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Clinical Development Experience

The following is a representative list of the clinical trials that have been designed and implemented by Cougar’s management and Board of Directors

Phase II study of oral Bropirimine in adult patients with BCG resistant bladder carcinoma in situ and intolerance to BCG. Sponsor: The Upjohn Company, 1993-1994. (principal investigator)

A double-blind, randomized, Phase III, multicenter study or Suramin versus placebo in the treatment of patients with metastatic, hormone-refractory prostate carcinoma (stage D2). Sponsor: Parke-Davis Pharmaceutical Research 1993-1994. (co-principal investigator)

Phase I/II study evaluating the biologic and clinical effects of PEG IL-2 prior to prostatectomy in patients with Stage B-2 and C prostate carcinoma. Sponsor: Cetus/Chiron Corporation 1994-5, 1996-7 (co-principal investigator)

Phase I/II clinical trial of immunotherapy using adoptive transfer of cytotoxic cells in the treatment of human cancer. Sponsor: National Cancer Institute 1994-1997. (co-principal investigator)

Phase I/II trial of continuous intravenous infusion FUDR and IL-2 in combination with interferon-alpha in the treatment of metastatic renal cell carcinoma. Sponsor: Hoffman La Roche 1994-1995. (co-principal investigator)

Oral Bropirimine vs. Intravesical BCG in patients with CIS of the Bladder. Sponsor: Upjohn 1995. (co-principal investigator)
Phase I/II Trial of Navelbine and Emcyt in Patients with Hormone Refractory Prostate Cancer. Sponsor: Burroughs Wellcome, 1995. (co-principal investigator)

The Treatment of Patients with Metastatic Renal Cell Carcinoma Utilizing in Vitro Expanded CD8+ Lymphocytes Isolated from Peripheral Blood in Combination with Recombinant Interleukin-2. Sponsor: Applied Immune Sciences, 1995. (co-principal investigator)

Tumor Infiltrating Lymphocyte Cell Therapy and Recombinant Interleukin-2 in Metastatic Renal Cell Cancer. Sponsor: Applied Immune Sciences, 1995. (co-principal investigator)
PSA Promoter Mediated Gene Therapy for Prostate Cancer. Sponsor: CaP CURE Foundation, December 1995. (principal investigator)

The Use on Oral ALRT1057 (9-Cis-Retinoic Acid) for Men with Hormone Refractory Prostate Cancer. Sponsor: Ligand Pharmaceuticals, 1996. (co-principal investigator)

An International Phase II Randomized, Double-Blind, Multicenter Study to Determine the Safety and Efficacy of Three Different Doses of Liarozole in Patients with Rising Prostate Specific Antigen Levels After Definitive Treatment. Sponsor: Janssen Research Foundation, 1996. (co-principal investigator)

Antisense TGF-b1 for Advanced Prostate Cancer. Sponsor: CaP CURE Foundation, 1996-97. (principal investigator)
A Phase I Study in Patients with Locally Advanced or Recurrent Adenocarcinoma of the Prostate using SCH 58500 (rAd/p53) Administered by Intratumoral Injection. Sponsor: Schering Plough Corporation, September 1997. (principal investigator)

A Phase I Study Evaluating the Safety and Efficacy of Interleukin-2 Gene Therapy Delivered by Lipid Mediated Gene Transfer (Leuvectin) in Prostate Cancer Patients. Sponsor: Vical, Inc., May, 1997. (principal investigator)

A Phase I/II Trial of Antigen-Specific Immunotherapy in MUC-1 Positive Patients with Adenocarcinoma of the Prostate Using Vaccinia-Virus MUC1-IL-2 (TG1031). Sponsor: Transgene, Inc. April 1998 - 2001. (principal investigator)

A Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer. Sponsor: Vical, Inc., May 1999 – Present. (principal investigator)

A Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Locally Recurrent Prostate Cancer Following Radiation. Sponsor: Vical, Inc., Nov. 1999 – Present. (principal investigator)

“Phase III Randomized, Double-Blind Study of DFMO vs. Placebo in Low Grade Superficial Bladder Cancer. Sponsor: Ilex Oncology, Inc., May 1999 – 2000. (principal investigator)

Randomized Prospective Study of Adjuvant Androgen Ablation in Radical Prostatectomy Patients at High-Risk for Disease Recurrence. Sponsor: TAP Pharmaceuticals, Sept. 1999 – 2000. (principal investigator)

A Single Center, Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of Seven Dose Levels of ABX-EGF in Renal, Prostate, Pancreatic, Non-Small Cell Lung or Esophageal Cancer Patients. Sponsor: Abgenix, Inc., October 1999 – Present. (principal investigator)

Chemoprevention of Superficial Bladder Cancer. Sponsor: NIH/National Cancer Institute 04/01/02 – 03/31/07. (principal investigator)

A Phase III Randomized, Multi-center Study of Adjuvant Oncophage vs. Observation in Patients with High Risk of Recurrence after Surgical Treatment for renal call carcinoma. Sponsor: Antigenics, Inc. Ongoing.

A Two-Part Multiple Dose Clinical Trial Evaluating the Safety and Effectiveness of ABX-EGF in Patients with renal cell cancer. Sponsor: Abgenix, Inc. Ongoing

Effect of Depression, Social Support and Spirituality on Patients with Metastatic Renal Cell Carcinoma (Cancer Control) Sponsor: MD Anderson Cancer Center. Ongoing

Clinical Trial Evaluating the Safety and Efficacy of ABX-EGF in Patients with Hormone Resistant Prostate Cancer with Elevated PSA without Metastasis. Sponsor: Abgenix, Inc. Ongoing

Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010 (MVA-MUC1-IL2) in Patients with Adenocarcinoma of the Prostate. Sponsor: Transgene, Inc. Ongoing

Phase I Safety Study of Xcellerate in Patients with Hormone Refractory Prostate Cancer. Sponsor: Xcyte Therapies, Inc. Ongoing.

Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety of 10mg Atrasentan in Patients with Non-Metastatic, Hormone-Refractory Prostate Cancer. Sponsor: Abbott Laboratories, Inc.

Phase III Extension study to Evaluate the Safety of 10mg Atrasentan in Men with Hormone-Refractory Prostate Cancer. Sponsor: Abbott Laboratories, Inc.

Phase II Trial of Recombinant Human Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) and Recombinant Human Interleukin-4 (IL-4) Used as Combination Therapy for Subjects with Hormone Refractory Prostate Cancer

A Single Center, Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of Seven Dose Levels of ABX-EGF in Renal, Prostate, Pancreatic, Non-Small Cell Lung, Esophageal or Colorectal Cancer Patients. Sponsor:Abgenix, Inc.