• Abgenix Inc., of Fremont, Calif., reported positive results from an ongoing Phase I trial of ABX10241 (ABX-PTH), its fully human monoclonal antibody that targets parathyroid hormone. An interim analysis revealed it was well tolerated and presented dose-related suppression of PTH and serum calcium levels in hemodialysis patients with secondary hyperparathyroidism. Abgenix announced the data at the 26th annual meeting of the American Society for Bone and Mineral Research. The company plans to begin a multidose study in the same indication.

• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix group entered an agreement to acquire one-third ownership of Leuchemix Inc., a privately held firm. For the equity stake of preferred stock, CombiMatrix will provide Leuchemix a total of $4 million, paid quarterly over the next two years. Amit Kumar, CombiMatrix's CEO, will become a director of Leuchemix. Leuchemix is developing a series of small molecules that have shown efficacy against various leukemias and solid tumors in animal models. The first indication is expected to be acute myelogenous leukemia.

• Allos Therapeutics Inc., of Atlanta, presented findings from its Phase III trial of the radiation sensitizer Efaproxyn (efaproxiral) in patients with brain metastases at the 46th annual meeting of the American Society for Therapeutic Radiation Oncology. A retrospective analysis showed the strongest prognostic factors for survival include Karnofsky Performance Status, prior brain tumor resection, the presence of extra cranial metastases and gender. Analysis affirmed the effectiveness of Efaproxyn in improving survival time across a heterogeneous patient population.

• Amgen Inc., of Thousand Oaks, Calif., said all doses used in twice yearly injections of AMG 162 significantly increased bone mineral density (BMD). The compound wasdeveloped from Fremont, Calif.-based Abgenix Inc.'s XenoMouse technology. The investigational therapy for bone loss increased BMD at the total hip vs. placebo at 12 months; at all doses that increase was similar or greater than that with Fosamax (alendronate, Merck & Co. Inc.). One-year results of the ongoing, multicenter Phase II dose-ranging trial in healthy postmenopausal women with low BMD were presented at the American Society for Bone and Mineral Research annual meeting in Seattle. The trial compared the drug to placebo and had an open-label cohort comparison to Fosamax. The compound was well tolerated with the most common adverse event being dyspepsia. Amgen began a pivotal Phase III study of AMG 162 in postmenopausal women with osteoporosis. Ongoing studies with the compound are examining treatment-induced bone loss, rheumatoid arthritis and bone metastases.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its partner, Boston Scientific Corp., of Natick, Mass., reported 30-day safety data from its Taxus V trial, which is testing the slow-release formulation of the Taxus Express2 paclitaxel-eluting stent system in 1,172 patients in the U.S. Taxus V expands on the Taxus IV pivotal trials, studying a higher-risk population, including patients with small vessels, large vessels and long lesions requiring overlapping stents. The data support early safety, as seen in the low overall MACE (Major Adverse Cardiac Events) rate of 4.4 percent at 30 days. Boston Scientific presented data at the annual Transcatheter Cardiovascular Therapeutics symposium in Washington.

• Cell Therapeutics Inc., of Seattle, said Phase I data on two of its products were presented at the EORTC-NCI-AACR meeting. In the Trisenox (arsenic trioxide) study, 63 patients with newly diagnosed disease were treated. After two treatments, 90 percent had complete remission. Of the 11 who relapsed, eight went back into remission after a third treatment. CTI said 88.5 percent in the ongoing study are alive with mean survival about 34 months. CTI markets the drug in the U.S. and Europe for relapsed-refractory acute promyelocytic leukemia. Data showed CT-2106, or polyglutamate campothecin, was well tolerated with manageable toxicity and activity in three tumor types.

• ConjuChem Inc., of Montreal, completed enrollment in its Phase II trial with DAC:GLP-1 in combination with Metformin. The company also said it has begun dosing in a Phase I program with DAC:GLP-1 with modified diluents. Those were formulated to improve the drug's tolerability, especially at higher doses. Results from both of the studies are expected to be available by the end of the year.

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., said that at the American Society for Dermatologic Surgery in San Diego, an independent group of investigators presented results from the first randomized, controlled study of Levulan (aminolevulinic acid) Kerastick, together with intense pulsed light (IPL) for photaging. Investigators assessed global photodamage, fine lines, mottled pigmentation, roughness and sallowness before treatment and four weeks after treatment in 20 patients. Pretreatment resulted in a statically significant improvement in global scores for photoaging with no significant increase of side effects.

