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P07-1 (NeoACT - NEOadjuvant Active Cellular ImmunoTherapy)

• Title: An Open Label, Phase 2 Phase 2 Clinical TrialA study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.CloseTrial of Immunotherapy with sipuleucel-T Sipuleucel-TAn investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs).Closeas Neoadjuvant Treatment in Men with Localized Prostate ProstateA gland in the male reproductive system. The prostate surrounds the part of the urethra (the tube that empties the bladder) just below the bladder, and produces a fluid that forms part of the semen.CloseCancer
• Objective: To assess the safety of and immune response induced by sipuleucel-T in men with localized prostate cancer. CancerCancer develops when cells in the body begin to grow out of control. Normal cells grow, divide, and die. Instead of dying, cancer cells continue to grow and form new abnormal cells. Cancer cells often travel to other body parts where they grow and replace normal tissue. This spreading process is called metastasis. When cancer spreads or metastasizes, it is still named after the part of the body where it started. For example, if prostate cancer spreads to the bones, it is still prostate cancer, not bone cancer. Some cancers, such as blood cancers, do not form a tumor. Not all tumors are cancer. A tumor that is not cancer is called benign and does not grow and spread the way cancer does.Close
• Study Design and Duration: Subjects will receive 3 infusions of sipuleucel-T beginning 6 to 7 weeks prior to a scheduled radical prostatectomy ProstatectomyAn operation to remove part or all of the prostate. Radical (or total) prostatectomy is the removal of the entire prostate and some of the tissue around it.Close(RP) surgery. To assess the immune response following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy BiopsyThe removal of a sample of tissue to see whether cancer cells are present. There are several kinds of biopsies. In a fine needle aspiration biopsy (sometimes used to check pelvic lymph nodes), a very thin needle is used to draw out fluid and cells. In a core biopsy, a larger needle is used to remove a thin cylinder of tissue.Closespecimen obtained prior to treatment with sipuleucel-T, with each subject serving as his own control. Following RP, subjects will be randomized 1:1 to receive either a booster infusion of sipuleucel-T or no further treatment with sipuleucel-T. All subjects will be followed for 72 weeks post-RP.

To learn more about the eligibility criteria and to find a clinical research facility nearest you, please go to http://www.clinicaltrials.gov. Eligibility for this trial is limited by your proximity to the clinical research facility.

P07-2 (ProACT - treatment of PROstate cancer with
Active Cellular ImmunoTherapy)

• Title: A Randomized, Multicenter, Single Blind Study in Men with Metastatic Androgen AndrogenAny male sex hormone. The major androgen is testosterone. CloseIndependent Prostate Cancer to Evaluate Sipuleucel-T Manufactured with Different Concentrations of PA2024 Antigen
• Objective: To compare the cumulative CD54 upregulation ratio between each of the cohorts, evaluate the magnitude of the immune response in each of the cohorts, and evaluate the overall survival in each of the cohorts
• Study Design and Duration: Subjects will be randomized to 1 of 3 antigen AntigenA substance that causes the body's immune system to react. This reaction often involves production of antibodies. For example, the immune system's response to antigens that are part of bacteria and viruses helps people resist infections. Cancer cells have certain antigens that can be found by laboratory tests. They are important in cancer diagnosis and in watching response to treatment. Other cancer cell antigens play a role in immune reactions that may help the body's resistance against cancer. Closeconcentration cohorts of PA2024 that will be used to prepare sipuleucel-T. Subjects will receive 3 infusions of sipuleucel-T and will be assessed at Months 2, 4, and 6 for safety and efficacy in the active follow-up phase of the trial. Following Month 6, all subjects will be followed in the long-term follow-up phase of the trial.

To learn more about the eligibility criteria and to find a clinical research facility nearest you, please go to http://www.clinicaltrials.gov. In order to ensure the integrity of the study data is maintained, study participants must be able to complete all study visits. For this reason, study participation is limited to those who live in a permanent residence within a comfortable driving distance (roundtrip within one day) to the clinical research site.

TRPM8

• Title: A Phase 1, Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Enteric Coated D-3263 Hydrochloride in Subjects with Advanced Solid Tumors
• Objectives: To assess the safety and to determine the maximum tolerated dose (MTD) of EC D-3263 HCl administered orally daily to subjects with advanced solid tumors, characterize the pharmacokinetics (PK) of EC D-3263 HCl after single and multiple daily dosing, and conduct a preliminary assessment of EC D-3263 HCl antitumor activity.
• Study Design and Duration: T08-1 is an open label, Phase 1, dose escalation study.

  Cycle 1 starts with an EC D-3263 HCl dose administered on Day 1 followed by a 6-day drug holiday. Safety and PK assessments are conducted from Day 1 through Day 7. If no dose limiting toxicity is observed by Day 7, the subject is treated with daily doses of EC D-3263 HCl for 21 days (Day 8 through Day 28). On Day 28 subjects return to the clinic where they receive an EC D-3263 HCl dose followed by PK assessments. Another drug holiday occurs between Day 29 and Day 35. Day 1 through Day 35 comprises Cycle 1.

  Subjects may continue with subsequent treatment cycles if they do not experience dose limiting toxicity or disease progression during Cycle 1. Subsequent treatment cycles each consist of 3 weeks of daily dosing followed by a 1-week drug holiday. Subjects return to the clinic every 7 days for safety and PK evaluations.

  Cohorts of 3 or 6 subjects will be evaluated at increasing dose levels until a maximum tolerated dose (MTD) is established. Safety at the MTD is tested further in an expansion cohort of up to 12 additional subjects. During Cycle 1 of the expansion cohort subjects receive daily EC D-3263 HCL doses from Day 1 through Day 28. Subjects who do not experience dose limiting toxicity or disease progression during Cycle 1 may proceed with continuous dosing following a 7-day drug holiday.

  The duration of each subject's study participation is dependent on the number of treatment cycles without experiencing dose limiting toxicity or progression of cancer. The anticipated study duration is 12 to 18 months.

To learn more about the eligibility criteria and to find a clinical research facility near you, please go to http://www.clinicaltrials.gov.