• Millennium Pharmaceuticals Inc., of Cambridge, Mass., presented data at the American Society of Clinical Oncology meeting in Chicago showing that a therapeutic regimen that employs Velcade (bortezomib) for newly diagnosed multiple myeloma patients, called Total Therapy 3 (TT3), generated a complete response and near-complete response rate of 84 percent when used prior to and as maintenance following stem cell transplantation, compared to 68 percent for previously reported results from Total Therapy 2 (TT2), a current standard of care that doesn't include Velcade. Also, TT3 produced an event-free survival of 83 percent compared to 75 percent for TT2.

Separate data showed that the addition of Velcade to current standards of care known as R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) produced high complete response rates in patients with newly diagnosed B-cell lymphoma and mantle cell lymphoma. Specifically, the investigational combination produced a complete response and unconfirmed complete response rate of 83 percent, a superior result compared to the historical 55 percent to 75 percent response for R-CHOP given for six cycles without Velcade.

In Velcade research supported by the International Myeloma Foundation, data from a follow-up to a Phase III trial shows the combination of Velcade and Doxil improves the probability of survival by 41 percent and also showed no increase in serious side effects such as neuropathy with the addition of Doxil to the Velcade.

In news on other Millennium programs, the company said preliminary Phase I results of its Aurora A kinase inhibitor MLN8054 showed that six patients maintained stable disease for longer than eight months, even though a maximum tolerated dose has not yet been identified. Based on these early findings, Millennium has advanced a second-generation Aurora A kinase inhibitor, MLN8237, into Phase I testing too.

In other ASCO news:

• Abraxis BioScience Inc., of Los Angeles, reported updated results from an ongoing, open-label, randomized Phase II trial comparing Abraxane (paclitaxel protein-bound particles for injectable suspension) and Taxotere (docetaxel, Sanofi-aventis Group) in the first-line treatment of metastatic breast cancer, demonstrating that 150 mg/m2 of Abraxane administered weekly and 300 mg/m2 every three weeks resulted in longer progression-free survival and an overall improved toxicity profile compared to 100 mg/m2 of Taxotere administered every three weeks. Also, 100 mg/m2 of Abraxane administered weekly resulted in comparable progression-free survival and significantly less toxicity compared to the Taxotere arm.

• Adherex Technologies Inc., of Research Triangle Park, N.C., said Phase II data on single-agent ADH-1 therapy in patients with N-cadherin-positive solid tumors showed it was well tolerated, and prolonged stable disease was seen in a number of patients. Also, encouraging data were seen in a Phase I study evaluating oral eniluracil combined with oral 5- FU.

• AEterna Zentaris Inc., of Quebec City, said Phase I data showed evidence of antitumor activity with 160 mg/m2 or 267 mg/m2 doses of its targeted cytotoxic luteinizing hormone-releasing hormone (LHRH) analogue, AEZS-108, in female patients with cancers expressing LHRH receptors. Specifically, seven of 13 showed signs of tumor response, including three with complete or partial responses. Separately, the company's partner Keryx Biopharmaceuticals Inc., of New York, presented Phase I and II results showing that perifosine generated an overall clinical benefit rate of 52 percent, which compares favorably with the activity of mTOR inhibitors, in treating advanced sarcoma.

• Agennix Inc., of Houston, said a fourth Phase II trial of its lead molecule talactoferrin alfa, an oral immunomodulatory protein with a novel mechanism of action, met its primary endpoint of a statistically significant improvement in overall survival when compared to placebo in patients with refractory non-small-cell lung cancer. Specifically, median overall survival in the 100-patient intent-to-treat (ITT) population was 62 percent higher in the talactoferrin group than in the placebo group, six months vs. 3.7 months (p=0.0476), and in the 81-patient, prospectively defined evaluable population, median overall survival was 73 percent higher in the talactoferrin group than in the placebo group, 7.6 months vs. 4.4 months (p=0.0213). Secondary efficacy endpoints also showed improvement consistent with the primary results, and oral talactoferrin was well tolerated, with fewer adverse events observed in the talactoferrin arm.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said an analysis of Phase III data showed that Soliris (eculizumab) is effective in paroxysmal nocturnal hemoglobinuria patients who have a history of aplastic anemia or myelodysplastic syndromes. The drug significantly reduced red blood cell destruction, decreased or eliminated blood transfusion requirements, improved fatigue and quality-of-life outcomes, and reduced thrombotic events in those who have a history of either one of those bone marrow disorders.

