News from the American Society of Clinical Oncology meeting that was held in New Orleans and ended Tuesday:
• Agennix Inc., of Houston, said Phase I/II data of oral recombinant human lactoferrin showed it was safe and well tolerated. It showed a 69 percent reduction in the average tumor growth rate in the 45 evaluable patients. In non-small-cell lung cancer and renal-cell cancer, it showed an 89 percent and a 105 percent reduction in average tumor growth rates, respectively.
• CancerVax Corp., of Carlsbad, Calif., reported data from Phase I/II trials of an immunotherapeutic candidate (SAI-EGF) that targets the EGFR signaling pathway. The studies indicated the compound was well tolerated, showed measurable immune responses and might increase survival in advanced non-small-cell lung cancer patients. In one study, 50 advanced-stage NSCLC patients received first-line chemotherapy and then were randomized to receive SAI-EGF or best supportive care. Survival was significantly greater (p<0.05) in SAI-EGF-treated patients, compared to controls (mean survival 19.54 months vs. 13.35 months). Also, data from three pilot Phase I/II trials evaluating 75 advanced-stage NSCLC patients showed immunized patients experienced a significant survival increase compared to non-randomized, untreated control patients with a history of the disease. CancerVax also shared Phase II data on Canvaxin, showing the candidate improved median overall survival of patients with Stage IV melanoma. CancerVax has signed nonbinding letters with CIMAB SA and YM Biosciences Inc. related to the license of SAI-EGF and two other SAI candidates targeting the EGFR signaling pathway.
• Cytogen Corp., of Princeton, N.J., said Quadramet has direct anticancer activity when used in treating bone metastases secondary to prostate cancer, breast cancer and multiple myeloma. Phase I/II data showed an overall response rate of 75 percent. Further data demonstrated that treatment with Quadramet was well tolerated. Quadramet is available as a non-narcotic alternative for pain relief from bone metastases.
• Cytokinetics Inc., of South San Francisco, said GlaxoSmithKline plc, of London, presented Phase I data showing SB-715992, a small-molecule inhibitor of kinesin spindle protein, was well tolerated in advanced solid tumors, and disease stabilization was seen in eight of 30 patients. A second dose-limiting study showed 15 of 45 patients had prolonged disease stabilization ranging from seven to 37 weeks. Based on those results, the recommended Phase II dose will be 18 mg/m2.
• Introgen Therapeutics Inc., of Austin, Texas, said data on Advexin showed it has excellent safety and tolerability profiles when administered as a single agent or in combination with chemotherapy or radiation in patients with several types of cancer. Safety data were collected from 445 cancer patients treated in 14 clinical trials. Researchers also said the drug showed efficacy in Phase II studies of squamous-cell carcinoma of the head and neck, non-small-cell lung cancer and breast cancer.
• NeoRx Corp., of Seattle, presented data from its Phase II dosimetry study of Skeletal Targeted Radiotherapy in multiple myeloma patients. Positive trends in patient response and safety were seen. Of the 10 evaluable patients, the objective response rate was 60 percent. NeoRx recently initiated a pivotal Phase III study in the same indication.
• SuperGen Inc., of Dublin, Calif., said Phase I data on Dacogen (decitabine) for injection to treat myelodysplastic syndromes demonstrated positive clinical results in patients with advanced solid tumors. The study enrolled 21 patients with a variety of chemo-resistant tumors and was conducted at three sites in the UK. Dacogen was well tolerated, with manageable side effects, the company said. The study confirmed the feasibility of using decitabine in combination with carboplatin.