News from the meeting of the American Society of Clinical Oncology, which ended Tuesday in Chicago:

• Abbott Laboratories, of Abbott Park, Ill., presented data from a Phase I study of ABT-510, an angiogenesis inhibitor. The data indicated that ABT-510 can be administered at doses of 20 mg to 100 mg daily without dose-limiting toxicity. Data also show that among the 37 patients with advanced cancer treated with ABT-510, one patient with soft-tissue sarcoma experienced shrinkage of his tumors that has lasted more than 12 months. Another three patients, two of whom also had soft-tissue sarcoma, have experienced prolonged disease stabilization for six months or more, Abbott said.

• Active Biotech AB, of Lund, Sweden, presented results from trials of its Tumour Targeted Superantigens CD2 substance. Results were presented from an ongoing open Phase IIa study in advanced renal cancer and results from a Phase I study in lung cancer patients.

• American Pharmaceutical Partners Inc., of Schaumburg, Ill., said investigators from the Insituto dei Tumori in Milan, Italy, reported on 108 patients receiving high-dose ABI-007, a novel cremophor-free protein engineered nanoparticle paclitaxel, by the intra-arterial route. Following the intra-arterial administration of ABI-007 in patients in a head and neck cancer Phase I/II trial, a response rate was noted in 76 percent of patients. Similar positive activity was noted in patients with squamous cell cancers of the pelvis.

• Aton Pharma Inc., of Tarrytown, N.Y., presented data on suberoylanilide hydroxamic acid (SAHA). It concluded a Phase I trial with intravenous SAHA and is conducting a Phase I trial with oral SAHA in patients with refractory solid tumors, lymphomas, myeloma and leukemias. The results support the company's observations that SAHA can induce antitumor responses of substantial durability, it said.

• Bioenvision Inc., of New York, reported interim results from a Phase I/II study combining its lead compound, clofarabine, with cytarabine (ara-C) in patients with relapsed/refractory acute leukemias showed that clofarabine can be combined with ara-C and that the combination has activity in patients with acute myeloid leukemia. The study was conducted by Bioenvision's North American co-development partner, Ilex Oncology Inc., of San Antonio.

• BioNumerik Pharmaceuticals Inc., of San Antonio, and The Cancer and Leukemia Group B at the University of Chicago presented results from a Phase II study of karenitecin BNP1350 in reducing tumor size and stabilizing disease in refractory and relapsed patients with advanced non-small-cell lung cancer. The groups said the rates of partial response plus stable disease and median survival were similar to other agents considered active.

• Celgene Corp., of Warren, N.J., said investigators presented preliminary data from three Phase I studies of Revimid in recurrent high-grade gliomas and other refractory central nervous system malignancies, advanced malignant melanoma and refractory metastatic cancers. The data suggest that Revimid demonstrated tolerability and potential clinical activity in solid tumor cancers. Also, Celgene said it would advance Actimid into a Phase II trial in prostate cancer later this year.

• Cell Therapeutics Inc., of Seattle, presented interim Phase I data from 21 patients in a study of escalating doses of Xyotax in combination with standard-dose cisplatin. Among 17 patients evaluable for response, Xyotax resulted in partial remissions in 30 percent of the patients studied. Disease control was observed in 82 percent of patients. Four of the five major responses were reported in tumors that were resistant to prior taxane and/or cisplatin therapy or in tumor types that were intrinsically resistant to taxanes, including patients with refractory ovarian cancer and patients with mesothelioma and malignant schwannoma. Separately, it said it reported the results of a case study review of seven refractory multiple myeloma patients treated with a combination of Trisenox, vitamin C and melphalan demonstrated that all patients achieved an objective response, ranging from 29 percent to 85 percent reduction in M-protein, with four of seven patients remaining free of cancer progression for a median of 34 weeks.

• GenOdyssee SA, of Les Ulis, France, presented preclinical data on its natural functional variants of interferon alpha. IFN a is a naturally occurring protein. The company presented data on the in vitro and in vivo antiviral, antiproliferative and immunomodulatory activities of its IFN a variants compared to IFN a2b. In the in vivo studies in both mouse and primate models, GenOdyssee's GEA009.2 demonstrated higher antitumor activity and lower toxicity, it said.