• Antisoma plc, of London, presented new data from its Phase II trials of ASA404 (formerly AS1404), a small-molecule vascular disrupting agent, with first-line docetaxel chemotherapy in hormone-refractory prostate cancer. Final PSA data showed a response rate of 59 percent for ASA404 plus docetaxel vs. 37 percent for docetaxel alone. The proportion of patients showing progression by PSA was 16 percent in the ASA404 group and 37 percent in the control group.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said its mTOR inhibitor AP23573 demonstrated efficacy in a single-agent, 45-patient Phase II trial in metastatic endometrial cancer. The primary endpoint was achieved, as 29 percent of patients had tumor regression or disease stabilization. Also, a Phase Ib trial of the small-molecule compound and paclitaxel demonstrated tolerability and antitumor activity. Finally, Ariad presented additional positive efficacy data on AP23573 from an ongoing Phase II trial in patients with metastatic and/or unresectable soft-tissue and bone sarcomas.

• Biogen Idec Inc., of Cambridge, Mass., said adding Zevalin (ibritumomab tiuxetan) radioimmunotherapy to a short-course first-line treatment followed by rituximab weekly for four weeks doubled the rate of complete response in patients with follicular lymphoma, from 44 percent with a standard treatment regimen to 88 percent. Additionally, the response rate for patients in the study was 100 percent based on PET scan assessment. Data in the Phase II trial were available from 50 patients with symptomatic, stages II-IV and grades 1-3, untreated follicular lymphoma.

• Celator Pharmaceuticals Inc., of Princeton, N.J., reported positive safety and efficacy results from its Phase I study of CPX-1 (Irinotecan HCI:Floxuridine) in patients with heavily pre-treated, advanced solid tumors. Among a total of 33 patients with different types of cancer who were treated in the dose-escalating study, 73 percent showed clinical benefit including either partial regression or stable disease. In 10 of them, delay of disease progression was greater than six months. Among a subset of 15 with colorectal cancer, median duration of progression-free survival was 5.3 months. Of those, 80 percent received CPX-1 as a third-, fourth- or fifth-line treatment, and 66 percent had prior treatment with irinotecan

• Cell Genesys Inc., of South San Francisco, and Medarex Inc., of Princeton, N.J., said follow-up data from an ongoing Phase I trial in patients with advanced prostate cancer receiving Cell Genesys' GVAX immunotherapy for prostate cancer administered in combination with ipilimumab (MDX-010), a fully human anti-CTLA-4 antibody that is being jointly developed by Medarex and Bristol-Myers Squibb Co., of New York, demonstrated anti-tumor activity in five patients, including prostate-specific antigen declines of greater than 50 percent that were maintained in four of them for at least six months, with the longest response to date at about 16 months. Separately, the company said follow-up Phase II data to a study of GVAX immunotherapy for pancreatic cancer include a median disease-free survival of about 16 months, which compares favorably to the 13 months disease-free survival recently reported for gemcitabine adjuvant therapy. Moreover, a comparison of the median overall survival of 60 patients from this trial to patients with operable pancreatic cancer who underwent surgery and adjuvant therapy without receiving GVAX indicated that the median overall survival of the latter group was about 21 months, or nearly six months shorter than those in the study. Their median overall survival was previously reported to be 26.8 months, a result which compares favorably to the 17 to 22 months median survival results published from multiple studies in patients undergoing pancreatic cancer surgery and adjuvant therapy.

