• Abraxis Oncology, a division of Schaumburg, Ill.-based American Pharmaceutical Partners Inc., reported Phase I data on Abraxane (albumin nanoparticle paclitaxel) indicating the drug was well tolerated at high doses in a weekly dosing schedule for non-hematologic malignancies, such as lung, ovarian and metastatic breast cancer, and patients who have had prior chemotherapies. The company recently filed its new drug application for Abraxane in breast cancer. (See BioWorld Today, March 9, 2004.)

• Advanced Viral Research Corp., of Yonkers, N.Y., said Phase I/II data on AVR118 in cachectic patients showed an increase in weight, strength and fat percentage, with more significant improvements in the two higher dose levels.

• Adventrx Pharmaceuticals Inc., of San Diego, reported positive data on CoFactor in combination with 5-fluorouracil and an antibody-based inhibitor of vascular endothelial growth factor in a mouse model of human colorectal cancer.

• AEterna Zentaris Inc., of Quebec City, and Keryx Biopharmaceuticals Inc., of New York, said Phase I data of KRX-0401 (perifosine) in combination with radiotherapy in patients with unresectable locally advanced tumors demonstrated acceptable safety and tolerability, with 150 mg/day established as the recommended dose.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said AP23573 demonstrated antitumor activity in two Phase I trials in patients with a broad spectrum of solid tumors.

• Celgene Corp., of Warren, N.J., said Phase II data of thalidomide in combination with temozolomide as an oral regimen for the adjuvant treatment of high-risk metastatic melanoma patients showed an overall survival rate at one year of 100 percent, at two years of 95.5 percent and at three years of 71.3 percent. Celgene also reported Phase II data of an oral combination therapy consisting of melphalan, prednisone and thalidomide used in newly diagnosed multiple myeloma patients showing the therapy induced a higher response rate than any other conventional chemotherapy programs.

• Cell Genesys Inc., of South San Francisco, said Phase I/II data on CG7870 oncolytic virus therapy for prostate cancer showed that five patients out of 23 enrolled had a decrease in prostate-specific antigen levels of 25 percent to 49 percent.

• Cell Therapeutics Inc., of Seattle, said Phase I data on CT-2106 in patients with advanced malignancies showed the therapy was well tolerated and lacked the severe gastrointestinal and bladder toxicities that are typical for camptothecins. One patient exhibited a partial response and another achieved disease control.

• ChemGenex Therapeutics Inc., of Menlo Park, Calif., said Phase I/II data on Quinamed (amonafide dihydrochrloride) showed evaluable responses were observed in three patients with gastrointestinal stromal, prostate and ovarian cancers.

• Corixa Corp., of Seattle, and GlaxoSmithKline plc, of London, said therapy with two different standard chemotherapeutic regimens, each followed by a single treatment with the Bexxar therapeutic regimen, produced complete responses in 80 percent to 83 percent of patients with advanced follicular B-cell non-Hodgkin's lymphoma.

• Dendreon Corp., of Seattle, said Phase I data show promising clinical activity of APC8024 in multiple HER2/neu-positive metastatic solid tumors, including those that are low HER2/neu-expressers.

• Epimmune Inc., of San Diego, said Phase I/II data of EP-2101 in non-small-cell lung cancer and colorectal cancer show the vaccine was safe and well tolerated and induced a multi-epitope response, with 60 percent of the patients responding to at least five of the nine epitopes included in the vaccine.

• Genentech Inc., of South San Francisco, and OSI Pharmaceuticals Inc., of Melville, N.Y., said Phase I/II data of Avastin (bevacizumab) and Tarceva (erlotinib HCl) to treat metastatic renal-cell carcinoma and relapsed non-small-cell lung cancer showed that 21 percent of patients experienced an objective response and 66 percent experienced a minor response and disease stabilization. Overall survival after six months was 92 percent. Separately, Genentech said Phase II data evaluating the combination of Avastin and gemcitabine chemotherapy in treating metastatic pancreatic cancer suggest that 21 percent of patients experienced a partial response to treatment lasting a median of 9.4 months, and 45 percent of patients achieved stable disease lasting a median of 5.4 months. Median survival was nine months. Data from a pivotal Avastin Phase III trial in metastatic colorectal cancer showed a 29 percent improvement in the primary endpoint of median survival, from 16.6 months in the Avastin and chemotherapy arm to 12.9 months in the chemotherapy arm. The improvement was not statistically significant, but it was clinically meaningful. Data also showed that the addition of Avastin to 5-FU/leucovorin provides a consistent improvement in median survival and progression-free survival.

• Genomic Health Inc., of Redwood City, Calif., and Istituto Nazionale Tumori, of Milan, Italy, said clinical data showed the patterns of expression of a substantial number of genes were clinically correlated to a pathological complete response to chemotherapy. It also showed that the Oncotype DX Breast Cancer Assay Recurrence Score significantly correlated with response to chemotherapy in breast cancer patients.

• Geron Corp., of Menlo Park, Calif., said Phase I/II data of its telomerase therapeutic vaccine in metastatic prostate cancer showed that 19 of 20 patients responded by generating telomerase-specific cytotoxic T cells.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, announced positive results with investigational immune-regulating hormones in preclinical models of radiation- and chemotherapy-induced bone marrow suppression.

• Human Genome Sciences Inc., of Rockville, Md., said Phase I data demonstrated the safety and tolerability of HGS-ETR1 in patients with advanced solid tumors or non-Hodgkin's lymphoma.