• Genomic Health Inc., of Redwood, City, Calif., reported preliminary data in clinical trials in which RNA analysis of thin sections of standard tumor biopsies were used to evaluate panels of genes that might predict breast cancer recurrence and response to chemotherapy as well as response to EGFR inhibitor therapy in lung cancer. Genomic Health has begun large-scale trials that will examine prospectively defined endpoints in breast cancer recurrence and plans to conduct similar large-scale trials looking at response to chemotherapy and EGFR inhibitor therapy, it said.

• GlycoGenesys Inc., of Boston, reported preclinical data that demonstrated in vitro that GlycoGenesys' GCS-100 killed both a chemotherapy-resistant human lymphoma cell line that overexpressed the Bcl-2 protein and an identical non-Bcl-2-overexpressing human lymphoma cell line. GCS-100 produced similar results in other human lymphoma cancer cell lines, it said.

• GPC Biotech AG, of Martinsried, Germany, reported satraplatin study results demonstrating statistical significance (p=0.023) in time to disease progression, doubling progression-free survival. The study involved 50 randomized patients and evaluated the use of satraplatin plus prednisone vs. prednisone alone for use as a first-line chemotherapy treatment in hormone-refractory prostate cancer. Satraplatin is a member of the platinum family of compounds.

• IDEC Pharmaceuticals Corp., of San Diego, presented updated results of four studies of Zevalin (ibritumomab tiuxetan). The results showed Zevalin produced complete and enduring responses in a subset of patients with low-grade, follicular and transformed B-cell non-Hodgkin's lymphoma. The data also indicated that Zevalin is associated with higher response rates and longer durations of response when used before multiple courses of chemotherapy, the company said. The drug was approved by the FDA in February 2002. (See BioWorld Today, Feb. 21, 2002.)

• Igeneon, of Vienna, Austria, presented Phase II data on its cancer vaccine, IGN101, an antibody-based product directed against epithelial cancers. The study tested IGN101 with chemotherapy treatment. The data showed that the vaccine retained an immune response (95 percent seroconversion rate) despite concomitant chemotherapies.

• Immunomedics Inc., of Morris Plains, N.J., reported data on the use of two therapeutic monoclonal antibodies, which bind to the CD20 and CD74 receptors, respectively. Immunomedics also reported therapeutic results with a CD74-binding humanized antibody. And it reported preclinical results of its humanized antibody against carcinoembryonic antigen, labetuzumab. Preliminary results showed that labetuzumab could significantly increase the chemosensitivity of human colon and breast cancer cells in vitro to several anticancer drugs. Also, animals with disseminated human colon cancer were found to show improved survival rates when the naked labetuzumab was given in combination with irinotecan.

• Introgen Therapeutics Inc., of Austin, Texas, reported data from a Phase I trial that showed direct intrabronchial instillation of its p53 drug, Advexin, is safe and showed evidence of therapeutic activity in cancer patients with bronchoalveolar lung carcinoma. It also reported that two abstracts describing an early stage Phase I/II study in esophageal cancer indicated Advexin therapy was well tolerated by patients and appeared to slow the advancement of the disease. Also, The University of Texas M.D. Anderson Cancer Center made available preliminary data from a Phase II study in locally advanced breast cancer that indicated Advexin can be combined with a two-drug standard chemotherapy regimen and that 90 percent of the patients responded to the therapy.

• Lorus Therapeutics Inc., of Toronto, said data on its two lead drugs, GTI-2040 and Virulizin, were presented. The presentation provided an overview of the safety, tolerability and pharmacokinetics from a Phase I trial conducted in a variety of tumor types. The data were used to design a Phase II trial of GTI-2040 for the treatment of renal cell carcinoma, which is currently in progress.

• Marshall Edwards Inc., of North Ryde, Australia, said Yale University researchers presented data indicating that phenoxodiol, manufactured by Novogen Ltd., of Stamford, Conn., when added to low levels of standard chemotherapy agents, produced reductions in the size of human ovarian cancer tumors in animals. The researchers also showed phenoxodiol had the ability to render ovarian cancer cells more susceptible to the cytotoxic effects of standard cancer drugs.

• MethylGene Inc., of Montreal, reported results from a DNA methylation analysis of clinical samples from an MG98 Phase II trial in head and neck cancer. The tumor samples tested demonstrated difference in degree of methylation between pre- and post-MG98 treatment. In the samples, general demethylation was observed post-MG98 treatment, including on some tumor suppressor genes or genes implicated in some cancers. The demethylation was specific for tumor tissue. The company is planning a larger study.

