• Advitech Inc., of Quebec, reported positive results from its trial of XP-828L, an oral product for mild to moderate psoriasis. Advitech said the study confirmed the efficacy of the drug compared with placebo, as measured by the physician's global assessment analysis. The PGA values demonstrate that 21.4 percent of patients treated with XP-828L experienced a reduction in the severity of their condition by at least one level.

• Amgen Inc., of Thousand Oaks, Calif., presented new interim data from a Phase II study of Aranesp to treat anemia in patients with myelodysplastic syndromes at the 17th International Symposium of the Multinational Association of Supportive Care in Cancer held in Geneva. Low-risk MDS patients receiving Aranesp every three weeks exhibited an overall response of 77 percent, increased hemoglobin levels and improvements in patient-reported fatigue. The FDA cleared Aranesp for marketing in 2001 to treat anemia associated with chronic renal failure.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., reported Phase III safety and efficacy results of Bio-E-Gel (bioidentical estradiol transdermal gel) for the treatment of moderate to severe hot flashes in menopausal women. A new drug application will be filed as soon as possible after completion of the data analyses from the 12-week, randomized, double-blind, placebo-controlled study of symptomatic menopausal women, it said.

• Bone Medical Ltd., of Bentley, Western Australia, reported data demonstrating that its drug candidate, BN006, was effective in inhibiting expression of tumor necrosis factor, and caused dose-dependent inhibition of up to 100 percent. The company's next step is to complete studies in an animal model of rheumatoid arthritis and then move into human testing. In other news, Bone Medical completed its Phase I trial of Perthoxal, an oral parathyroid hormone product in development to treat osteoporosis. Results from the trial involving 18 post-menopausal women are expected in October.

• Cell Genesys Inc., of South San Francisco, initiated a second Phase III trial of GVAX vaccine for prostate cancer in patients with metastatic hormone-refractory prostate cancer. The 600-patient trial, called VITAL-2, will compare GVAX plus Taxotere (docetaxel) chemotherapy to Taxotere plus prednisone with respect to survival benefit. Cell Genesys received a special protocol assessment from the FDA in May. VITAL-1 began in July 2004 and is expected to enroll 600 chemotherapy-na ve, asymptomatic patients to determine whether GVAX is superior to Taxotere plus prednisone in survival. The company recently reported data from a Phase II trial of GVAX in lung cancer, which demonstrated median overall survival of 5.4 months for the vaccine-only arm and 9.5 months for the vaccine-plus cyclophosphamide treatment arm, though the difference was not statistically significant. Those results were presented at the 11th World Conference on Lung Cancer meeting in Barcelona, Spain. Cell Genesys previously announced plans to discontinue the development of GVAX for lung cancer. (See BioWorld Today, June 8, 2005.)

• Cell Therapeutics Inc., of Seattle, presented results of its STELLAR Phase III trial of Xyotax (paclitaxel poliglumex) at the International Association for the Study of Lung Cancer meeting in Barcelona, Spain, that showed the drug demonstrated comparable or superior efficacy when compared to controls including docetaxel and paclitaxel/carboplatin. Xyotax also showed superior survival results in certain patient groups, even though it missed its primary endpoint of survival in non-small-cell lung cancer patients. (See BioWorld Today, March 8, 2005.)

• ChemDiv Inc., of San Diego, and Euroscreen SA, of Brussels, Belgium, are partnering to discover and develop drug candidates against a panel of chemokine receptors, a subset of G protein-coupled receptor targets involved in inflammation, immunomodulation and carcinogenesis. ChemDiv will contribute its expertise in synthetic and medicinal chemistry, while Euroscreen will develop respective GPCR assays and ensure the screening and general molecular biology support of the joint venture. Financial terms were not disclosed.

• Corixa Corp., of Seattle, said preliminary results of its first clinical trial of CRX-675, an intranasally administered Toll-like receptor 4 agonist, in subjects allergic to ragweed demonstrated safety, with no serious adverse events reported. Further studies are planned to evaluate the efficacy of CRX-675 in allergic rhinitis. Those are expected to begin in late 2005 or early 2006.

