• Alba Therapeutics Corp., of Baltimore, began dosing of AT-1001, an orally administered zonulin receptor antagonist in development to treat celiac disease. The study will evaluate the safety, tolerability and pharmacokinetics of the drug in 24 normal volunteers.

• Berlex Inc., of Montville, N.J., a U.S. affiliate of Berlin-based Schering AG, said updated data from the Betaseron 16-year follow-up study have identified 331 of the 372 original patients, and found that 51 percent of the multiple sclerosis patients treated with 250 mcg of Betaseron have reported being able to walk with or without assistance, compared to 45 percent of those assigned to the placebo group. Data also showed that 95 percent of the patients in the Betaseron group are still alive, compared to 83 percent in the placebo group. Those results were presented at the American Neurological Association meeting in San Diego.

• Cell Therapeutics Inc., of Seattle, presented results from a recently completed Phase II trial of Xyotax as a first-line treatment of advanced non-small-cell lung cancer, which showed that the 35 women who received Xyotax plus carboplatin had a 36 percent probability of living at least one year, compared to only 16 percent of the 39 men receiving the same regimen. The results were consistent with data from a pooled analysis of Xyotax-treated patients from the Phase II study and the company's two pivotal trials. Data were presented at the UBS Global Life Sciences Conference in New York.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, said the Phase II trial of Quinamed (amonafide dihydrochloride) has been expanded to include patients with breast and ovarian cancer. The trial was expanded beyond prostate cancer as planned based on results from earlier clinical studies, clinical advice and to provide the company with a broader range of target indications to choose from for the Phase III product registration trial.

• Cognetix Inc., of Salt Lake City, said scientists used neurotensin receptor knockout mice to identify the neurotensin NTR1 receptor as the specific site through which its lead compound, CGX-1160, produces analgesia. A series of in vitro experiments also revealed that the compound is able to produce a stronger activation of the NTR1 receptor than neurotensin. CGX-1160 is in development for the treatment of chronic intractable pain and has received orphan drug designation for the intrathecal treatment of neuropathic pain associated with spinal cord injury.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., began a five-arm Phase Ib study of Actilon for the treatment of chronic hepatitis C virus. The trial is designed to enroll 60 adult patients in 18 U.S. centers. Coley expects preliminary data from the study to be available in late 2006. Actilon acts through the Toll-like receptor 9 found in dendritic and B cells and stimulates the body's own production of antiviral cytokines and chemokines, such as interferons.

• Corcept Therapeutics Inc., of Menlo Park, Calif., said a slower-than-anticipated pace of patient enrollment in one of its three Phase III trials of Corlux in the treatment of psychotic features of psychotic major depression will delay results from the first half of 2006 to the second. The timelines for the other two studies remain the same, with one study expected to report data by the end of the first half of next year, and data from the other trial coming during the second half. The company also said its cash and marketable securities of $36.7 million, as of June 30, will sustain operations through clinical development of Corlux. In other news, Corcept said it plans to close enrollment in its clinical study evaluating the safety and efficacy of Corlux to improve cognition in patients with mild to moderate Alzheimer's disease. Ongoing review of blinded safety data from that trial has not revealed any serious safety findings.

CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, initiated patient dosing in a Phase Ib open-label, multicenter, proof-of-concept trial evaluating PXD101, a small-molecule histone deacetylase inhibitor, to treat advanced solid tumors, including colorectal cancer. The trial initially will enroll up to 15 patients with advanced solid tumors to establish the maximum tolerated dose of PXD101 used in combination with 5-fluorouracil.

• DOV Pharmaceutical Inc., of Hackensack, N.J., said Phase II results of DOV216,303, a triple reuptake inhibitor for depression, showed that patients in the drug and control groups who completed two weeks of treatment demonstrated reductions from baseline in the total HAM-D scores. The trial involved 67 patients and compared 50 mg twice per day of DOV216,303 to 20 mg twice per day citalopram, a selective serotonin reuptake inhibitor. In both groups, the reductions from baseline in the HAM-D scores were greater than 40 percent. DOV sublicensed DOV216,303 in August 2004 from Merck & Co. Inc., of Whitehouse Station, N.J.

Dynavax Technologies Inc., of Berkeley, Calif., has selected Tolamba as its brand name for its ragweed allergy immunotherapy and Haplisav as its brand name for its hepatitis B prophylaxis product. Tolamba and Haplisav are in Phase III trials and are based on Dynavax's proprietary immunostimulatory sequence technology that reprograms the immune system through specific targeting of Toll-like Receptor 9.

