• Allos Therapeutics Inc., of Westminster, Colo., said Phase II data reported at the American Society for Therapeutic Radiology and Oncology meeting in Philadelphia showed that Efaproxyn (efaproxiral) produced superior survival in patients with unresectable non-small-cell lung cancer receiving sequential chemoradiotherapy compared to those with similar characteristics in another trial, the Radiation Therapy Oncology Group (RTOG) 94-10 study. Specifically, median survival of Efaproxyn patients was 20.6 months as compared to 13.3 months for matched cases in the sequential chemoradiotherapy arm of the RTOG 94-10 study and 16.9 months in the concurrent chemoradiotherapy arm of that study.

• AmpliMed Corp., of Tucson, Ariz., said final results from its 49-patient Phase I trial of Amplimexon (imexon for injection) in advanced solid tumors showed the drug was well tolerated, with a maximum tolerated dose of 875 mg/m2/day, and showed evidence of antitumor activity. Data were reported at the EORTC-NCI-AACR meeting in Prague, Czech Republic.

• ArQule Inc., of Woburn, Mass., said interim Phase I data reported at the EORTC-NCI-AACR meeting in Prague, Czech Republic, demonstrated ARQ 197's clinical tolerability, favorable pharmacokinetics and promising signs of antitumor activity in cancer patients with a broad range of metastatic solid tumor types who had failed prior treatment regimens. Of the 31 evaluable patients treated with the c-Met receptor tyrosine kinase inhibitor, 15 achieved a best response of stable disease or better, ranging from six-plus to 33 weeks. Two of them achieved a partial response.

• AVI BioPharma Inc., of Portland, Ore., said clinical trial results showed that three Neugene antisense drugs entered the cerebral spinal fluid of healthy adult male volunteers following a single 100-mg dose via intravenous or subcutaneous injections, suggesting the potential of treating central nervous system disorders. The three drugs tested were AVI-4020 for West Nile virus, AVI-4065 for hepatitis C virus and AVI-4126 for cancer.

• Bioenvision Inc., of New York, filed for authorization in Germany to begin two Phase I studies of clofarabine gel in psoriasis and, upon approval, expects to start enrolling patients in December. The first trial would test clofarabine gel in 20 healthy subjects, and the second is a proof-of-concept study to determine the gel's activity in 15 psoriasis patients. Clofarabine, a next-generation purine nucleoside analogue, is approved - as Clolar in the U.S. and Evoltra in the European Union - for pediatric relapsed or refractory acute lymphoblastic leukemia, and is being studied in other cancers and inflammatory diseases.

• Cangene Corp., of Toronto, said its varicella zoster immune globulin (VariZIG) received orphan drug designation from the FDA for passive immunization for exposed, susceptible individuals at risk of complications from varicella. That designation would give VariZIG seven years of marketing exclusivity upon approval.

• CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, said updated Phase Ib results reported at the EORTC-NCI-AACR meeting in Prague, Czech Republic, showed that intravenous PXD101 was well tolerated when administered in combination with standard doses of carboplatin and paclitaxel, with no dose-limiting toxicities encountered and no Grade 4 adverse events noted. To date, 23 patients have been enrolled, and evidence of clinical activity was noted in two who achieved a partial response, and 10 achieved stable disease lasting from two to more than 13 cycles.

• Cytokinetics Inc., of South San Francisco, said data from a Phase Ib combination trial of ispinesib and capecitabine in patients with advanced solid tumors demonstrated an acceptable tolerability profile, with a maximum tolerated dose of ispinesib, given at 18 mg/m2 via intravenous infusion every 21 days, and with oral doses of capecitabine, given at 2,000 mg/m2 and 2,500 mg/m2 for 14 days. Data were presented at the EORTC-NCI-AACR meeting in Prague, Czech Republic.

• Dendreon Corp., of Seattle, said data reported at the Chemotherapy Foundation Symposium in New York detailed an exploratory analysis of two Phase III studies that showed a prolonged survival benefit for patients initially treated with Provenge (sipuleucel-T) who then went on to receive docetaxel chemotherapy after disease progression. The median survival observed in Provenge-treated patients who subsequently received docetaxel was 34.5 months compared to 25.4 months for placebo patients who went on to receive docetaxel, a difference of 9.1 months (HR=1.90; p=0.023).

• Geron Corp., of Menlo Park, Calif., said early data reported at the EORTC-NCI-AACR meeting in Prague, Czech Republic, showed that its telomerase inhibitor cancer drug, GRN163L, was safe and well tolerated. In addition, levels of the drug were measurable for eight to 12 hours after the start of infusion, and the maximum plasma concentration during the six-hour infusion averaged 1.44 micro-g/ml, with an initial half-life of about four hours.

• ImmunoGen Inc., of Cambridge, Mass., said Phase I data reported at the EORTC-NCI-AACR meeting in Prague, Czech Republic, showed that huN901-DM1 demonstrated evidence of anticancer activity, including one complete remission in a patient with recurrent Merkel cell cancer and marked tumor shrinkage in a patient with relapsed small-cell lung cancer. The anticancer agent, which is being developed for small-cell lung cancer other CD56-expressing solid tumors, also was well tolerated.

• Kosan Biosciences Inc., of Hayward, Calif., said data reported at the EORTC-NCI-AACR meeting in Prague, Czech Republic, showed KOS-1584 produced antitumor activity in 17 percent of heavily pretreated patients in a Phase I study, and in 29.5 percent of patients in another study. In the first, there was one confirmed partial response, and the other study had one unconfirmed partial response.

• Novacea Inc., of South San Francisco, said Phase I data of AQ4N (banoxantrone), a drug designed to target the hypoxic regions present in most solid tumors, showed that it was well tolerated when administered on a weekly schedule following eight weekly doses in 16 patients with renal-cell, ovarian and non-small-cell lung cancers. Data were presented at the EORTC-NCI-AACR meeting in Prague, Czech Republic.

• Protalex Inc., of New Hope, Pa., said preliminary feedback from the FDA included concern related to data on certain subjects who participated in the company's Phase I safety study of PRTX-100. Protalex plans to conduct additional analyses of the data, but said the planned investigational new drug application in idiopathic thrombocytopenia purpura, initially expected in the fourth quarter, will be delayed. Shares of Protalex (OTC BB:PRTX) fell 20 percent, or 50 cents, Friday to close at $2.

• Reata Pharmaceuticals Inc., of Dallas, said interim results from its ongoing Phase I trial of RTA 744 in advanced primary brain tumors showed positive signs of activity in patients with recurrent glioblastoma multiforme, and one patient who has received RTA 744 since January experienced complete tumor abrogation as measured by repeat molecular resonance imaging. Data were presented at the EORTC-NCI-AACR meeting in Prague, Czech Republic.

• Ziopharm Oncology Inc., of New York, said Phase I data reported at the EORTC-NCI-AACR meeting in Prague, Czech Republic, showed that treatment with ZIO-101 produced clinical activity over a range of doses in both hematological cancers and solid tumors. Specifically, there was clinical activity in 13 of 43 evaluable patients, and clinical and pharmacokinetic data showed that the organic arsenic is safe at doses up to 420mg/m2/d for five consecutive days every four weeks.

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