• Actelion Ltd., of Allschwil, Switzerland, released its first-quarter figures that showed an operating profit of CHF3.7 million (US$2.7 million) and net profit of CHF4.8 million. The company said it was "very pleased that Actelion has achieved profitability after only five years of operations." Tracleer, its product for pulmonary arterial hypertension, brought in sales of CHF60.7 million in the first quarter, an increase of 27.8 percent over the fourth quarter. In the first quarter, Tracleer was launched in the Netherlands, Spain, Portugal and Finland.

• Advanced Magnetics Inc., of Cambridge, Mass., and Cytogen Corp., of Princeton, N.J., reported the presentation of data from two separate studies indicating that magnetic resonance imaging plus the investigative lymph node imaging agent Combidex (ferumoxtran-10) also can aid in assessing residual and primary brain and head and neck tumors. Results of the studies are being presented at the American Society of Neuroradiology meeting in Washington.

• Advanced Tissue Sciences Inc., of San Diego, entered an agreement to sell additional fixed assets and intellectual property rights to the wound management unit of Smith & Nephew plc, of London, as part of its Chapter 11 liquidating plan of reorganization. Smith & Nephew could end up bidding against others to acquire Advanced Tissue's intellectual property rights related to cartilage, orthopedics, spinal, neurological and dental applications, including rights to a pending clinical trial using Dermagraft in a periodontal application. The agreement also covers transferring certain research and development equipment and assets related to the manufacturing of collagen. Smith & Nephew will pay $700,000 at closing, in addition to future milestone and royalty payments conditional on future product development. Smith & Nephew took over Advanced Tissue's La Jolla, Calif.-based interest in their Dermagraft joint venture last fall. (See BioWorld Today, Oct. 14, 2002.)

• AGY Therapeutics Inc., of South San Francisco, named Cynthia Ladd president and CEO and a member of the board, effective immediately. Most recently, Ladd worked as senior vice president and general counsel at Pharmacyclics Inc., of Sunnyvale, Calif. Privately held AGY is developing treatments for central nervous system diseases.

• Applied Imaging Corp., of Santa Clara, Calif., entered an agreement with the Wellcome Trust Sanger Institute near Cambridge, UK, to be its sole imaging development partner in Sanger's Atlas of Gene Expression project. Applied Imaging will develop applications for high-throughput analysis of tissue samples using its Ariol software. Applied Imaging will have exclusive worldwide commercial rights to sell the various Ariol applications developed under the agreement. The goal of the Sanger Institute's Atlas of Gene Expression is to map human protein expression patterns at the cellular level.

• Avant Immunotherapeutics Inc., of Needham, Mass., reported additional analysis of data from a Phase II study of its lead complement inhibitor, TP10. Findings from the adult cardiac surgery trial suggest a treatment benefit to male patients, but no significant benefit to females. The results have been submitted for presentation at the American Society of Anesthesiologists meeting this fall in San Francisco. A year ago, Avant's stock fell 64.7 percent when the company first reported that TP10 did not meet a primary endpoint in the study. (See BioWorld Today, Feb. 21, 2002.)

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., published positive study results of its BioAir calcium phosphate nanoparticulate (CAP) delivery system for inhalable insulin in the American Association of Pharmaceutical Scientists' AAPS PharmSci journal. The study, which evaluated an insulin formulation using CAP and polyethylene glycol (PEG) particles in suspension, demonstrated that CAP-PEG particles significantly reduced the elimination of insulin, increasing its systemic residence time and duration of action. Insulin available in the bloodstream through the BioAir insulin-CAP-PEG formulation was 1.8 times that of insulin injected subcutaneously, it said.

• Boston Biomedica Inc., of Bridgewater, Mass., entered an agreement to sell products developed at Ambion RNA Diagnostics, a division of Ambion Inc., of Austin, Texas. Ambion's Armored RNA and RunReady products will be available for purchase through Boston Biomedica's diagnostics unit. Ambion will continue to sell the products to existing customers, with Boston Biomedica as the exclusive sales representative to the clinical diagnostics market. Financial terms were not disclosed.

• ChondroGene Ltd., of Toronto, said it would raise up to C$3 million (US$2.1 million) through the private placement of 6 million common shares. Specifically, Dundee Securities Corp. will act as a financial adviser and agent to sell 4 million shares at C50 cents apiece, while ChondroGene's chairman committed to buy 2 million shares at the same price. The placement is expected to close on or about June 16. ChondroGene said it would use the funds to accelerate its biomarker and therapeutic target programs.

