• Alkermes Inc., of Cambridge, Mass., and Indianapolis-based Eli Lilly and Co. said results of a Phase II study of inhaled insulin in patients with Type I diabetes demonstrated that the inhaled system achieved blood sugar levels similar to patients treated with injected insulin. Using the standard measure of blood sugar, A1C, patients showed an average level of 7.9 using the Lilly/Alkermes inhaled insulin system, compared to 8 in the injected insulin group. The findings were presented at the American Diabetes Association meeting in San Diego.

• Amarin Corp. plc, of London, said that the Huntington Study Group began recruitment for the U.S. Phase III trial of Miraxion in Huntington's disease. The HSG will be conducting a clinical study of ultra-pure ethyl-EPA in people 35 years of age or older who have mild to moderate Huntington's disease. The HSG is a worldwide, not-for-profit group of physicians and other clinical researchers.

• Biogen Idec Inc., of Cambridge, Mass., said a Phase II study demonstrated that galiximab, its monoclonal antibody targeting CD80, could be used in combination with Rituxan, and the drugs might prolong event-free survival in patients with relapsed or refractory, follicular non-Hodgkin's lymphoma, compared to previous results with Rituxan alone. The combination produced a 64 percent overall response rate, including 31 percent achieving a complete response. Results were presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland.

• Biosynexus Inc., of Gaithersburg, Md., a firm that focuses on developing products to treat staphylococcal infections, said it became a wholly owned subsidiary of QVT Fund LP, as of May 26. Biosynexus also appointed Irwin Scher CEO. Scher previously worked at Germany-based Merck KGaA as vice president of global clinical research and development and consultant to the CEO.

• Cellectis SA, of Romainville, France, which has had a patent dispute with Johns Hopkins University and Richmond, Calif.-based Sangamo Biosciences Inc. involving targeted recombination and gene correction, said it has won the latest decision by the European Patent Office. The EPO revoked Sangamo's patent, titled "Functional Domains in Flavobacterium okeanokoites Restriction Endonuclease," due to the lack of an inventive step, Cellectis said.

• Chiron Corp., of Emeryville, Calif., said the Global Alliance for TB Drug Development initiated Phase I trials for the tuberculosis drug candidate PA-824, which Chiron acquired in 1995 through its acquisition of Seattle-based PathoGenesis Corp. Chiron granted the TB alliance exclusive worldwide rights to PA-824 and related compounds in 2002. Clinical trials should begin this month.

• Ciphergen Diagnostics, of Fremont, Calif., a division of Ciphergen Biosystems Inc., said a publication in the International Journal of Cancer presented findings that suggest that surface enhanced laser desorption/ionization time of flights mass spectrometry-based immunologic and chromatographic assays can be used to detect post-translationally modified forms of host response proteins. Ciphergen said those proteins might aid in the classification of cancer.

• Cortex Biochem Inc., of Raleigh, N.C., established an exclusive distribution and limited license agreement with Bouty SpA, of Milan, Italy. The agreement allows Bouty and its subsidiary biotechnology division, Technogenetics SrI, to promote, market and sell Cortex Biochem's MagaZorb nucleic acid isolation kits and associated reagents in Italy.

• Cytokinetics Inc., of South San Francisco, filed a shelf registration statement to allow the company to sell, from time to time, up to $100 million in common stock, preferred stock and warrants. Specific terms and the use of proceeds will be detailed in the prospectus at the time of an offering. The company is focused on the discovery, development and commercialization of small-molecule drugs that target the cytoskeleton.

• DCV Technologies Inc., of Little Rock, Ark., received a grant from the National Cancer Institute for preclinical research on the company's dendritic-cell immunotherapy in ovarian cancer. DCV, a start-up located at the University of Arkansas for Medical Sciences, focuses on creating dendritic-cell vaccines for cancers of the reproductive tract and has one product in Phase I development for cervical cancer.

• DiaGenic ASA, of Oslo, Norway, said results of a study into the expression of 37 genes that can pinpoint whether a woman has breast cancer showed that the cancer was accurately diagnosed in at least 82 percent of patients. DiaGenic said the genes are not specifically cancer genes or involved in the tumor, and the discovery could lead to a blood test designed to detect breast cancer earlier than mammograms. The results were published in the June 14, 2005, issue of Breast Cancer Research.

• DNAPrint Genomics Inc., of Sarasota, Fla., selected Proteos Inc., of Kalamazoo, Mich., to manufacture the first batch of its therapeutic candidate, PT-401, for preclinical testing. PT-401 is a theranostic product described as a "Super EPO" (erythropoietin) dimer protein drug, for the treatment of anemia in renal dialysis patients.

