• Abraxis BioScience Inc., of Los Angeles, and the U.S. Oncology Research Network said preliminary findings from two Phase II studies of albumin-bound paclitaxel (nab-paclitaxel) in combination and alone in advanced non-squamous non-small-cell lung cancer and platinum-sensitive, recurrent ovarian, peritoneal or fallopian tube cancer showed the drug to be well tolerated with encouraging response rates. The 50-patient NSCLC study of nab-paclitaxel in combination with bevacizumab (Avastin, Genentech Inc.) and carboplatin showed that 31.3 percent of the 36 patients who completed all four cycles of therapy had a partial response and 52.1 percent had stable disease. Kaplan-Meier estimated survival was 15.8 months. In the ovarian cancer study, the overall response rate was 63.6 percent, with 14 complete and 14 partial responses out of 44 evaluable patients. Median duration of response was 6.5 months, with a median progression-free survival of 8.5 months.

• Cell Therapeutics Inc., of Seattle, said data on Xyotax showed reduced medical resource utilization and associated costs with that treatment compared to gemcitabine or vinorelbine in treatment of non-small-cell lung cancer. The total average treatment cost, excluding drug costs, for Xyotax patients was nearly half the cost of treatment for patients on standard chemotherapy ($2,518 vs. $4,834 per patient) and was associated with a significant reduction in many of the toxic side effects. Xyotax (paclitaxel poliglumex) is expected to begin testing in two Phase III studies in women with advanced NSCLC.

• Celtic Pharma, of New York, and Neurobiological Technologies Inc., of Emeryville, Calif., reported updated results from a Phase III trial of Xerecept showing that long-term Xerecept therapy in peritumoral edema patients appears to be safe and well tolerated, and is associated with reduced exposure to dexamethasone overall, resolution or improvement in associated steroid side effects and neurological stability or improvement. Of the first 30 patients to complete 12 weeks, 20 of them were able to reduce their dexamethasone dosing, and eight discontinued dexamethasone altogether. To date, 65 patients have enrolled in the 501 study, including 11 patients who have been on Xerecept therapy for more than one year.

• EntreMed Inc., of Rockville, Md., presented results from a Phase II study showing that Panzem in patients with glioblastoma multiforme resulted in one partial response and seven stable diseases. Of the 27 patients enrolled, 78 percent had received two or more prior cancer agents. Panzem was well tolerated, with reversible transaminase elevations as the only Grade 3 toxicity in more than one patient, and no Grade 4 toxicities.

• GlaxoSmithKline plc, of London, reported results from an ongoing Phase II study of pazopanib, an angiogenesis inhibitor targeting VEGF, platelet-derived growth factor receptor and c-kit, showed a preliminary week 12 response rate for all 225 renal-cell carcinoma patients of 27 percent, with stable disease achieved in 46 percent of patients, for a total disease control rate of 73 percent. Data from a separate Phase II study of pazopanib in patients with ovarian cancer who have failed standard platinum-based therapy showed that biological activity, as measured by a decrease in CA-125, was seen in 41 percent of evaluable patients (9/22) with relapsed disease. In a trial in soft-tissue sarcoma, 34 percent of pazopanib-treated patients (27/80) achieved progression-free survival at 12 weeks. GSK also reported at ASCO new Phase III data from of its cervical cancer vaccine candidate, Cervarix, showing that at 18 months after the first of a three-dose regimen, 100 percent of women up to age 55 had antibodies present against the two most common cancer-causing human papillomavirus types, 16 and 18. And, in non-small-cell lung cancer, GSK's MAGE-A3 antigen-specific cancer immunotherapeutic (ASCI) demonstrated a 27 percent reduction in the relative risk of cancer recurrence following surgery in MAGE-A3-positive patients following surgery compared to placebo. Based on the NSCLC data, the pharma firm is opening patient recruitment in a Phase III study of MAGE-A3 ASCI, a purified recombinant MAGE-A3 protein combined with GSK's adjuvant system containing the QS-21 Stimulon adjuvant from New York-based Antigenics Inc., which is entitled to future milestone payments as part of the companies' collaboration. The Phase III lung cancer trial also will involve the use of Wellesley, Mass.-based Coley Pharmaceutical Group's VaxImmune, a Toll-like receptor 9 agonist, as a vaccine adjuvant. The trial's primary endpoint is disease-free survival.

