• Cell Genesys Inc., of South San Francisco, reported results of an analysis examining the potential association between immune responses to GVAX immunotherapy in prostate cancer and increased patient survival in a Phase II trial in metastatic hormone-refractory prostate cancer. More than 400 patient-specific GVAX-induced antibody responses were identified in the sera of the treated patients, which confirmed that GVAX treatment results in a broad, multi-antigen immune response. An ongoing analysis of those responses demonstrated that at least two of the antibody responses are associated with patient survival. Those data were presented at the ASCO Genitourinary Cancer Symposium in San Francisco.

• Diamyd Medical AB, of Stockholm, Sweden, received approval to begin a U.S. Phase I study of NP2, its first drug candidate emerging from the Nerve Targeting Drug Delivery System gene therapy platform, in chronic pain. NP2 is designed to work by producing enkephalin directly in the sensory neurons to block pain signals before they are transmitted through the spinal cord to the brain. The Phase I study is expected to enroll a total of 12 patients who suffer from severe cancer-related pain, with the option of expanding the trial to 24 patients pending positive results.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said the data monitoring committee, after a review of data from the ongoing Phase III study of PRO 2000, a vaginal microbicide for HIV prevention, recommended that the low-dose arm (0.5 percent) continue to be tested for safety and efficacy in the trial, though it recommended that the high-dose arm (2 percent) be closed as there is no more than a small chance of the high dose showing protection against HIV infection compared to placebo gel. The trial is sponsored by the UK's Medical Research Council.

• Medical Therapies Ltd., of Sydney, Australia, said interim results from its first trial of Cuprindo indicated that the drug is safe and well tolerated. The trial's healthy volunteer subjects reported in patient diaries 100 percent compliance with the dosing protocol, which involved application of Cuprindo suppositories twice daily over a seven-day period. In additional, post-trial colonoscopy uncovered healthy mucosa and no evidence of rectal inflammation or ulceration. Cuprindo is in development for procitis, a disease characterized by inflammation and ulceration of the colon.

• Novacea Inc., of South San Francisco, said Clinical Cancer Research published a proof-of-principle Phase I study of AQ4N (banoxantrone) in 32 patients with advanced solid tumors showing that activated AQ4 was detected in all tumor samples, with the highest levels present in glioblastoma and head and neck tumors, while 22 of the patients had tumor AQ4 concentrations greater than or equal to 0.2 mcg/g. AQ4N, a prodrug, is designed to convert selectively to the active form, AQ4, a topoisomerase II inhibitor, within hypoxic tumor cells. The drug is being investigated in a Phase Ib/IIa trial in glioblastoma multiforme patients.

• OncoGenex Technologies Inc., of Vancouver, British Columbia, reported that its lead cancer drug, OGX-011, was well tolerated in combination with either docetaxel or mitoxantrone administered as second-line chemotherapy in patients with hormone-refractory prostate cancer. Additionally, patients treated with second-line chemotherapy plus OGX-011 showed ongoing survival durations better than results published with chemotherapy alone. Those Phase II data were presented at the ASCO Genitourinary Cancer Symposium in San Francisco. OGX-011 is partnered with Carlsbad, Calif.-based Isis Pharmaceuticals Inc.

• Poniard Pharmaceuticals Inc., of South San Francisco, said data from its Phase I study of picoplatin in prostate cancer showed a prostate-specific antigen (PSA) response of 65 percent (20 of 31 evaluable patients), though survival data are not yet available. To date, 33 patients have completed the maximum of 10 cycles of treatment, each of which is comprised of escalating doses of picoplatin plus docetaxel and prednisone. Nine patients received 120 mg/m2 picoplatin and 75 mg/m2 docetaxel every 21 days plus 5 mg prednisone twice daily, and that treatment regimen has been well tolerated. Data were presented at the ASCO Genitourinary Cancer Symposium in San Francisco.