• ImClone Systems Inc., of New York; Merck KgaA, of Darmstadt, Germany; and Bristol-Myers Squibb Co., of New York, said Erbitux (cetuximab) injection in patients with advanced squamous-cell carcinoma of the head and neck showed an overall response rate of 12.6 percent. The disease control rate was 45.6 percent. Median time to progression was 2.3 months, median survival was 5.9 months and median duration of response was 5.9 months. In a Phase I study, Erbitux combined with one of three doses of 5-FU and either cisplatin or carboplatin demonstrated a disease control rate of 69.8 percent. The overall response rate was 35.9 percent.

• Kosan Biosciences Inc., of Hayward, Calif., said Phase I and Ib trials of 17-allylamino-17-demethoxy-geldanamycin showed it was well tolerated and the recommended dose was 295 mg/m2 given weekly three out of four weeks. The company also reported Phase I data of KOS-862 in patients with advanced solid tumors that showed drug-related toxicities appear amenable to supportive care and that the pharmacokinetics and pharmacodynamics were linear over the doses tested. In 33 patients, there was one partial response and a minor response.

• Kudos Pharmaceuticals Inc., of Cambridge, UK, and Novacea Inc., of South San Francisco, said Phase I data of AQ4N in 13 of an expected 22 patients show it is was well tolerated with a favorable pharmacokinetic profile.

• Ligand Pharmaceuticals Inc., of San Diego, said several clinical and in vitro studies on Targretin, Ontak and Avinza were presented, showing synergistic growth inhibitory activity of Targretin and Iressa on human non-small-cell lung cancer cell lines, Ontak's potential to improve immune response to tumors and enhance the activity of immunotherapies, and Avinza's ability to give cancer patients pain relief.

• MGI Pharma Inc., of Minneapolis, said Aloxi injection for the prevention of chemotherapy-induced nausea and vomiting showed that 90 percent of 39 patients evaluated during the acute time period had a complete response, with 97 percent of patients experiencing no emetic episodes. Data of irofulven in hormone-refractory prostate cancer, hepatocellular carcinoma and metastatic colorectal cancer showed consistent antitumor activity of irofulven alone and in combination with other chemotherapeutic drugs.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said Phase I data of MLN2704 in patients with progressive metastatic hormone-refractory prostate cancer show it was well tolerated and produced antitumor activity.

• NeoPharm Inc., of Lake Forest, Ill., said Phase I data of LE-SN38 provide preliminary evidence of improved patient safety and tolerability.

• OncoGenex Technologies Inc., of Vancouver, British Columbia, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., said Phase I data of OGX-011 showed it was well tolerated, achieved excellent drug concentration in target tissue and produced a 91 percent dose-dependent down-regulation of its target, clusterin, in prostate cancer.

• Pharmacyclics Inc., of Sunnyvale, Calif., said Xcytrin (motexafin gadolinium) injection in combination with Taxotere (docetaxel) to treat patients with advanced refractory tumors resulted in a partial response in four patients, including two of the three patients suffering from non-small-cell lung cancer.

• PharmaMar SA, of Madrid, Spain, said interim results from a Phase II trial of Yondelis show the therapy has activity in a heavily pre-treated group of patients with sarcomas. Also, PharmaMar said Phase I data of Kahalalide F in patients with advanced or metastatic androgen-refractory prostate cancer showed the therapy can be administered safely as a one-hour intravenous infusion during five consecutive days at a dose of 560 mg/m(2)/day once every three weeks.

• Point Therapeutics Inc., of Boston, said clinical data showed talabostat (PT-100) can accelerate neutrophil recovery in patients receiving myelosuppressive chemotherapy for solid tumors.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said Phase I data of its vascular endothelial growth factor (VEGF) Trap in patients with advanced solid tumors showed it was well tolerated and achieved a long elimination half-life of about 25 days.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., said preclinical data on NBT-287 in human tumor cell lines suggest the therapy may have potential in treating both paclitaxel-resistant and treatment-na ve cancers.

• Therion Biologics Corp., of Cambridge, Mass., said data support the safety profile of the company's cancer vaccines and suggest early evidence of extended overall survival in patients with advanced pancreatic cancer. The data from more than 30 trials form the basis for its upcoming pivotal trial of Panvac-VF to treat metastatic pancreatic cancer.

• Transgene SA, of Strasbourg, France, said Phase II trials with its MVA-Muc1-IL2 therapeutic cancer vaccine in lung and prostate cancers were positive. In the lung cancer trial, seven patients responded to treatment and five patients had their disease stabilized for more than 12 weeks. In the prostate cancer trial, data show the therapy was biologically active and may decelerate progression of the disease. Good tolerance and safety were observed in both studies.

• VasGene Therapeutics Inc., of Los Angeles, said Phase I data of VEGF-AS (Veglin) demonstrated that it lowered levels of a key protein required to grow tumors and was safe in patients with a variety of cancers.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said Phase I data of cloretazine (VNP40101M) showed it was well tolerated and produced minimal non-hematologic toxicity. No objective responses were observed, but there was evidence of antitumor effect consisting of stable disease or tumor shrinkage. Phase I data of cloretazine in combination with cytosine arabinoside in leukemia resulted in a maximum tolerated dose of 500 mg/m(2) for cloretazine and 1500 mg/m(2) for Ara-C, as well as three complete responses out of the 25-patient group.

• Xcyte Therapies Inc., of Seattle, said data from three Phase I/II trials of Xcellerated T cells showed that 79 percent of chronic lymphocytic leukemia patients demonstrated a more than 50 percent reduction in the size of their enlarged lymph nodes, 51 percent of multiple myeloma patients had a reduction of at least 90 percent in M-protein, and two of 19 prostate cancer patients had a greater than 50 percent reduction in prostate-specific antigen.

• ZymoGenetics Inc., of Seattle, said data of interleukin-21 plus low-dose rituximab showed the therapy enabled survival of 70 percent of mice injected with an aggressive non-Hodgkin's lymphoma cell line, compared with only 10 percent of mice treated with rituximab alone.

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