• Aerogen Inc., of Mountain View, Calif., named John Hodgman president and CEO. Jane Shaw resigned as CEO and effective June 30, will resign as chairman. As of that time, Jean-Jacques Bienaime will become lead director of Aerogen. Hodgman joined Cygnus Inc. in 1994, becoming president and CEO in 1998 and also serving as chairman for the past six years. Aerogen is a specialty pharmaceutical company that develops products based on its OnQ Aerosol Generator technology to improve the treatment of respiratory disorders in the acute care setting.

• Affymax Inc., of Palo Alto, Calif., said preclinical data and Phase I study results for its lead product candidate, Hematide, a peptide-based erythropoiesis-stimulating agent, showed that the drug can produce a sustained effect on red blood cell production. Hematide is in development for the treatment of anemia in patients with chronic kidney disease cancer and is being evaluated in Phase II trial in kidney disease patients who are not on dialysis. The results were presented at the European Hematology Association meeting in Stockholm, Sweden.

• AgraQuest Inc., of Davis, Calif., completed a $14.4 million private round of financing. The deal was co-led by Otter Capital LLC and new investors Texas Pacific Group and Halcyon Capital. AgraQuest is a biotechnology company focused on discovering, developing and marketing environmentally friendly natural pest management products for agricultural, institutional and home markets.

• Antigenics Inc., of New York, said Oncophage was granted orphan drug status in Europe to treat renal-cell carcinoma (RCC). The FDA granted orphan drug status in May 2002 for RCC. Derived from each individual's tumor, Oncophage contains the antigenic fingerprint of the patient's particular cancer, and is designed to reprogram the body's immune system to target only cancer cells bearing the fingerprint. It is in Phase III trials for RCC and metastatic melanoma.

• Avantogen Ltd., of Sydney, Australia, said it is initiating a preclinical study to develop a therapeutic vaccine for HSV-2 in collaboration with the University of Alabama at Birmingham. Avantogen said it will combine its GPI-0100 adjuvant, which has been shown to enhance the immune response in cancer and chronic infectious diseases, with a genetically engineered, live, attenuated HSV-2 vaccine candidate. The vaccine is aimed at reducing the recurrence and shortening the duration of herpetic lesions and, if effective, is expected to be useful for immunization of high-risk groups.

• CardioVascular BioTherapeutics Inc., of Henderson, Nev., said its preclinical animal studies showed positive results for Cardio Vascu-Grow for wound healing in diabetic mice. The product demonstrated, at defined times, up to a sixfold increase in the healing rate in diabetic mice, compared to the control groups. The company plans to conduct clinical trials to establish the positive effect of the drug candidate at improving the quality of life for those suffering from heart disease, stroke and diabetic wounds.

• Celgene Corp., of Summit, N.J., said the FDA formally accepted for review the company's new drug application for Revlimid to treat transfusion-dependent myelodysplastic syndromes with deletion 5q chromosomal abnormality. The NDA was based on the results of a multicenter Phase II trial of 148 MDS patients. Celgene completed its rolling NDA filing in April. (See BioWorld Today, April 11, 2005.)

• Chelsea Therapeutics Inc., of Charlotte, N.C., said the UK's Medicines and Healthcare products Regulatory Agency approved a clinical trial authorization application from Chelsea for the clinical testing of CH-1504, an orally available antifolate that has potential anti-inflammatory and antitumor properties. Chelsea expects to begin a Phase I trial in the UK this month.

• Ciphergen Biosystems Inc., of Fremont, Calif., introduced Deep Proteome Research Services, making Equalizer protein biomarker discovery technology available to scientists for the first time, the company said. The services will be preferentially provided to Ciphergen's ProteinChip System customers.

• CMC Biopharmaceuticals A/S, of Copenhagen, Denmark, and Ambrx Inc., of San Diego, entered a development and manufacturing agreement for the cGMP production of PEGylated recombinant growth hormone using Ambrx's ReCODE technology. The product will be manufactured for use in human studies, set to begin following the planned submission of an investigational new drug application in 2006 for Ambrx's human growth hormone.

• Copernicus Therapeutics Inc., of Cleveland, said collaborators David Yurek at the University of Kentucky and Muna Naash at the University of Oklahoma presented results at the American Society of Gene Therapy meeting in St. Louis describing the effectiveness and non-toxicity of using DNA nanoparticles to introduce DNA into brain cells using Copernicus' nonviral nucleic acid nanoparticle technology. Data showed that DNA nanoparticles were more than 10-fold more efficient than competing gene transfer systems in introducing DNA into the cells of the retina.

