• Active Biotech, of Lund, Sweden, initiated a Phase I dose-escalation study of TASQ for prostate cancer. The four-week tolerance study could be extended up to one year to assess long-term tolerability and safety. The study includes patients who did not respond well to hormonal therapy. Patient recruitment will continue into 2005 at urology clinics in Sweden.

• Advancis Pharmaceutical Corp., of Germantown, Md., said researchers published findings regarding its pulsatile dosing of antimicrobials in this month's issue of the Journal of Antimicrobial Chemotherapy. Results indicate that pulsatile dosing, as proposed by Advancis, might represent a "unique and more potent strategy" for dosing beta-lactam antimicrobials.

• The Allen Institute for Brain Science in Seattle released data from its Allen Brain Atlas, a neurogenomic atlas of the mouse brain that will be used to advance research into human brain function, behavior and diseases. The gene-expression data includes information for nearly 2,000 genes - about 10 percent of the mouse genome - together with tools to analyze the data at www.brainatlas.org or www.brain-map.org.

• American Pharmaceutical Partners Inc., of Schaumberg, Ill., reported positive Phase II results at the San Antonio Breast Cancer Symposium indicating that weekly administration of Abraxane (nanoparticle albumin-bound paclitaxel) resulted in long-term disease control in patients with metastatic breast cancer whose disease had progressed while being treated with taxanes. Other findings showed that despite a high 125-mg/m2 weekly dose in highly pre-treated, prior taxane-exposed patients, only three of 75 in the study had to discontinue Abraxane due to peripheral neuropathy. The trial was sponsored by American Bioscience Inc., of which American Pharmaceutical Partners is a majority-owned subsidiary.

• Amgen Inc., of Thousand Oaks, Calif., said that data from a head-to-head study showed that 200 mcg of Aranesp (darbopoetin alfa) dosed once every two weeks has similar efficacy to 40,000 U of epoetin alfa dosed once every week in boosting hemoglobin and reducing the need for blood transfusions in breast cancer patients with chemotherapy-induced anemia. Separately, Amgen said that new data from a Phase III study showed that the majority of neutropenic complications occur in the first cycle of chemotherapy treatment for breast cancer patients who are not administered Neulasta. The results were presented at the 27th annual San Antonio Breast Cancer Symposium.

• Anadys Pharmaceuticals Inc., of San Diego, and LG Life Sciences Ltd., of Seoul, South Korea, reported positive interim data from a Phase II trial of ANA380 in patients infected with lamivudine-resistant hepatitis B virus at the Asian Pacific Association for the Study of the Liver in New Delhi, India. After 12 weeks of treatment, patients receiving 30-mg and 60-mg doses of ANA380 showed an average DNA viral load reduction of 2.8 and 3.2 log10 units, respectively. Interim data from the 90-mg cohort showed an average viral load reduction of 2.7 log10 units after four weeks. The data also showed that administration of ANA380 was well tolerated and safe. ANA380 is an oral prodrug of ANA317, a nucleotide analogue that has exhibited activity against HBV, the company said.

• Aradigm Corp., of Hayward, Calif., entered an agreement with Defence R&D Canada (DRDC) for the aerosolized delivery of liposomal-encapsulated ciprofloxacin to develop a treatment and prophylaxis for serious respiratory infections, including inhalation anthrax. The drug will be delivered by Aradigm's AERx technology platform. DRDC is funding Aradigm's product and formulation development work and initial preclinical studies. Work is scheduled to begin in January. Aradigm will hold the intellectual property associated with the inhalation of liposomal ciprofloxacin, and it is receiving exclusive worldwide manufacturing rights from Inex Pharmaceuticals Corp., of Vancouver, British Columbia.

• Cambria BioSciences LLC, of Woburn, Mass., said it achieved several milestones in its multiyear collaboration with Dow AgroSciences LLC, of Indianapolis, to develop insecticides for crop protection and urban pests. The company said it validated target sites and functional assays for a number of lead insecticidal compounds furnished to Cambria by Dow, triggering undisclosed payments to Cambria. The findings also open the door to additional revenue on chemistries that are developed and commercialized by Dow.

• CepTor Corp., of Hunt Valley, Md., consummated a reverse merger into a publicly held company. Under terms of the transaction, the company has become a wholly owned subsidiary of Medallion Crest Management Inc., which has adopted the CepTor name. CepTor stockholders acquired a controlling interest in the public company, and the company's officers and directors will continue in their positions. The transaction represents completion of CepTor's spinout from New Brunswick, N.J.-based Xechem International Inc., which will continue to hold a minority stake. CepTor's lead product, Myodur, is in Phase I/II trials for Duchenne's muscular dystrophy.

