• American BioScience Inc., of Santa Monica, Calif., said preclinical data reported at the San Antonio Breast Cancer Symposium showed that use of its nanoparticle albumin-bound paclitaxel product, called Abraxane, resulted in both higher intra-tumor concentrations and higher efficacy in breast cancer models, compared to equal doses of Taxol. The drug also was the subject of Phase III research reported by investigators from Northwestern University in Chicago, which revealed that metastatic breast cancer patients receiving Abraxane (nab paclitaxel) experienced a statistically significant higher tumor response rate and slower time to tumor progression than patients receiving Taxol. More specifically, Abraxane patients tolerated a higher dose of paclitaxel, experienced a significantly lower incidence of neutropenia, and did not experience the severe hypersensitivity reactions commonly seen with Taxol.

• Anadys Pharmaceuticals Inc., of San Diego, reported interim Phase Ib results at the International Meeting on Hepatitis C and Related Viruses in Kyoto, Japan, demonstrating that isatoribine (ANA245) is safe and well-tolerated. The company added that though efficacy is not one of the trial's stated objectives, and the patient sample was small, results showed that isatoribine is biologically active in adults with chronic hepatitis C virus infection.

• Arcturus Bioscience Inc., of Mountain View, Calif., said findings reported at the San Antonio Breast Cancer Symposium showed that researchers from the James Graham Brown Cancer Center at the University of Louisville in Kentucky and Arcturus' scientists were able to use the company's Laser Capture Microdissection instrumentation to identify and isolate pure populations of tumor cells from 300 breast cancer tumor biopsy samples. They also used Arcturus reagents and DNA microarrays to measure which of nearly 22,000 profiled genes were expressed within the microdissected tumor cells.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said data reported at the American Society of Hematology meeting in San Diego showed that AP23464 effectively blocks the growth of leukemia cells harboring clinically relevant mutations commonly observed in patients who have become resistant to Gleevec (imatinib, Novartis AG). Ariad's small molecule is designed not only to treat certain forms of leukemia, but also to treat and prevent the spread of cancer by inhibiting the activity of another cancer-related protein, Src. The research, conducted by a team at the Oregon Health & Science University Cancer Center, was headed by a researcher who played a role in Gleevec's discovery and development.

• Biobase GmbH, of Wolfenbuttel, Germany, entered a nonexclusive agreement to be the worldwide distributor of NetPro, a protein-interaction database belonging to Molecular Connections, of Bangalore, India. The product contains more than 30,000 protein-protein interactions along with additional information on cellular localizations, biological metabolic paths, species, experimental techniques and diseases.

• Bioenvision Inc., of New York, said data reported at the San Antonio Breast Cancer Symposium pointed to the ability of its lead breast cancer treatment Modrenal (trilostane) to suppress the activity of estrogen at two groups of genes involved in breast cancer growth. Researchers from Queen Mary, University of London found that Modrenal blocks gene activity in both a preferred pathway, via estrogen receptors that activate genes that drive tumor cell proliferation and through an alternative cell growth pathway by way of a site in the nucleus known as the AP1 receptor. On the other hand, while tamoxifen blocks the preferred pathway, in certain circumstances it also will promote cell growth via AP1 dependent genes. That could explain why patients develop a resistance to tamoxifen, Bioenvision said, adding that it plans to conduct new UK-based studies of the drug in pre-menopausal, pre-operative and post-menopausal women.

• Caliper Technologies Corp., of Hopkinton, Mass., laid off about 65 employees - 12 percent of its total workforce - as part of a second phase of a planned reduction and reorganization of its senior management team. The company called the step the culmination of its efforts to reconfigure following its midsummer $72 million acquisition of Zymark Corp., of Mountain View, Calif. The first phase of the reorganization included 50 layoffs in August. (See BioWorld Today, July 10, 2003.)

• Cyclacel Ltd., of Dundee, Scotland, acquired exclusive rights in nearly all world territories to an investigational anticancer drug called CYC682 from Sankyo Co. Ltd., of Tokyo. Cyclacel plans to begin Phase I/II studies next year to further evaluate the oral small-molecule nucleoside analogue, which already has completed two U.S.-based Phase I studies in 88 patients. Sankyo, which retained first-negotiation rights for Japan, received an up-front payment and will receive milestones and royalties down the road. More specific financial terms were not disclosed.