• Evotec OAI AG, of Hamburg, Germany, and Boehringer Ingelheim, of Ingelheim, Germany, said that in less than one year after the start of their three-year research collaboration on selected G protein-coupled receptors, the first milestone was achieved successfully. Evotec received a first milestone payment, and the payment was granted for the identification of a number of lead series for a priority target of the collaboration.

• Exact Sciences Corp., of Marlborough, Mass., and OncoMethylome Sciences SA, of Liege, Belgium, and Durham, N.C., entered a research collaboration to evaluate the performance of certain gene methylation markers for use with Exact's next-generation, non-invasive colon cancer screening technology. The markers were identified by researchers at Johns Hopkins University and are exclusively licensed to OncoMethylome. OncoMethylome said the agreement will further solidify the potential of its methylation-specific PCR technology and its patented genes in cancer diagnosis and personalized medicine.

• Favrille Inc., of San Diego, said the first patient was enrolled in a physician-sponsored Phase II trial evaluating the company's lead product, FavId. The trial is being conducted in Europe in patients with all subtypes of indolent B-cell non-Hodgkin's lymphoma. Both treatment-na ve patients and patients who are relapsed or refractory to prior treatments are eligible for the trial.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., entered a partnership with INC Research. Genaissance, a developer and user of genetic information to help guide medical therapy, will provide pharmacogenetic clinical development services to clients of INC Research.

• Generex Biotechnology Corp., of Toronto, said that diabetes investigators at the Hadassah Hebrew University Hospital in Jerusalem published an Oral-lyn research paper in the June 2005 issue of Diabetes Care. The paper is titled "Dose Response Relationship of Oral Insulin Spray in Healthy Subjects." The purpose of the study was to evaluate the pharmacodynamics and pharmacokinetic properties and the dose-ranging effects of Oral-lyn in comparison with subcutaneous regular insulin.

• GenoMed Inc., of St. Louis, plans to conduct a clinical trial to prevent and treat West Nile virus encephalitis this summer. Last year, GenoMed's protocol was used by bird rescuers with a 50 percent success rate.

• Hemosol Corp., of Toronto, received a "compliance" rating from Health Canada following the completion of the regulatory agency's license inspection of Hemosol's Meadowpine facility in Mississauga, Ontario. Formal licensing of the facility will allow Hemosol to proceed with shipping Hepalean products under its contract with Organon Canada and to attract and fulfill other commercial biomanufacturing relationships. Hemosol expects to receive the formal license and to begin shipping product in the coming weeks.

• Illumina Inc., of San Diego, announced the commercial availability of two single nucleotide polymorphism-based assay panels designed to study genetic variation and function in the MHC region of the human genome.

• Immunetrics Inc., of Pittsburgh, entered a collaboration to discover inflammation biomarkers with the University of Cologne in Germany and the Ludwig Boltzmann Institute for Experimental and Clinical Traumatology in Vienna, Austria. The partners will conduct a joint effort to discover biomarkers of inflammation using Immunetrics modeling platform to simulate the immune response in a wide range of organisms and experimental scenarios, while the academic institutions provide human clinical data and animal model data.

• Introgen Therapeutics Inc., of Austin, Texas, and the University of Texas M.D. Anderson Cancer Center said they have identified the molecular pathways by which mda-7, the active component of INGN 241, induces growth arrest and apoptosis in cancer cells. Preclinical studies using lung cancer cells have demonstrated that mda-7 protein binds to a critical cellular enzyme called PKR, and the binding appears to be essential for the drug's anticancer activity. The data were published in two separate papers in the most recent issue of Molecular Therapy.

• Lorus Therapeutics Inc., of Toronto, received orphan drug status for Viruluzin in Europe to treat pancreatic cancer. A Phase III global trial in pancreatic cancer should be complete by the second half of the year. Virulizin received orphan drug status for pancreatic cancer in the U.S. in 2001.

• Maxim Pharmaceuticals Inc., of San Diego, said the Journal of Molecular Cancer Therapeutics published an article that describes the discovery of a class of apoptosis-inducing 3,5-diaryl-1,2,4-oxadiazoles and their molecular target, TIP47, an IGF-11 receptor binding protein, as a novel pathway for activation of apoptosis. The article reported that those compounds have demonstrated activity in preclinical tumor models in which they selectively induce apoptosis in tumor cells vs. normal cells. The anticancer compounds were identified using Maxim's cell and chemical genetics-based screening assay.

