CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, reported encouraging preliminary results from three clinical trials of intravenous PXD101. Phase Ib data showed two partial objective responses in patients with advanced, refractory cancer and stable disease in three other patients lasting greater than 10 cycles of treatment in a study of PXD101 in combination with paclitaxel and carboplatin. Phase II results showed nine patients receiving PXD101 monotherapy achieved
Alfacell Corp., of Bloomfield, N.J., reported Phase IIIa data showing that patients with unresectable malignant mesothelioma treated with Onconase (ranpirnase) had greater median survival times than those treated with doxorubicin, as measured by the prognostic scoring systems of both the Cancer and Leukemia Group B and European Organization for Research and Treatment of Cancer. Findings were presented at the 8th International Mesothelioma Interest Group conference in Chicago. Onconase, which
Advanced Magnetics Inc.&, of Cambridge, Mass., said the independent Data Monitoring Committee providing oversight of the ferumoxytol Phase III intravenous iron replacement therapy program met and informed the company that no safety concerns were identified. The DMC recommended the continuation of the studies with no modifications. At that meeting, the DMC reviewed safety data from more than 1,200 subjects enrolled in the Phase III program. Algeta ASA, of Oslo, Norway, disclosed further
AM-Pharma BV, of Bunnik, the Netherlands, disclosed positive results from a pilot study in sepsis with its patented alkaline phosphatase drug. The study assessed the safety of a single treatment with 200 U alkaline phosphatase I.V./kg in patients suffering from severe sepsis. Efficacy parameters were recorded as secondary variables. Thirty-six patients admitted to intensive care units with the diagnosis of severe sepsis were included in the study, and the treatment proved well tolerated
Accentia Biopharmaceuticals Inc., of Tampa, Fla., said a new study has shown that the administration of a BiovaxID formulation given to patients with relapsed follicular non-Hodgkin's lymphoma following chemotherapy, with or without concomitant Rituxan (rituximab, Genentech Inc. and Biogen Idec Inc.), can induce complete long-lasting remissions. In the study, 80 percent of patients achieved an immune response to the BiovaxID formulation, and among those responders, the median time of complete
AVI BioPharma, of Portland, Ore., announced a multicenter, double-blind, randomized, placebo-controlled study of AVI-5126, a new generation of the Neugene antisense drug, for coronary vascular disease. AVI-5126 silences a gene known as c-myc, involved in cardiovascular restenosis. The study will evaluate the therapeutic benefit of exposing a saphenous vein to AVI-5126 before connecting it to the coronary artery circulation of patients undergoing coronary artery bypass grafts. Initial patient
KeyNeurotek AG, of Magdeburg, Germany, initiated a European Phase II trial of KN 38-7271, a cannabinoid receptor agonist, in traumatic brain injury patients. The study is expected to involve more than 100 patients and is designed to demonstrate tolerability and efficacy of the drug. Neurologix Inc., of Ft. Lee, N.J., finished a Phase I trial of its gene therapy for Parkinson's disease, with statistically significant results. The trial confirmed the safety and tolerability in all 12 patients
Antisoma plc, of London, reported positive data from its Phase II trial of AS1404 in ovarian cancer, with investigators' assessments showing a response rate of 75 percent for those receiving the company's drug plus chemotherapy, compared with 63 percent for patients receiving chemotherapy alone. Those findings were presented at the International Gynecological Cancer Society meeting in Santa Monica, Calif. Phase II studies of AS1404 are ongoing in ovarian and prostate cancers, with further data
Advanced Life Sciences Holdings Inc., of Woodbridge, Ill., reported data at the Infectious Disease Society of America meeting in Toronto comparing the safety and efficacy of cethromycin at varying doses for the treatment of acute bacterial sinusitis. In one study, the clinical and bacteriological cure rates generally were greater in the 300-mg QD group than in both the 150-mg and 600-mg QD groups. Findings from another study, combined with previous clinical trials for community-acquired
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase I trial of an RNAi treatment for respiratory syncytial virus (RSV) infection, ALN-RSV01, in the U.S. The inhaled treatment will be administered in a nebulized formulation on healthy adults. Two previous Phase I studies tested the drug in an intranasal form. Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, reported data from an 80-patient investigator initiated trial at Duke University Medical Center with The