• Depomed Inc., of Menlo Park, Calif., received a $25 million milestone payment from Biovail Corp., of Toronto, based on the FDA's approval of Glumetza, once-daily extended-release metformin, for the treatment of Type II diabetes. Recently regulatory applications for Glumetza were approved in the U.S. and Canada. The $25 million milestone was based on U.S. approval as required under the license agreement between Depomed and Biovail.

• DNAPrint Genomics Inc., of Sarasota, Fla., said its board authorized a 1-for-20 consolidation of the company's stock, effective Tuesday, July 12. Shareholders previously approved a stock combination of at least 1-for-10 and no more than 1-for-20. Following consolidation, DNAPrint Genomics will have about 62 million shares outstanding.

• Emisphere Technologies Inc., of Tarrytown, N.Y., said it received the first milestone payment from Basel, Switzerland-based F. Hoffmann-La Roche Ltd. as part of an agreement to develop oral formulations of a Roche small-molecule compound to treat bone-related diseases. The undisclosed milestone resulted from Roche's initiation of a clinical study using Emisphere's eligen delivery technology. In other news, Emisphere said Winstanley Enterprises LLC completed its purchase of a facility previously used by Emisphere for preclinical, toxicology and analytical laboratory work for $4.2 million, following the adjustment for ongoing environmental remediation. The 110,000-square-foot facility is located on 29 acres in Farmington, Conn.

• EntreMed Inc., of Rockville, Md., said its collaborators presented preclinical results of 2-methoxyestradiol (2ME2, or Panzem) in models of non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) at the 11th World Conference on Lung Cancer held in Barcelona, Spain. Results showed that 2ME2 and 2ME2 analogues effectively inhibited the in vitro growth of 19 distinct NSCLC and SCLC cell lines. Panzem NCD demonstrated a statistically significant, dose-dependent increase in survival in an orthotopic animal model of NSCLC.

• Galapagos NV, of Mechelen, Belgium, entered a research collaboration under which its genomics partnering division, Galadeno, will design a research program for Novartis Pharmaceuticals UK Ltd., a division of Novartis AG, of Basel, Switzerland, using the SilenceSelect platform for functional assays in human primary cell assays. The technology is based on Galadeno's collection of adenoviruses with human gene sequences that specifically knock down more than 4,000 different human proteins by producing siRNA in a human cell. Galadeno will receive payments related to research services and its technology.

• Generex Biotechnology Corp., of Toronto, said results of a 12-day pilot study to compare Oral-lyn, its oral insulin buccal spray formulation, with injectable insulin showed that its product helped Type I diabetes patients maintain comparable blood glucose levels. The results were presented at the Metabolic Disease World Summit in San Francisco.

• GlycoGenesys Inc., of Boston, has regained compliance with the minimum bid price requirement of $1 for the Nasdaq SmallCap Market. GlycoGenesys is focused on carbohydrate-based drug development.

• GPC Biotech AG, of Munich, Germany, said a Phase I study evaluating its lead drug candidate, satraplatin, in combination with Taxotere (docetaxel) in patients with advanced solid tumors has opened for accrual. Satraplatin is in a Phase III registration trial as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer.

• GTC Biotherapeutics Inc., of Framingham, Mass., filed its response to the European Medicines Agency's list of outstanding issues generated during review of its marketing authorization application for ATryn, a recombinant form of human antithrombin. GTC expects the agency to make a determination on the application before the end of October.

• Hemispherx Biopharma Inc., of Philadelphia, said newly published studies from researchers at the Centers for Disease Control and Prevention provide molecular evidence of the central role of exercise intolerance in the morbidity of patients suffering from chronic fatigue syndrome (CFS). The CDC reports that genes measured in peripheral blood of women with CFS show metabolism genes might be associated with bodily functions such as muscle contraction and oxygen consumption, and those are impaired in women with CFS. Hemispherx recently completed a Phase III study of 234 CFS patients using its investigational therapeutic.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, reported the FDA determined that it is safe to proceed with Phase I trials of Neumune in the U.S. Neumune is being developed the for treatment of acute radiation syndrome under the animal efficacy rule.