• Exact Sciences Corp., of Marlborough, Mass., said its chief technology officer presented information on the company's latest applied research efforts on Sunday at the Conference on Colon Cancer in Murine Models and the Human in Bar Harbor, Maine. Data demonstrated the benefit of maximizing DNA stability during sample handling, as well as the increased ability to identify colorectal cancer-associated mutations in tissues using recently developed scanning techniques.

• Genaera Corp., of Plymouth Meeting, Pa., said the FDA granted fast-track designation to squalamine, a small-molecule anti-angiogenic drug for the treatment of wet age-related macular degeneration. The company expects to report early data from its first Phase II study later this year and release additional data in the first half of 2005. It also plans to start a Phase III trial that will run concurrently with its largest Phase II. Iintravenously administered squalamine is being evaluated in three Phase II trials.

• Genmab A/S, of Copenhagen, Denmark, got positive safety data in a HuMax-EGFr Phase I/II study in head and neck cancer. No patients experienced dose-limiting toxicity receiving doses up to 8 mg/kg, and preliminary pharmacokinetic data suggest that saturation of the EGF receptor is provided by doses close to 2 mg/kg. Genmab expanded the ongoing study to include a group of up to 10 additional patients at the highest dose level.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, released data from a pilot study indicating that non-human primates treated with Neumune (HE2100) after exposure to a high dose of radiation experienced an improved rate of survival vs. animals receiving placebo or no treatment. Neumune is an investigational immune-regulating hormone being developed by HGS for radiation injury pursuant to the FDA's "animal rule" for biodefense.

• Human Genome Sciences Inc., of Rockville, Md., closed its private placement of $280 million in 2.25 percent convertible notes due 2011, which included $30 million in notes pursuant to the exercise of a portion of the initial purchasers' option. The initial purchasers have the option within the next 24 days to purchase an additional $20 million in notes. HGS plans to use net proceeds to repurchase, from time to time, a portion of its outstanding convertible subordinated debt.

The Huntington Study Group presented Phase III data on tetrabenazine at the American Neurological Assocation's 129th annual meeting in Toronto. The compound, a dopamine depletor on the market in parts of Europe, Australia and Canada for hyperkinetic movement disorders, is indicated for the treatment of chorea associated with HD. The study involved 84 HD patients, who were randomized to receive tetrabenazine or placebo for 12 weeks. The primary outcome was the difference in baseline and the Unified Huntington's Disease Rating Scale score. Secondary outcomes included the global impression score. The adjusted mean tetrabenazine chorea score declined by 5 points, while the placebo group showed a 1.5 point difference (p<0.0001). The drug also outscored placebo in the global impression score. Forty-eight patients in the treated group had at least one adverse effect compared with 21 subjects in the placebo group (p=0.03).

• LAB International Inc., of Laval, Quebec, secured a total of $8.25 million in a new long-term bank financing from HSBC Bank Canada and MKB Bank of Hungary. About $4 million will support investments in the two main research facilities in Laval and Veszprem, Hungary. The rest will support the advancement of the company's product pipeline and for general working capital purposes.

• Medarex Inc., of Princeton, N.J., received two grants from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., to support Medarex's research and development of MDX-1303, a fully human antibody being developed for use against human anthrax infection. If all performance milestones are met, the grants could total about $7.2 million over the next three years.

• Nanobac Life Sciences Inc., of Tampa, Fla., signed a manufacturing agreement with Medicorp Inc., of Montreal, to produce two blood tests for the detection of nanobacteria. Nanobac is transferring production of the Nano-Capture ELISA assay and the Nano-Sero IgG ELISA assay from its Nanobac Oy research laboratory in Kuopio, Finland, to Medicorp in preparation for FDA clinical trials and expanded distribution.

• NeoPharm Inc., of Lake Forest, Ill., said Phase I results demonstrated the safety and tolerability of LE-SN38, its NeoLipid compound used to treat patients with advanced cancers. The company also established a maximum tolerated dose of 35 mg/m2 for all but a small subset of patients who metabolize SN-38 slowly. Data were presented at the 16th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. LE-SN38 is NeoPharm's liposomal formulation of SN-38, the active metabolite of irinotecan.