• Cell Therapeutics Inc., of Seattle, said independent, prospective cooperative group data validated the potential survival benefit of Xyotax (paclitaxel poliglumex) over standard chemotherapy in treating advanced non-small-cell lung cancer in women whose estrogen levels are in the normal range for pre-menopausal women. Findings from one retrospective analysis show free estradiol (E2) levels in serum are prognostic in men as well as women with non-small-cell lung cancer, showing that men with higher levels of free E2 have shorter survival, consistent with the shorter survival noted in pre-menopausal women when compared to older women. Another retrospective analysis showed younger women with advanced non-small-cell lung cancer, those younger than 60, have shorter survival than older women.

• Celldex Therapeutics Inc., of Phillipsburg, N.J., said interim Phase I data suggested intradermal administration of CDX-1307 resulted in localization of the beta subunit of human chorionic gonadotropin, a tumor-associated antigen, in antigen-presenting cells of the skin. Also, updated data from the Phase II ACTIVATE trial and ACT II continuation study of CDX-110, an immunotherapy that targets EGFRvIII, in patients with newly diagnosed glioblastoma multiforme currently shows a median survival time of 126.1 weeks, and a median time to progression of 64.5 weeks (p=0.0001) vs. a historical control's median of 28.52 weeks.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, presented data from a Phase I/IIa trial of Quinamed (amonafide dihydrochloride) in heavily pretreated patients with solid tumors. It said it demonstrated that dose level could be optimized according to patient genotype, that the drug was well tolerated, and that anticancer activity was seen.

• Cougar Biotechnology Inc., of Los Angeles, said interim Phase I/II data on the prostate cancer drug CB7630 (abiraterone acetate) showed that 22 of 34 patients who were evaluable for response, or 65 percent of them, experienced a confirmed decline in prostate-specific antigen levels of greater than 50 percent, with 10 of the 34 (29 percent) experiencing PSA declines of greater than 90 percent. Of the 20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses in 11, or 55 percent, with seven patients demonstrating ongoing stable disease and three with regressing bone disease.

• Cytogen Corp., of Princeton, N.J., said Quadramet (samarium Sm-153 lexidronam injection) can be safely administered to prostate cancer patients who are also receiving Taxotere (docetaxel, Sanofi-aventis Group), according to data from an open-label Phase I study, so plans are under way for Phase II. Preliminary data from another Phase I trial in 10 patients who received repeated doses of the combination showed that all had bone metastases and all seven symptomatic patients had improvement in pain. Median baseline PSA was 77 ng/ml, and four of the 10 achieved a 50 percent decline that lasted for four or more weeks.

• Cytokinetics Inc., of South San Francisco, said interim Phase II findings showed that treatment with ispinesib as a monotherapy at 7 mg/m2 on days one, eight and 15 every 28 days in advanced kidney cancer patients does not appear to lead to objective responses but appears to be well tolerated. Another study, which produced one partial response with a duration of 42 weeks and five patients with stable disease, failed to get to a second stage of testing because none of the 22 evaluable patients had a CA-125 response and the median time to CA-125 progression was 5.3 weeks. An ongoing study of another of the company's drugs, SB-743921, showed it to be well tolerated to date, without prophylactic Granulocyte colony-stimulating factor in the first cohort of the Phase I portion of the trial. It continues to dose-escalate.

• Diatos SA, of Paris, presented Phase I data of the doxorubicin prodrug DTS-201, demonstrating safety, tolerability and the ability to deliver high doses of free doxorubicin in humans. It determined a recommended dose for Phase II trials of the drug, also known as Super-Leu-Dox or CPI-0004Na.

• Eli Lilly and Co., of Indianapolis, said Phase III data suggested Altima (pemetrexed for injection) plus carboplatin showed comparable quality-of-life benefit along with reduced toxicity vs. Gemzar plus carboplatin, in patients with advanced non-small-cell lung cancer.

• EntreMed Inc., of Rockville, Md., said Phase II results on the capsule formulation of Panzem (2-methoxyestradiol) demonstrated prolonged stable disease and minor responses in patients with relapsed and plateau phase multiple myeloma. Progression-free survival rates were 24 percent, 17 percent and 11 percent for all patients at one, two and three years. The product was well tolerated and did not cause significant neuropathy, myelosuppression or thromboembolic disease.

