Acorda Therapeutics Inc., of Hawthorne, N.Y., said it will design and conduct an additional Phase III trial of Fampridine-SR in people with multiple sclerosis. The company expects to discuss with the FDA a study of the same or shorter duration as its MS-F203 study with a single criterion for efficacy, a consistent response on the timed 25-foot walk. Ambrilia Biopharma Inc., of Montreal, said the Phase I repeat-dose study with PPL-100, the company's lead protease inhibitor to treat HIV and

AVI BioPharma Inc., of Portland, Ore., started a clinical program for the treatment of Duchenne's muscular dystrophy using its ESPRIT (Exon Skipping Pre-RNA Interference Technology) exon-skipping technology. The program is based on positive preclinical data amassed over the past two years, including collaborator studies published in the October 2006 issue of Neuromuscular Disorders and the February 2006 issue of Nature Medicine. The technology is designed to delete disease-causing gene

Dynavax Technologies Corp., of Berkeley, Calif., started a Phase I dose-escalation trial with its TLR9 agonist in combination with a standard chemotherapeutic regimen for metastatic colorectal cancer. The enrollment target of the trial is 15 patients, all of whom will have been previously treated for colorectal cancer but had a recurrence of the disease. The trial, which will be conducted at three centers in the U.S., is designed to identify the optimum dose and to yield safety and tolerability

Arpida Ltd., of Basel, Switzerland, reported positive results from its first Phase III trial of iclaprim, showing that the primary efficacy endpoint of statistical noninferiority compared to Zyvox (linezolid, Pfizer Inc.) in the clinical cure rate at the test-of-cure visit in patients with skin and skin structure infections. Data from the ASSIST-1 study showed that the overall clinical cure rates for the intent-to-treat population of 497 patients were 85.5 percent and 91.9 percent iclaprim and

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., initiated a human experimental infection study with respiratory syncytial virus designed to establish a safe and reliable RSV infection of the upper respiratory tract in adult volunteers. Upon determination of the optimal level of RSV inoculum, the company plans to begin a subsequent clinical protocol to test the antiviral activity of ALN-RSV01, an RNAi therapeutic. About 40 subjects are expected to be enrolled in the study. Alnylam also is

Biothera, of Eagan, Minn., initiated a Phase I/II trial of Imprime PGG in combination with G-CSF for mobilization of bone marrow stem cells into the peripheral blood in normal human subjects. The study's objective is to determine whether that combination is better than G-CSF alone for enhancing stem cell mobilization. Biothera anticipates completing the enrollment of 56 subjects by the end of the year. Dyax Corp., of Cambridge, Mass., completed the double-blind portion of its pivotal Phase

Aradigm Corp., of Hayward, Calif., said results of a Phase IIa trial of inhaled hydroxychloroquine (HCQ) in patients with moderate-persistent asthma did not meet the pre-specified clinical efficacy endpoints. The trial was funded by Tucson, Ariz.-based APT Pharmaceuticals Inc., and APT and Aradigm plan to continue data analysis to decide whether to pursue additional work on inhaled HCQ. No serious adverse events were reported, either related to the drug or Aradigm's AERx delivery system

Celtic Pharmaceutical Holdings LP, of Hamilton, Bermuda, and Neurobiological Technologies Inc., of Emeryville, Calif., said an interim report of an open-label extension study in a Phase III program of Xerecept (corticorelin acetate injection) showed that, of 20 subjects, 11 had reduced their dexamethasone dosage during the four-week study, and two took no concomitant dexamethasone. Improvement or resolution of steroid-related conditions was observed in eight of 18 (45 percent) of subjects with

Bioheart Inc., of Sunrise, Fla., said it is expanding its U.S. and European trials of MyoCell adult myogenic stem cell composition and MyoCath needle-injection catheter product candidates. In October, the company finalized its proposed protocol for a U.S. Phase II trial, which is designed to enroll up to 450 patients to confirm the safety and efficacy of adult myogenic stem cell transplantation in treating heart failure. In Europe, Bioheart expanded its Phase IIa trial from five testing centers

Advanced Viral Research Corp., of Yonkers, N.Y., filed an amendment with the FDA to its existing investigational new drug application to expand the use of its product, AVR118, to include topical and intralesional therapy, which could be used in treating dermatologic conditions. AVR118 is a cytoprotective agent in development for cachexia-related disorders and has shown topical wound healing properties in animal models. Dyax Corp., of Cambridge, Mass., said findings from its 77-patient EDEMA2

AEterna Zentaris Inc., of Quebec City, and Spectrum Pharmaceuticals Inc., of Irvine, Calif., said Phase II results demonstrated that ozarelix, a luteinizing hormone-releasing hormone antagonist, achieved its primary goal of determining that a dose of 130 mg administered intramuscularly every four weeks during a three-month test period ensured continuous suppression of testosterone at castration level in patients with hormone-dependent, inoperable prostate cancer. Data showed the drug also

Allos Therapeutics Inc., of Westminster, Colo., said Phase II data reported at the American Society for Therapeutic Radiology and Oncology meeting in Philadelphia showed that Efaproxyn (efaproxiral) produced superior survival in patients with unresectable non-small-cell lung cancer receiving sequential chemoradiotherapy compared to those with similar characteristics in another trial, the Radiation Therapy Oncology Group (RTOG) 94-10 study. Specifically, median survival of Efaproxyn patients was

Anacor Pharmaceuticals Inc., of Palo Alto, Calif., started dosing patients in a Phase IIb study of ANO128, a topical anti-inflammatory candidate for atopic dermatitis. The trial is expected to enroll 200 patients between the ages of 2 and 17 with moderate forms of the disease who will receive ANO128 or a placebo cream twice a day for six weeks. Researchers plan to assess efficacy using a 6-point static global assessment scale. Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia

Adherex Technologies Inc., of Research Triangle Park, N.C., said data from its proof-of-mechanism trial of eniluracil showed that three patients who received a single, oral dose of the drug 12 to 14 hours prior to surgery for colorectal cancer resulted in inhibition of dihydropyrimidine dehydrogenase (DPD) activity. The company also reported results from 16 patients enrolled to date in its Phase I trial of eniluracil plus 5-fluorouracil in solid tumors. In the 13 patients for whom DPD results

Inspire Pharmaceuticals Inc., of Durham, N.C., reported results of a 28-day Phase II study of denufosol inhalation solution in cystic fibrosis patients, ages 5 to 7, showing that both the 20-mg and 60-mg doses of the drug given three times daily were well tolerated, with a safety profile similar to placebo. Data were presented at the 2006 North American Cystic Fibrosis Conference in Denver. Inspire has initiated the first of two planned Phase III trials to evaluate 60 mg of denufosol vs

Adherex Technologies Inc., of Research Triangle Park, N.C., entered an agreement with the International Childhood Liver Tumor Strategy Group, a multidisciplinary group of specialists under the umbrella of the International Society of Pediatric Oncology, to conduct a Phase III trial of Adherex's sodium thiosulfate (STS) to reduce or prevent hearing loss in children associated with platinum-based chemotherapies. The randomized study, which is expected to begin early next year, will enroll about

Dendreon Corp., of Seattle, said data from an exploratory analysis of Phase III studies D9901 and D9902A showed a significant correlation between cumulative CD54 up-regulation and survival for patients treated with Provenge (sipuleucel-T), the company's cellular immunotherapy for men with advanced androgen-dependent prostate cancer. Data were presented at the International Society for Biological Therapy of Cancer annual meeting in Los Angeles. Dendreon has submitted two portions of a rolling

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