• MetriGenix Inc., of Toronto, completed the acquisition of Woburn, Mass.-based GeneXP Biosciences Inc., which has been developing a portfolio of gene expression-based biomarker tests. Terms of the acquisition were not disclosed. GeneXP President Michael Cohen has been named CEO of the combined company. MetriGenix is completing field trials of its MGX-8 Expression System for gene-expression profiling.

• Neurome Inc., of San Diego, received a Phase I Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md., to develop and validate software that will accelerate the graphic delineation of brain regions on digital images used in the production of 3-dimensional digital brain atlases. Neurome focuses on developing therapeutics for neurodegenerative diseases and developing delivery systems for targeted mucosal vaccines.

• Novasite Pharmaceuticals Inc., of San Diego, appointed Tim Harris president and CEO. Harris previously had served as the CEO of Structural Genomix Inc., also of San Diego. Novasite focuses on discovering and developing allosteric modulators of G protein-coupled receptors

• Open Biosystems Inc., of Huntsville, Ala., reported the imminent completion of its Expression Arrest Whole Genome human short hairpin RNA library.

• Orion Genomics LLC, of St. Louis, is collaborating with Andrew Feinberg of the Johns Hopkins University School of Medicine to better understand the role of DNA's "Second Code" in colon cancer, and to enable the development of a diagnostic test for early detection. The agreement calls for Orion and Feinberg to study the pattern of chemical groups known as the Second Code, or DNA methylation, that regulate the function of genes. The Second Code is believed to be involved in the development of many cancers, including colon cancer.

• Sangamo BioSciences Inc., of Richmond, Calif., said data related to its zinc finger technology demonstrated that engineered ZFPs could be used to disrupt the expression of the gene for CCR5, a cell-surface receptor that serves as a co-receptor for HIV entry into cells. Sangamo also applies its technology for therapeutic gene regulation, and presented data that described the aim of zinc finger protein transcription factors to selectively and efficiently turn off the phospholamban gene. When delivered into the hearts of rats, the product improved the calcium flux and contractility in the heart muscles. All the data were presented at the 8th annual meeting of the American Society of Gene Therapy in St. Louis.

• Sirna Therapeutics Inc., of Boulder, Colo., said Hepatology published an article addressing the activity of chemically modified short interfering RNA in a mouse model of hepatitis B virus replication. In the article, Sirna demonstrated in vivo validation of chemical modifications of siRNAs and the distinct differences between modified and unmodified molecules necessary for therapeutic relevance. Chemically modified siRNAs demonstrated improved delivery characteristics, both in terms of stability and efficacy in vivo.

• Solvay Pharmaceuticals Inc., of Marietta, Ga., submitted a drug master file (DMF) to the FDA for its cell-derived influenza vaccine. Following submission of the DMF, and the validation of its cell culture production facility, the company plans to submit an investigational new drug application to begin evaluating the safety and efficacy of the product in clinical trials.

• Tercica Inc., of South San Francisco, presented data from two pharmacokinetic studies at the 87th annual meeting of the Endocrine Society in San Diego that demonstrated that, following a dose of recombinant human insulin-like growth factor-1 (rhIGF-1), there was a prompt increase in serum insulin-like growth factor-binding protein-3. Preliminary observations of the effect were included in the company's new drug application for Increlex (mecasermin [rDNA origin] injection), or rhIGF-1, which was accepted for filing and granted priority-review by the FDA on April 29. Tercica is seeking marketing approval in children with short stature due to growth hormone deficiency. (See BioWorld Today, March 1, 2005.)

• TorreyPines Therapeutics, of San Diego, formerly Neurogenetics Inc., filed an investigational new drug application with the FDA for NGX267, the first of several compounds in the company's pipeline that are designed to treat Alzheimer's disease. NGX267 is a selective cholinergic muscarinic receptor agonist with properties suggesting the potential for both symptomatic and disease-modification therapy in Alzheimer's disease.

• Tripos Inc., of St. Louis, was awarded a Marie Curie Fellowship for Transfer of Knowledge by the European Union under its Sixth Framework Programme for Research and Technological Development. The grant, valued at about €875,000 (US$1.1 million) will pay for seven biology and chemistry research fellows to join Tripos Discovery Research Ltd. in Bude, UK, for 18 months over a four-year period to work in lead discovery and development.

• Valentis Inc., of Burlingame, Calif., is expanding the scope of its collaboration with Berlin-based Schering AG. Valentis agreed to grant Schering a worldwide license to its GeneSwitch gene regulation and PINC polymer delivery technologies for research purposes on a nonexclusive basis. Schering paid Valentis an up-front license fee and Valentis is entitled to annual license maintenance fees. The initial agreement was formed in December 2002. (See BioWorld Today, Dec. 23, 2002.)