• Elite Pharmaceuticals Inc., of Northvale, N.J., raised about $3.3 after completing a private placement of about 1.6 million common shares with a group of investors that include certain company directors. Elite, which is working to develop oral, controlled-release products, said the financing would support its near-term objectives.

• eXegenics Inc., of Dallas, could be the subject of a boardroom shakeup after several investors said they received enough votes to remove the company's existing directors and elect five replacements. Bruce Meyers, the M and B Weiss Family Limited Partnership of 1996, Melvyn Weiss and Michael Stone said they have received and delivered to eXegenics consents exceeding a majority of the company's issued and outstanding preferred and common shares as of Sept. 5.

• Human Genome Sciences Inc., of Rockville, Md., said GlaxoSmithKline plc, of London, revealed plans to advance an investigational cardiovascular disease compound labeled 480848 into Phase III trials next year, with a 2008 target for a new drug application to the FDA. The lipoprotein-associated phospholipase-A2 (Lp-PLA2) inhibitor would be the first genomics-derived, small-molecule drug arising from the partners' 10-year-old collaboration to enter such late-stage development. Human Genome Sciences will receive a milestone payment should 480848 move into registration, and will receive royalties if the compound is commercialized. In addition, the company has an option to co-promote an approved drug in the North American and European markets. Two other small molecules discovered by GlaxoSmithKline using Human Genome Sciences technology have entered Phase I development - 462795, a cathepsin-K inhibitor for osteoporosis and osteoarthritis, and 659032, also an Lp-PLA2 inhibitor for cardiovascular disease.

• ID Biomedical Corp., of Vancouver, British Columbia, said data from the most recent influenza human challenge study of its nonlive, intranasal FluINsure vaccine confirmed the efficacy of both the one- and two-dose vaccine regimens. The one- and two-dose treatment groups did not significantly differ from one another, but the comparison of all vaccine-treated subjects with placebo demonstrated the product's protective effect, as evidenced by an overall efficacy of 91 percent (p=0.018).

• Immunomedics Inc., of Morris Plains, N.J., said preclinical findings reported at the San Antonio Breast Cancer Symposium showed that hRS7 (IMMU-112) labeled with iodine-131 using a new, residualizing method patented by the company resulted in an almost 10-fold increase in uptake and retention in human breast cancer growing in mice, as compared to results obtained with the same humanized antibody conjugated with I-131 using conventional methodology. Also, the new approach resulted in a radiation dose to the tumor that was 4.3 times higher than the conventional radio-iodinated antibody, and resulted in significantly greater inhibition of tumor growth in the animals, Immunomedics said.

• Introgen Therapeutics Inc., of Austin, Texas, said it would begin a Phase I/II study to evaluate its INGN 225 vaccine therapy in advanced breast cancer patients. The trial will be conducted at the University of Nebraska Medical Center in Omaha and the H. Lee Moffitt Cancer Center in Tampa, Fla., with the latter site preparing the vaccine and participating in immunologic evaluations. INGN 225 uses Introgen's Advexin drug to stimulate the patient's dendritic cells, which are then used as a therapeutic vaccine to immunize a patient against the cancer.

• Medivir AB, of Huddinge, Sweden, said GlaxoSmithKline plc, of London, reported in vitro data indicating that 204937 (MIV-210) is effective against a range of resistant viruses. The nucleoside analogue reverse transcriptase inhibitor is the subject of a partnership in which GlaxoSmithKline is responsible for its development in exchange for exclusive worldwide rights except in the Nordic countries, where Medivir retains rights. (See BioWorld Today, May 28, 2003.)

• MedImmune Inc., of Gaithersburg, Md., said data from studies of its live, attenuated influenza vaccine show a strong antibody response against the currently circulating drifted A/Fujian/411/2002 (H3N2)-like strain. The company added that the data support results from a pivotal FluMist trial demonstrating the vaccine was safe and 86 percent effective against another drifted A/H3N2 influenza strain in the 1997-1998 flu season. The new findings were culled from a preclinical study of FluMist and a clinical trial using an investigational, refrigerator-stable formulation of a live attenuated flu vaccine (CAIV-T).

