• Accera Inc., of Broomfield, Colo., presented data from the Phase IIb study of its lead compound, AC-1202, in Alzheimer's disease. The randomized, double-blind, placebo-controlled trial evaluated 152 subjects with mild to moderate AD. Consistent with the findings of Accera's Phase IIa study, those who did not have the ApoE4 genotype, a known genetic risk factor that occurs in half of all AD patients, responded particularly well to treatment, as reflected in statistically significant improvement in AD Assessment Scale-Cognitive scores. Regardless of genotype, those treated with AC-1202 showed a trend toward improvement (p=.072). Accera said AC-1202 is an orally available, liquid compound converted by the liver into ketone bodies, an alternative energy source the brain can metabolize even when it cannot process glucose. Data were presented at the American Academy of Neurology meeting in Boston.

• Active Biotech AB, of Lund, Sweden, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said 36-week data from a Phase IIb trial demonstrated that an oral 0.6-mg dose of laquinimod given daily significantly reduced magnetic resonance imaging disease activity by 38 percent in relapsing-remitting multiple sclerosis patients. In addition, there was a favorable trend toward reducing annual relapse rates, the number of relapse-free patients and time to first relapse compared with placebo. The randomized, double-blind study included 306 patients. Teva said it anticipates initiating Phase III studies to confirm oral laquinimod's therapeutic benefits later this year. Results were presented at the American Academy of Neurology meeting in Boston.

• Acusphere Inc., of Watertown, Mass., said its second Phase III trial of Imagify (perflubutane polymer microspheres) failed to achieve a specificity endpoint but exceeded the criteria for success on two other primary endpoints, accuracy and sensitivity. The company, which said high accuracy and sensitivity were the study's top priorities, believes those results will support a new drug application to be submitted in the fourth quarter. Imagify previously generated superior specificity in its first Phase III trial. On Tuesday, Acusphere's stock (NASDAQ:ACUS) lost $1.12, or 28.1 percent, to close at $2.87.

• Amgen Inc., of Thousand Oaks, Calif., said final Phase III results published in this month's issue of the Journal of Clinical Oncology showed that Vectibix (panitumumab) prolonged progression-free survival compared to best supportive care in metastatic colorectal cancer patients who had failed chemotherapy regimens that contained fluoropyrimidine, irinotecan and oxaliplatin. September's FDA approval of the fully human monoclonal antibody was based on data from that randomized study of 463 patients, in which Vectibix yielded a 46 percent decrease in the relative progression rate. In addition, the mean progression-free survival was 96 days for Vectibix-treated patients compared to 60 days.

• Anesiva Inc., of South San Francisco, said top-line Phase II data of 4975 in postsurgical pain associated with total knee replacement demonstrated a significant reduction in pain on first ambulation on first day postsurgery and reduction in "pain right now" and "worst pain in past 24 hours" on Brief Pain Inventory at two weeks postsurgery. Further results showed a trend toward lower concomitant morphine usage in the 4975-treated group vs. the placebo group. A follow-on Phase II trial in about 80 patients is expected to begin during the first half of this year.

• Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., presented various data on the long-term safety of Zenvia (dextromethorphan/quinidine) and the prevalence of involuntary emotional expression disorder. Zenvia is in late-stage studies for treating IEED and diabetic peripheral neuropathic pain. Data were presented at the American Academy of Neurology meeting in Boston.

• Cadence Pharmaceuticals Inc., of San Diego, said it intends to discuss with the FDA a proposal to increase the number of patients to be enrolled in the ongoing Phase III trial of Omigard (omiganan pentahydrochloride 1% aqueous gel) for the prevention of local catheter site infections. The plan to increase the number of patients is intended to maintain the statistical power of the trial and was prompted by a planned re-analysis of data from an initial Phase III trial. The re-analysis, which uses a slightly different, stricter definition of the infections, indicated a statistically significant reduction of about 42 percent in the Omigard arm compared to the povidone-iodine treatment arm; the previous analysis indicated a 49 percent reduction, as well as a reduction in the overall infection rate. The catheter colonization and catheter-related bloodstream infection results from the initial Phase III study were not impacted by the re-analysis.

• Cardium Therapeutics Inc., of San Diego, and its Tissue Repair Co. subsidiary are advancing Excellarate, a DNA-based collagen gel, into a Phase IIb trial as a potential topical treatment for non-healing diabetic foot ulcers. The randomized, double-blind, placebo-controlled, comparator-arm study will enroll about 210 Type I or II diabetic patients with non-healing ulcers of the lower extremity for at least six weeks prior to enrollment and who have failed standard-of-care therapy. The primary endpoint is complete ulcer closure at 12 weeks or earlier, and secondary endpoints are time to complete ulcer closure, change in ulcer area, durability of closure and safety and tolerance.

• Cephalon Inc., of Frazer, Pa., presented data from a Phase III trial demonstrating that Fentora (fentanyl buccal tablet) is beneficial for the treatment of breakthrough pain in patients with neuropathic pain who already are taking opioids to manage the pain. Fentora, which is approved for the management of breakthrough pain in patients with cancer who are taking opioids, is designed to provide early onset analgesia via a chemical reaction that enhances fentanyl absorption across the inner lining of the cheek. Cephalon is pursuing clinical development of Fentora in breakthrough pain associated with conditions other than cancer, including chronic neuropathic pain, and said it expects to file a supplemental new drug application this year. Data were presented at the American Academy of Neurology meeting in Boston.

