• Acologix Inc., of Hayward, Calif., initiated a Phase II study of AC-100 (dentonin) for the treatment of periodontal bone loss. AC-100 is delivered during periodontal surgery in combination with a collagen matrix to regrow bone that has been lost due to periodontal disease. AC-100 is a synthetic peptide derived from an endogenous human protein produced by bone and dental cells.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., formed a collaboration with researchers from the University of Georgia to discover and develop a direct RNAi therapeutic to treat and prevent respiratory infection from newly emerging, highly pathogenic strains of influenza virus. The company will apply its technology to the discovery of short interfering RNAs that target flu genes required for virus replication and demonstrate antiviral activity across human and avian flu strains.

• Amarin Corp. plc, of London, completed its registered direct offering of 13.7 million American depository shares for gross proceeds of $17.8 million and net proceeds totaling about $14.7 million. The company said the offering included the redemption of $2 million in loan notes. Proceeds will be used to support Phase III trials of Miraxion in Huntington's disease, expected to begin around mid-year. The drug also is in Phase II development for treatment-unresponsive depression. Leerink Swann & Co. served as placement agent.

• Bionomics Ltd., of Adelaide, Australia, agreed to acquire the Melbourne, Australia-based drug discovery company Iliad Chemicals Pty. Ltd. for $9 million in Bionomics shares, with a potential $3 million milestone payment in Bionomics shares if an Iliad development product achieves an agreed upon clinical or commercial milestone. Bionomics said the acquisition will add to its pipeline an advanced series of preclinical drug candidates aimed at targeting blood vessels involved in tumors, which are expected to move into the clinic in 2007. Iliad founder and shareholder Bernard Flynn will join Bionomics when the acquisition is complete. Bionomics also has completed a placement, raising A$6 million (US$4.6 million) to fund development programs in cancer and central nervous system disorders.

• BioVeris Corp., of Gaithersburg, Md. entered an option agreement with the University of Massachusetts at Amherst for exclusive patent rights to a vaccine candidate for chlamydia. The company acquired a first option for rights to commercialize products for use in the prevention, diagnosis and treatment of all chlamydial infections.

• Cangen Biotechnologies Inc., of Bethesda, Md., said it entered a research collaboration with Tokyo-based Olympus Corp. for the development of a hybrid DNA- and protein-based diagnostic test for lung cancer. Olympus is responsible for refining and further developing its microarray technology, designed to enable the DNA-based portion allowing high-throughput testing, in an effort to accommodate Cangen's development of the test.

• Celera Genomics Group, of Rockville, Md., presented data describing the efficacy of its tryptase inhibitor for the treatment of allergic asthma at the annual international conference of the American Thoracic Society in San Diego. Celera Genomics said its tryptase inhibitor, among other things, completely inhibited the ovalbumin-induced airway hyperresponsiveness and eosinophil influx, to the same extent as budesonide, the positive control compound.

• Ciphergen Biosystems Inc., of Fremont, Calif., said that scientists presented results Tuesday at the American Urological Association meeting in San Antonio suggesting that two protein markers, in combination with PSA levels, might be useful in predicting the risk of recurrence of prostate cancer within five years of diagnosis. The study analyzed serum from 104 patients with prostate cancer, half of whom did not have a recurrence after five years of follow up.

• Crucell NV, of Leiden, the Netherlands, and its contract manufacturer, DSM Biologics, of Groningen, the Netherlands, signed a PER.C6 commercial license agreement with Ferring Pharmaceuticals A/S, of Copenhagen, Denmark. The agreement allows Ferring to use the PER.C6 cell line in the field of women's health care. Financial details were not disclosed.

• CytoGenix Inc., of Houston, obtained a commercial evaluation license from the National Institutes of Health for a DNA plasmid developed by scientists from the National Institute of Allergy and Infectious Diseases Vaccine Research Center. The license gives CytoGenix the right to conduct experiments using the DNA vaccine, derived from HIV gene sequences contained in the NIH plasmid.

• Enzo Biochem Inc., of New York, said that its wholly owned subsidiary, Enzo Life Sciences, launched a new DNA-labeling system aimed at array comparative genomic hybridization, a technique that detects alterations in the genome leading to changes in DNA copy number.

• Genpathway Inc., of San Diego, said its researchers and Baylor College of Medicine in Houston applied a new suite of integrated transcription-based assays to identify genes important in breast cancer. The genes were identified as a result of being directly regulated by a coactivator shown previously to be a critical regulator in breast cancer. The study was reported in the Proceedings of the National Academy of Sciences.

• GenVec Inc., of Gaithersburg, Md., said the FDA informed the company that all issues have been addressed and it may resume enrollment in a Phase II trial of TNFerade in rectal cancer. The trial will be conducted in collaboration with the surgery branch of the National Cancer Institute to evaluate TNFerade in combination with chemoradiation for rectal cancer to improve complete response rates, surgical outcomes and survival. The FDA placed a clinical hold on TNFerade trials in October when an esophageal cancer patient receiving the treatment died of a pulmonary embolism. Patient accrual in the Phase II esophageal study is complete, and follow up is ongoing. (See BioWorld Today, Oct. 8, 2004.)

