Two individuals (MC 03 and MC 05) developed 1:6,400 anti-GnRH antibody titers; three individuals (MC01, MC 02, and MC 07) reached 1:3,200; two individuals (MC 04 and MC 06) developed 1:1,600 titers; and one patient (MC 08), developed 1:800 anti-GnRH antibody titers. were recorded and evaluated. The vaccine was well tolerated. Significant reductions in serum levels of testosterone and PSA were seen after four immunizations. Castrate levels of testosterone were observed in all individuals at the end of the immunization routine, which remained at the lowest level for at least 20 weeks. Inside a 10-12 months follow-up three out of six individuals who completed the entire trial survived. In contrast only one out eight individuals survived in the same period inside a matched randomly selected group receiving standard anti-hormonal treatment. Heberprovac vaccination showed a good security profile, as well as immunological, biochemical and, most importantly, medical benefit. The vaccinated group displayed survival advantage compared with the research group that received standard treatment. These results warrant further medical tests with Heberprovac including a larger cohort. = 8) with related disease status, who received standard anti-hormonal treatment. Statistics The data were double came into and validated using Microsoft Access, and then imported into SPSS 13.0, for analysis. The rate of recurrence distribution and central inclination and dispersion CC-401 hydrochloride were estimated by mean standard deviation, median, interquartilic range (QR), and the maximum and minimum ideals (range) for qualitative and quantitative variables. For each type of adverse event, the rate of recurrence distribution (IC NFBD1 95%) was estimated with the classical and Bayesian statistics. For survival, statistical analysis was carried out using Log Rank test. Results Study Populace Between March and July 2007, eight males with confirmed analysis of advanced prostate malignancy (phases III/IV) were included in the security study with CC-401 hydrochloride the vaccine candidate Heberprovac. At the same time, 8 individuals with advanced prostate malignancy were randomly selected in the uro-oncology services, who began treatment with the standard therapy for prostate malignancy and were used as external control group (EG). Furniture 1A, ?,B.B. The age of individuals ranged from 63 to 78 years old (71.3 years normally). All individuals experienced high Gleason score confirmed from the histological study. The individuals were evaluated at recruitment, after the fourth and last (7th) immunizations, the later on after they received the RT (Number 1). The treatment routine was completed in 6 individuals, who were adopted up for recurrence during 10 years (2007C2017) Diagram 1. Table 1A TNM classification and Gleason score of individuals included in the Phase I medical trial with Heberprovac. 0.01). On the other hand, individuals who received standard CC-401 hydrochloride therapy also experienced an important benefit in relation to the reduction of the size of the prostate. In this way individuals EG 03, EG 05, EG 06, and EG17 experienced a decrease of 30% or more of the prostate size. The patient EG 12 was the one that showed a greater reduction of prostatic size among all with 49%. The remaining 2 individuals showed a decrease of 10 and 29% of the prostatic volume in connection with the beginning (Number 2B). Open in a separate window Number 2 Prostate volume evaluation by trans-rectal ultrasound of the prostate malignancy individuals included in the medical Heberprovac medical trial and the External Group of prostate malignancy individuals with related stage. (A) Individual measurement of prostate volume of individuals before the treatment and after finishing the full immunization routine and RT. (B) External Group prostate measurement using transrectal ultrasound before and after total standard hormonal therapy and RT. Anti-GnRH Immune Response and Surrogate Biochemical Markers Heberprovac is definitely a vaccine candidate designed to generate anti-GnRH antibodies. Such humoral immune response was evaluated at the mid and end phases of the trial and compared with the values at the moment of patient recruitment. Table 3 shows Testosterone and PSA correspondence with the anti GnRH antibody titers. All individuals generated anti-GnRH antibodies after the fourth immunization. Two individuals (MC 03 and MC 05) developed 1:6,400 anti-GnRH antibody titers; three individuals (MC01, MC 02, and MC 07) reached 1:3,200; two individuals (MC 04 and MC 06) developed 1:1,600 titers; and one patient (MC 08), developed 1:800 anti-GnRH antibody titers. After completion of the reminder three immunizations, the anti-GnRH immune responses continued.