• Advancis Pharmaceutical Corp., of Germantown, Md., said data on the protein-release response of Streptococcus pneumoniae cultures grown under laboratory conditions might provide insight as to why repeated pulses of antibiotic cause the bacteria to react in a way that make them more sensitive and die faster. The company is developing a portfolio of anti-infective drugs based on its discovery that bacteria exposed to antibiotics in front-loaded staccato bursts are killed more efficiently than those addressed with standard treatments. As a result, Advancis developed Pulsys, its once-a-day pulsatile delivery technology.

• Agilent Technologies Inc., of Palo Alto, Calif., launched a microfluidics-based technology for liquid chromatography/mass spectrometry (LC/MS) at the American Society of Mass Spectrometry conference in Nashville, Tenn. The technology includes a re-usable polymer high-performance LC chip that eliminates the need for traditional LC columns to separate and identify biological compounds.

• Altana AG, of Bad Homburg, Germany, said Phase III data show that once-daily treatment with Alvesco (ciclesonide) in mild to moderate asthma patients has no effect on normal adrenal function, as demonstrated by measurements of the hypothalamic-pituitary-adrenal axis. Alvesco, an inhaled corticosteroid, works by reducing inflammation in the lungs and airways. The two Phase III trials included patients 12 years and older receiving three different doses of ciclesonide, or placebo, once daily for 12 weeks.

• Alteon Inc., of Parsippany, N.J., said an abstract detailing the effects of its A.G.E. Crosslink Breaker alagebrium (formerly ALT-711) in treating aged, spontaneously hypertensive rats was reported at the American Society of Hypertension meeting in New York. In addition, the abstract and a separate paper recently were published in the American Journal of Hypertension. Study results showed that alagebrium therapy demonstrated beneficial cardiovascular and renal effects by reducing systolic blood pressure, left ventricular mass and urinary protein excretion, as well as improving left ventricular function and aortic distensibility.

• Attenuon LLC, of San Diego, said the first patient has been enrolled and treated in a Phase I trial of ATN-224. Cancer Research UK is conducting the trial under a collaboration with Attenuon. ATN-224, a second-generation version of tetrathiomolybdate, a compound licensed from the University of Michigan at Ann Arbor, has been shown to inhibit tumor angiogenesis and growth in preclinical models.

• Bruker Daltonics, an operating company of Bruker BioSciences Corp., of Billerica, Mass., launched new products at the American Society of Mass Spectrometry conference in Nashville, Tenn. Among them were additions to its ClinProt platform solution for clinical proteomics and peptide/protein biomarker discovery, the Proteineer-LC, the Top-Down Proteineer, its PharmaTools suite of products and the ultrOTOF-Q mass spectrometer.

• Cepheid Inc., of Sunnyvale, Calif., was awarded a National Cancer Institute grant to validate the use of the GeneXpert platform for the isolation and detection of tumor markers in tissue sections. Cepheid received $922,381 in funding for the first year of the grant. The total two-year grant is for $1.88 million. Cepheid will develop molecular-based diagnostic test protocols and procedures using GeneXpert to detect the presence of RNA from cancer cells in tissue cross-sections from lymph nodes.

• Ciphergen Biosystems Inc., of Fremont, Calif., said researchers reported findings at the American Society of Mass Spectrometry conference in Nashville, Tenn., that detailed their biomarker discovery and identification progress across a variety of diseases through the use of the company's Seldi ProteinChip technology. Data describe Ciphergen's Seldi-based discovery and identification of interacting proteins of Grb2 growth factor receptor using the company's Interaction Discovery Mapping platform, proteomic profiling methodologies using Seldi combined with pattern-recognition analysis for multi-biomarker discovery in serum and tissues, and improvements in protein identification and quantitation.

• Efeckta Technologies Corp., of Steamboat Springs, Colo., launched its ProTS-Data product at the American Society of Mass Spectrometry conference in Nashville, Tenn. ProTS-Data is an automated software program used for analyzing raw data associated with mass spectrometry-based proteomics research.