• Gloucester Pharmaceuticals Inc., of Cambridge, Mass., presented interim data from a Phase II study of romidepsin, a histone deacetylase inhibitor, for treating cutaneous T-cell lymphoma and peripheral T-cell lymphoma. In the CTCL patient group, four of 70 patients achieved a complete response. A partial response was seen in 18 of 70 patients. In the PTCL group, three of 39 patients achieved a complete response. A partial response was seen in eight of 39 patients.

• GPC Biotech AG, of Martinsried, Germany, Pharmion Corp., of Boulder, Colo., and IDM Pharma Inc., of Irvine, Calif., said preliminary results from a Phase II study of Uvidem melanoma vaccine showed that the drug was well tolerated with evidence of efficacy and induction of immune response in patients with progressive metastatic disease. Data showed that 30 percent of evaluable patients (9/30) showed evidence of clinical benefit, with one complete response, two partial responses and six stable disease with duration of response ranging from 9.4 months to 26.5 months. Uvidem is partnered with Paris-based Sanofi-aventis Group.

• GPC Biotech AG, of Martinsried, Germany, Pharmion Corp., of Boulder, Colo., and Spectrum Pharmaceuticals Inc., of Irvine, Calif., said additional data from the Phase III SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial showed that satraplatin lowers the risk of disease progression by 33 percent compared to control. The trial was designed to test satraplatin plus prednisone vs. placebo plus prednisone in 950 patients with hormone-refractory prostate cancer who failed prior chemotherapy. The relative risk of disease progression favored satraplatin for all pre-specified patient subsets, including prior Taxotere use, geographies, and the presence or absence of pain. For each of the 20 subsets presented, the reduction in relative risk of disease progression ranged from 26 percent to 46 percent corresponding to hazard ratios between 0.74 and 0.54. A new drug application for satraplatin is under priority review at the FDA.

• ImClone Systems Inc., of New York, reported the first-in-human results for IMC-A12, a monoclonal antibody targeted to IGF-1R (insulin-like growth factor type 1 receptor). ImClone said IMC-A12 was well tolerated and showed activity in patients with advanced solid tumors. Separately, the company said its approved IgG1 monoclonal antibody Erbitux, which targets the epidermal growth factor receptor, was the subject of nine oral and 46 poster presentations.

• Infinity Pharmaceuticals Inc., of Cambridge, Mass., and MedImmune Inc., of Gaithersburg, Md., reported updated interim results from a Phase I trial of IPI-504, a heat-shock protein 90 inhibitor, in patients with relapsed, refractory gastrointestinal stromal tumors and other advanced soft-tissue sarcomas. Data showed that 83 percent of evaluable patients (15/18) treated with in a 21-day cycle, with treatments on days 1, 4, 8 and 11, followed by 10 days off treatment achieved stable disease or better, as measured by the European Organization for Research and Treatment of Cancer's PET response criteria. Twenty-two percent of patients (4/18) treated with twice-weekly dosing without a drug holiday achieved partial responses by PET.

