• Abgenix Inc., of Fremont, Calif., named William Ringo CEO and president effective Aug. 30, following Ray Withy's decision to step down. Ringo also will serve on the board, alongside Withy, who remains on the company's board. Most recently, Ringo served as a director at a number of biotechnology companies and currently is the nonexecutive chairman of InterMune Inc., of Brisbane, Calif. Abgenix is developing fully human antibody product candidates.

• Access Pharmaceuticals Inc., of Dallas, said there has been no evidence of neurotoxicity in its Phase I study of AP5346 - an observation the company said is supported by preclinical data - as the polymer platinate product does not contain oxalic acid. The company said it would file an investigational new drug application this quarter to begin a study evaluating AP5346 in combination with 5-FU/leucovorin to determine a clinical dosing regimen. When the trial is complete, Access plans to begin a Phase II study evaluating AP5346 in combination with 5-FU/leucovorin in colorectal cancer.

• Aeolus Pharmaceuticals Inc., of Research Triangle Park, N.C., formerly Incara Pharmaceuticals Corp., said at the initial meeting of its new board, directors endorsed management's proposal to pursue clinical trials of its class of catalytic antioxidant compounds in amyotrophic lateral sclerosis and cancer radiation therapy. The latter would be a second clinical program, along with the company's current proposed trial for Lou Gehrig's disease. Aeolus' stock (OTC BB:AOLS) gained 26 cents on Wednesday, or 23 percent, to close at $1.38.

• Atrix Laboratories Inc., of Fort Collins, Colo., agreed to grant a worldwide license to develop and market its BEMA technology to Arius Pharmaceuticals Inc., of Research Triangle Park, N.C. The delivery system is a biodegradable polymer disc developed for either systemic or local drug delivery. All related research and development, including three existing investigational new drug applications and certain manufacturing equipment, will be transferred to Arius' facilities over the next several months. In exchange, Atrix will receive an up-front licensing fee and could receive additional milestone-based cash payments, reimbursement for research and development support and royalties. Atrix also retains co-promotion rights to the BEMA fentanyl product. A development committee comprised of representatives from each company will oversee product development.

• Bavarian Nordic A/S, of Copenhagen, Denmark, said it received fast-track designation from the FDA for its investigational new drug application for its smallpox vaccine candidate Imvamune. Ongoing studies of the third-generation product are designed to evaluate its immune response in comparison to Dryvax, as well as to test the vaccine in special populations for which Dryvax is contra-indicated.

• Cangene Corp., of Toronto, said the new U.S. distributor for its lead product, WinRho SDF, would be Baxter Healthcare Corp., of Deerfield, Ill., following expiration of the current distribution agreement in March. The product, which is used for an autoimmune-generated blood clotting deficiency called immune thrombocytopenic purpura, presently is distributed by Nabi Biopharmaceuticals, of Boca Raton, Fla. Cangene said the change would enhance worldwide marketing efforts as Baxter Healthcare SA is its European distribution partner.

• Cylene Pharmaceuticals Inc., of San Diego, and collaborators at the University of Arizona said findings published in the Journal of the American Chemical Society provide evidence that a quadruplex that regulates expression of the c-myc oncogene can adopt different parallel-loop isomers. A quadruplex-forming DNA sequence in the regulatory region of the oncogene was used to elucidate the structures of both the naturally occurring G-quadruplex and its complex with a ligand. The G-quadruplex DNA motif was shown to occur as a dynamic mixture of four parallel-loop isomers. Upon incubation with the ligand, G-quadruplex parallel-loop isomers adjust their structure to a mixture of parallel/anti-parallel G-quadruplex configuration.

• Dyadic International Inc., of Jupiter, Fla., said it plans to relocate its corporate headquarters and research and development laboratory to a part of Jupiter called Abacoa. The company, which manufactures proteins and other biological products, said it decided to remain in the area after the Florida government struck a deal to attract the Scripps Research Institute in La Jolla, Calif.