• Encysive Pharmaceuticals Inc., of Houston, said Phase IIb/III data of Thelin (sitaxsentan) in pulmonary arterial hypertension support the company's belief that earlier-stage patients can benefit from the therapy. Data showed that 53 percent of patients on 100 mg and 44 percent of those on 300 mg improved at least one New York Heart Association (NYHA) functional class when treated for a maximum of 58 weeks. Most of the improvement was seen in the first 12 weeks of therapy, but the 100-mg dose had a more favorable safety and efficacy profile than the 300-mg dose. Thelin, a small molecule that blocks the action of endothelin, also improved NYHA functional class and six-minute walk distance after one year of drug therapy.

• Genetronics Biomedical Corp., of San Diego, signed an extended collaboration and licensing agreement with Merck & Co. Inc., of Whitehouse Station, N.J., to develop and commercialize the MedPulser DNA delivery system, which will be developed for use with Merck's DNA vaccine programs. Merck receives the right to use Genetronics' technology for two specific antigens and has an option to extend the agreement to include a limited number of additional target antigens. Genetronics will receive an up-front payment, as well as milestone payments and royalties. Merck also obtains a nonexclusive license to Genetronics' intellectual property. The companies will co-develop certain components of the electroporation system designed for administering DNA vaccines. Merck will be responsible for all development costs and clinical programs.

• GenOway SA, of Lyon, France, entered an agreement to generate conditional knockout and knock-in rat models with Altana AG, of Bad Homburg, Germany. Terms were not disclosed. GenOway, which creates the genetically modified rats using its nuclear transfer technology, also received €1 million in French government funding for its Eureka-labeled program for developing rats.

• Inotek Pharmaceuticals Corp., of Beverly, Mass., said it received notification from the FDA that INO-1001 was designated a fast-track product for complications associated with thoracoabdominal aortic aneurysm (TAAA) repair surgery. Phase II trials are expected to start at the beginning of next quarter. INO-1001 inhibits the nuclear cell death enzyme Poly (ADP-ribose) Polymerase (PARP) and is being evaluated for a variety of critical-care diseases associated with reperfusion injury and inflammation, including ischemic stroke, acute respiratory distress syndrome, TAAA repair surgery and the prevention of complications associated with cardiopulmonary bypass surgery, among others.

• Isolagen Inc., of Houston, said the FDA approved the company's request for a special protocol assessment relating to the design of two pivotal Phase III trials for Isolagen's process in treating nasolabial folds and glabellar lines. Isolagen specializes in developing and commercializing autologous cellular therapies for soft- and hard-tissue regeneration.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., acquired exclusive worldwide rights to the Peptide YY patent, patent applications and related information from the Cedars-Sinai Medical Center in Los Angeles. Nastech will use the rights to support ongoing commercialization efforts for its PYY 3-36 nasal spray for obesity. Peptide YY is a naturally produced hormone associated with the modulation of appetite circuits in the brain. Cedars-Sinai will receive license fees, milestone payments and a future sales royalty interest.

• Neose Technologies Inc., of Horsham, Pa., closed its previously reported registered direct offering of 4.7 million common shares at $6.77 apiece for aggregate gross proceeds of about $32 million. Investors included existing shareholders, new shareholders and several company executives. JP Morgan Securities Inc. and UBS Securities LLC acted as lead placement agent and co-placement agent, respectively. (See BioWorld Today, May 19, 2004.)

• Octapharma AG, of Lachen, Switzerland, received FDA approval to market Octagam, a liquid, ready-to-use, solvent/detergent-treated immunoglobulin intravenous product that has been on the market in Europe for more than 10 years. Octagam is indicated to treat primary immunodeficiency diseases. Octapharma USA Inc. will distribute it in the U.S. The approval was based partly on a U.S. study of 46 patients, with the observed rate of serious infections as the primary efficacy endpoint.

• Pharmacyclics Inc., of Sunnyvale, Calif., said preclinical data described the use of compounds, based on the company's texaphyrin technology, for imaging vulnerable atherosclerotic plaque, which is believed to be a major cause of heart attacks. The studies are aimed at developing compounds to target and visualize vulnerable plaque using noninvasive magnetic resonance imaging procedures. Texaphyrins are synthetic small molecules that resemble naturally occurring porphyrins.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., said it spent the first quarter hiring and training a 40-person sales force to market Plenaxis (abarelix for injectable suspension), which was approved by the FDA in November to treat a defined subset of advanced symptomatic prostate cancer patients. Praecis has identified about 3,500 target prescribers. Praecis is beginning a 2,000-patient Phase IV clinical study evaluating the commercial use of Plenaxis. It also received FDA clearance to initiate a Phase I/II study evaluating the use of Plenaxis in androgen-independent prostate cancer patients whose disease has progressed.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., said its attorneys have issued a demand letter to the Berlin Stock Exchange requesting immediate removal of the company's stock from the exchange. The company said it is one of more than 200 U.S. companies recently listed without authorization.

