ProstAtak, Theragene, and the evolution of “vaccine-like” therapies for prostate cancer


In May this year we initially commented on a media announcement about a new form of vaccine-like therapy that was entering Phase III clinical trials for the first-line treatment of intermediate- and high-risk prostate cancer.

Information about the Phase III trial of the ProstAtak™ vaccine is now available on the ClinicalTrials.gov web site. The trial is designed to compare the following two treatment regimens:

  • AdV-tk (ProstAtak) + valacyclovir + external beam radiation therapy
  • Placebo + valacyclovir + external beam radiation therapy

About 700 patients are expected to be randomized to one or other arm of the trial. At this time only one clinical center (in the USA) is open for study enrollment, but we assume that others will be opening over the next few months.

At the same time, an announcement by Jae-Ho Kim, MD, PhD, who is Chairman of the Department of Radiation Oncology at Henry Ford Hospital in Detroit, MI, has announced the initiation of a Phase III clinical trial of what appears to be a very similar form of prostate cancer treatment, which he refers to as “double-suicide gene therapy” with a product called called Theragene. Theragene appears to be an Ad-tk/cd adenovirus-based product that may have close similarities to the AdV-tk (ProstAtak) product. We suspect that Theragene also needs to be used in combination with radiation therapy, and that it is intended for use as a form of first-line therapy (although the media release from Dr. Kim does not state this explicitly).

There are no data (that we have been able to find) about any trials of Theragene on the ClinicalTrials.gov web site. It is possible, however, that trials of Theragene have been and are being carried out in South Korea rather than the USA and Europe.

2 Responses

  1. These trials should be applauded, but it looks like they have been talking abut several cancer vaccines for years and we are still in the very early stages, when it comes to really successful treatment

    Each of these recent prostate cancer “breakthroughs” give the patient only a few more months to live at most and the cost is always substantial.

    I’m looking forward to the times where metastatic prostate cancer, although perhaps not truly curable, will be really a manageable chronic disease, similar to the HIV infection nowadays

    It looks like we are definitely over a decade away from such reality … and probably much more. :-(

  2. Paul:

    I try to take a more positive attitude. Ten years ago not a single drug had been approved for the treatment of men with castration-resistant prostate cancer. It the past 18 months we have seen the approval and the demonstration of effectiveness of four new drugs … and there are a host of new ones on the way.

    In the next couple of years, we will also see the results of use of several of these drugs in earlier stages of the disease. It is perfectly possible that — within the next 10 years — for some (not all) categories of men with metastatic prostate cancer, we will be seeing 10-year survival routinely after the onset of evident metastasis. This is not enough … but it is clear progress.

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