• Evotec OAI AG, of Hamburg, Germany, said it was selected by Morphochem AG, of Munich, Germany, as a preferred partner for the chemical and pharmaceutical development of one of its dual-action antibiotics. Evotec will support Morphochem with development through preclinical development and into Phase I trials using its integrated chemical and pharmaceutical development platform, EVOdevelop.

The Georgia Institute of Technology in Atlanta launched a research and education initiative called the Center for Drug Design, Development and Delivery (CD4). Its goals are to better integrate the process involved in creating new pharmaceuticals and to help industry bring new products to market. The effort involves more than 20 faculty members from six academic areas at Georgia Tech.

• Hoffmann-La Roche Inc., of Nutley, N.J., submitted a supplemental biologics license application to the FDA and European regulatory authorities to market Pegasys (peginterferon alfa-2a) for chronic hepatitis B. The pegylated alpha-interferon already is indicated for use in combination with Copegus for adults with chronic hepatitis C.

• ILEX Oncology Inc., of San Antonio, said the FDA would grant six months of extended market exclusivity to clofarabine under the Best Pharmaceuticals for Children Act. The drug, which is being developed outside North America by Bioenvision Inc., of New York, remains under priority review by the FDA for the treatment of refractory or relapsed acute leukemia in children. Clofarabine previously was granted orphan drug designation for adult and pediatric acute lymphoblastic leukemia and acute myeloid leukemia.

• InSite Vision Inc., of Alameda, Calif., began a pair of pivotal Phase III studies of its lead drug candidate, AzaSite, for acute bacterial conjunctivitis. Formerly called ISV-401, the compound pairs the broad-spectrum antibiotic azithromycin, not currently used in ophthalmology, with DuraSite, the company's drug delivery vehicle. InSite received FDA approval for its Phase III protocol last year. (See BioWorld Today, Jan. 17, 2003.)

• Insmed Inc., of Richmond, Va., said six-month data from its ongoing pivotal Phase III trial of SomatoKine (rhIGF-I/rhIGFBP-3) in children with severe short stature due to growth hormone-insensitivity syndrome showed a statistically significant increase (p<0.0001) in height velocity in children receiving SomatoKine as a once-daily injection. The company said the profile of once-daily injections of SomatoKine was similar to that observed by Pharmacia (now part of Pfizer Inc., of New York) in its pivotal study of twice-daily rhIGF-I injections given to a similar population. SomatoKine has been well tolerated and safely increased and sustained circulating IGF-I (insulin-like growth factor-I) levels. Insmed said it would report final results next year at a scientific forum.

• Introgen Therapeutics Inc., of Austin, Texas, said it contacted the Berlin-Bremen Stock Exchange and requested an immediate halt to trading of its common stock. Introgen learned its stock has been listed on the exchange without its prior knowledge, consent or authorization. In recent months, a number of other publicly traded U.S. companies have been listed on the exchange without their permission, which they speculate is the result of an effort to avoid SEC restrictions against naked short selling. Introgen's stock (NASDAQ:INGN) gained 98 cents on Wednesday, or 32.3 percent, to close at $4.01.

• Invitrogen Corp., of Carlsbad, Calif., said it earned $19.7 million in second-quarter net income for the period ended June 30, ahead of $16.9 million earned in the same quarter last year. The product and service company also reaffirmed its earnings guidance for the year, but on slightly lower revenue projections. For the second half of the year, it expects quarterly revenues to range from $255 million to $260 million. Previous revenue forecasts called for a range of $258 million to $265 million from the second through fourth quarter. Investors did not take the news well. Invitrogen's stock (NASDAQ:IVGN) dropped $14.99 on Wednesday, or 22.7 percent, to close at $51.16.

• Isolagen Inc., of Houston, began pivotal Phase III trials of its autologous cellular therapies for facial wrinkles. The two identical, randomized, double-blind, placebo-controlled studies each will enroll 100 patients. Conducted at various U.S. sites, the simultaneous trials will measure efficacy by a two-point improvement on a six-point scale, as evaluated by an independent assessor after four months.

