DeCode Genetics Inc., of Reykjavik, Iceland, began enrolling patients in its Phase I development program for DG051, the company's follow-on compound for preventing heart attacks. The study will examine DG051, a small-molecule inhibitor of leukotriene A4 hydrolase. The compound is similar to DG031, its lead compound for the preventing heart attacks now in a Phase III trial. Depomed Inc., of Menlo Park, Calif., completed a Phase I trial to evaluate the delivery and absorption of a compound used
Ceragenix Pharmaceuticals Inc., of Denver, began enrolling patients in a trial to assess EpiCeram compared to Cutivate, a mid-strength steroid, in patients with moderate to severe atopic dermatitis. The company expects to have results in the fourth quarter. The study will consist of 90 children between the ages of 6 months and 18 years, with half receiving treatment with EpiCeram and the other half receiving the steroid for a four-week period. Ceragenix received 510(k) clearance in April from
CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, started a Phase I trial evaluating the administration of oral PXD101, a small-molecule histone deacetylase inhibitor, in patients with advanced solid tumors. The open-label, multicenter trial is designed to establish the maximum tolerated dose for oral PXD101 administered once or twice daily. Patients in the U.S. and Europe will be treated with oral PXD101 in a dose-escalation regimen and may continue to receive up
Karo Bio AB, of Huddinge, Sweden, expects to receive an undisclosed milestone payment from partner Madison, N.J.-based Wyeth, which has entered the clinic with a compound targeting LXR, a nuclear hormone receptor that regulates cholesterol metabolism
Cell Therapeutics Inc., of Seattle, said the Data Safety Monitoring Committee recommended that a Phase III study of pixantrone continue after preliminary data showed encouraging confirmed and unconfirmed complete response rates observed among the first 40 aggressive non-Hodgkin's lymphoma patients treated in the trial. Patients are randomized to receive either pixantrone or another single-agent drug to examine the complete response rate, time to tumor progression and overall survival. The
Novelos Therapeutics Inc., of Newton, Mass., said the FDA granted fast-track designation to NOV-002 for use in combination with first-line chemotherapy for advanced non-small-cell lung cancer. NOV-002 is a small-molecule drug based on oxidized glutathione that acts as a chemoprotectant and immunomodulator. The company recently finalized a special protocol assessment with the FDA for a pivotal Phase III trial in advanced NSCLC for NOV-002 in combination with first-line chemotherapy, and patient
Arpida Ltd., of Basel, Switzerland, received authorization from the UK Medicines and Healthcare products Regulatory Agency to start the first-in-man studies with AR-709. The authorization of the clinical trial application for AR-709 allows Arpida to initiate a microdose study in healthy volunteers in the UK. Hana Biosciences Inc., of South San Francisco, started a Phase I study of Sphingosome Encapsulated Vinorelbine in patients with advanced solid tumors. The study is designed to assess the
Biota Holdings Ltd., of Melbourne, Australia, said the Phase Ia safety trial of its human rhinovirus drug had been completed and that the drug received approval to continue into Phase Ib. BTA798 is an antiviral for the treatment of HRV, the common cold virus, known to cause significant clinical complications in sufferers of asthma and chronic obstructive pulmonary disease, the fourth-leading cause of death in the U.S. Cerexa Inc., of Alameda, Calif., disclosed positive top-line results for
Akorn Inc., of Buffalo Grove, Ill., received clearance to begin the pivotal trial in the U.S. for AK-1015 in 200 patients. The product is being developed for ocular anesthesia. The trial will begin this month, and the company intends to file a new drug application in 2007 with a potential product launch in 2008. The U.S. market for the drug is about 5 million ophthalmic procedures per year. Columbia Laboratories Inc., of Livingston, N.J., completed enrollment in its Phase III study of
Aida Pharmaceuticals Inc., of Hangzhou, China, successfully concluded Phase I trials for its gene therapy antitumor drug Rh-Apo2L. The studies, which included 20 patients with different cancers, found that the drug reduces tumor size of non-Hodgkin's lymphoma, sarcoma and adrenal gland cortical tumors, and has an effect on other tumor types. The company plans to apply for Phase II and Phase III trials, and said it anticipates completing all trials by the end of next year for potential
Allos Therapeutics Inc., of Westminster, Colo., said the FDA conferred orphan drug status to PDX (pralatrexate), the company's next-generation antifolate for T-cell lymphoma. Allos plans to begin a Phase II study of PDX in patients with relapsed or refractory peripheral T-cell lymphoma this quarter. Cytogen Corp., of Princeton, N.J., said Quadramet (samarium Sm-153 lexidronam injection) is part of a Phase III trial to evaluate its ability to treat osteoblastic metastases arising from lung