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said multiple preclinical studies showed that second-generation antisense drugs selectively inhibited activity of proteins that promote inflammation and improved a variety of symptoms in mouse models of asthma and chronic lung inflammation. The data were presented this week at the 100th annual meeting of the American Thoracic Society.

• Kiadis BV, of Groningen, the Netherlands, and NV Organon, of Oss, the Netherlands, entered an evaluation agreement centered on the use of Kiadis' core on-line screening technology, BioSelect, for Organon's reproductive medicine discovery program. Terms of the collaboration call for Organon to supply Kiadis with a target, though financial terms were not disclosed. Kiadis will be responsible for delivering active compounds against the target using its technology.

• Manhattan Pharmaceuticals Inc., of New York, said its lead product candidate, Oleoyl-estrone (OE), demonstrated efficacy in inducing significant weight loss in a preclinical pharmacology study administered alone and in combination with other obesity treatments. Findings of the study were published in a paper, titled "Effects of Oleoyl-estrone with Dexfenfluramine, Sibutramine or Phentermine on Overweight Rats," in the April 2005 issue of the European Journal of Pharmacology. Data showed that rats dosed with OE had weight loss of 0.8 percent per day vs. less than 0.4 percent observed with other products, and that weight loss was maximal when OE was combined with sibutramine and dexfenfluramine, with losses of 1 percent and 1.1 percent per day, respectively.

• MedImmune Inc., of Gaithersburg, Md., said data from a preclinical study indicated a correlation between interleukin-9 and increased airway hyperreactivity (AHR), a component of asthma. Data showed that one of IL-9's roles in AHR is the regulation of mast cells, which release mediators that cause the bronchi or bronchial airway to construct. Results presented at the 100th Annual International Conference of the American Thoracic Society in San Diego also demonstrated that using an anti-IL-9 monoclonal antibody reduced AHR.

• Neurocrine Biosciences Inc., of San Diego, said data presented at the 2005 American Psychiatric Association annual meeting showed that nightly administration of indiplon capsules resulted in significant and sustained improvement in sleep onset and sleep maintenance in patients with chronic insomnia over the entire treatment period. Data also showed there was no evidence of tolerance over the three months or withdrawal upon discontinuation of treatment. Neurocrine submitted a new drug application in April for indiplon capsules for the treatment of insomnia in adult and elderly patients. If approved, the drug will be co-promoted in the U.S. with New York-based Pfizer Inc.

• North American Science Association Inc., of Northwood, Ohio, agreed to acquire Kalamazoo, Mich.-based CeeTox Inc., a scientific and medical services company that provides predictive evaluations of the toxicological properties of chemical and biological substances. NAMSA has acquired 51 percent of CeeTox's outstanding shares and will obtain the remaining shares as certain undisclosed milestone payments are met.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., said a further milestone has been reached in its collaboration with NV Organon, a unit of Oss, the Netherlands-based Akzo Nobel, resulting in a cash payment to Pharmacopeia. Organon has initiated regulatory GLP toxicological studies with the development candidate announced in November. The companies have worked together since 2002 to identify and optimize drug candidates.

• SeraCare Life Sciences Inc., of Oceanside, Calif., priced a public offering of 3.5 million shares of its common stock at a public offering price of $12.25 a share. About 3 million shares are being offered by the company and 476,000 shares are being offered by certain selling shareholders. The underwriters have a 30-day option to purchase up to 525,000 additional shares to cover overallotments, if any.

• Structural Genomics Consortium, of Oxford, UK, an Anglo-Canadian charitable consortium of public and private agencies, delivered its first 50 human and malaria protein structures to the public domain two months ahead of schedule.

• Valentis Inc., of Burlingame, Calif., said it has granted to London-based Organon Laboratories Ltd. a nonexclusive, worldwide license for its GeneSwitch gene-regulation technology. Terms of the agreement call for Organon to pay an up-front license fee, with Valentis entitled to yearly license maintenance fees. GeneSwitch allows researchers to control the level and duration of selected genes in transgenic animals and cell cultures.

• Ym BioSciences Inc., of Mississauga, Ontario, said that its cancer vaccine Norelin, which targets the gonadotropin-releasing hormone, has completed a proof-of-concept study in men with hormone-dependent prostate cancer. The majority of treated patients developed antibodies to GnRH, demonstrating the development of an immunological response, the primary objective of the trial. The company intends to take the drug forward into larger trials.

• Ziopharm Inc., of Charleston, Mass., initiated its second Phase I study to assess safety and dosing of ZIO-101, its small-molecule organic arsenic. The trial is being conducted in up to 40 patients with diverse solid tumors and complements the recently initiated Phase I study in patients with hematological malignancies. ZIO-101 is the first molecule from a family of organic arsenics, the company said, and it expects that the Phase I trials will be followed by a Phase I/II trial in advanced myeloma in the second half of the year, and will be continued with a registration study in that indication to begin in the second half of 2006.