• Rigel Pharmaceuticals Inc., of South San Francisco, began a multidose Phase I/II trial of R803 to treat hepatitis C virus. The goals are to assess multiple-dose administrations of R803, a non-nucleoside HCV polymerase inhibitor. It also will explore dosing regimens. Results are expected by the fourth quarter. Patients will be divided into eight groups and dosed for two to four days.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said Christopher Clement would become CEO after this year's annual stockholder meeting, at which time current Chairman and CEO Sim Fass will retire. Fass will be nominated for election as a director at the meeting, as will Clement, the company's current president and chief operating officer. Savient markets two products in the U.S., Oxandrin (oxandrolone) and Delatestryl (testosterone enanthate).

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., reported plans to begin in the fourth quarter a European Phase III trial of Zadaxin (thymosin alpha-1) for hepatitis C. SciClone's marketing and development partner, Sigma-Tau Group, of Rome, will conduct the multicenter, double-blinded study in about 550 patients with chronic hepatitis C who are nonresponders to prior pegylated interferon-alpha and ribavirin therapy. The trial will compare the triple combination therapy of Zadaxin, peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) to placebo, Pegasys and Copegus.

• Sinovac Biotech Ltd., of Beijing, began Phase I trials of its vaccine for severe acute respiratory syndrome at a hospital in that city. The company said it would release more details in the future.

• Titan Pharmaceuticals Inc., of South San Francisco, began two Phase II studies of Pivanex to treat refractory chronic lymphocytic leukemia and refractory malignant melanoma. The studies will assess the safety and efficacy of Pivanex administered as a single agent. The studies will enroll 30 and 28 patients, respectively. Titan also said it completed enrollment in a 225-patient Phase IIb study of Pivanex in combination with docetaxel for the second-line treatment of non-small-cell lung cancer. The study should be completed by the end of the year. Pivanex is an agent that inhibits histone deacetylases, a class of enzymes important for cell growth.

• Tripos Inc., of St. Louis, released Lithium 2.0, a desktop development and delivery system that provides a collaborative decision support environment, including visualization of 3-dimensional chemical information. The company said the product streamlines communication between researchers and computational chemists. Tripos' stock (NASDAQ:TRPS) gained $1.13 Monday, or 22.7 percent, to close at $6.10.

• United Therapeutics Corp., of Silver Spring, Md., said new data concerning the benefits of Remodulin therapy to patients with pulmonary arterial hypertension (PAH) showed significant clinical improvements in de novo patients and maintenance of clinical effect in patients who have transitioned from Flolan. Data on the effect of the combination of subcutaneous Remodulin and oral sildenafil showed the combination was well tolerated and improved exercise treadmill time. Remodulin also was found to be safe and effective as a long-term therapy. It is approved in the U.S. for PAH patients.

• ViroPharma Inc., of Exton, Pa., said it concluded the conversion consideration determination period for its exchange offer of new 6 percent convertible senior plus cash notes due June 1, 2009. The base share amount and the auto-conversion price is to be fixed as of the second trading day immediately preceding the May 25 expiration date of the exchange offer, unless extended by ViroPharma. The company commenced an offer in April to exchange up to $99.1 million aggregate principal amount of its new 6 percent notes for up to all of the $127.9 million in outstanding 6 percent convertible subordinated notes. U.S. Bancorp Piper Jaffray Inc. is serving as the dealer manager for the exchange offer, and U.S. Bank National Association is serving as the exchange agent.

• Weill Cornell Medical College in New York said its researchers published data in the May 9, 2004, advance online edition of Nature Cell Biology showing that they have enabled fruit flies to live 51 percent longer by switching off one copy of a gene called stunted. They also found that the gene works by encoding a molecule that connects to the G protein-coupled receptor.