• Adeona Pharmaceuticals Inc., of Ann Arbor, Mich., received institutional review board approval to initiate a 60-patient, randomized, double-blind, placebo-controlled trial of Zinthionein ZC-GS150 in Alzheimer's disease and mild cognitive impairment. The clinical trial, titled "CopperProof 2," will test the effects of a gastro-retentive, sustained-release zinc/cysteine combination tablet on the amelioration of subclinical zinc deficiency, and elevated percentage serum-free copper, associated with Alzheimer's disease.

• CureVac GmbH, of Tuebingen, Germany, said German authorities approved the start of a Phase IIa trial of CV9103, an RNAactive-derived mRNA vaccine, in prostate cancer. The trial will study the drug in 21 patients, administered CV9103 via intradermal injection. First results are expected by the second half of 2010.

• Juvaris BioTherapeutics Inc., of Burlingame, Calif., has begun enrolling patients in a Phase II trial of its lead compound, JVRS-100, as an adjuvant for seasonal influenza vaccines in the elderly population. The randomized, double-blind, controlled trial will enroll approximately 472 subjects 65 years and older and compare antibody and T-cell responses to trivalent inactivated influenza vaccine administered with and without the JVRS-100 adjuvant. Primary objectives are to assess its safety, tolerability and ability to enhance immune responses (both antibody and cellular immunity) to the influenza vaccine.

• NovaBiotics Ltd., of London, said the first patients enrolled in its 48-subject Phase IIa trial of Novexatin, a topical antifungal compound targeting fungal nail infection, completed the 28-day application, and results gathered so far confirmed the positive data from an earlier Phase I trial. The remaining patients are expected to complete the study shortly, with data anticipated later this year. NovaBiotics has said it plans to out-license or partner the drug for further clinical development.

• Noxxon Pharma AG, of Berlin,, has begun dosing healthy volunteers in a first-in-human trial with Spiegelmer NOX-A12 for use in autologous hematopoietic stem cell transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma. The single center study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in up to 42 individuals.

• Optimer Pharmaceuticals Inc., of San Diego, said new data from fidaxomicin's North American Phase III study showed that in patients with more pronounced diarrhea (i.e. not resolving in the first 24 hours of therapy), fidaxomicin was associated with a faster time to resolution than vancomycin (79 hours vs. 105 hours). Those data were presented at the Infectious Diseases Society of American meeting in Philadelphia. In a separate presentation, data indicated that fidaxomicin-treated patients with Clostridium difficile-based infection had a significantly improved global cure rate vs. vancomycin (72 percent vs. 50 percent), lower CDI recurrence rate (40 percent vs. 23 percent) and higher clinical cure rate (87 percent vs. 77 percent). Optimer reported top-line data from the pivotal study last year. (See BioWorld Today, Nov. 12, 2008.)

• Seaside Therapeutics LLC, of Cambridge, Mass., initiated a Phase I trial of STX107, a selective mGluR5 antagonist, in development for the treatment of Fragile X Syndrome. The single ascending dose study is designed to evaluate the safety, tolerability and pharmacokinetics of STX107 in healthy volunteers. Fragile X Syndrome is the most common inherited form of mental impairment and the most common known cause of autism.

• SkyePharma plc, of London, said partner Mundipharma International Corp. Ltd., of Cambridge, UK, completed the final Phase III trial of Flutiform (fluticasone 500 mcg/formoterol 20 mcg) in Europe, with the higher dose strength meeting its primary endpoints. The study included 529 patients suffering from persistent and reversible asthma, and top-line analysis confirmed that Flutiform produced similar results (statistically not inferior) when compared with concurrent administration of Flixotide (fluticasone 500 mcg) and Foradil (formoterol 24 mcg). Primary endpoints were the changes in mean predose forced expiratory volume in the first second at baseline compared to the predose FEV1 and the two-hour postdose FEV1 at eight weeks. Analysis of secondary endpoints is ongoing. The companies anticipate regulatory filings in Europe in the first quarter of 2010. Shares of SkyePharma (LSE:SKP) jumped 22 percent Monday to close at 103 pence.

• YM BioSciences Inc., of Mississauga, Ontario, reported positive 48-month survival data for its EGFR-targeting antibody, nimotuzumab, in head and neck cancer. The data, a follow-up to 30-month survival data presented at ASCO 2009, showed that at 48 months, 41 percent of the patients in the nimotuzumab+chemoradiotherapy (CRT) arm were alive compared to 21 percent in CRT-alone arm, and 34.7 percent in the nimotuzumab+radiotherapy (RT) arm were alive compared to 13 percent in the RT-alone arm. Data were presented at the American Society for Therapeutic Radiology and Oncology meeting in Chicago.