• Adolor Corp., of Exton, Pa., and London-based GlaxoSmithKline plc submitted the complete new drug application for Entereg (alvimopan) capsules for the management of postoperative ileus. The companies are collaborating on worldwide development and commercialization. The FDA granted fast-track designation to Entereg in February. The NDA consists of Phase III data evaluating more than 2,000 patients in three efficacy studies and one safety study. The companies began filing a rolling NDA in May. (See BioWorld Today, May 10, 2004.)

• Adventrx Pharmaceuticals Inc., of San Diego, released statistically significant tumor inhibition and survival data from CoFactor combination treatments in a pancreatic tumor model. Results were presented Saturday at the Pancreatic Cancer 2004 Advances and Challenges conference in San Francisco. Treatment with CoFactor and 5-fluorouracil (5-FU) showed statistically significant inhibition of tumor growth compared to control-treated mice. Furthermore, CoFactor/5-FU tumor inhibition was comparable to that observed with gemcitabine treatment. Combining an anti-VEGF (vascular endothelial growth factor) antibody with CoFactor/5-FU resulted in the greatest tumor inhibition, compared to all other treatment groups including those with or without anti-VEGF administration. Mice treated with CoFactor/5-FU/anti-VEGF had significantly greater survival than all other treatment groups.

• Affymetrix Inc., of Santa Clara, Calif., reported the commercial availability of the GeneChip Mapping 10K 2.0 Array and the GeneChip Mapping 100K Array Set. The latter enables scientists to perform high-density genome scans and genome-wide association studies on the genetics of diseases and drug response.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, completed enrollment of its pivotal vascular wrap study and enrolled an additional 28 patients for a total of 108. In early June, the firm said it intended to expand its original European safety study into a pivotal trial. The study involves Angiotech's treatment designed to prevent an obstructing scar from forming at the site of a bypass connection.

• Arrow Therapeutics, of London, said its antiviral for respiratory syncytial virus successfully completed Phase I trials. The compound was shown to be safe and well tolerated with pharmacokinetics indicating once-daily oral dosing. Phase II trials are planned for the second half of 2004.

• Australian Cancer Technology, of Sydney, said the SEC declared effective its American depository receipt program, enabling the company to access the U.S. capital markets and to expand its shareholder base. The company hopes to list its stock on the Nasdaq National Market. Global Markets Capital Group, of New York, is managing the ADR program, and the Bank of New York will serve as the depository bank.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said the FDA designated for priority review their biologics license application for Antegren (natalizumab) to treat multiple sclerosis. The next step is for the FDA to formally accept the application. The companies submitted the BLA in May. Antegren, a humanized monoclonal antibody, is the first alpha-4 antagonist in the new selective adhesion molecule inhibitor class.

• Cell Genesys Inc., of South San Francisco, initiated enrollment of a multicenter Phase II trial of GVAX lung cancer vaccine in patients with advanced-stage bronchoalveolar carcinoma. It is the second of two Phase II studies, and will enroll about 100 patients. Cell Genesys also said it expects to begin the first Phase III trial of GVAX prostate cancer vaccine in July. In other news, the company said researchers presented Phase II data on GVAX pancreatic cancer vaccine in patients with inoperable metastatic pancreatic cancer at the Lustgarten Foundation for Pancreatic Cancer Research's annual meeting. Data showed that treatment with GVAX in combination with cyclophosphamide was generally well tolerated and demonstrated a trend toward an improved outcome by all measures of clinical activity.

• Cobra Biomanufacturing plc, of Keele, UK, said its collaborator, the Cancer Research Institute, formed an agreement with the Ludwig Institute for Cancer Research to produce Coley's Toxin cancer vaccine for clinical trials. Coley's Toxin will be produced from two different bacteria under controlled conditions. The project will take six months, it said.