• Connetics Corp., of Palo Alto, Calif., reported the U.S. commercial launch of Evoclin (clindamycin 1 percent) delivered in Connetics' VersaFoam vehicle for the treatment of acne vulgaris. Evoclin is the first product approval in the acne market for Connetics and is available in 50-g and 100-g trade unit sizes as well as 10-g professional samples.

• Dendreon Corp., of Seattle, reported results from two Phase I studies demonstrating promising clinical activity of the company's investigational immunotherapy, APC8024, in HER2/neu-positive advanced breast cancer. A statistically significant (p<0.0001) T-cell immune response was observed in patients with HER2/neu-positive breast cancer treated with APC8024 from a combined analysis of 30 evaluable patients. The results were presented at the 27th annual San Antonio Breast Cancer Symposium.

• Discovery Laboratories Inc., of Warrington, Pa., reported additional clinical data from its primary Phase III study, called SELECT, at this week's Hot Topics in Neonatology meeting in Washington. New analyses based on the pooling of data from SELECT and STAR, another Phase III trial, support a survival advantage for premature babies treated with Surfaxin as compared with the animal-derived comparator surfactant therapies (Survanta and Curosurf) used in the studies. The product is under FDA review, as the company filed a new drug application in the spring. (See BioWorld Today, April 15, 2004.)

• DNA 2.0 Inc., of Menlo Park, Calif., and Tokyo-based MediBIC formed a collaboration in Japan focused on protein engineering and gene synthesis. The relationship will integrate the capabilities of each company in the areas of bioinformatics, data analysis, machine learning algorithms and gene synthesis to support the work of genomic drug discovery and research science. Under terms of the agreement, MediBIC will collaborate with DNA 2.0 in new product research and development, and it will be the sole Japanese distributor for DNA 2.0's existing repository of synthesized genes.

• ExonHit Therapeutics, of Paris, reached its first research milestone in its collaboration with Allergan Inc., of Irvine, Calif., as ExonHit's chemists synthesized a new, orally active small molecule to modulate a pathway identified by its alternative splicing profiling technology, Datas. The compound was shown to have a good profile in Allergan's in vivo preclinical models of neuropathic pain. The companies' collaboration was established last year to identify, develop and commercialize drugs targeted at the treatment of neurodegenerative diseases, pain and ophthalmology.

• Genmab A/S, of Copenhagen, Denmark, said the FDA accepted its investigational new drug application to start a Phase I/II dose-escalation trial in the early part of 2005 for HuMax-CD20 to treat active rheumatoid arthritis in patients who have failed one treatment with one or more anti-rheumatic drugs. A total of 60 patients will be randomized into three cohorts. In each cohort, 16 of 20 patients will receive two infusions of HuMax-CD20 and four patients will receive placebo. All patients in the study will receive methotrexate. They will be followed for 24 weeks to evaluate safety and efficacy and then every 12 weeks until B-cell counts return to baseline levels.

• GlycoGenesys Inc., of Boston, said its board approved a 1-for-6 reverse split of its common stock. Shares held as of the close of business on Dec. 20 will be split and begin trading on a post-split basis the following day. In addition to reducing the number of shares outstanding, the number of authorized shares available for future issuance also will be reduced by a 1-for-6 ratio. All warrants, options and preferred stock outstanding at the time of the split also are subject to the reverse split formula, including customary upward repricing. The company is focused on carbohydrate-based drug discovery.

• InfaCare Pharmaceutical Corp., of Neptune, N.J., named John Post president and CEO. Most recently, he has served as chief operating officer of the specialty pharmaceutical company focused on developing therapies for neonates and older children.

• Inpharmatica Ltd., of London, formed a discovery collaboration with Novartis Institutes for BioMedical Research, a unit of Basel, Switzerland-based Novartis AG. For an undisclosed sum, Novartis Discovery Technologies will use Inpharmatica's Chematica technology to identify molecular targets for Novartis' bioactive compound project. Chematica is capable of target selection through druggability assessment and identification of hits and leads against those targets.

• KetoCytonyx Inc., of London, completed a Phase I study of KTX 0101, its lead therapeutic targeting prevention of cognitive impairment in patients undergoing coronary artery bypass graft (CABG) surgery. The product was found to be well tolerated by all 20 volunteers, with no serious adverse events reported, and drug pharmacokinetics were as predicted in the dose-escalation study. Also, statistically significant changes compared to placebo were seen in electroencephalogram recordings, indicating that KTX 0101 had a pharmacodynamic effect on the central nervous system. The effect is similar to that seen in patients when hypothermia was used to provide neuroprotection for patients undergoing CABG surgery and following head injury.