• EntreMed Inc., of Rockville, Md., said the Sept. 15, 2005, issue of Clinical Cancer Research published results of the multicenter Phase II study for Panzem capsules in hormone-refractory prostate cancer. In the double-blind, randomized study, 33 patients received either 400 mg or 1200 mg of 2-methoxyestradiol per day until disease progression. Seven patients treated at the higher dose level, and one patient in the lower dose level, experienced a 21 percent to 40 percent decrease in prostate specific antigen levels. Panzem capsules were well tolerated.

• Genelabs Technologies Inc., of Redwood City, Calif., received a staff determination letter from the Nasdaq stating the company's common stock is subject to delisting because the stock's closing bid price is not at least $1. Genelabs said it intends to appeal the determination and will present a plan for its continued listing at a hearing before the Nasdaq Listings Qualification Panel.

• Genzyme Corp., of Cambridge, Mass., announced the commercial availability of a new laboratory test to help identify patients likely to respond to therapies targeted to treat non-small-cell lung cancer. The company's EGFR Mutation Assay will help to detect the presence of epidermal growth factor receptor mutations in patients with NSCLC.

• Halozyme Therapeutics Inc., of San Diego, presented new pharmacokinetic and efficacy data with a chemically modified form of a recombinant human hyaluronidase enzyme in animal ischemic stroke models at the 2005 American Neurological Association annual meeting in San Diego. The enzyme, called rHuPH20, when conjugated to polyethylene glycol, demonstrated a dramatically longer serum half-life compared with the unmodified form, thereby preventing it from being rapidly cleared from circulation. Both rHuPH20 and PEG-rHuPH20 demonstrated increased survival in stroke models.

• IDM Pharma Inc., of San Diego, is moving to the second stage of a Phase II study of its cancer vaccine, Uvidem, to treat melanoma. The single arm study is a two-step design, in which one or more of the first 12 patients enrolled must have evidence of clinical activity in order to enroll an additional 25 patients. IDM achieved the initial goal with a partial response among the first few patients, and the study will continue to enroll up to 37 patients.

• Immune Response Corp., of Carlsbad, Calif., said it will begin enrolling patients in Italy for a Phase I/II study investigating IR103 in HIV. The randomized, double-blind study will follow up to 100 patients for 52 weeks, with a primary objective of evaluating drug's safety and its ability to generate HIV-specific immune responses in subjects who have not initiated highly active antiretroviral therapy. IR103 combines the company's HIV-1 immunogen with Amplivax, an immunostimulatory oligonucleotide adjuvant developed by Idera Pharmaceuticals Inc., of Cambridge, Mass.

• J. Craig Venter Institute, of Rockville, Md., along with the Ludwig Institute for Cancer Research and the Johns Hopkins University School of Medicine, identified three mutations in two receptor tyrosine kinases in glioblastoma tumors using high-throughput sequencing. Scientists said the mutations provide the potential for targeted cancer therapies, as receptor tyrosine kinases can be targeted by either small molecules or antibodies. Results from the study will be published this week in the Proceedings of the National Academy of Sciences. Researchers from the University of California in San Diego also contributed to the project.

• Lipoxen Technologies Ltd., of London, signed a research and product collaboration with Baxter Healthcare Corp., of Deerfield, Ill., to investigate the effectiveness of conjugating Baxter's proteins with PolyXen, Lipoxen's technology. Financial terms were not disclosed. Lipoxen also expanded its agreement with the Serum Institute of India to increase the number of drugs, which include erythropoietin, paclitaxel and pneumococcal vaccine. Additionally, Lipoxen will receive an initial $750,000 up-front payment, plus royalties, from National Biotechnologies OAO, which licensed Lipoxen's extended-release insulin and interferon products for Russia, Ukraine and Kazakhstan markets.

• Medicago Inc., of Quebec City, signed an agreement with Acambis Inc., the U.S. subsidiary of Cambridge, UK-based Acambis plc, to evaluate the expression of recombinant vaccines using Medicago's plant-based Proficia system. Terms call for Medicago to receive milestone payments to assess the feasibility of using Proficia Protein Technology. The company said it also expects to announce further agreements in the areas of vaccine development and manufacturing.