Acologix Inc., of Hayward, Calif., said results from a 40-patient Phase II feasibility study of AC-100 in periodontal defects demonstrated a favorable safety profile but the drug did not significantly regenerate more periodontal bone vs. placebo. The company believes the dose evaluated in the study exceeded what might be the optimal dose and intends to conduct additional Phase II studies to determine appropriate dosing. AC-100 is a synthetic peptide derived from an endogenous human protein
CytRx Corp., of Los Angeles, said the final patients completed dosing and follow-up with arimoclomol in a Phase IIa trial in amyotrophic lateral sclerosis. The trial randomized patients to receive either placebo or one of three dose levels three times daily for 12 weeks followed by four weeks without the drug. Results are expected to be released in the fourth quarter. Arimoclomol has received fast-track and orphan drug status from the FDA. Lipid Sciences Inc., of Pleasanton, Calif., said the
AVI BioPharma Inc., of Portland, Ore., plans to fill two new cohorts of patients to extend the duration of treatment with AVI-4065 in its hepatitis C virus clinical trial. One cohort will be treated twice daily for 28 days, and the second will receive therapy twice daily for 56 days. The extension of the treatment duration from 14 days to 28 days and 56 days is the first of several variables that the company is considering to potentially enhance the pharmacokinetics and viral and clinical
Amazon Biotech Inc., of New York, signed an interim letter of agreement with the Immunology Clinic of New York to conduct a Phase I/II, randomized, double-blind, placebo-controlled study to test the safety and efficacy of its botanical drug product, AMZ0026, in pre-symptomatic HIV-positive patients undergoing no other anti-retroviral therapies
Aegis Therapeutics LLC, of San Diego, completed its first clinical study, a 10-patient, three-way crossover trial, designed to confirm the effectiveness of Intravail absorption enhancement agents in increasing intranasal bioavailability of peptide and protein drugs. The study revealed an average systemic bioavailability of about 35 percent for the Intravail formulation of a marketed drug, compared to an average of 7 percent for the identical commercial formulation without Intravail. Aegis
Acadia Pharmaceuticals Inc., of San Diego, said results from three clinical studies demonstrated that ACP-104 is safe and well tolerated after repeated dosing of up to 600 mg per day in 74 schizophrenics, and initial signals of antipsychotic effects were observed within its tolerated dose range. In addition, plasma levels of ACP-104 correlate with brain receptor occupancies indicating good penetration into the brain. The product, also called N-desmethylclozapine, is the major metabolite of
Computer Sciences Corp., of El Segundo, Calif., said DynPort Vaccine Co. LLC, of Frederick, Md., has entered a Phase II trial for its recombinant plague vaccine candidate, rF1V. The study will test different vaccine dosages and schedules in 400 healthy volunteers between the ages of 18 and 55. The clinical trial is under way and will continue into 2007 at eight locations across the U.S. Cougar Biotechnology Inc., of Los Angeles, enrolled the first patient in a Phase I trial of CB7630
BioMimetic Therapeutics Inc., of Franklin, Tenn., completed enrollment in its Canadian pilot study with its lead candidate, GEM OS1 Bone Graft. As a result of the preliminary data obtained, the company received authorization from the Canadian government to expand the study from 20 patients to up to 60. BioMimetic hopes to file for Canadian registration for orthopedic indications in 2007. The company also has completed enrollment in its U.S. pilot study for foot and ankle fusions and its Swedish
AnorMed Inc., of Vancouver, British Columbia, finished enrolling 300 multiple myeloma patients in the first of two pivotal Phase III trials of Mozobil for stem cell transplant. Recruitment continues for the second Phase III study in non-Hodgkin's lymphoma, and 300 patients are expected to be enrolled in that trial by the end of the year. Both trials are designed to evaluate Mozobil in a standard stem cell mobilization regimen. AnorMed anticipates reporting top-line data by the second quarter of
DeCode Genetics Inc., of Reykjavik, Iceland, began enrolling patients in its Phase I development program for DG051, the company's follow-on compound for preventing heart attacks. The study will examine DG051, a small-molecule inhibitor of leukotriene A4 hydrolase. The compound is similar to DG031, its lead compound for the preventing heart attacks now in a Phase III trial. Depomed Inc., of Menlo Park, Calif., completed a Phase I trial to evaluate the delivery and absorption of a compound used