• DeCODE genetics Inc., of Reykjavik, Iceland, reported positive, top-line Phase I results showing that DG051 reduced leukotriene B4 production in a dose-dependent manner, with a peak reduction of more than 70 percent compared to baseline after seven days of treatment in healthy volunteers. In addition, DG051 was found to have good bioavailability, with low variability between subjects, and it was well tolerated at all dose levels tested, with no serious adverse events reported. The small-molecule inhibitor of leukotriene A4 hydrolase is being developed for the prevention of heart attacks.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said the FDA approved its investigational new drug application for PEG-SN38, its PEGylated form of SN38, the active metabolite of the cancer drug irinotecan. The company plans to begin a Phase I trial in patients with solid tumors or lymphoma in the fist half of this year.

• Genentech Inc., of South San Francisco, and Biogen Idec Inc., of Cambridge, Mass., reported positive data from a Phase II study of Rituxan (rituximab) in patients with relapsing-remitting multiple sclerosis. The double-blind, placebo-controlled study evaluated Rituxan in 104 adult patients with RRMS. The total number of gadolinium lesions at weeks 12, 16, 20 and 24 was reduced in a statistically significant manner vs. placebo (p<0.0001). At week 24, the total cumulative mean number of gadolinium lesions per patient was reduced by 91 percent, to 0.5 in the Rituxan from 5.5 in the placebo group. In addition, the proportion of patients with relapses over 24 weeks in the Rituxan arm was 14.5 percent compared to 34.3 percent in the placebo arm (p=0.0238). Results were presented at the American Academy of Neurology meeting in Boston.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, said the FDA OK'd its Phase I trial plans for HE3286 in metabolic disorders, and the company expects to begin such studies this quarter. Preclinical data supporting the plans were reported recently at the International Congress on Prediabetes and the Metabolic Syndrome in Barcelona, Spain, indicating that HE3286 improves glucose disposal in models of Type II diabetes and that the compound is acting through a new pathway that may offer benefits over existing insulin sensitizers.

• Poniard Pharmaceuticals Inc., of South San Francisco, began a pivotal Phase III trial of picoplatin in small-cell lung cancer. Designated SPEAR (Study of Picoplatin Efficacy After Relapse), the trial received a special protocol assessment agreement from the FDA. The randomized, controlled study is enrolling about 400 patients who are refractory to, or who have progressed within six months of completing, treatment with first-line, platinum-containing chemotherapy of cisplatin or carboplatin. Its primary efficacy endpoint is overall survival, and overall response rates, progression-free survival and disease control also will be evaluated. (See BioWorld Today, Jan. 4, 2007.)

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said positive results from the first clinical trial of its investigational HIV drug PRO 140 showed that patients receiving a single 5 mg/kg dose achieved an average maximum decrease of viral concentrations in the blood of 98.5 percent (1.83 log10), with individual reductions ranging up to 99.7 percent (2.5 log10). In those patients, reductions in viral load of greater than 90 percent (1.0 log10) on average persisted for two to three weeks after dosing. In addition, PRO 140 was generally well tolerated in the Phase Ib proof-of-concept study. The product has fast-track status from the FDA, and Progenics plans to begin additional clinical testing in the second half of this year.

• Sirion Therapeutics Inc., of Tampa, Fla., initiated Phase III programs for two of its pipeline compounds: ST-601 (difluprednate) for anterior uveitis, and ST-603 (cyclosporine) for dry eye syndrome. That brings to five the number of clinical programs in Sirion's pipeline, which also includes a Phase II-stage drug, ST-602 (oral fenretinide) in development for indications such as dry age-related macular degeneration, geographic atrophy and Stargardt's disease. Last month, the company completed a $45 million Series B round to fund ongoing drug development. (See BioWorld Today, April 10, 2007.)

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., reached its enrollment target in a Phase IIb trial of ozarelix in benign prostatic hypertrophy patients. The randomized, double-blind, placebo-controlled study's primary endpoint is measuring the improvement of BPH symptoms as measured by the International Prostate Symptom Score. Urine flow and quality of life are secondary endpoints. Data are expected in the second half of this year, with safety and efficacy results expected to be used to support a new drug application. A Phase III trial is expected to begin enrollment in the second half of this year as well.

• Targeted Genetics Corp., of Seattle, the University College London's Institute of Ophthalmology and Moorfields Eye Hospital in London started a Phase I/II trial testing an adeno-associated virus (AAV) vector designed to deliver a normal copy of the RPE65 gene into the cells of the retina to treat a form of childhood blindness. The trial, funded by the UK Department of Health, involves adults and children who have a progressive deterioration in vision caused by an abnormality in the RPE65 gene that prevents normal function of the retina. Preliminary data to date suggested that the AAV-based delivery of genes to sites within the eye can be accomplished without significant complications.

• Transport Pharmaceuticals Inc., of Framingham, Mass., began a randomized, double-blind, placebo-controlled Phase II study designed to evaluate the safety and efficacy of the SoloVir electrokinetic transdermal system with single-use drug cartridges containing Transport's acyclovir gel formulation in more than 240 patients with recurrent herpes labialis, or cold sores. Primary efficacy will be measured by clinician-assessed duration of the herpetic episode, and safety will be assessed by adverse events. Prevention of progression to classical lesions is a key secondary endpoint.

• Trigen Ltd., of London, completed its first Phase I study of PR-15, a platelet adhesion inhibitor, and said results are encouraging enough to warrant further safety and efficacy evaluation in the management of arterial thrombosis. PR-15 is designed to work by preventing firm platelet adhesion to sites of arterial wall damage, including ruptured atherosclerotic plaques. That adhesion can lead to myocardial infarction and stroke.

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