• Human Genome Sciences Inc., of Rockville, Md., said the results of a Phase II trial demonstrated that HGS-ETR1 (mapatumumab) was well tolerated and can be administered safely in patients with advanced non-small-cell lung cancer. Data on 32 patients were presented in Barcelona, Spain, at the 11th World Conference on Lung Cancer. The primary objective of the study was to evaluate tumor response. The secondary objectives were to evaluate the safety and tolerability of HGS-ETR1, and to determine plasma concentrations of HGS-ETR1 for use in a population pharmacokinetic analysis. No immunogenic responses were observed. Stable disease was observed in 29 percent of the patients treated.

• Ligand Pharmaceuticals Inc., of San Diego, presented results of its two pivotal Phase III studies of Targretin (bexarotene) capsules in front-line combination therapy with standard chemotherapy to treat non-small-cell lung cancer at the 11th World Conference on Lung Cancer in Barcelona, Spain. Intent-to-treat analysis of both studies showed that the addition of Targretin failed to improve overall survival or progression-free survival, as was previously reported at the American Society of Clinical Oncology meeting in Orlando, Fla. Further subset analysis showed that a sizable group of patients developed high-grade hypertriglyceridemia early on during treatment in the Targretin arm. Ligand said biochemical and genetic marker analysis for the administration of Targretin is ongoing.

• Lorus Therapeutics Inc., of Toronto, completed the last patient visit in the global Phase III study of Virulizin in combination with Gemzar to treat pancreatic cancer. The trial began in early 2002 and since has enrolled 436 patients in North America and Europe. Lorus expects to have results by the end of the year. The FDA agreed in May to a rolling new drug application for Virulizin.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., began a Phase I study with its intranasal parathyroid hormone to treat osteoporosis. The study will be conducted using the company's advanced intranasal formulation that uses its tight junction drug delivery technology to enable needle-free delivery of therapeutic levels of drugs, such as peptides and proteins, which otherwise would require an injection. The objective of the study will be to determine the nasal absorption and safety of the PTH1-34 nasal spray vs. the approved subcutaneous product.

• Neurochem Inc., of Laval, Canada, finished recruiting 950 patients with mild to moderate Alzheimer's disease for its North American Phase III trial of Alzhemed, an orally administered molecule designed to modify the course of AD through its anti-amyloid activity. The company expects to begin patient recruitment for its Phase III trial in Europe this fall. (See BioWorld Today, June 22, 2004.)

• Novavax Inc., of Malvern, Pa., completed a financing resulting in gross proceeds of $4 million. Novavax issued 4 million shares of its common stock at a price of $1 per share. The shares were issued under a shelf registration statement. Proceeds will be used for product development and working capital purposes. Novavax has applied its micellar nanoparticle technology to commercialize Estrasorb and complete Phase I trials for Androsorb.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said the FDA accepted for filing the supplemental new drug application for use of Tarceva (erlotinib) plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous treatment. The company said Tarceva is the only endothelial growth factor receptor therapy shown to provide a statistically significant survival benefit in patients treated in first-line locally advanced or metastatic pancreatic cancer in combination with gemcitabine. Tarceva also was granted priority review by the FDA.

• Oxxon Therapeutics Ltd., of Boston, and Bavarian Nordic A/S, of Copenhagen, Denmark, signed a cross-licensing agreement, which provides Oxxon certain rights to Bavarian Nordic's recombinant Modified Vaccinia Ankara (MVA) technology and Bavarian Nordic with access to Oxxon's PrimeBoost technology. Oxxon receives certain rights to develop and commercialize recombinant MVA-575, and further rights to use a nondisclosed, antigen-specific MVA product in a heterologous PrimeBoost regimen in exchange for royalties on commercial sales. Bavarian Nordic obtains the right to use Oxxon's homologous PrimeBoost regimens for MVA. Bavarian Nordic also gains an option to use MVA-BN in heterologous PrimeBoost regimens in exchange for royalties on commercial sales.

