progress or scheduled to test the effectiveness and safety of NX-1207 in prostate cancer.

10 Responses

  1. Why don’t they publish this in a peer reviewed journal?

  2. I am sure that they will seek to do exactly that.

  3. “You take a group of men who show no indication that they need treatment.”

    It’s nice that you say that but unfortunately, in some places, there are almost as many prostatectomies being done as there ever have been.

    So the sad fact is that there are still a lot of urology surgeons out there who, unlike you, still think men in this group should be aggressively treated.

  4. David,

    Picture the TV adds.

    Similar to the ED adds, with a beautiful woman purring, “The superior choice for unnecessary treatments of your man.”

  5. David:

    And equally unfortunately there are a lot of newly diagnosed patients (and their family members) who freak out when they hear the word “cancer” and insist on treatment of some type even though they are very clearly advised that active monitoring or watchful waiting will be entirely appropriate because the chance that this form of cancer will lead to their deaths is near to non-existent. Not all of that unnecessary treatment is because urologic surgeons are recommending it.

  6. What is so bad about any poor guy with a proven Gleason 6 wanting to get rid of it with a single 15 mg shot that takes only minutes? What would be wrong with having a shot like this every 5 years or so, potentially keeping “widespread” Gleason 6 or even more aggressive prostate cancer at bay? Kicking the can down the road so to speak. Basically no side effects!

    Just scrap the whole thing, they can make more money anyway with surgery and destroy your life. Instead let’s just listen to the negative skeptic (who is most likely a surgeon) and can the whole idea. Yea, that’s the ticket. … Just have surgery and ruin your life. Yes, just give up.

    Does not anyone realize that certain people in this BUSINESS are threatened by any new developments or potential breakthroughs?

    Morons.

  7. Dear Shane:

    When Nymox publishes some peer-reviewed data to show how well (or not) the product actually works, we’ll be in a better position to discuss your premise. At present we have no real data, and the one thing I know for certain is that there is no such thing as a drug that “has no side effects”. Even things like Mylanta have side effects (albeit very few).

    And then there is the other question. What do you think Nymox is going to want to charge for what they appear to see as a “miracle drug”?

    Many of us would love to see the availability of a high-quality, low risk, reasonably priced therapy for low-risk prostate cancer. But I know of no data to suggest that Nymox’s product is capable of preventing clinically significant prostate cancer at all.

  8. It’s certainly curious that there is no Phase III trial underway of NX-1207 for prostate cancer. But there have been completed clinical trials of this drug for BPH.

    Perhaps Nymox’s game plan — just my speculation — is to first get FDA approval for the BPH indication, and then hope that doctors start using it off-label for prostate cancer based on phase II trials like this.

    But even for BPH, approval seems a long time in coming. Two phase III trials (NCT00918983 and NCT00945490) are reported to have completed in April 2013 and May 2014 respectively. Two subsequent Phase III trials (NCT01438775 and NCT01846793) involved giving a second 2.5 mg injection to the participants of the earlier trials. The latter trials notably have safety as their primary endpoint. So perhaps Nymox is having a hard time convincing the FDA that this treatment does not have unacceptable risks or side effects.

    There was an earlier Phase II trial that concluded NX-1207 is non-inferior to finasteride for BPH. (But given the choice of a daily pill or a transrectal injection, I know which I would choose.)

    I have not found any published result of any of these phase III trials. And no indication of how the drug works, other than that it is a protein that induces apoptosis in cells. So I agree with Sitemaster that until Nymox publishes some peer-reviewed data, we really have nothing to go on.

  9. Dear Tom:

    In July last year the company issued this media release stating that Nymox “intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals” (whatever that means). To date there has been no media release whatsoever indicating that they have actually competed such a filing.

    Frankly, this fact, taken in concert with the utter lack of any published data whatsoever, only adds to my concern that the rat I have been smelling for some time now appears to have an increasingly strong aroma. If I had been an investor in this company I would want a detailed and public explanation from the CEO, and my lawyers would be pursuing this with alacrity.

  10. Dear Tom:

    In July last year the company issued this media release stating that Nymox “intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals” (whatever that means). To date there has been no media release whatsoever indicating that they have actually competed such a filing.

    Frankly, this fact, taken in concert with the utter lack of any published data whatsoever, only adds to my concern that the rat I have been smelling for some time now appears to have an increasingly strong aroma. If I had been an investor in this company I would want a detailed and public explanation from the CEO, and my lawyers would be pursuing this with alacrity.

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