New data on prostate cancer vaccine BPX-101

Straight from a “late-breaking poster” at the annual meeting of the Association for the Advancement of Cancer Research going on in Washington, DC, comes data about BPX-101 — another dendritic cell-based immunotherapeutic “vaccine” for the possible treatment of late-stage prostate cancer.

BPX-101 is in development by Bellicum Pharmaceuticals, Inc. At the poster presentation earlier today, the research team was able to announce interim Phase I/II data suggesting a correlation between dose-related variations in levels of inflammatory serum markers and measurable clinical responses in patients treated with BPX-101.

The Phase I/II trial was designed to assess  the safety and the maximum tolerated dose or MTD of BPX-101 when administered every other week for six dose to patients with metastatic castration-resistant prostate cancer (CRPC). Data presented today are based on only 6 patients, but appear to show the following (according to the media release issued by Bellicum Pharmaceuticals):

  • The combination of BPX-101 and an activating agent (AP1903) is safe and well tolerated at low- and mid-level doses of BPX-101, with no signals for unexpected drug-related adverse events.
  • Clinical responses were observed within 12 weeks of initial treatment, in patients who received low- and mid-level dose cohorts.
    • 4/6 patients (66.7 percent) had stable disease after 12 weeks.
    • 3/3 patients on study for at least 6 months remain stable.
    • 1/3 patients on study for at least 6 months experienced a 20 percent decline in measurable disease after 12 weeks, and a further decline to a 25 percent decline at 6 months.
  • 4/6 patients achieved a maximal decrease in serum PSA levels of at least 10 percent from baseline (including the specific individual mentioned above, who achieved a maximal serum PSA decline approaching 50 percent).
  • 5/6 patients experienced a significant increase in PSA doubling time (PSADT) by 12 weeks, including 2/6 patients with PSA levels below baseline and 3/6 patients with PSADT increases of 80 to 300 percent, relative to their pre-treatment PSADT.
  • 4/6 patients achieved declines in their serum interleukin-6 (IL-6) level of between 75 and 99 percent from baseline. (Serum IL-6 is a putative biomarker of metastatic prostate cancer.)

Systemic immunological responses were determined by assessment of a panel of chemokines and cytokines at each dose and 1 week after each dose. Clinically responding subjects tended to exhibit dramatic and consistent increases in these serum markers 1 week after each dose, returning to baseline the following week. Antigen-specific immune responses, measured in injection site reaction biopsies taken after three doses, were detected in 4/4 assessable subjects.

The apparent dose-response correlation between clinical and immunological responses still needs to be investigated in six patients who are currently enrolling in a third, high-level dose cohort.

3 Responses

  1. Tengo CA, prostatico, diagnosticado hace 9 años, con metastasis indeterminada a esa fecha, se lo trato con operación de Linfadenectomia y posterior tratamiento de hormono terapia mixta al tercer año comenzo a subir en antigeno y la cambiamos por dietilestilbestrol y el antigeno a variado entre 0,5 y 3,00 en función de la dosis usada entre 1 y 2,5mg por dosis a razon de 1 diaria. He usado conjuntamente, generalmente vitaminas y Graviola. En Agosto 2009, deje de tomar dietilbestrol hasta esta fecha (9 meses), con PSA inicial de 0,98 ng/ml, el que subio paulatinamente, en Enero de 2010 hasta 2,97 ng/ml, en un control 40 dias despues, bajo a 2,48 ng/ml, el dato curioso es que no estoy en tratamiento hormonal y solo estuve usando 1,200 mg. diarios de Graviola durante ese periodo. Ha partir de examen estoy usando la misma dosis de Graviola, 1 comprimido de Pharmaton, 1 gr. de Spirulina y 8 mg. de astaxantina, dentro de 1 semana me tomare el PSA. de control.

    En Agosto 2009, el resultado del Cintigrama óseo, no detecto metastasis ósea, la Ecotomografia de prostata, se ve homogenea, de tamaño normal, Vesicula Seminal de aspecto normal. Vegiga de mediano llenado, de bordes regulares, no deja residuo post-miccional. Riñones, dentro de limites normales, sin signos de ectasia.

    Tengo la historia completa desde el diagnostico del CA. Prostatico en 2001 con PSA de 35, los tratamientos, evolución por medio de los resultado de los PSA. Espero sea util como información.

    José Cáceres, Chile,

  2. Promising.

  3. Dear Senor Cáceres:

    If you had surgery, had a pelvic lymphadenectomy with a negative result, took some form of hormone therapy for 3 years, and then took diethylstilbestrol (DES) for another 5-6 years, there is an excellent chance that your cancer is in remission. Of course your PSA could start to rise again tomorrow.

    Whether the graviola and other herbal agents and supplements made any difference, who can tell? We have no data at all to support or refute the therapeutic use of such products.

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