• NeoPharm Inc., of Lake Forest, Ill., said two studies were presented as poster discussions and a third was published in the ASCO program proceedings. The preliminary data include peri- and intra-tumoral delivery of IL13-PE38QQR for treatment of malignant glioma. The findings suggest evidence of the tumor cytotoxic effects of IL13-PE38QQR against malignant glioma tumor cells at a concentration as low as 0.125 micrograms/mL. Although not designed to address efficacy, encouraging survival results were observed to beyond one year, it said.

• Novuspharma SpA, of Milan, Italy, presented results of a Phase II study of BBR 3576, administered as a single agent every four weeks in patients with advanced hormone-refractory prostate cancer. The results revealed a PSA response rate of 25 percent and evidence of BBR 3576's ability to control pain suffered by patients. Novuspharma plans to initiate a second Phase II trial of BBR 3576 in combination with prednisone later this year.

• Penwest Pharmaceuticals Co., of Danbury, Conn., said Endo Pharmaceuticals, of Chadds Ford, Pa., reported positive results from an oxymorphone ER Phase III trial in cancer pain. The trial compared the analgesic efficacy and tolerability of two opioids in patients with moderate to severe cancer pain. Endo said that in the study, oxymorphone ER provided pain relief for patients with moderate to severe cancer pain equivalent to oxycodone controlled release at half the milligram dose.

• Pharmacyclics Inc., of Sunnyvale, Calif., reported an analysis performed by the Radiation Therapy Oncology Group of Phase I results of Xcytrin (motexafin gadolinium) Injection, plus radiation therapy for the treatment of glioblastoma multiforme, suggested a survival benefit in favor of Xcytrin compared to matched historical cases from the oncology group's database of patients entered into clinical trials.

• Point Therapeutics Inc., of Boston, presented results from a study of PT-100 that demonstrated immunostimulatory effects and tumor growth suppression in mice. The study showed that oral treatment with PT-100 in tumor-bearing mice significantly suppressed tumor growth and also increased the expression of certain chemokines and cytokines within the tumor and local lymph nodes.

• SangStat Medical Corp., of Fremont, Calif., presented data from a mouse tumor model showing treatment with RDP58, SangStat's anti-inflammatory drug candidate, allowed a significant increase in the dose of irinotecan without increasing gastrointestinal toxicities and treatment-related mortality. Irinotecan is used in first- and second-line treatment of metastatic colorectal cancer. RDP58 is being studied in a Phase Ib trial in patients with metastatic colorectal cancer undergoing chemotherapy.

• Sigma-tau Research Inc., of Gaithersburg, Md., reported data showing positive indicators of antitumor activity with the oral camptothecin derivative gimatecan (ST1481). The data showed improvements in dose schedule-dependent tolerability in patients with solid tumors, the company said.

• SuperGen Inc., of Dublin, Calif., presented Phase II data suggesting its anticancer compound, Nipent (pentostatin for injection), in combination with cyclophosphamide and rituximab, is an active and well-tolerated regimen for the treatment of previously treated patients with chronic lymphocytic leukemia. Nipent is approved as a single-agent treatment for hairy-cell leukemia.

• Therion Biologics Corp., of Cambridge, Mass., said Georgetown University researchers presented data confirming the safety and the first evidence of clinical activity of Therion's Tricom vaccines. Tricom induced tumor-specific immune responses and clinical benefit in some patients with CEA-expressing cancers (in this study, predominantly gastrointestinal cancers). Specifically, disease stabilization was achieved in 40 percent of study participants, with one patient exhibiting a complete response.

• The University of Cologne in Germany presented data from ongoing phase II trial of combination fludarabine phosphate (Fludara) and alemtuzumab (Campath, ILEX Oncology Inc., of San Antonio) therapy suggesting the protocol is both effective and safe for the treatment of patients suffering from relapsed/refractory B-cell chronic lymphocytic leukemia.

• Vion Pharmaceuticals Inc., of New Haven, Conn., reported initial data from a Phase I trial of VNP40101M in leukemia. Data showed a complete response in a patient with myelodysplasia and significant reduction or elimination of marrow blasts at the end of the first cycle in five patients, including resolution of leukemic gingival hypertrophy in one. Also, it reported data from a Phase I trial of Triapine in combination with gemcitabine that showed, among other things, Triapine achieves serum concentrations that are capable of enhancing gemcitabine activity in tumor cell lines.