• Pharmos Corp., of Iselin, N.J., initiated a clinical program to commercialize its NanoEmulsion drug delivery technology. The company plans to initiate a Phase I/II feasibility clinical trial before year-end. The study will evaluate safety, pharmacokinetics and the analgesic effect of an approved non-steroidal anti-inflammatory drug formulated in its NanoEmulsion in patients with osteoarthritic pain in the knee.

• Power3 Medical Products Inc., of The Woodlands, Texas, reported results from recently completed studies measuring levels of biomarkers from blood serum to diagnose and follow patients with neurological disorders involving muscle control. The studies revealed that 21 of 34 blood serum protein biomarkers are useful in distinguishing patients with Lou Gehrig's and Parkinson's diseases.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., initiated a Phase I trial evaluating the VEGF (vascular endothelial growth factor) Trap in certain eye diseases using intravitreal injections to the eye. The dose-escalating trial is being conducted in patients with the neovascular or the "wet" form of age-related macular degeneration.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., began enrolling and dosing subjects in a Phase III study to evaluate the efficacy and safety of Xifaxan (rifaximin) tablets 200 mg for the prevention of travelers' diarrhea. Xifaxan, a gut selective, nonsystemic, virtually non-absorbed oral antibiotic, is approved for the treatment of travelers' diarrhea caused by noninvasive strains of E. coli in patients 12 years of age and older.

• Seattle Genetics Inc., of Bothell, Wash., presented data from a Phase II trial at the 11th World Conference on Lung Cancer held in Barcelona, Spain, suggesting that the administration of SGN-15 three days prior to Taxotere resulted in greater synergy and drug effect than when the combination was administered simultaneously. The company has decided to discontinue development of SGN-15, a first-generation antibody-drug conjugate (ADC) used to treat non-small-cell lung cancer patients, to focus on advancing other pipeline programs and second-generation ADC technology. The company has two other products, SGN-30 and SGN-40, in clinical development. The company's stock (NASDAQ:SGEN) fell 22 cents Wednesday to close at $5.38.

• Serologicals Corp., of Atlanta, said that Celliance, its wholly owned subsidiary, is launching a new bovine albumin manufactured exclusively from animals originating in Australia. Probumin Plus Albumin has been developed to incorporate the qualities of its premium albumin grades with the benefits of raw material from Australia, a country classified as bovine spongiform encephalopathy-free, Celliance said.

• SRI International, of Menlo Park, Calif., is working with DOR BioPharma Inc., of Miami, and Cambrex Corp., of East Rutherford, N.J., to develop a recombinant vaccine, RiVax, for protection against exposure to the ricin toxin. In September, the National Institute of Allergy and Infectious Diseases awarded DOR a grant that supports process development and large-scale manufacturing being conducted by Cambrex. SRI will optimize the immune response to the vaccine and perform preclinical safety.

• StemCells Inc., of Palo Alto, Calif., entered an agreement with London-based ReNeuron Holdings plc, giving the former exclusive access to the latter's c-mycER adult human stem cell immortalization technology for use in developing therapies for lysosomal storage diseases, spinal cord injury, cerebral palsy and multiple sclerosis. ReNeuron also gains exclusive access to StemCells' adult neural stem cell patent estate for the development of its own c-mycER conditionally immortalized neural stem cell therapies for stroke, Parkinson's disease and Huntington's disease. StemCells has taken an equity interest in ReNeuron, and the agreement provides for reciprocal royalties and milestone payments.