• Exelixis Inc., of South San Francisco, reported integrated data from six Phase II trials of XL999 in patients with non-small-cell lung cancer, renal cell carcinoma, metastatic colorectal cancer, recurrent ovarian cancer, acute myelogenous leukemia and multiple myeloma showing preliminary antitumor activity in patients with lung cancer and AML, as well as a cardiovascular adverse event profile consistent with previously reported data. The company said the data provided a clear basis for the tyrosine kinase inhibitor's further development. Separately, Phase I data on XL880, a small molecule that simultaneously inhibits MET and VEGFR2, showed that it produced five partial responses and prolonged stable disease of more than three months in an additional 20 patients.

• Favrille Inc., of San Diego, said early Phase II data showed that FavId in combination with maintenance Rituxan to be feasible and well tolerated in treating indolent B-cell non-Hodgkin's lymphoma (NHL). The study remains open to enrollment.

• Genomic Health Inc., of Redwood City, Calif., said data suggested the Oncotype DX Recurrence Score provides accurate information regarding the likelihood of breast cancer recurrence for patients with hormone receptor-positive breast cancer. The score was a highly significant predictor of recurrence in chemotherapy-treated patients in the 776-patient study, it said.

• Genta Inc., of Berkeley Heights, N.J., said Phase II results showed that Ganite (gallium nitrate) plus Rituxan (rituximab) and dexamethasone in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) produced a major objective response in 41 percent of patients, including 36 percent with complete or unconfirmed complete responses and 5 percent with a partial response. Two of the major responders had previously failed a stem cell transplant; both patients remain in sustained remission more than a year after their last relapse. Six other patients achieved stable disease.

• GlaxoSmithKline plc, of London, reported positive data from three studies of its oral small-molecule HER2 kinase inhibitor, Tykerb. Data were presented on one study with paclitaxel as first-line treatment for advanced breast cancer; another showed Tykerb has clinical activity in heavily pretreated patients with CNS metastases from HER2-positive breast cancer; and a third found that fewer patients on Tykerb plus capecitabine developed brain metastases vs. capecitabine alone.

• Celegene Corp., of Summit, N.J. said strong one-year survival data from a Phase III cooperative group study demonstrated the benefits of using Revlimid (lenalidomide, Celgene Corp.) with reduced doses of the steroid dexamethasone. The complete dataset showed that patients younger than 65 had the greatest one year survival, 98 percent with Revlimid and low-dose dexamethasone compared to 90 percent with Revlimid and high-dose dexamethasone. Patients older than 65 had the greatest degree of benefit from the former combination, with a 95 percent survival compared to 83 percent for the latter combination. Also, the combined survival rate at one year was 96.5 percent with Revlimid and low-dose dexamethasone compared to 86 percent with Revlimid and high-dose dexamethasone. Based on those findings, a committee of leading myeloma researchers called the U.S. Myeloma Forum approved plans to study new therapeutic options for newly diagnosed myeloma patients, without first offering bone marrow transplants that have been the standard of care up until now. Top-line findings from the cooperative group study were reported last month.

• IDM Pharma Inc., of Irvine, Calif., said interim Phase II data showed its EP-2101 vaccine to be well tolerated and suggested a survival benefit in patients with non-small-cell lung cancer who were vaccinated with EP-2101 compared to concurrent non-vaccinated patients. Specifically, one-year survival in those treated with EP-2101 was 60 percent compared to 49 percent in a group of patients who were HLA-A2-negative but otherwise comparable. Median survival for EP-2101 patients was 583 days compared to 361 days for those in the control group, and 91 percent of EP-2101 patients, who were tested for immune response, had a measurable response to at least one of the epitopes included in the vaccine, with 64 percent responding to at least three of the epitopes. In addition, generation of a robust immune response was also demonstrated.