• NeoRx Corp., of Seattle, named Karen Auditore-Hargreaves its president, effective immediately. She also will continue to serve as the company's chief operating officer, a position to which she was promoted in June. Outgoing President Jack Bowman will continue as chairman and CEO at NeoRx, a cancer therapeutics development company.

• Novogen Ltd., of Sydney, Australia, said its Marshall Edwards Inc. subsidiary received $10.1 million from warrants exercised by its shareholders. Marshall Edwards, which is developing cancer therapeutics, is publicly listed on the London Stock Exchange and is registered for a U.S. listing. (See BioWorld Today, Sept. 29, 2003.)

• Nutra Pharma Corp., of Beverly Hills, Calif., said data published in Neurology showed an oral formulation of Immunokine to be safe and well tolerated in a placebo-controlled, double-blinded, UK-based study that also revealed a 12.5 percent improvement in patients. The product is being developed for Adrenomyeloneuropathy, a neurologic disorder with clinicopathologic similarities to multiple sclerosis. The company plans to begin a Phase IIb/III trial early next year to evaluate an injectable version of Immunokine.

• OSI Pharmaceuticals Inc., of Melville, N.Y., filed a registration statement with the SEC to allow holders of its previously issued 3.25 percent convertible senior subordinated notes due 2023 to resell them and the common shares into which they are convertible. Issued three months ago, the notes are convertible at $50.02 per share. (See BioWorld Today, Sept. 4, 2003.)

• Prolexys Pharmaceuticals Inc., of Salt Lake City, entered a research collaboration agreement with the Whitehead Institute for Biomedical Research in Cambridge, Mass., related to the investigation of interactions between small-molecule drug candidates and proteins for oncology. The HySpec mass spectrometry proteomics technology platform from Prolexys, formerly known as Myriad Proteomics Inc., will be used to identify proteins that bind to specific pharmacologically active compounds. Resulting information will be used to identify compounds with a desired anticancer activity but without significant toxicity and side effect liability.

The Puget Sound Blood Center in Seattle said a pair of its researchers reported findings at the American Society of Hematology meeting in San Diego detailing their discovery of a gene that most likely plays a significant role in thrombocytopenia, a human bleeding disorder. The gene appears to be responsible for low platelet counts in one large family and can result in bleeding disorders, though the scientists said they have yet to fully understand its role in platelet development. Another Puget Sound researcher reported early findings indicating that it may be possible to extend platelet preservation from five days to eight days or more.

• Transgenomic Inc., of Omaha, Neb., said findings reported at the American Society of Hematology meeting in San Diego point to the use of its WAVE System in detecting mutations in the BCR-ABL gene that are potentially associated with resistance to therapy with imatinib (Gleevec, Novartis AG) in chronic myeloid leukemia patients. The other study detailed the detection of small duplications and point mutations in the FLT3 gene, which has been implicated in the pathogenesis of acute myeloid leukemia.

• V.I. Technologies Inc., of Watertown, Mass., raised about $3.4 million in gross proceeds after entering agreements to sell about 3.8 million common shares to institutional investors at 90 cents apiece. The investors also will receive a five-month option to purchase 944,444 additional shares at the same per-share price, as well as four-year warrants to purchase about 1.5 million shares, exercisable for cash only, at $1.32 apiece. The transaction is expected to close on or before Dec. 9. SG Cowen Securities Corp. acted as the deal's exclusive placement agent for the company, which plans to use the proceeds to fund its ongoing clinical development of the Inactine Pathogen Reduction System for red blood cells and other general working capital purposes.

• Xanodyne Pharmacal Inc., of Florence, Ky., agreed to merge with Integrity Pharmaceutical Corp., of Indianapolis, creating a 150-employee combined business to focus on pain management, bleeding disorders, urology and women's health. The new entity will operate as Xanodyne Pharmaceuticals Inc. in Florence, located in the greater Cincinnati area.

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