• Dynavax Technologies Corp., of Berkeley, Calif., reported positive data from a Phase II/III trial of its hepatitis B virus vaccine, which showed statistically significant superiority in protective antibody response and robustness of protective effect after three vaccinations vs. London-based GlaxoSmithKline plc's Engerix-B vaccine in an older adult population that is difficult to immunize with conventional vaccine therapy. The results confirm interim data released in December. Dynavax said it intends to initiate a pivotal Phase III program beginning around the middle of the year. (See BioWorld Today, Dec. 10, 2004.)

• Exelixis Inc., of South San Francisco, submitted an investigational new drug application to the FDA for XL184, the seventh compound to advance into clinical development from the company's internal discovery program within two years. In preclinical studies, XL184 has shown inhibition of the hepatocyte growth factor receptor and vascular endothelial growth factor receptor 2 receptor tyrosine kinases and proteins that are believed to play synergistic roles in promoting tumor growth and angiogenesis.

• Gene Bridges, of Dresden, Germany, and Covalys Biosciences AG, of Witterswil, Switzerland, formed a collaboration to develop "Copy & Paste" DNA engineering kits to generate SNAP-tag fusion proteins based on Gene Bridges' Red/ET recombination technology.

• Generex Biotechnology Corp., of Toronto, said clinical trial results of Oral-lyn, its oral insulin buccal spray formulation, showed that Oral-lyn's glucodynamic profile was better than the profile of Humulin-R, and that it can be used safely by patients with Type II diabetes on once-a-day metformin. Generex reported that Oral-lyn especially was effective in controlling post-prandial glucose excursions in patients maintained on glargine and metformin. The data were presented at the American Diabetes Association meeting in San Diego.

• Immunicon Corp., of Huntingdon Valley, Pa., said that it and the Fox Chase Cancer Center, based in the Philadelphia area, were awarded a Small Business Technology Transfer grant totaling about $587,000 by the National Institutes of Health. The NIH grant is intended to fund the development of a new strategy to actively monitor the effectiveness of cancer drugs in clinical trials.

• Ingenuity Systems, of Mountain View, Calif., said that the Serono Genetics Institute in Evry, France, licensed its Pathways Knowledge base for use in developing state-of-the-art internal drug discovery and development tools.

• Insilico GmbH, of Vienna, Austria, and the German Resource Center for Genome Research (RZPD) in Berlin are working on a joint project to link Insilico's SQL-based MASI database with RZPD's material index. The cooperative effort will allow researchers the ability to cross-reference sources, and to identify research material suitable for solving biological problems. MASI integrates information on RNA, DNA and proteins, as well as their native tissues and cells.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said data from an interim Phase II analysis indicated that ISIS 113715 reduced HbA1c and plasma glucose after six weeks of dosing. The drug, a second-generation antisense product, did not cause hypoglycemia and appeared to be well tolerated. The results were presented at the American Diabetes Association meeting in San Diego.

• MannKind Corp., of Valencia, Calif., said additional findings from two separate studies of inhaled Technosphere Insulin indicated that the product can be used in conjunction with an oral diabetes medication and with less risk of hypoglycemia. Studies also demonstrated the reliability of absorption and effect of Technosphere Insulin, which the company said compared favorably to subcutaneously administered insulin. The data were presented at the American Diabetes Association meeting in San Diego.

• Medarex Inc., of Princeton, N.J., and Boehringer Ingelheim GmbH, of Ingelheim, Germany, formed an agreement for the development of fully human therapeutic antibodies. Boehringer Ingelheim intends to use Medarex's UltiMAb Human Antibody Development System to generate antibodies to disease targets. Financial terms were not disclosed.

• Myelin Repair Foundation, of Saratoga, Calif., said its collaboration of five leading neuroscientists identified three new "switches," or signals, operating in the brain and spinal column that appear to turn on and off the nerve cells' ability to repair myelin, the protective coating surrounding nerve cells that is damaged by multiple sclerosis. Scientists said the findings could lead to the development of specific drugs to repair the damage caused by MS.

• Nektar Therapeutics Inc., of San Carlos, Calif., reported that results from three two-year studies showed that Exubera (human insulin powder), an inhalable, short-acting dry powder insulin, provided effective, sustained glycemic control and was well tolerated in adults with Type II diabetes. A fourth study showed that three months of Exubera therapy was well tolerated and as effective as subcutaneous short-acting insulin in achieving glycemic control in adults with Type I diabetes. The product is being jointly developed by Sanofi-Aventis Group, of Paris, and Pfizer Inc., of New York. The inhalation device was developed by Nektar.

