¿ Access Pharmaceuticals Inc., of Dallas, said a product license application should be filed in the UK before the end of the year for Zindaclin, its acne medication. Data analysis of a Phase III trial of Zindaclin is complete, and Access expects to release those details in the near future. Access licensed rights to Zindaclin, also known as ResiDerm, to Straken Ltd. in 1998.
¿ AnorMED Inc., of Vancouver, British Columbia, said its platinum-based anticancer agent ZD0437, designed to overcome resistance to other platinum-based drugs, proved negative for nephrotoxicity or neurotoxicity, showing only short-lived hematological toxicity. Five of 11 patients treated in the Phase I study of the drug in combination with paclitaxel showed disease stabilization. A separate study of the drug in combination with gemcitabine in 13 patients yielded similar results, with six of eight evaluable patients with advanced, pretreated solid malignancies gaining clinical benefit. AnorMED licensed the compound exclusively and around the world to AstraZeneca plc, of London.
¿ Bio-Tech Imaging Inc., of Frederick, Md., began production and marketing of its cell-based HIV-1 detector. The gp120 Tagger for HIV-I uses monoclonal antibody markers to attach to glycoprotein 120 (gp120), expressed on the surface of cells from which replicated HIV-1 viruses are departing. The product, designated for research only, can determine the number of cells with the gp120 env protein on peripheral blood lymphocyte surfaces relative to the total number of CD4+ lymphocytes in human whole blood.
¿ Celgene Corp., of Warren, N.J., said updated clinical trial data indicated that its cancer/immune disorder therapeutic Thalomid (thalidomide) as a single agent for treatment of multiple myeloma produced reductions in paraproteins greater than 25 percent and improvements in bone marrow histology in a third of patients with refractory disease. At 18 months, data showed, the therapy produced a 55 percent overall survival rate and 30 percent event-free survival.
¿ Chiron Corp., of Emeryville, Calif., said data supports the early use of tobramycin solution for inhalation (TOBI) for cystic fibrosis patients with serious lung infections. A Chiron study comparing rate of lung function decline in CF patients under age 25 treated with TOBI to rate of lung function decline in patients given placebo indicates the treated population experienced a rate of lung function loss of 1.36 percent per year, compared to the placebo population's rate of 9.4 percent per year.
¿ Cubist Pharmaceuticals Inc., of Cambridge, Mass., said it will continue its collaboration with Novartis Pharma AG, of Basel, Switzerland, for another year. The collaboration was begun in February 1999, and would have expired in February. Cubist recently achieved a milestone in the collaboration for the delivery of a novel anti-infective target and drug discovery assay.
¿ Elan Corp., of Dublin, Ireland, completed its acquisition of Dura Pharmaceuticals Inc. with the necessary approvals of shareholders and regulatory agencies. Dura shareholders will receive 0.6715 of an Elan American Depository Note for every share of Dura owned. Elan said the acquisition will be accretive to its 2001 earnings, and that it estimates $50 million in synergies will be achieved in the first year.
¿ EntreMed Inc., of Rockville, Md., said data indicates continuous administration of recombinant human Endostatin protein improves its efficacy as compared to bolus injection in treatment of model tumors in mice. Data show that continuous injection produces similar efficacy to bolus injection with 10 times less agent required, and the same amount of agent delivered continuously as delivered once daily produces significant tumor regression in mice.
¿ Gilead Sciences Inc., of Foster City, Calif., received fast-track status designation from the FDA for its AIDS drug, tenofovir, a nucleotide analogue that blocks reverse transcriptase. Gilead plans to launch the drug in early 2002, and analysts estimate that sales of the drug could peak at $400 million per year.
¿ ImmunoGen Inc., of Cambridge, Mass., said a 20-patient Phase I/II trial of huC242-DM1/SB-408075, its lead tumor-activated prodrug for colorectal, pancreatic and non-small-cell lung cancers, showed tolerability and no evidence of immunogenicity. The study is ongoing, and a second Phase I/II trial with a weekly dosing regimen also is under way.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., said results from a Phase I/II trial of ISIS 3521, the company's antisense anticancer drug, show the drug, in combination with standard chemotherapy agents, is active in patients with Stage IIIb or Stage IV non-small-cell lung cancer based on survival time and response rate. The average survival time to date for patients in the trial is 19 months. Of the 48 patients tested in the study, 83 percent have improved, showing complete or partial responses or stabilization. A randomized 600-patient Phase III trial of the drug in combination with carboplatin and paclitaxel began in October.
¿ Luminex Corp., of Austin, Texas, entered a multiyear strategic partnership for the development of human leukocyte antigen-based tissue typing applications with its LabMAP technology with One Lambda Inc., of Canoga Park, Calif. The agreement calls for One Lambda to take worldwide non-exclusive rights to develop and distribute reagents and instrumentation based on the LabMAP technology in return for making an up-front payment to Luminex and paying royalties from product commercialization.
¿ Maret Pharmaceuticals Inc., of Newport Beach, Calif., said results from a Phase I/II trial of MARstem as a hematopoietic therapy to treat or prevent pancytopenia following chemotherapy in adjuvant breast cancer patients indicated the compound reduced the frequency of grades 2-4 thrombocytopenia, grades 2-4 anemia and grades 3-4 lymphopenia. The study found the compound to exhibit an excellent safety profile, Maret said.
¿ Millennium Pharmaceuticals Inc., of Cambridge, Mass., said preclinical and clinical studies of LDP-341, formerly PS-341, a proteasome inhibitor, showed the compound induces apoptosis, reduces tumor volume and shows activity in combination with standard chemotherapy agents or radiation. The drug exhibited up to 80 percent proteasome inhibition.
¿ Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Cytogen Corp., of Princeton, N.J., said they developed a new generation of monoclonal antibodies directed against prostate-specific membrane antigen with potential as prostate cancer therapeutics. The companies are developing the antibodies for use in naked radiolabelled and toxin-conjugated forms capable of selectively targeting and destroying PSMA-expressing cancer cells.
¿ SciClone Pharmaceuticals Inc., of San Mateo, Calif., reformulated CPX, its lead protein-repair therapy for cystic fibrosis, as an orally administered therapeutic, and plans to initiate expanded Phase II studies of the drug.
¿ Seattle Genetics Inc., of Bothell, Wash., entered a development and manufacturing agreement with ICOS Corp., also of Bothell, that calls for ICOS to develop, scale up and manufacture GMP-grade supplies of a monoclonal anticancer antibody for testing. Financial terms of the agreement were undisclosed, and Seattle Genetics will retain commercialization rights to the antibody.