• Targacept Inc., of Winston-Salem, N.C., presented clinical results of ispronicline (TC-1734) at the 8th World Congress of Biological Psychiatry in Vienna, Austria. The data showed that elderly subjects dosed with 80 mg or 50 mg of ispronicline performed better on certain memory and attention measures than elderly subjects dosed with placebo. The company has completed more than half of its target enrollment of 180 elderly subjects for its ongoing Phase II trial of ispronicline in age-associated memory impairment.

• Telik Inc., of Palo Alto, Calif., reported positive interim data from two Phase II studies of Telcyta in combination with standard chemotherapy for first-line treatment of advanced non-small-cell lung cancer at the 11th World Conference on Lung Cancer in Barcelona, Spain. In one trial, objective tumor responses were observed in 15 patients, indicating a 58 percent objective response rate. In the other trial, objective partial responses were observed in eight patients for a 32 percent objective response rate.

• Theratechnologies Inc., of Montreal, said the first patient began treatment in its Phase III trial of TH9507 in HIV-associated lipidystrophy. An additional 29 sites are expected to open and a total of 400 patients will be enrolled. The 26-week trial will evaluate whether daily doses of 2 mg TH9507 can reduce excess visceral adipose tissue for a period of 26 weeks. An additional 26 weeks will look at long-term safety and the effects at discontinuing treatment. (See BioWorld Today, April 1, 2005.)

• Tranzyme Pharma Inc., of Research Triangle Park, N.C., presented data for TZP-101, its lead product to treat post-operative ileus and diabetic gastroparesis, at the 20th International Symposium on Neurogastroenterology & Motility in Toulouse, France. TZP-101 is a small-molecule ghrelin receptor agonist that has been shown to selectively stimulate motility of the gastrointestinal tract. In vivo data demonstrate that the gastroprokinetic activity of TZP-101 takes place without the release of growth hormone.

• U.S. BioDefense Inc., of City of Industry, Calif., signed a six-month option to license patent applications relating to stem cells from the University of British Columbia. U.S. BioDefense will evaluate the neural crest stem cell line and its use in human transplantation, which can be used to treat brain and spinal cord repair.

• United Biomedical Inc., of Hauppauge, N.Y., was awarded a $17 million contract from the National Institutes of Health to develop and manufacture a vaccine for AIDS. The contract will cover the full costs to develop the vaccine led by the company's CEO Chang Yi Wang, in collaboration with Carl Hanson of the California Department of Health Services and Krishna Murthy of the Southwest Foundation for Biomedical Research.

• Vasogen Inc., of Toronto, completed its Phase I trial of VP025, which is being developed to regulate chronic inflammation of the central nervous system associated with a number of severe neurological conditions, such as Alzheimer's disease. The double-blind, placebo-controlled trial examined the safety and tolerability of three doses of VP025 in 24 healthy volunteers. Multiple administrations of all doses were shown to be safe and well tolerated compared to placebo.

• Verus Pharmaceuticals Inc., of San Diego, acquired exclusive, worldwide rights to Twinject from Hollister-Stier Laboratories LLC, of Spokane, Wash. In 2003, the FDA approved Twinject, an epinephrine auto-injector indicated for the emergency treatment of severe allergic reactions. In addition to Twinject, Verus has acquired rights to other intellectual property and assets, including complementary and next-generation device designs and ongoing development programs.

• ViroLogic Inc., of South San Francisco, signed a multiyear, $4.8 million service agreement to use its HIV-resistance testing technology to support drug discovery and development programs of the Schering-Plough Research Institute, an arm of Schering-Plough Corp., of Kenilworth, N.J. Schering-Plough plans to use ViroLogic's assays for the clinical development of its CCR5 receptor antagonist, vicriviroc, an HIV entry inhibitor. The Phase III program for vicriviroc is scheduled to begin this year.

• Xcyte Therapies Inc., of Seattle, said it implemented a plan to identify and evaluate its strategic options, including "mergers, acquisitions, sale or purchase of assets, in-licensing opportunities, and out-licensing certain of our assets." The company also said Ron Berenson has transitioned from serving as president and CEO to directing its Xcellerate research and development. Robert Kirkman was appointed acting president and CEO.

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