• Kosan Biosciences Inc., of Hayward, Calif., began the first Phase I trial of 17-dimethylaminoethylamino-17-demethoxy-geldanamycin (DMAG) in cancer patients with advanced solid tumors. The company said the second-generation Hsp90 inhibitor is water soluble and has good oral bioavailability. Its first-generation Hsp90 inhibitor includes an original drug substance, 17-AAG, in a DMSO and egg lecithin vehicle, and a new formulation, KOS-953, both of which are being evaluated in the clinic. The DMAG trial is sponsored by the National Cancer Institute in Bethesda, Md., under a Cooperative Research and Development Agreement between Kosan and the NCI's Cancer Therapy Evaluation Program.

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., and collaborators at McMaster University and Syracuse University said findings published in the Journal of the American Chemical Society demonstrate the expansion of the company's Single Amino Acid Chelate (SAAC) technology for use with fluorescent microscopy. The new fluorescence-based technology called SAACQ enables the visualization of radiopharmaceuticals interacting with cellular structures, the company said.

• NeurAxon Inc., of Mississauga, Ontario, raised C$2.5 million (US$1.9 million) in its first round of venture capital funding. Established in 2004 as a spinout of a medicinal chemistry company called MCR Research Inc., of Toronto, NeurAxon plans to develop and commercialize small molecules that interact with established molecular targets for pain management. Ventures West led the seed financing round, with participation from H.I.G. Ventures, NeuroVentures Fund and Genesys Capital Partners, the manager of the Triax-Covington New Generation Biotech Funds.

• Neuro3d SA, of Mulhouse, France, extended its research collaboration with Johnson & Johnson Pharmaceutical Research & Development in Beerse, Belgium, a unit of Johnson & Johnson, of New Brunswick, N.J., after the latter identified a compound for further characterization from Neuro3d's libraries. Neuro3d said that the compound is outside its main area of focus, which is in the psychiatric arena.

• Neurochem Inc., of Montreal, said the Alzheimer's Association of the United States highlighted Alzhemed as a promising treatment for Alzheimer's disease during the International Conference on Alzheimer's Disease and Related Disorders in Philadelphia. The product is in a Phase III trial at 70 North American centers that will enroll about 950 patients who will receive the medication over 18 months. The company expects to launch a Phase III European trial early next year.

• Neuropharma SAU, of Madrid, Spain, said preclinical data reported at the International Conference on Alzheimer's Disease and Related Disorders in Philadelphia showed that prolonged oral treatment of Tet/GSK3Beta mice with two GSK3Beta inhibitors induced a dose-dependent significant decrease on tau phosphorylation in hippocampus, where the transgene is most highly expressed, while not showing any apparent clinical signs. The company said the data prove the products' potential as a new therapeutic agent for Alzheimer's disease and other central nervous system disorders. Neuropharma is wholly owned by Zeltia SA, also of Madrid.

• Signet Laboratories Inc., of Dedham, Mass., said it would develop and commercialize predictive diagnostics and preventive therapeutics to combat sepsis and acute renal failure. The company said it would draw on its current portfolio of diagnostic markers and intellectual property in those areas, as well as existing partnerships in clinical and regulatory development, to create the products.

• SomaLogic Inc., of Boulder, Colo., said it expanded its intellectual property base by acquiring an exclusive license to several foreign and domestic patents that enable the development of aptamers with enhanced chemical diversity. The company, which integrated the DNA-modification chemistries into its Selex process, said they are expected to improve aptamer performance for virtually any protein target.

• Target Discovery Inc., of Palo Alto, Calif., released its UltraTrol suite of pre-coat reagents for capillary and microchannel electrophoresis. The company said the products allow for the direct integration of capillary electrophoresis with mass spectrometry, high-performance liquid chromatography and other downstream analytical methods.

• Vical Inc., of San Diego, began a Phase I trial of its DNA vaccine for anthrax. The study will test the prophylactic, cationic lipid-formulated, bivalent plasmid product in up to 52 healthy adult volunteers for safety and immune responses. The primary endpoint is safety, and secondary endpoints include the immunogenicity of the vaccine at various doses and regimens. Its successful completion could lead to larger trials to support marketing approval under the FDA's animal rule. The trial is being supported by the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md.

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