• Metabolic Pharmaceuticals Ltd., of Melbourne, Australia, reported positive Phase IIb results showing that daily dosing of AOD9604 restores suppressed fat metabolism in obese people by mimicking the fat metabolic effects of growth hormone. The study's primary efficacy endpoints were to determine the product's effect on body-weight reduction and/or fat reduction. Patients receiving the 1-mg dose lost the most weight, averaging a weight loss over the 12 weeks of 6.2 pounds, more than triple the weight lost by placebo patients who lost an average of 1.8 pounds. The rate of weight loss was maintained throughout the treatment period. AOD9604 also demonstrated, compared to placebo, an improvement in cholesterol profiles, and a reduction in the number of patients with impaired glucose tolerance.

Nature magazine published the first detailed analysis of the chicken genome, which was compiled by 170 researchers from 49 institutions worldwide, in its Dec. 9, 2004, issue. Scientists hope to gain new insights in fields including agriculture, developmental biology and immunology, and the prevalence and possible functions of so-called junk DNA from the genome. The chicken is the first bird, the first agricultural animal and the first descendant of dinosaurs to have its genome sequenced. A draft sequence was published in March.

• Neurobiological Technologies Inc., of Richmond, Calif., said Canadian regulatory authorities approved Ebixa (memantine, H. Lundbeck A/S) for moderate to severe Alzheimer's disease. The product is sold in more than 30 countries around the world, mostly in Europe. In the U.S., memantine is sold by Forest Laboratories Inc., of New York. Under an exclusive marketing agreement, Neurobiological Technologies receives royalty payments on the drug's sales for Alzheimer's disease.

• Provalis plc, of Deeside, UK, signed an option agreement with Aventis Pasteur, the vaccines business of the Sanofi-Aventis Group, of Paris, for the development of vaccine candidates to prevent Streptococcus pneumoniae infection. Aventis was granted a 24-month exclusive option to evaluate Provalis' protein-based antigen vaccine candidates to prevent S. pneumoniae infection. Aventis Pasteur will pay an initial option fee to Provalis and will pay all costs, back-dated to May 2004, connected with the patients relating to those vaccine candidates.

• Samaritan Pharmaceuticals Inc., of Las Vegas, established a subsidiary in Ireland to take advantage of global and European BioPartnering grant opportunities. The company intends to apply for manufacturing and drug delivery grants, in collaboration with Pharmaplaz, Ireland, capitalizing on its ability to develop new manufacturing and drug delivery techniques. Samaritan Pharmaceuticals Ltd. in Ireland will be focused on the development of oral-dosage finished pharmaceutical formulations.

• Sinovac Biotech Ltd., of Beijing, said its severe acute respiratory syndrome vaccine has induced SARS-neutralizing antibodies in tests of the human volunteers' blood serum. After a 56-day observation period, 11 out of 12 volunteers who received high-dosage vaccine, and 12 out of 12 who received low-dosage vaccine, showed blood serum conversion. The conversion indicates the ability of the induced antibodies to neutralize the SARS virus.

• TheraSTrat, of Allschwil, Switzerland, entered a worldwide exclusive commercialization agreement to use its SafeBase Knowledge Base with Discovery Partners International Inc., of San Diego, to help enhance DPI's lead identification, selection and optimization programs. SafeBase will provide drug safety-relevant knowledge to find candidates for preclinical and clinical development. By using knowledge obtained from compounds that have caused serious safety problems for individuals carrying single allelic variants or related haplotypes, the companies will try to enhance the safety of lead compounds.

• ViRexx Medical Corp. and AltaRex Medical Corp., both of Edmonton, Alberta, said shareholders of each company voted in favor of an acquisition of AltaRex worth about C$28.4 million (US$23.1 million). The companies completed the arrangement last week with a final order from the Court of Queen's Bench of Alberta. Shares of the combined company will trade on the Toronto Stock Exchange beginning Dec. 15 under the symbol "VIR." AltaRex shareholders will receive one-half of one common share of ViRexx for each AltaRex share owned. Canaccord Capital acted as the exclusive financial adviser to ViRexx, and Orion Securities advised AltaRex. The acquisition first was announced in October. (See BioWorld Today, Oct. 18, 2004.)

• The Wales College of Medicine at Cardiff University said its cancer and cell-aging researchers secured more than £15 million (US$28 million) to study cancer and DNA damage. The funding is expected to aid in their studies of unraveling the complexities of how cells maintain their chromosomes, how the repair of DNA in cells is influenced by chromosome structure and to analyze components in DNA-repair complexes.

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