Another new “vaccine” enters clinical trials


According a media release earlier today, Bellicum Pharmaceuticals, Inc. has announced dosing of their first patient in a Phase I/II clinical trial of “BP-GMAX-CD1, a novel pharmacologically regulated dendritic cell vaccine for the treatment of prostate cancer.”

The media release goes on to say that “BP-GMAX-CD1 is a novel cancer vaccine that can be precisely activated at an optimal time and location in the body. It is produced by genetically modifying autologous antigen-loaded dendritic cells to express an inducible costimulatory CD40 (iCD40) receptor. Twenty-four hours after intradermal administration, these genetically modified dendritic cells are activated in draining lymph nodes by intravenous administration of AP1903, a small-molecule dimerizer agent developed by ARIAD Pharmaceuticals, Inc. …. In this way, the immune system’s innate homeostasis is overridden and a potent and durable antigen-specific T cell response may be generated.”

The Phase I/II trial is designed to investigate the safety of BP-GMAX-CD1 and AP1903 in at least 24 patients with castrate-resistant prostate cancer (CRPC). Six doses will be administered on a weekly or every other week schedule, and responses assessed at week 13. Patients whose disease has not progressed at the end of this acute phase will be eligible to receive booster vaccinations every 8 weeks for up to 1 year. Exploratory efficacy endpoints include prostate-specific antigen dynamics, circulating tumor cell count, antigen-specific immune response, and clinical response. The trial is expected to report preliminary data at some time in 2010. Additional information about this trial can be found on the ClinicalTrials.gov web site. Additional information about the vaccine therapy and is accessible on the Bellicum Pharmaceuticals web site.

It is not entirely clear from any of the available information how long a patient might needed to be treated with this product if the vaccine is actually clinically effective, but this may simply reflect the fact that the clinical investigators have no answer to this question, as yet.

3 Responses

  1. Preemptive Provenge?

  2. Only if (a) it comes with a longer survival benefit, (b) one can take it for a limited timeframe (as opposed to for life), and (c) the adverse effects profile is no worse that that of Provenge. Managing all three of those may be a challenge.

  3. Managing all three of these can be challenging. However, with proper patient education it can be accomplished. I am grateful to have this article to refer my staff and patients to. Dendritic cell therapy is very effective.

    Keith Barton D.Ir.

    http://www.candidatherapythatworks.com

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