• Neurologix Inc., of Fort Lee, N.J., presented data showing NLX-P101 was well tolerated and effective in a primate model of Parkinson's disease at the 16th annual Symposia on Etiology, Pathogenesis and Treatment of Parkinson's disease and other Movement Disorders in Toronto. The study's corresponding author related that the NLX-P101-treated group showed a statically significant improvement in motor scores over time, while the control group first experienced decline followed by little change. At 60 weeks, fluorodeoxyglucose PET scans revealed that the treated group also exhibited higher metabolism in the motor cortex, correlating with clinical improvement, compared to the controls.

• NPS Pharmaceuticals Inc., of Salt Lake City, said two-year data on Preos (parathyroid hormone) confirm that the compound builds new bone with normal fracture-resistant architecture and potentially offers a new treatment for women at increased risk of osteoporotic fractures. The study showed that one year of Preos followed by one year of alendronate was more effective at building bone than two years of alendronate alone. The data were presented at the 26th annual meeting in Seattle of the American Society for Bone and Mineral Research.

• Nucleonics Inc., of Horsham, Pa., requested that the U.S. Patent and Trademark Office re-examine a patent belonging to Benitec Ltd., of Queensland, Australia, and the Australian Commonwealth Scientific and Industrial Research Organization. U.S. Patent No. 6,573,099 is titled "Genetic Constructs for Delaying or Repressing the Expression of a Target Gene." The request submits prior art documents showing the patent claims are invalid because they lack novelty or they were obvious at the time the priority patent application was filed. Nucleonics also believes that the claims are ambiguous. Nucleonics made a similar filing in September with the Commissioner of Patents in Australia.

• Nuvios Inc., Cambridge, Mass., appointed C. Richard Lyttle president and CEO. Lyttle comes from Madison, N.J.-based Wyeth, which he served as vice president of discovery for women's health and bone and head of the Women's Health Research Institute. Nuvios is focusing on developing a new class of drugs that build back bone lost with osteoporosis and related metabolic diseases.

• Ortho Biotech Products LP, of Bridgewater, N.J., and a Johnson & Johnson Co., received a subpoena from the Inspector General, Department of Health and Human Services, requesting documents related to the sales and marketing of Procrit (Epoetin alfa), a prescription for anemia. The company said it is cooperating in responding to the subpoena.

• Pharmacyclics Inc., of Sunnyvale, Calif., presented Phase I trial results describing the use of Antrin (motexafin lutetium) phototherapy for the treatment of coronary atherosclerosis. A presentation included data from intravascular ultrasound imaging studies showing that Antrin prevented plaque build-up following balloon angioplasty and stent placement in patients receiving optimum doses of drug and light therapy. The presentation was made at the 16th annual scientific meeting of Transcatheter Cardiovascular Therapeutics in Washington and sponsored by the Cardiovascular Research Foundation.

• PharmaMar SA, of Madrid, Spain, presented data from six studies, four of which were from pharmacogenomics research projects at the EORTC-NCI-AACR conference in Geneva. The results presented at the conference reported on two studies of Yondelis, one of Aplidin and one of Kahalalide F.

• ProBioGen AG, of Berlin, entered an agreement with Chiron Vaccines, a unit of Emeryville, Calif.-based Chiron Corp. to evaluate ProBioGen's vaccine cell lines for vaccine production. ProBioGen will create cell lines derived from primary tissue under pre-specified criteria. Chiron Vaccines will test the lines' capabilities in virus propagation and productivity against currently used vaccine cell substrates. Both companies have option rights to enter into collaboration to further develop cell lines for vaccine applications.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said a number of patients in its Phase I trial are receiving additional cycles of Davanat-1, a combination of Davanat plus 5-Fluorouracil (5-FU). The trial was designed for refractory patients to be dosed in two cycles. The company said it expects to complete the trial in early 2005.

• Senetek plc, of Napa, Calif., said that on Sept. 30, it completed the restructuring of its senior secured notes and warrants on the terms of the preliminary agreement. The terms had been previously reported in a news release issued on Aug. 16. The agreement provides for a $1.6 million principal prepayment, with no further principal payments due until maturity in April 2007. The interest rate on the notes will remain at 8.5 percent through the term of the loan. The remaining $3.3 million principal amount of notes become exchangeable, at the election of the holders of the notes, for Senetek ordinary shares at a fixed exchange value of 80 cents a share. The Series A and B warrants will become exercisable at a reduced price of 50 cents a share on a pro-rata basis as the related notes are exchanged for stock or are paid.