• ImClone Systems Inc., and Bristol-Myers Squibb Co., both of New York, reported data of its cancer drug Erbitux showing that the drug slightly prolonged survival in previously untreated colorectal cancer patients who also are receiving chemotherapy. Results showed that the addition of Erbitux increased survival to 8.9 months vs. 8 months in the chemotherapy-only group.

• ImmunoGen Inc., of Cambridge, Mass., reported encouraging data from Tumor-Activated Prodrug compounds in solid tumors. Tumor shrinkage was seen with huN901-DM1 in patients with relapsed small-cell lung cancer or other CD56-expressing small-cell carcinomas; four of 10 patients who received trastuzumab-DM1 had an objective response; and HuC242-DM4 has not been associated with dose-limiting toxicity in Phase I evaluation.

• Immunomedics Inc., of Morris Plains, N.J., said data showed its humanized anti-CD20 monoclonal antibody was active in patients with non-Hodgkin's lymphoma at a low dose of 80 mg/m2. The overall objective response rate in the Phase I/II trial for 56 assessable patients was 45 percent, with 20 percent of patients having a complete response.

• Innovive Pharmaceuticals Inc., of New York, presented additional Phase I data from its ongoing trial of INNO-406, a dual Bcr-Abl and Lyn-kinase inhibitor. INNO-406 was well tolerated at doses and generated hematological, cytogenetic and molecular responses in Gleevec-resistant chronic myelogenous leukemia. A pivotal Phase II study is expected to start in the third quarter.

• Introgen Therapeutics Inc., of Austin, Texas, said updated Phase II data in patients with recurrent squamous cell carcinoma of the head and neck demonstrated a significant correlation between abnormal p53, tumor responses and increased survival following Advexin therapy. There was a statistically significant increase in median survival for each of the responder populations compared to the six-month median survival of the nonresponders.

• Kosan Biosciences Inc., of Hayward, Calif., said preliminary data from a Phase II monotherapy trial showed tanespimycin (KOS-953) demonstrated antitumor activity and tolerability in patients with metastatic melanoma. Also, the Hsp90 inhibitor, in combination with bortezomib, showed a high degree of antitumor activity in patients with multiple myeloma who had progressed following other treatments. Kosan also said a Phase I trial of KOS-1584/R1645, an epothilone, demonstrated activity patients in 13 of 41 evaluable solid-tumor patients. Finally, Phase I data showed alvespimycin, a second-generation Hsp90 inhibitor, demonstrated promising antitumor activity and tolerability in combination with Herceptin in patients with refractory HER2-positive metastatic breast cancer and in refractory ovarian cancer.

• Micromet Inc., of Bethesda, Md., said final Phase II data showed a significant prolongation of time to progression in metastatic breast cancer patients treated with the higher dose of adecatumumab (MT201) compared to those receiving the lower dose (p<0.05). The exploratory, post hoc subgroup analysis follows previous data showing that the primary endpoint of the trial was not reached, a 25 percent clinical benefit rate at week 24. Adecatumumab is being developed in collaboration with Merck Serono, a division of Merck KGaA, of Darmstadt Germany.

• Novacea Inc., of South San Francisco, said final results from a Phase I/II trial of Asentar (DN-101) in combination with Taxotere in patients with late-stage non-small-cell lung cancer demonstrated tolerability, with the maximum dose not having been reached. Separately, it provided positive data from its ASCENT trial on C-reactive protein as a prognostic marker in men with androgen-independent prostate cancer.

• OncoGenex Technologies Inc., of Vancouver, British Columbia, said a Phase I/II trial of OGX-011 plus chemotherapy in non-small-cell lung cancer resulted in median overall survival of 14 months compared to published estimates of eight to 11 months for chemotherapy alone and 12.3 months for Avastin plus chemo. In a Phase II trial in prostate cancer, OGX-011 plus chemo and prednisone achieved the primary endpoint of a PSA response in 50 percent of patients, as did chemo alone. Median progression-free survival was 7.3 months for OGX-011 vs. 5.8 months for chemo alone.