Ceregene Inc., of San Diego, said the gene therapy CERE-120 for Parkinson's disease was well tolerated and appeared to reduce symptoms by approximately 40 percent (p<0.001), as measured by the Unified Parkinson's Disease Rating Scale motor "off" score, in an open-label Phase I study in 12 patients with advanced disease. Initial results of the study were presented by William Marks, principal investigator of the study and associate professor of neurology at the University of California San
The move to the clinic triggers a $2 million milestone payment from Paris-based Sanofi-Aventis SA, which licensed the compound as part of a broad collaboration agreement to discovery, develop and commercialize cancer drugs using ImmunoGen's antibody expertise and its Tumor-Activated Prodrug technology
AVI BioPharma Inc., of Portland, Ore., said results from the second phase of its exploratory study of Neugene antisense compound AVI-4065 in patients with chronic active hepatitis C virus infection showed the drug exhibited favorable safety and tolerability profiles in 12 patients. Consistent with the preliminary results reported in May, the therapeutic threshold required for efficacy was not achieved at the treatment dose used in the study protocol. AVI decided to initiate a protocol
Adherex Technologies Inc., of Research Triangle Park, N.C., initiated a Phase I trial of ADH-1 in combination with chemotherapy in conjunction with the U.S. Oncology Research network. The study, expected to involve up to 55 patients with N-cadherin positive solid tumors, is designed to define the dose-limiting toxicities and maximum tolerated dose of ADH-1 in three separate combinations - with docetaxel, with carboplatin, or with capecitabine. ADH-1 also is being tested as a single agent in two
Advanced Life Sciences Holdings Inc., of Woodridge, Ill., said trial data from its lead candidate, cethromycin, a second-generation ketolide antibiotic, demonstrated safety and efficacy at multiple dose levels in community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and anthrax. Results were presented at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco. Cethromycin is in Phase III studies testing 300 mg QD in community
Adherex Technologies Inc., of Research Triangle Park, N.C., began a Phase I/II trial of eniluracil combined with 5-fluorouracil (5-FU) in Asian patients with liver cancer. The Phase I dose-escalation part of the study, which is expected to enroll about 25 patients with hepatocellular cancer, is intended to establish dosing safety and the combination's schedule in that patient population. The Phase II part is expected to enroll 25 additional patients to provide initial efficacy information in
Kalypsys Inc., of San Diego, initiated a Phase Ia study of KD3010, for metabolic diseases and expects to complete it in October. Begun in mid-July, the trial will evaluate the safety, tolerability and pharmacokinetics of KD3010 vs. placebo in healthy volunteers. Kalypsys plans to follow that study with a 28-day safety trial in obese volunteers in early 2007, it said. Pervasis Therapeutics Inc., of Cambridge, Mass., is enrolling patients in two Phase I trials of the company's first product
Astex Therapeutics, of Cambridge, UK, began dosing first patients in a Phase I/IIa trial of its investigational cancer drug, AT9283. Astex discovered AT9283, a potent inhibitor of Aurora kinases, using its innovative fragment-based drug discovery technology, Pyramid. The company's lead product, AT7519, already is in a Phase I trial at sites in the U.S. and the UK. CV Therapeutics Inc., of Palo Alto, Calif., said top-line results from its MERLIN TIMI-36 study of Ranexa (ranolazine) would be
Acadia Pharmaceuticals Inc., of San Diego, provided an update on the timing of its Phase II adjunctive therapy trial with ACP-103 in patients with schizophrenia, saying enrollment is ahead of schedule, which should enable the company to report top-line results for the complete 400-patient clinical trial during the first quarter of 2007, ahead of earlier expectations. The company no longer plans an interim analysis based on the first 200 patients, which had been planned to be conducted by the
Alba Therapeutics Corp., of Baltimore, dosed its first patient in a Phase II trial for the treatment of celiac disease. The study will evaluate AT-1001 in 79 celiac disease subjects during gluten challenge. Bioenvision Inc., of New York, said the latest results from its ongoing European study of Evoltra (clofarabine) in pediatric acute lymphoblastic leukemia patients confirmed that the drug delivers a significant response rate in that population. Data showed a complete response rate of 28
CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, reported encouraging preliminary results from three clinical trials of intravenous PXD101. Phase Ib data showed two partial objective responses in patients with advanced, refractory cancer and stable disease in three other patients lasting greater than 10 cycles of treatment in a study of PXD101 in combination with paclitaxel and carboplatin. Phase II results showed nine patients receiving PXD101 monotherapy achieved