• Adherex Technologies Inc., of Research Triangle Park, N.C., said final data in a Phase I study of the molecularly targeted cancer drug, ADH-1, showed the drug was well tolerated and demonstrated evidence of antitumor activity in four patients with advanced, chemotherapy-resistant cancer. One patient achieved a rapid and durable partial response, a confirmed reduction of at least 50 percent in tumor size, which continued for nine months from initiation of the study. Adherex also said a study on the effects of eniluracil on the enzymes responsible for the activation of the chemotherapeutic agent 5-fluorouracil found that eniluracil can reversibly and competitively inhibit uridine phosphorylase and thymidine phosphorylase at clinically relevant doses.

• Ascenta Therapeutics Inc., of San Diego, said Phase I data of AT-101 demonstrated early evidence of single-agent activity in treatment-na ve patients with chronic lymphocytic leukemia who are at high risk for early disease progression and inferior survival. AT-101 is in Phase II trials for CLL, non-Hodgkin's lymphoma and prostate cancer.

• Biogen Idec Inc., of Cambridge, Mass., said data show that lymphoma patients with refractory and hard-to-treat disease, specifically mantle cell lymphoma, follicular non-Hodgkin's lymphoma and primary central nervous system lymphoma, experienced improved response and remission rates once treated with Zevalin (ibritumomab tiuxetan) radioimmunotherapy. Data also suggest the use of Zevalin as a component of a transplant regimen may reduce patients' risk of relapse.

• Celator Pharmaceuticals, of Princeton, N.J., said Phase I data of CPX-1, a formulation of irinotecan and floxuridine, in colorectal cancer showed that of 23 evaluable patients, 15 had stable disease and two showed partial clinical responses. The company plans to initiate a Phase II study in the third quarter.

• Celldex Therapeutics Inc., of Phillipsburg, N.J., said Phase II data of epidermal growth factor receptor variant III (EGFRvIII) peptide vaccination in primary glioblastoma demonstrated minimal toxicity without evidence of autoimmunity, and generated both humoral and cellular responses against the EGFRvIII peptide. Median time to progression from surgery in vaccine-treated patients was 12 months, compared to a historical matched unvaccinated cohort that had a median time to progression of 7.1 months.

• Ciphergen Biosystems Inc., of Fremont, Calif., said results of a multicenter study showed that all seven biomarkers it tested demonstrated statistically significant power to differentiate ovarian cancer patients from women with benign disease, and most biomarkers had p<0.00001. An index derived from the seven markers demonstrated improved specificity for discriminating ovarian cancer from benign pelvic masses, as well as for the detection of early stage cancer.

• Gemin X Biotechnologies Inc., of Montreal, said Phase I data of GX15-070 in patients with refractory solid tumors and lymphomas showed the compound was generally well tolerated at doses resulting in biological activity. The trial enrolled 18 patients who had failed a median of four prior types of treatment. Clinical responses achieved to date include six patients with stable disease from 15 weeks to more than 47 weeks.

• Genomic Health Inc., of Redwood City, Calif., said a study evaluating tumor expression of 192 genes to predict response to docetaxel in patients with breast cancer has established a molecular blueprint for docetaxel-sensitive breast cancer and could lead to the development of a predictive test to reduce unnecessary treatment, toxicity and cost. The study evaluated biopsies from 72 patients with locally advanced breast cancer prior to treatment with neoadjuvant docetaxel.

• Gloucester Pharmaceuticals Inc., of Cambridge, Mass., said interim results from a pivotal trial of depsipeptide in cutaneous T-cell lymphoma showed a 36 percent overall response rate. The rate includes a 7 percent complete response rate and a 29 percent partial response rate among the 28 evaluable patients.

• GPC Biotech AG, of Martinsried, Germany, said new Phase I data of satraplatin, which now is in a fully enrolled Phase III trial, showed the drug appeared to be well tolerated in advanced solid-tumor patients with mild to moderate liver impairment, as well as in advanced solid tumor patients with reduced kidney function. Pharmion GmbH, a subsidiary of Boulder, Colo.-based Pharmion Corp., holds exclusive commercialization rights to satraplatin in Europe and certain other territories. GPC in-licensed satraplatin from Spectrum Pharmaceuticals Inc., of Irvine, Calif., in 2002.