• Copernicus Therapeutics Inc., of Cleveland, reported positive results from a gene therapy trial involving cystic fibrosis patients and a compacted DNA technology produced by the company. The 12 participants in the Phase I trial completed the course without significant side effects and the treatment was well tolerated. Also, data indicated that the cystic fibrosis gene was transferred to airway cells. The study began a year ago at University Hospitals of Cleveland, Case Western Reserve University School of Medicine in Cleveland, Children's Hospital of Denver and Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation in Bethesda, Md. Copernicus developed the nonviral gene transfer system that tightly binds strands of DNA to pass through a cell membrane and into the nucleus.

• Corus Pharma Inc., of Seattle, filed an investigational new drug application for Corus 1030 (inhaled lidocaine) and dosed its first patient in a Phase II trial. The U.S.-based, multicenter, randomized, blinded, placebo-controlled study is designed to evaluate the compound's safety, tolerability and efficacy in treating asthma. Participants will receive the inhaled lidocaine or placebo via eFlow, an inhalation technology developed by PARI GmbH, of Starnberg, Germany.

• Focus Technologies Inc., of Herndon, Va., began supplying public health labs, commercial laboratories and hospitals with laboratory reagents for detecting flavivirus antibodies. Flavivirus also is known as West Nile virus. Focus' products are based on protein antigen technology licensed from the Centers for Disease Control and Prevention in Atlanta. Focus said labs in more than 30 states have ordered flavivirus reagents.

• Genencor International Inc., of Palo Alto, Calif., said it met and exceeded the project goal well ahead of schedule in its three-year program to develop an economically viable enzymatic process for converting biomass to ethanol. Specifically, as part of its $17 million contract with the U.S. Department of Energy's National Renewable Energy Laboratory, Genencor said its integrated technology platforms delivered enzyme systems enabling a 10-fold improvement in the economics of using enzymes to break down biomass and complex carbohydrates into fermentable sugars.

• GenVec Inc., of Gaithersburg, Md., signed a letter of intent to form a Collaborative Research and Development Agreement with the Vaccine Research Center at the National Institute of Allergy and Infectious Disease of the National Institutes of Health to pursue the development of a severe acute respiratory syndrome (SARS) vaccine using GenVec's adenovector technology. GenVec reported on Thursday that it had agreed with the NIH to add a SARS vaccine to its ongoing vaccine development program with the NIH. The CRADA will be complementary to the existing funded contract with the NIH. (See BioWorld Today, April 28, 2003.)

• Hemispherx Biopharma Inc., of Philadelphia, reported data at the International Conference on Antiviral Research from its Phase IIb trial in which patients' antiviral regimens are interrupted and Ampligen is substituted. The findings showed that patients taken off highly active antiretroviral therapy (HAART) but given Ampligen, an experimental immunotherapeutic, continued to show virus levels below 5,000 copies/ml for a mean time of 25 weeks and counting, but the control group, which also was taken off HAART but not given Ampligen, had an HIV rebound with a mean of 13 weeks.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, reported the presentation of additional data from preclinical and clinical studies with investigational immune-regulating hormones in infectious diseases. The data include results from a recently completed pilot trial with HE2000 addressing opportunistic infections such as tuberculosis in late-stage AIDS patients as well as new preclinical data in tuberculosis. The data will be presented at the International Conference on Antiviral Research in Savannah, Ga., that continues through Thursday.

• Hybrigenics SA, of Paris, acquired Semaia BV, of Utrecht, the Netherlands. Hybrigenics said the all-share transaction provides it access to new targets for cancer therapeutic research and advanced know-how in several areas of oncology. By combining its functional proteomics technology and cancer knowledge with Semaia's oncology target candidates, Hybrigenics plans to accelerate the discovery of compounds to treat colorectal and other cancers. Financial terms were not disclosed.

• Inpharmatica Ltd., of London, entered a drug discovery collaboration with functional genomics firm Galapagos Genomics NV, of Mechelen, Belgium. Inpharmatica will use its PharmaCarta chemogenomics technology platform to determine the druggability of targets selected by Galapagos in its internal disease programs. Galapagos will provide access to its PhenoSelect adenoviral expression platform for a subset of nuclear receptors belonging to Inpharmatica, which will use the technology in its in-house programs to further validate and prioritize the receptors as targets. Financial terms were not disclosed.