• Neurocrine Biosciences Inc., of San Diego, said the FDA accepted for review its new drug application for indiplon capsules to treat insomnia in both adult and elderly patients. Indiplon acts on a specific site of the GABA-A receptor believed to be responsible for promoting sleep. The company filed for approval in October. (See BioWorld Today, Oct. 20, 2004.)

• Qiagen NV, of Venlo, the Netherlands, completed the acquisition of Beijing-based Tianwei Times, a privately held company that manufactures and supplies nucleic acid sample preparation consumables. Under the terms of the agreement, Qiagen has acquired certain assets of Tianwei for about $2 million in cash, plus potential earn-outs estimated at about $2 million over two years. Qiagen expects to incur one-time charges relating to the acquisition of $500,000 in the third quarter. The transaction is pending approval by the Chinese government.

• QuatRx Pharmaceuticals Co., of Ann Arbor, Mich., said a Phase IIb study of patients treated with becocalcidiol, a topical vitamin D analogue for mild to moderate psoriasis, met the primary study endpoints by demonstrating a statistically significant difference from vehicle, according to the physicians' global assessment. Greater than five times the number of patients reached the endpoint at the high dose of becocalcidiol compared with vehicle, and patients treated at the high dose level also showed a statistically significant reduction in psoriasis symptom severity and affected body surface area. QuatRx has entered discussions with potential partners for Phase III studies and product commercialization.

• Sangamo BioSciences Inc., of Richmond, Calif., said preclinical data from its program to develop a zinc finger DNA-binding protein therapeutic for diabetic neuropathy were presented at the American Diabetes Association 65th scientific sessions held in San Diego. The results demonstrate animal efficacy for a zinc finger DNA-binding protein transcription factor (ZFP TF) that is being tested in a Phase I trial. The data show that local, intramuscular injection of the ZFP TF plasmid significantly increases both motor and sensory nerve conduction velocities in rats with experimental diabetic neuropathy.

• Santarus Inc., of San Diego, said the June 15 issue of Alimentary Pharmacology & Therapeutics published clinical trial results showing that immediate-release Zegerid (omeprazole) powder for oral suspension, 40 mg, significantly reduced gastric acidity throughout the night compared to Protonix (pantoprazole) delayed-release tablets, 40 mg, when dosed once a day in the evening. Both drugs are proton pump inhibitors used to reduce gastric acid and treat symptoms of gastroesophageal reflux disease. The study included 36 patients with nighttime symptoms of GERD. A 20-mg powder version of Zegerid was launched in October, and the 40-mg version was launched in February.

• Scios Inc., of Fremont, Calif., said an expert panel of cardiology and heart failure clinicians encouraged the company to continue enrolling patients in ongoing trials of Natrecor (nesiritide) for acute heart failure. The panel also endorsed the company's plan to conduct several trials to further assess benefits and risks of Natrecor, in response to concerns regarding the drug's possible effects on renal function and mortality. Natrecor was approved in 2001 as an intravenous treatment in patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity.

• The Immune Response Corp., of Carlsbad, Calif., said clinical research conducted by the company in association with Oregon Health & Science University indicated that a deficiency of FOXP3, a specific genetic marker on T cells known to be involved in maintaining immune tolerance and regulation of autoimmune diseases, likely is linked to deficient numbers of regulatory T cells. The company said those findings, published in the July issue of the Journal of Neuroscience Research, seem to support the mechanism of action for its immune-based therapy, NeuroVax, which is designed to induce regulatory T cells.

• Tibotec Inc., of Yardley, Penn., said it plans to initiate an expanded access program for its investigational protease inhibitor, TMC114, this fall for people with HIV/AIDS who need the compound to construct a viable treatment regimen. The company also plans to seek accelerated approval for TMC114 in the U.S. and Europe through regulatory submissions filed by early 2006. The submissions will be based primarily on the 24-week analysis from two Phase IIb trials.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., completed its public offering of 11.75 million shares, raising $152.8 million in gross proceeds. The underwriters - Merrill Lynch & Co., JPMorgan Securities Inc. and UBS Securities LLC - have an overallotment option for up to about 1.8 million shares. The company intends to use the proceeds for general corporate purposes. (See BioWorld Today, June 9, 2005.)

• Vical Inc., of San Diego, received orphan drug designation from the FDA for its bivalent (two-plasmid) formulation of its vaccine to prevent clinically significant cytomegalovirus viremia, CMV disease and associated complications in at-risk hematopoietic cell transplant and solid organ transplant populations. The vaccine is expected to enter Phase II trials in the second half of 2005.