• Leeds Teaching Hospitals, of Leeds, UK, said interim data from a new international Phase III study called CAM 307 showed that previously untreated patients with progressive B-cell chronic lymphocytic leukemia exhibited strong response rates and a favorable toxicity profile when treated with MabCampath (alemtuzumab), when compared to patients who were treated with chlorambucil.

• MediciNova Inc., of San Diego, said Phase I data of MN-029 in solid-tumor cancer patients showed it significantly reduced tumor blood flow at doses that were well tolerated, including those below the maximum tolerated dose. The company plans to initiate Phase II/III studies later this year.

• MGI Pharma Inc., of Minneapolis, said enrollment is complete in its multicenter Phase II alternate dosing trial of Dacogen in patients with myelodysplastic syndromes. It also reported Phase II results of Aloxi injection in patients with germ cell tumors, indicating the combination of Aloxi plus dexamethasone was well tolerated, and that a three-dose regimen provides comparable or better overall protection from nausea and emesis than a standard five-day ondansetron-based regimen. Phase II results from a separate study showed the combination of Aloxi plus olanzapine given on the first day of chemotherapy was a safe and effective option for controlling acute and delayed chemotherapy-induced nausea and vomiting. The company also presented results of a Phase III Dacogen trial, showing an overall response rate of 21 percent, as well as Phase I data of Dacogen plus valproic acid in patients with AML.

• NovaRx Corp., of San Diego, said Phase II data in patients with advanced stages of non-small-cell lung cancer treated with Lucanix demonstrated two-year survival more than four times that of individuals treated with the current standard of care. In clinical studies to date, the side effects of Lucanix have been minimal compared to those associated with traditional therapies. The company plans to move the product into a two-arm, controlled Phase III trial in about 400 patients with advanced NSCLC.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said data on Tarceva (erlotinib) showed it may be used earlier in the treatment of lung cancer, in subsets of patients previously viewed as less responsive to therapy with EGFR inhibitors, and in the treatment of additional cancers. It is approved for advanced non-small-cell lung cancer and in combination with gemcitabine for advanced pancreatic cancer. Data presented also supported earlier reports of encouraging antitumor activity for Tarceva in combination with chemotherapy in treating head and neck cancer and for the activity of Tarceva in male smokers with squamous-cell carcinoma or NSCLC.

• Oxxon Therapeutics Ltd., of Oxford, UK, said its Hi-8 MEL therapeutic vaccine in patients with advanced non-resectable melanoma met its endpoints in a Phase II dose-escalation trial. It demonstrated that immunization with the vaccine is well tolerated at all doses and shows clinical benefit in HLA-A2 positive patients.

• PDL BioPharma Inc., of Fremont, Calif., and Biogen Idec Inc., of Cambridge, Mass., said new Phase II data on volociximab showed it appears to be well tolerated when used in patients with metastatic renal-cell carcinoma, adenocarcinoma of the pancreas and melanoma. Results show volociximab may inhibit tumor angiogenesis regardless of the pro-angiogenic growth factors that promote tumor growth.

• The Cancer and Leukemia Group B, of Chicago, said a clinical trial of cetuximab and chemotherapy in previously untreated patients with metastatic colorectal cancer showed a significantly higher response rate among patients treated with cetuximab and chemotherapy compared with patients treated with chemotherapy alone (52 percent vs. 38 percent). The trial included 238 patients with untreated metastatic adenocarcinoma of the colon or rectum. Cetuximab is branded Erbitux, from ImClone Systems Inc., of New York.

• Xanthus Pharmaceuticals Inc., of Cambridge, Mass., said Phase I data of Symadex showed it was well tolerated in patients with advanced solid tumors and the recommended dose of 480 mg/m2 yielded a predictable safety profile. Symadex is in two Phase II trials in patients with metastatic colorectal cancer and metastatic breast cancer. Xanthus also said it completed a planned interim analysis of its Phase II study of Xanafide (amonafide malate) to treat patients with secondary acute myeloid leukemia, and an independent data safety monitoring board recommended continuation of the trial.