• BioMimetic Therapeutics Inc., of Franklin, Tenn., reported interim results from its 20-patient pilot trial comparing GEM OS1 Bone Graft to autogenous bone graft in foot and ankle indications that show 39 percent of patients receiving GEM OS1 exhibited fusion, as defined by osseous bridging of greater than 50 percent of the joint surface, compared to 33 percent of autograft patients at six weeks. At 12 weeks, 69 percent of GEM OS1-treated patients showed fusion vs. 50 percent of the autograft group. Complete clinical union at 24 weeks following surgery was 85 percent for GEM OS1 and autograft was 85 percent and 100 percent, respectively. Data were presented at the American Orthopedic Foot and Ankle Society meeting in Toronto. Also at that meeting, BioMimetic reported interim results from a 60-patient, open-label study showing that fusion assessed on CT scans occurred in 42 percent of the patients at six weeks and in 70 percent of patients by 12 weeks.

• Carrington Laboratories Inc., of Irving, Texas, said its wholly owned subsidiary, DelSite Biotechnologies Inc., took delivery of several thousand doses of the H5N1 influenza antigen from a secured source and is preparing to start the first U.S. clinical program of a nasal powder bird flu vaccine. The vaccine combines the H5N1 antigen with DelSite's GelVac dry powder delivery platform. An investigational new drug application is expected to be filed later this year, pending successful results of toxicology studies, which are set to begin within 30 days.

• CSL Behring, of King of Prussia, Pa., completed patient enrollment in a Phase III trial of a 20 percent formulation of subcutaneous immunoglobulin (SCIg) in patients with primary immunodeficiency who require immune globulin replacement therapy. The 54-patient study is designed to assess SCIg stabilized with proline (IgPro20) and will evaluate the rate of serious bacterial infections, including bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis and visceral abscess. The trial also will aim to show non-inferiority in steady-state under the curve of immunoglobulin G levels of weekly subcutaneous infusions of IgG with proline compared to the previous three or four weekly intravenous treatments. Data from the study is expected to support a market application submission in the U.S.

• Dendreon Corp., of Seattle, said the Securities and Exchange Commission is conducting an informal inquiry into the Provenge clinical trials and FDA review. Dendreon's stock fell 64 percent in May after the FDA issued an approvable letter for Provenge in prostate cancer. The SEC investigation follows a shareholder lawsuit alleging that certain Dendreon officers and directors engaged in wrongful disclosure and insider trading. (See BioWorld Today, May 10, 2007.)

• ImClone Systems Inc., of New York, initiated a randomized Phase II trial of IMC-A12, a monoclonal antibody targeting insulin-like growth factor-1 receptor (IGR-IR). The trial will enroll 40 to 72 patients with metastatic colorectal cancer refractory to prior treatment with ImClone's Erbitux (cetuximab). The study will evaluate the efficacy, safety and pharmacology of IMC-A12 administered as a single agent or in combination with Erbitux. Erbitux is approved for colorectal cancer and head-and-neck cancer, but last week the drug failed a Phase III trial in non-small-cell lung cancer. (See BioWorld Today, July 13, 2007.)

• Memory Pharmaceuticals Corp., of Montvale, N.J., completed enrollment of a targeted 80 patients in a Phase IIa Alzheimer's disease trial of MEM 3454, a nicotinic alpha-7 receptor partial agonist. The randomized, double-blind, placebo-controlled, dose-ranging trial will assess safety, tolerability and cognitive effects. Top-line data are expected in the fourth quarter, as are top-line data from a Phase IIa trial of MEM 1003 in Alzheimer's disease.

• Protalix BioTherapeutics Inc., of Carmiel, Israel, reached an agreement with the FDA on a special protocol assessment for a pivotal Phase III trial of prGCD, a plant cell-expressed recombinant form of human glucocerebrosidase, in Gaucher's disease. The study is expected to start enrolling adult male and female patients with the lysosomal storage disorder in the third quarter.