• SkyePharma plc, of London, said it reached accord with Merck KGaA, of Darmstadt, Germany, to assign the companies' agreement signed in August 1998, to a new Swiss company founded by former Merck executives. The agreement surrounded the development of a formulation of an unnamed drug using SkyePharma's Geomatrix oral delivery technology. The Swiss company will assume all funding obligations from Merck for development including the Phase III under way in Europe. It also will seek marketing partners outside Europe. SkyePharma is entitled to sales-dependent royalties and will manufacture product at its Lyon, France, plant. Merck retains marketing rights in Germany and Austria.

• Stellar Biotechnologies Inc., of Port Hueneme, Calif., won a $3 million award from the National Cancer Institute to develop production methods, quality standards and facilities to commercialize Keyhole Limpet Hempcyanin (KLH) for cancer vaccines. It is a continuation of a Small Business Innovation Research Phase II grant already awarded to Stellar funded through an NCI program for the development of aquaculture technology for Megathura crenulat, the source of KLH. KLH is a highly immunogenic, T-cell-dependent protein used as a vaccine platform or carrier molecule for vaccine antigens, and is combined with tumor-associated antigens to create cancer vaccines to combat the immune system's tolerance of self antigens.

• Telik Inc., of Palo Alto, Calif., reported additional positive data from a Phase II study of Telcyta (TLK286) administered in combination with Doxil in platinum-refractory or -resistant ovarian cancer. A total of 51 patients were enrolled, and the objective response rate by RECIST was 42 percent. The overall disease control rate was 74 percent. Separately, Telik reported additional positive data from a multicenter Phase II trial of Telcyta administered in combination with carboplatin in platinum-refractory or -resistant ovarian cancer. A total of 53 patients have been enrolled, and the objective response rate by RECIST was 54 percent. The data were reported at the 10th Biennial International Gynecologic Cancer Society meeting in Edinburgh, Scotland.

• Teva Neuroscience Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., of Jerusalem, said Agilect (rasagiline mesylate) taken once daily significantly improved symptoms of Parkinson's disease both as initial monotherapy in patients with early Parkinson's disease and as adjunct treatment to levodopa in moderate to advanced patients. The data were presented at the American Neurological Association annual meeting in Toronto. Teva Neuroscience and Eisai Inc., of Teaneck, N.J., will co-promote Agilect in the U.S. The studies were conducted in the U.S. and Canada and included more than 875 patients.

• Triathlon Medical Ventures LLC, of Cincinnati, closed a $96 million Midwest-based venture capital fund focused exclusively on life science investments. Triathlon will make private equity investments in early stage emerging companies nationwide. The fund plans to invest in about 20 companies over the next five years with initial investments of between $500,000 and $4 million per company. In addition to its Ohio headquarters, the fund will open offices in Indiana, Kentucky and St. Louis.

• Triton BioSystems Inc., of Chelmsford, Mass., and XOMA Ltd., of Berkeley, Calif., formed an agreement in which Triton has in-licensed the exclusive worldwide rights to commercially use XOMA's antitumor human engineered ING-1 monoclonal antibody with Triton's Targeted Nano-Therapeutics (TNT) System. The TNT System ablates tumors by using tiny magnetic spheres delivered systemically with antibodies. The license to Triton includes U.S. and foreign patent rights related to XOMA's ING-1 and human engineering technologies along with several pending applications.

• Vasogen Inc., of Toronto, presented preclinical research demonstrating the ability of VP025 to significantly delay the onset of disease and increase survival in a model of amyotrophic lateral sclerosis - also referred to as Lou Gehrig's disease. VP025, the lead product candidate from a new class of structurally related drugs, is being developed for the treatment of chronic neuroinflammatory disorders. VP025 is designed to interact with immune cells leading to modulation of cytokines.

• ZymoGenetics Inc., of Seattle, said the FDA gave it clearance to initiate studies with TACI-Ig in patients with advanced B-cell malignancies. Phase Ib studies evaluating the safety and pharmacokinetics of multiple doses of TACI-Ig are planned in patients with multiple myeloma, chronic lymphocytic leukemia and non-Hodgkins lymphoma.

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