• Columbia Laboratories Inc., of Livingston, N.J., submitted to gain approval of Striant SR 30 mg under the mutual recognition procedure in the European Union. The mucoadhesive buccal tablets would be indicated as a testosterone-replacement therapy in men with primary or secondary hypogonadism. The UK approved Striant SR in February, and it was launched by Ardana Bioscience Ltd., of Edinburgh, Scotland. Licenses in other European countries are expected to be granted over the next 12 months. Columbia will receive about $1.4 million in milestone payments upon receiving approval in major European countries as part of its 2002 agreement with Ardana and 2003 agreement with Milan, Italy-based Mipharm SpA, which holds rights in Italy.

• DOV Pharmaceutical Inc., of Hackensack, N.J., said the FDA agreed to lift the clinical hold on ocinaplon, the company's anxiolytic, subject to its review of a revised clinical trial protocol that, among other things, includes more frequent liver enzyme testing. The company intends to submit such revised protocol shortly and expects to commence the pivotal trial in 2004. The FDA would allow, subject to further protocol review, DOV to proceed with a 28-day, multicenter, randomized, placebo-controlled, double-blind trial in which 270 patients with generalized anxiety disorder would receive a maximum daily dose of 60 mg of ocinaplon.

• Gentara Corp. relocated to Malvern, Pa., from Princeton, N.J. The company is focused on developing pharmaceutical products for HIV infection and cancer.

The Institute for Diabetes Discovery LLC, of Branford, Conn., presented data on aldose reductase inhibitors developed to reduce the impact of diabetic peripheral neuropathy at the American Chemical Society's national meeting. As part of its adlose reductase inhibitor program, the institute produced several series of inhibitors that led to the discovery of lidorestat - which has advanced to Phase II trials - among other things.

• Interleukin Genetics Inc., of Waltham, Mass., signed an agreement with Tufts University in Boston for exclusive rights to develop and commercialize tests and nutritional products based on variations in the perilipin gene that have been associated with body-weight differences. Perilipin is a protein in fat cells that influences fat metabolism.

• Introgen Therapeutics Inc., of Austin, Texas, said preclinical data of INGN 241 in combination with radiation therapy in an animal model of non-small-cell lung cancer showed the therapy inhibited tumor growth. Additional data show that the MDA-7 protein sensitizes the cells that give rise to new blood vessels to the effects of radiation without affecting other normal cells. The studies were conducted at the University of Texas M.D. Anderson Cancer Center in collaboration with Introgen scientists, and the data were published in the current edition of Molecular Therapy. INGN 241 is in Phase II trials in malignant melanoma and has completed Phase I/II studies in multiple solid-tumor indications.

• Ligand Pharmaceuticals Inc., of San Diego, received notice that the Centers for Medicare and Medicaid Services will provide reimbursement for Targretin (bexarotene) for patients with cutaneous T-cell lymphoma. The FDA approved Targretin in December 1999 to treat CTCL patients who are refractory to at least one prior systemic therapy.

• Momenta Pharmaceuticals Inc., of Cambridge, Mass., said underwriters of the firm's recent initial public offering of about 5.4 million shares exercised in full their overallotment option to purchase an additional 802,500 shares of common stock at the IPO price of $6.50 per share. Momenta's net proceeds from the overallotment option are about $4.85 million. (See BioWorld Today, June 23, 2004.)

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., raised $12.5 million through the sale of about 1.1 million shares of common stock at $11 per share to an institutional investor. The price represents a 15 percent premium to the closing price of Nastech's stock on June 24. The transaction also includes warrants to purchase 511,364 shares of Nastech common stock at $14.40 per share. The sale was made pursuant to the company's shelf registration statement. WR Hambrecht + Co. LLC served as financial adviser. The company plans to use proceeds for general corporate purposes.

• NexMed Inc., of Robbinsville, N.J., initiated a 400-patient study of Femprox in China. The study will test the efficacy of Femprox cream in women diagnosed with female sexual arousal disorder. Femprox is topically applied and incorporates alprostadil with the NexACT permeation enhancer. In April, NexMed reported that it had received a notice of allowance for its patient application.

