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
Avicena Group Inc., of Palo Alto, Calif., said a Phase II trial was initiated of two combination therapies incorporating ALS-08, a candidate for amyotrophic lateral sclerosis. Investigators will assess ALS-08 in separate combinations with celecoxib and minocycline. The six-month, multicenter, double-blind controlled trial will enroll up to 120 ALS patients, and the primary endpoint is the change in the revised ALS Functional Rating Scale. Baxter International Inc., of Deerfield, Ill., started
They are the first of the company's programs to enter the clinic and are part of DanioLabs' focus on improving the quality of life of patients with intractable neurological conditions
Aastrom Biosciences Inc., of Ann Arbor, Mich., said it completed the patient accrual and treatment portion of its U.S. Phase I/II multicenter long bone fracture trial using its cell-based Tissue Repair Cells (TRCs) for tissue regeneration on all 36 patients enrolled. The trial is evaluating the use of TRCs - a mixture of stem, stromal and progenitor cells derived from the patient's bone marrow - in the treatment of severe fractures that have failed prior treatment interventions. Acologix Inc
Adventrx Pharmaceuticals Inc., of San Diego, said a study found that peak plasma levels of drug from a two-hour infusion of 60 mg/m2 CoFactor were similar to bolus administration and should be sufficient for biological effect. A Phase IIb trial is ongoing using CoFactor plus 5-FU in an infusional regimen for first-line treatment of metastatic colorectal cancer. Data were presented at the 8th World Congress on Gastrointestinal Cancer in Barcelona, Spain. Adventrx also reported encouraging
Separate results showed that after intranasal administration, formulations containing a single peptide or pegylated peptide permeation enhancer produced similar or better bioavailability of the therapeutic peptide in the bloodstream than formulations using multiple small-molecule excipients, which previously have demonstrated enhanced bioavailability in the clinic
Avera Pharmaceuticals Inc., of San Diego, completed a Phase II study of gantacurium chloride as an adjunct to general anesthesia to enable rapid intubation of patients undergoing surgery. Gantacurium chloride is a new, non-depolarizing ultra-short acting neuromuscular blocker. The study was designed to evaluate the product in healthy adult patients undergoing endotracheal intubation prior to surgery under general anesthesia. It enrolled 230 subjects. The study achieved greater than 90 percent
Adventrx Pharmaceuticals Inc., of San Diego, said an independent data safety monitoring board recommended that a Phase IIb study of CoFactor (ANX-510) continue without any modifications after a planned interim analysis. CoFactor is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). The evaluation was based on data from 150 patients, half of the planned total. Antares Pharma
Amazon Biotech Inc., of New York, negotiated a Phase I/II protocol with the FDA, allowing the company to start a trial of AMZD026 in HIV patients. The trial will test the safety, immunological and antiviral effects of the product. The double-blind, placebo-controlled study involves 32 non-symptomatic HIV subjects who have yet to be treated with highly active anti-retroviral therapy. Avigen Inc., of Alameda, Calif., plans to begin clinical development of AV650 in the second half of this year
Actelion Ltd., of Allschwil, Switzerland, reported a preliminary analysis of its 413-patient, Phase IIb dose-finding study showing that its intravenous clazosentan reached statistical significance vs. placebo at all three doses tested - 15 mg/hour, 5 mg/hour and 1 mg/hour. All met the primary endpoint of reducing the occurrence of moderate or severe cerebral vasospasm, as measured by cerebral angiography at day nine post-aneurysm rupture compared to placebo. However, results also showed a lack
Amgen Inc., of Thousand Oaks, Calif., said Phase II data show that, in patients with symptomatic heart failure and anemia, Aranesp (darbepoetin alfa) was well tolerated and effectively raised hemoglobin. Results from a prespecified pooled analysis, including those data and data from a second Phase II study presented in March, show that treatment with Aranesp may decrease the risk of heart failure hospitalization and all-cause mortality, and improve symptoms. The results require confirmation
ArQule Inc., of Woburn, Mass., said data from two Phase Ib combination therapy trials, one testing ARQ 501 with docetaxel and one testing ARQ 501 with gemcitabine, support findings demonstrating clinical tolerability, favorable pharmacokinetics and promising signs of antitumor activity in cancer patients with a range of advanced solid tumors who had failed prior treatments with chemotherapy. Based on the findings, a regimen of weekly administration of 450 mg/m2 of ARQ 501 is expected to be used
Advanced Magnetics Inc., of Cambridge, Mass., said the independent Data Monitoring Committee providing oversight for the ferumoxytol Phase III iron-replacement therapy program met and informed the company that it has reviewed the cumulative safety data and identified no safety concerns. The DMC also recommended the continuation of the ferumoxytol Phase III studies with no modifications. The product is being developed as an I.V. iron-replacement therapeutic in chronic kidney disease, whether on
Amgen Inc., of Thousand Oaks, Calif., said the FDA has accepted the biologic license application for panitumumab, a fully human monoclonal antibody that targets the epidermal growth factor receptor, and has granted priority review. The rolling BLA submission was initiated in December and completed in March and aims to gain approval of panitumumab to treat metastatic colorectal cancer patients who have failed prior chemotherapy. The drug received fast-track designation from the FDA in July 2005
That marks the second compound to enter the clinic from the companies' collaboration signed in 2003 to develop a once-a-day inhaled combination medicine comprised of a LABA and a corticosteroid for asthma and chronic obstructive pulmonary disease. (See BioWorld Today, Jan. 7, 2003
Access Pharmaceuticals Inc., of Dallas, began its first Phase II study of ProLindac, a DACH platinum polymer prodrug in ovarian cancer patients who have relapsed after first-line platinum therapy. The trial is expected to accrue about 40 patients. Access anticipates initiating one or more additional studies within the next 12 months. Potential indications include colorectal and lung cancers in combination with existing treatment regimens. Array BioPharma Inc., of Boulder, Colo., and
Sirtris Pharmaceuticals Inc., of Cambridge, Mass., said it completed dosing 85 subjects in a Phase I trial of SRT501, which is the first small molecule designed to target SIRT1 to enter the clinic
Acuity Pharmaceuticals Inc., of Philadelphia, said its lead compound bevasiranib sodium, formerly Cand5, appeared safe and showed clinical evidence of efficacy in the first results from a Phase II trial in wet age-related macular degeneration. Results indicated a dose-related effect evident across multiple endpoints, including near vision, lesion size and time to rescue. Bevasiranib is a small interfering RNA therapeutic designed to silence the gene that produces VEGF, the growth factor
Corautus Genetics Inc., of Atlanta, filed a response to the FDA's clinical hold on the GENASIS trial, which was imposed in April due to potential safety concerns with the delivery of its gene therapy product for angina. The VEGF-2 product is administered via the Stiletto catheter system from Boston Scientific Corp., of Natick, Mass. The rate of tamponade events experienced in the trial was 1.36 percent, or four out of 295 patients treated. The partners said they have appropriately investigated
Biogen Idec Inc., of Cambridge, Mass., and Fumapharm AG, of Lucerne, Switzerland, reported positive results of a Phase II study of BG-12, an oral fumarate, in patients with relapsing-remitting multiple sclerosis. The study achieved its primary endpoint, demonstrating BG-12 led to a statistically significant reduction in the total number of gadolinium-enhancing brain lesions, as measured by MRI, after six months of treatment vs. placebo. Data were presented at the annul meeting of the European
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