• Oxford BioMedica plc, of Oxford, UK, and Sanofi-aventis, of Paris, said Phase II data on 48 evaluable patients with progressive metastatic renal cell cancer showed the immunotherapy product TroVax was well tolerated and that it induced anti-5T4 antibody responses in 91 percent of patients. In patients with clear-cell RCC, disease control was shown in 24 of 35 evaluable patients. Preliminary analysis showed a statistically significant relationship between reduction in tumor burden and anti-5T4 antibody responses.

• Pfizer Inc., of New York, said single-agent, oral Sutent (sunitinib malate) treatment prolonged progression-free survival across all patient risk groups, including those with the poorest prognoses for survival, vs. interferon-alfa. Results came from new data from a Phase III trial in the first-line treatment of advanced renal cell carcinoma. Pfizer also presented Phase II data on Sutent, a multi-kinase inhibitor, in several tumor types.

• Pharmacyclics Inc., of Sunnyvale, Calif., said preliminary results from an open-label Phase II trial of Xcytrin (motexafin gadolinium) injection showed comparable response rates and survival to approved second-line therapies for metastatic non-small-cell lung cancer. A pivotal trial in that indication is planned for next year.

• Pharmion Corp., of Boulder, Colo., presented data on several candidates. It reported favorable interim data vs. topotecan from a Phase II study of Amrubicin, a third-generation synthetic anthracycline, in the second-line treatment of platinum-sensitive small-cell lung cancer patients with extensive disease. Forty percent of 15 Amrubicin patients showed an objective tumor response, while no responses were seen among the nine topotecan patients. Median progression-free survival at the interim analysis was 4.1 months for Amrubicin vs. 2 months for topotecan. Pharmion and MethylGene Inc., of Montreal, said preliminary Phase II and Phase I/II data on MGCD0103, an isotype-selective histone deacetylase inhibitor, showed significant antitumor activity in patients with Hodgkin's lymphoma, myelodysplastic syndromes and acute myelogenous leukemia. A Phase II trial in refractory and relapsed Hodgkin's lymphoma patients showed a complete and partial response rate of 40 percent and a disease control rate of 45 percent. Overall, 75 percent of patients experienced a reduction in tumor size. Separately, Pharmion reported final Phase III results demonstrating that the addition of Thalidomide to standard therapy improves overall survival by 17.6 months in patients 75 or older with newly diagnosed multiple myeloma compared to the current standard of care, melphalan and prednisone. In the final analysis, the median overall survival in the Thalidomide plus melphalan and prednisone arm was 45.3 months, compared to 27.7 months for the patients treated with melphalan, prednisone and placebo (p=0.05 log-rank test). Pharmion also reported interim results of several studies of Vidaza (azacitidine) in hematologic malignancies and advanced solid tumors. In one, 61 percent of myelodysplastic syndrome patients experienced hematologic improvement after receiving two or more cycles of therapy. Findings from a separate study showed the combination of Vidaza and valproic acid is safe and active in advanced solid tumors, with 25 percent of study patients experiencing stable disease.

• Poniard Pharmaceuticals Inc., of South San Francisco, said new picoplatin results confirmed and extended previously announced data from a Phase II trial, which demonstrated a survival benefit in patients with recurrent small-cell lung cancer. Updated efficacy results from 77 patients showed a median overall survival of 27 weeks with picoplatin, a new-generation platinum agent, vs. a median of 17 to 22 weeks for other second-line chemotherapy. Picoplatin is in a pivotal Phase III trial in SCLC.

• PTC Therapeutics Inc., of South Plainfield, N.J., presented data from Phase I studies in healthy volunteers evaluating PTC299, its VEGF inhibitor. Data showed PTC299 was well tolerated and safely achieved the desired target plasma concentrations at all tested doses.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., and Sigma-Tau SpA, of Pomezia, Italy, said thymalfasin (Zadaxin, thymosin alpha 1) achieved its primary endpoint in a Phase II trial treating patients diagnosed with Stage IV malignant melanoma. Results showed that thymalfasin in combination with dacarbazine (DTIC) chemotherapy tripled the overall response rate and extended overall survival by nearly three months compared to patients treated with DTIC, the current standard of care, and interferon alpha.