• Nuvelo Inc., of Sunnyvale, Calif., completed enrollment of its Phase II trial with lead product candidate, alfimeprase, showing that alfimeprase restored blood flow in the limbs of patients with acute peripheral arterial occlusion in four hours or less. While the full data set is still being analyzed, the preliminary data suggest that there was a dose response. There were no incidences of intracerebral hemorrhage and no major bleeding events were unequivocally attributed to alfimeprase. The company plans to meet with the FDA to discuss a pivotal Phase III.

• Optimer Pharmaceuticals Inc., of San Diego, acquired exclusive rights from Nippon Shinyaku Co. Ltd., of Kyoto, Japan, to develop and commercialize prulifloxacin in the U.S. Prulifloxacin is a fluoroquinolone antibiotic used in Japan for the treatment of various bacterial diseases, including respiratory and urinary tract infections, skin infections, infectious enteritis, cystitis and prostatitis. Fluoroquinolones are a class of antibiotics designed to be effective against disease-causing bacteria.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., said the National Institute of Environmental Health Sciences agreed to expand its current research relationship with Paradigm to include a study of four to six additional known liver toxicants and the integrated analysis of gene expression, metabolic profiles and quantitative tissue feature data. Results from the broadened study will generate a preliminary data set for a research version of the Chemical Effects in Biological Systems database at the institute's National Center for Toxicogenomics.

• Schering-Plough Europe, of Brussels, Belgium, reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of a shorter 24-week course of PegIntron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy for patients chronically infected with hepatitis C virus genotypes 2 or 3. PegIntron is approved in the European Union for a 48-week course of therapy.

• SkinMedica Inc., of Carlsbad, Calif., plans to acquire all U.S. rights and certain international rights to Vaniqa (eflornithine hydrochloride) cream 13.9 percent from Women First HealthCare Inc., of San Diego, for $36.6 million. The acquisition will be funded by a combination of debt and private equity and will close in mid-July. Vaniqa is approved in 26 countries. It gained U.S. approval in 2000 to slow the growth of unwanted facial hair in women. Bristol-Myers Squibb Co., of New York, will continue to manufacture Vaniqa for SkinMedica.

• Spectral Genomics Inc., of Houston, introduced the Constitutional Chip 1.0 for Comparative Genomic Hybridization. The company said the chip is part of an expanding product line of human BAC clone arrays developed and manufactured by the company.

• Spotfire Inc., of Somerville, Mass., formed an agreement with Applied Biosystems Group, of Foster City, Calif., to combine Spotfire's data visualization and guided analytics with Applied Biosystem's expression-array system. Applied Biosystems will build analysis capabilities on top of the DecisionSite platform in the form of DecisionSite guides. It will offer 90-day evaluation licenses of SpotFire's DecisionSite for functional genomics software with its expression array system.

• SRI International, of Menlo Park, Calif., said its bioscience division will receive $12.3 million over seven years in two contracts from the National Cancer Institute to evaluate the preclinical safety and pharmacology of potential cancer treatments and chemopreventive agents. The NCI will use SRI's preclinical studies to support investigational new drug applications. The first contract, funded about $5 million from 2004 to 2009, involves the testing of chemopreventive agents that are used to prevent cancer in at-risk populations. The second program, which is funded at about $7.3 million from 2004 to 2011, encompasses research on new cancer chemotherapy drugs.

• Sunesis Pharmaceuticals Inc., of South San Francisco, initiated the first of its two planned Phase I studies of SNS-595, its lead small-molecule cancer drug. The trial is an open-label, dose-escalation study. SNS-595 is a first-in-class cell-cycle modulator that is designed to kill proliferating cancer cells by inducing apoptosis. Patients with advanced malignancies are being enrolled.

• Zonagen Inc., of The Woodlands, Texas, learned from Nasdaq that it no longer complies with the minimum $10 million stockholders' equity requirement necessary for continued listing. The shortfall is a result of the January self-tender offer, in which the company repurchased 6.5 million shares of common stock at $14 million. The company's shares will be delisted from Nasdaq on July 2, unless it applies for a SmallCap listing or appeals the decision.

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