New prostate cancer vaccine makes it through Phase Ia trial


A company called OncBioMune Pharmaceuticals has announced initial data from a Phase Ia/Ib clinical trial of a new form of vaccine in the treatment of men with progressive prostate cancer who meet the following criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Prior, definitive first-line that must have been completed at least 6 months previously, including
    • Radical prostatectomy
    • Radiation therapy (with or without neoadjuvant or adjuvant androgen deprivation therapy [ADT]) and a current serum testosterone level > 50 ng/dl
    • ADT with a serum testosterone level of > 50 ng/dl
  • A rising PSA documented by three increasing values over the last 6 months prior to study enrollment
  • A PSA value within 4 weeks of starting therapy that is < 20 ng/ml for hormone-naïve patients (defined as hormone-naïve patients and patients who received hormone therapy in the past who currently have total testosterone greater than 50 ng/dL) or < 60 ng/mL for hormone-independent patients.

The initial Phase Ia component of the trial is complete; the Phase Ib component is ongoing; and the company has stated that it is now planning for a Phase II trial.

The vaccine is a multi-component PSA/IL-2/GM-CSF vaccine (currently known as ProscaVax) that can be injected subcutaneously. Data from the Phase Ia component of the trial is reported in this corporate media release on the Yahoo!Finance web site. At this stage what we know is that the vaccine can be administered to patients reasonably safely. We have no data on its efficacy or its long-term safety as yet.

On the company’s web site, OncBioMune claims that this vaccine “could become the standard of care for prostate cancer treatment.” That seems like a bit of a stretch based on the data available as yet. Even if it was to do phenomenally well in clinical trials it is currently being tested only in men with progressive disease after some form of first-line therapy.

2 Responses

  1. As of Oct30 2016
    https://clinicaltrials.gov/ct2/show/results/NCT02058680 showed:
    Study Status: This study is currently recruiting participants.
    Estimated Study Completion Date: December 2015
    Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

    AND IT ALSO SHOWED
    “No Study Results Posted on ClinicalTrials.gov for this Study”.

    If the completion was December 2015, one would think that a report might be out 10 months later.

    “That seems like a bit of a stretch based on the data available as yet.” 10 months later seems even more generous. What does the company say is the issue?

  2. Dear Name Witheld:

    All I can tell you is what it says on the company web site here and in this media release.

    I suspect that some of the original data from the Phase I trial may have been presented as a poster at any one of a dozen or more possible meetings. The company is unlikely to formally publish such data at this stage.

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