• 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. A new drug application for satraplatin is under priority review at the FDA.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., said two Phase I studies of TPI 287 showed the next-generation taxane agent to be both safe and well tolerated in heavily pretreated patients with advanced, incurable cancers. Early signals of antitumor activity were seen. Tapestry plans to begin Phase II trials in three cancer types this year.

• Transave Inc., of Monmouth Junction, N.J., said Phase Ib/IIa results showed that sustained-release, liposomal inhalation-targeting Cisplatin to patients with relapsed/progressive osteosarcoma that has metastasized to the lung was safe and well tolerated, and responses suggestive of antitumor activity also were observed in some patients. The product is designed to deliver targeted concentrations of the chemotherapy agent directly to tumors in the lung.

• Vical Inc., of San Diego, said interim data on 19 subjects in an ongoing Phase I clinical trial demonstrated that intratumoral delivery of plasmid DNA encoding interleukin-2 into melanoma tumors, followed by electroporation, was administered safely following sedative premedication. No serious adverse events related to the study drug or to the administration procedure were reported and the treatment was well tolerated. Responses were seen in 12 of 39 evaluated tumors after injection.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said the use of Cloretazine (VNP40101M) as a single agent in a Phase II trial in patients with relapsed or refractory small-cell lung cancer led to partial responses in six of 20 evaluable patients in the sensitive relapse arm, with one awaiting confirmation of response. That's an overall 35 percent response rate, and three other patients have stable disease. Of the 28 patients with refractory disease treated with Cloretazine (VNP40101M), one achieved a partial response and three have demonstrated stable disease.

• Wyeth Pharmaceuticals, of Collegeville, Pa., a division of Madison, N.J.-based Wyeth, presented analyses from its Phase III trial of Torisel (temsirolimus) in advanced renal-cell carcinoma, in which investigators concluded that the drug improves overall survival of patients with both clear-cell and other tumor cell types and that patients with advanced RCC who were treated with Torisel had significantly greater quality-adjusted survival. The 626-patient pivotal trial compared Torisel or a combination of Torisel plus interferon-alpha to interferon-alpha alone as a first-line therapy.

• Xanthus Pharmaceuticals Inc., of Cambridge, Mass., said initial results from trial sites of its Phase II study of Xanafide in 88 patients with secondary acute myeloid leukemia indicated that 44 percent of patients achieved complete remission with or without complete hematopoietic recovery, the trial's primary endpoint. Patients in the study received a daily dose of Xanafide, a topoisomerase II inhibitor, for five days in combination with a standard dose of ara-C as a continuous infusion for seven days. Also, it said Bayer Schering Pharma AG, of Berlin, presented Phase I data from a study of P2045, which targets tumors that overexpress somatostatin receptors, in patients with advanced lung cancer showing encouraging tolerability and survival results. Five of eight patients had stable disease at eight weeks.

• Ziopharm Oncology Inc., of New York, said Phase I/II data from the organic arsenic agent ZIO-101 (darinaparsin) showed four of 10 evaluable advanced multiple myeloma patients achieved stable disease of more than four months. Treatment was well tolerated. Separately, preliminary Phase I data of ZIO-101 in advanced cancers showed encouraging results regarding toxicities, maximum tolerated dose and pharmacokinetics, as well as antitumor effects. And interim Phase I data on the tubulin-binding agent indibulin (ZIO-301) in advanced solid tumors showed stable disease had been achieved in six patients.

• ZymoGenetics Inc., of Seattle, said interim Phase Ib data showed atacicept in B-cell chronic lymphocytic leukemia was well tolerated and biologically active at all dose levels. Three of six patients given 10 mg/kg and 15 mg/kg showed signs of disease stabilization. Biological activity of atacicept (formerly TACI-Ig) was demonstrated by reduced immunoglobulin concentrations.

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