• Medarex Inc., of Princeton, N.J., and partner, New York-based Bristol-Myers Squibb Co., said results from multiple studies of immunotherapy candidate ipilimumab (MDX-010), an antibody that binds to CTLA-4, demonstrated an antitumor response in some patients with advanced melanoma, either as a monotherapy or in combination with other therapies. Data from a Phase II monotherapy trial showed that 19 percent of patients (17/88) experienced control of their disease, including tumor shrinkage and stabilization, and in a cohort of 23 patients given 10 mg/kg doses, disease control was achieved in 39 percent (9/23) and lasted six months or longer in all but one of those patients. Data aggregated from six Phase I and II trials showed that complete or partial response was achieved in 13 percent of patients (46/356) with advanced melanoma when treated with ipilimumab alone or in combination with traditional chemotherapy, interleukin-2 or a gp100 peptide vaccine. Of those 46 patients, 61 percent (28/46) achieved an objective response at week 12 or later, 35 percent (16/46) achieved stable disease prior to objective response and 22 percent (10/46) achieved a partial response, which developed into a complete response.

• MGI Pharma Inc., of Bloomington, Minn., reported the impact of Dacogen injection in patients with acute myelogenous leukemia showing an overall response rate ranging from 50 percent to 57 percent observed across the three clinical trials with complete and partial response rates of 24 percent and 6 percent, respectively, and hematologic improvement and marrow complete response rates of 15 percent and 6 percent, respectively. The median survival for Dacogen-treated patients was 12.6 months, the median duration of response was 8.8 months and one- and two-year survival rates were 51 percent and 26 percent, respectively. Results from a separate Phase I studies of Dacogen in relapsed or refractory acute lymphocytic leukemia showed that two of seven patients treated and retreated with Dacogen and given hyperCVAD had complete bone marrow response. In other ASCO presentations, MGI reported results from a 41-patient trial of its Aloxi injection in solid tumors, which showed that the intravenous drug in combination with dexamethasone and aprepitant demonstrated a complete response in 75 percent of patients on day one and in 67 percent of patients during the delayed period of days two through five. A Phase III trial of Aloxi in pediatric patients showed a day one complete response (CR: no emetic episodes and no rescue medication) rates of 37.1 percent and 54.1 percent in the 3 mcg/kg and 10 mcg/kg groups, respectively. In another trial, MGI researchers reported survival data for patients treated with rotational multi-agent chemotherapy compared to those receiving chemotherapy and MGI's Gliadel Wafer. After a median follow-up, the group that received Gliadel had an extended median survival of 89.4 weeks compared to 72.7 weeks in the chemotherapy-only group. And results from a Phase II trial of irofulven in hormone-refractory prostate cancer patients who failed first-line docetaxel treatment demonstrated a trend toward increased survival in patients receiving irofulven compared to the control arm. The observed median overall survival was 19.6 months for patients treated with irofulven plus prednisone, 9.4 months for patients receiving irofulven plus prednisone and capecitabine and 7.3 months in the mitoxantrone plus prednisone group.

• OSI Pharmaceuticals Inc., of Melville, N.Y., presented results of several Tarceva studies, including a Phase I trial in which a maximum tolerated dose was identified at 300 mg per day for non-small-cell lung cancer patients who smoke, as opposed for the 150 mg dose for former/never smokers. A second part of that study is ongoing to compare pharmacokinetics of Tarceva at both doses. Analysis of a 816 evaluable patients in a Phase II study suggested a correlation between skin rash development and severity and treatment outcome in patients with Stage IIIb and Stage IV NSCLC, with a disease control rate of 60.1 percent (nine complete response, 95 partial response and 261 with stable disease) in patients who developed a rash vs. a disease control rate of 38.4 percent in patients who did not develop rash. Another Phase I/II study suggested that giving docetaxel every three weeks with intermittent dosing of Tarceva resulted in a favorable response rate and time to progression in previously treated NSCLC patients. In that study, two of 37 patients had a complete response, 12 had a partial response and 15 had stable disease. In other disease areas, Tarceva showed biological activity in combination with Avastin (bevacizumab, Genentech Inc.) in patients with advanced hepatocellular carcinoma and previously untreated Stage IIIb/IV NSCLC, as well as activity in combination with cisplatin and docetaxel in metastatic/recurrent head and neck squamous-cell carcinoma.

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