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"Phase I/II Trial of BP-GMAX-CD1 Vaccine Therapy plus Activating Agent AP1903 for Men with Advanced Androgen Independent Prostate Cancer"
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Standard dose escalation Phase I study, with primary and secondary endpoints of:
- Safety
- Maximum tolerated dose (MTD)
- Magnitude of antigen-specific immune response compared to pre-therapy
- Preliminary efficacy (PSA, clinical response)
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Two schedules evaluated, x 6 doses:
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For patients who remain free from disease progression, vaccinations will continue every 8 weeks for up to 48 weeks
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The product concept for BP-GMAX-CD1 and the clinical protocol have been reviewed publicly by NIH RAC and allowed to proceed, pending FDA review
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An IND for this clinical protocol is in preparation, in accordance with feedback received in early consultation with FDA.
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Tentatively scheduled to open in early 2008, subject to FDA review of the clinical trial protocol and supporting information
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Clinical trial location: Center for Clinical and Translational Sciences, UTHSC and the Center of Innovation and Research, Memorial Hermann Hospital - TMC, Houston, TX
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