• Migenix Inc., of Vancouver, British Columbia, completed a Phase IIa monotherapy study of celgosivir (MX-3253), an orally administered a-glucosidase I inhibitor in development for the treatment of chronic hepatitis C virus infections. The study met its objectives by confirming the drug was well tolerated, with evidence of antiviral activity in chronic HCV patients. Migenix said a Phase IIb combination therapy study is expected to begin enrollment shortly.

• Nanoscience Technologies Inc., of New York, appointed David Keenan as president and CEO. He will assume responsibility for all operating venues and focus on developing corporate research and development partnerships and licensing opportunities. He previously worked for MicroMachines, Sheldahl Inc. and the 3M company.

• NeoPharm Inc., of Lake Forest, Ill., said enrollment in its PRECISE trial has surpassed 250 patients for its lead drug product candidate cintredekin besudotox. Enrollment completion is expected for the end of this year. A biologics license application submission could occur sometime in 2006. Also, Phase I/II survival data were positive for patients with confirmed recurrent glioblastoma multiforme. Median survival for 10 patients still being monitored is 98 weeks.

• Nephros Therapeutics Inc., of Lincoln, R.I., has changed its name to RenaMed Biologics Inc. to further brand its mission to improve the lives of patients with critical diseases involving severely compromised kidney function. Its focus is on the development of its Bio-Replacement Therapies for acute renal failure. Its lead product, Renal Bio-Replacement Therapy, uses physiologically active human renal epithelial cells administered ex vivo in a hollow fiber cartridge to provide more comprehensive kidney function support.

• NPS Pharmaceuticals Inc., of Salt Lake City, said several studies demonstrate treatment with Preos parathyroid hormone for injection improves bone strength and architecture as well as reduces the risk of vertebral fracture in patients with osteoporosis. Data were presented at the American Society for Bone and Mineral Research 27th annual meeting in Nashville, Tenn. The new drug application for Preos is under review by the FDA.

• Osta Biotechnologies Inc., of Montreal, said its researchers have shown for the first time that the parathyroid hormone related peptide (PTHrP) derived from bone-forming cells is an endogenous peptide for bone formation, and modifies the therapeutic efficacy of administered human PTH 1-34, a peptide similar in structure to Forteo, a bone anabolic agent approved to treat osteoporosis. These data were published in a recent online edition of The Journal of Clinical Investigation.

• Pluristem Life Systems Inc., of Haifa, Israel, appointed Zami Aberman CEO, as Shai Meretzki resumes his position as chief technology officer. Aberman holds a bachelor's of science in mechanical engineering from Ben Gurion University and has held CEO positions in companies in Israel, the U.S., Europe and Japan.

• Prima Biomed Ltd., of Melbourne, Australia, said London-based AstraZeneca plc agreed with Arthron Pty Ltd., a Prima subsidiary, to extend its research program of Arthron's Fc receptor technology until June 30, and to enable AstraZeneca to conduct additional studies at its UK facilities. The agreement, originally signed in October 2004, called for AstraZeneca to fund a six-month validation study, and, upon successful completion, to hold the right to nonexclusively license the Fc Receptor technology for research, clinical development and commercialization of drugs designed to inhibit the receptor.

• Samaritan Pharmaceuticals Inc., of Las Vegas, entered an exclusive five-year supply agreement with Newry, Northern Ireland-based Norbrook Laboratories S.R.O. for raw formulation materials for the manufacturing of Samaritan's lead HIV drug, SP-01A, upon regulatory approval. Norbrook, operating through its Czech subsidiary, P.F. Services, is presently the only supplier with an FDA Drug Master File for the raw formulation material of SP-01A.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., expects to unblind and report top-line data by mid-December for its two U.S. Phase III hepatitis C virus trials evaluating Zadaxin as an adjunctive treatment for patients who have failed prior therapy. Previously, the company had planned to unblind and report the data in the early part of 2006. The trials are designed to determine the benefit of adding Zadaxin to pegylated interferon alpha to treat hepatitis C non-responder patients.

• SGX Pharmaceuticals Inc., of San Diego, announced Troxatyl has been granted orphan drug status in Europe for the treatment of acute myeloid leukemia. Troxatyl is in a pivotal Phase II/III trial for the third-line treatment of AML.

• Siga Technologies Inc., of New York, entered a $3.2 million agreement with the U.S. Army Medical Research and Material Command for the rapid identification and treatment of antiviral diseases. The one-year contract is funded by the U.S. Air Force. Siga will aid the Air Force's Special Operations Command in its use of computational biology to design and develop specific countermeasures against the biologic threats smallpox and adenovirus.

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