• InterBioScreen Ltd., of Moscow, entered a partnership to produce new generations of discovery molecules with Princeton BioMolecular Research Inc., of Monmouth Junction, N.J. More specifically, they signed a long-term collaborative agreement to exploit their core, discovery research competencies in small-molecule chemistry, including InterBioScreen's natural and synthetic chemistry organization and resources and Princeton BioMolecular's U.S.-based molecular and medicinal chemistry research capabilities. Financial terms were not disclosed.

• Locus Pharmaceuticals Inc., of Blue Bell, Pa., entered a collaboration to design and develop renin inhibitors with the Speedel Group, of Basel, Switzerland. Privately held Locus will apply its computational technology to design small-molecule renin inhibitors for further development by Speedel, which will reimburse Locus' research costs and also make milestone and royalty payments.

• Nonlinear Dynamics Ltd., of Newcastle Upon Tyne, UK, said the University of Texas Medical Branch at Galveston upgraded to its Progenesis Discovery Informatics product. UTMB invested in one of Nonlinear's 2-D analysis solutions, Progenesis Discovery, more than a year ago and recently chose to upgrade.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said the publication of a study in the April 21, 2003, issue of the Archives of Neurology supports the potential of statin drugs in treating Alzheimer's disease. The six-week study found that the patients taking statins lowered levels of an important product of brain cholesterol metabolism by 21.4 percent. Other recent reports indicated that this form of cholesterol was elevated in Alzheimer's patients. Nymox said it has global patent rights covering the use of statins for Alzheimer's.

• Pain Therapeutics Inc., of South San Francisco, completed enrollment in a pilot study of PTI-901, a compound being developed for irritable bowel syndrome patients. The company said it planned to report results of the 50-patient, open-label, Israel-based study next month. The trial evaluated PTI-901's safety and efficacy profiles over four weeks of treatment and during a subsequent follow-up period.

• Pharmasset Inc., of Atlanta, reported data at the Clinical Virology Symposium in Clearwater Beach, Fla., from a study aimed at determining the effect of antiviral nucleoside drugs on mitochondrial DNA. In the study, seven anti-HIV-1, FDA-approved nucleoside analogues were tested over the concentration range of 1 to 100 micromolar in a variety of cell lines (HepG2, Huh7 and PBMC) using a real-time PCR assay. Several experimental compounds also were tested, including a series of nucleoside analogues with anti-HIV activity, dual anti-HIV and anti-HBV activity, and anti-HCV activity. While general toxic effects such as reduction in cell growth and reductions in ribosomal DNA and mitDNA could be seen for several compounds in these series, specific mitochondrial toxicity was only detected in the 2',3'-dideoxy-modified nucleosides. None of the antiviral compounds caused specific reductions in mitochondrial RNA.

• ProSanos Corp., of La Jolla, Calif., established an office in Harrisburg, Pa., to house its product development efforts. The facility is located in an incubator operated by the Life Sciences Greenhouse of Central Pennsylvania, a public/private joint venture designed to accelerate the commercialization of biotechnology research in central Pennsylvania.

• Stanford University in Palo Alto, Calif., said researchers at its medical center isolated the first member of a recalcitrant group of proteins called the Wnts two decades after their discovery. Findings published in the April 27, 2003, advance online edition of Nature showed that the animal development-regulating proteins play a role in keeping stem cells in their youthful, undifferentiated state. The ability to isolate Wnt proteins could help researchers grow some types of stem cells for use in bone marrow transplants or other therapies.

• University of Pittsburgh Medical Center researchers found that gene therapy may not only be feasible, but also may be an ideal treatment for neuropathic erectile dysfunction. Results of the study were presented at the annual meeting of the American Urological Association and are published in the AUA proceedings. In the study, researchers injected herpes simplex virus vectors that deliver neurotrophic factors, factors that facilitate the recovering of injured nerves, into the corpus cavernosum or cavernous nerve of rats at the time of cryo-injury to the cavernous nerve. The cavernous nerve is the one that stimulates erection, and cryo-injury has similar effects on the nerve as radical prostatectomy. After injection, the researchers found that the viral vectors transported the neurotrophic factors to the nerve. On electrical nerve stimulation, nerve-injured rats that expressed the viral vector experienced an increase in intracavernous pressure.