• Advanced Magnetics Inc., of Cambridge, Mass., closed a registered direct sale of common stock and warrants, and expects net proceeds of the sale to total $13.6 million. The funds will be used to support clinical development programs, including the continued development of ferumoxytol as an iron-replacement therapeutic, and for general working capital purposes. The stock and warrant sale was made to affiliates of Great Point Partners LLC, of Greenwich, Conn., and one of the company's directors. Each unit, comprised of five shares of common stock and a warrant to purchase one share, was priced at $47.50, and the exercise price for each warrant is $13. The company sold a total of 1.5 million shares and warrants to purchase 290,525 additional shares.

• Aerogen Inc., of Mountain View, Calif., appealed the May 25 decision of Nasdaq to delist its stock from the Nasdaq SmallCap Market by filing a request for a hearing before a Nasdaq Listing Qualifications Panel. The company's stock will continue to be listed on the Nasdaq SmallCap Market until the hearing has been held and the panel has issued a decision. Aerogen is a specialty pharmaceutical company.

• Amgen Inc., of Thousand Oaks, Calif., and Wyeth Pharmaceuticals, of Collegeville, Pa., a division of Wyeth, said the FDA approved an expanded indication for Enbrel (etancercept) to improve physical function in patients with psoriatic arthritis. The FDA also approved an update to the Enbrel label to include new radiographic data demonstrating that Enbrel continued to inhibit the progression of joint destruction for two years among most psoriatic arthritis patients who received ongoing therapy. Enbrel was first approved to treat the signs and symptoms of psoriatic arthritis in 2002. (See BioWorld Today, Jan. 17, 2002.)

• Biovail Corp., of Toronto, and Depomed Inc., of Menlo Park, Calif., said the Therapeutic Products Directorate Canada has issued a notice of compliance for 500-mg and 1,000-mg Glumetza, a once-daily, extended-release formulation of metformin hydrochloride to treat Type II diabetes. Biovail said the new formulation should address the problems of poor patient compliance to medications and dosing regimens and it expects to launch the product in the fourth quarter.

• Cell Signaling Technology Inc., of Beverly, Mass., formed an agreement with Emeryville, Calif.-based Chiron Corp. to perform a pilot study employing Cell Signaling's PhosphoScan technology to identify phosphorylation sites and prospective biomarkers of protein tyrosine kinase targets. The technology enables the determination of cellular PTK phospho-profiles and can provide direct insight into disease mechanisms and kinase target function.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, reported results of the first of its Phase I trial tests of CTCE-0214, which showed that it is associated with significant increases in total white blood cell and neutrophil counts in healthy volunteers treated at the highest dose. Those trials are designed to test the safety and efficacy of CTCE-0214 for stimulating rapid mobilization and regeneration of infection-fighting white blood cells and other cells of hematopoietic origin. The company said that CTCE-0214 has the potential to restore a cancer patient's immune system and blood cells between cycles of chemotherapy.

• Codexis Inc., of Redwood City, Calif., received the first milestone payments from New York-based Pfizer Inc. under a research collaboration established in July that focuses on applying Codexis' process research and development platform to some of Pfizer's small-molecule therapeutics. The multiyear, nonexclusive agreement includes up-front payments, technology access fees and milestone payments to Codexis, which could total up to $40 million over the first few years. (See BioWorld Today, July 27, 2004.)

• CoTherix Inc., of South San Francisco, initiated a Phase II trial of its marketed product, Ventavis (iloprost) Inhalation Solution, to expand the indication for pulmonary hypertension associated with idiopathic pulmonary fibrosis (IPF). Ventavis was approved by the FDA in December for the treatment of pulmonary arterial hypertension in patients with NYHA Class III or IV symptoms.

• Crucell NV, of Leiden, the Netherlands, started an evaluation program with Medarex Inc., of Princeton, N.J., to optimize the application of Crucell's STAR technology in bioreactor culture. The program will be performed with a fully human antibody developed using Medarex's UltiMAb technology. Further details were not disclosed.

• Cytogen Corp., of Princeton, N.J., presented seven-year outcome data relating to Prostascint (capromab pendetide), a monoclonal antibody-based molecular imaging agent that targets prostate-specific membrane antigen, during the 26th American Brachytherapy Society Annual Meeting in San Francisco. The data confirm previous studies that show Prostascint imaging can be used to assess the extent and location of disease in prostate cancer patients. The study evaluated the use of Prostascint fusion imaging to assess disease in the prostate gland and lymph nodes of newly diagnosed prostate cancer patients undergoing brachytherapy.

• Diversa Corp., of San Diego, received an undisclosed milestone payment from XOMA Ltd., of Berkeley, Calif., after the companies announced a research and development milestone in their therapeutic antibody generation and optimization license agreement to generate an antibody that binds with sub-picomolar affinity. Under the terms of the agreement signed in January 2004, Diversa uses its evolution technologies to create and optimize antibodies against targets identified by XOMA, and is entitled to milestone payments and royalties on future sales.

• Favrille Inc., of San Diego, enrolled 220 eligible patients into its Phase III registration trial testing its lead product candidate, FavId, following Rituxan in patients with follicular non-Hodgkin's lymphoma. That represents about 65 percent of the 342 randomized, evaluable patients required to be enrolled in the trial. The company expects to complete enrollment by year's end.

• Generex Biotechnology Corp., of Toronto, established satellite offices in Europe and the Middle East. In anticipation of the 2005 submission to the Medicines and Healthcare products Regulatory Agency of an Oral-lyn protocol for the beginning of Phase III trials in Europe, the company established an office in the UK. Oral-lyn is an oral insulin formulation.

• Geron Corp., of Menlo Park, Calif., said Oncogene published data on cell and animal testing of GRN163L, the company's telomerase inhibitor cancer drug. The results describe the synthesis and structure of the drug, its potency for inhibiting telomerase in multiple types of human cancer cells in culture, its ability to trigger telomere shortening and tumor cell death, and its in vivo uptake by tumor tissue and the resulting telomerase inhibition within the cancer cell. The paper was authored by researchers at Geron, the Indiana University Cancer Center and the University of Texas Southwestern Medical Center.

• Helix BioMedix Inc., of Bothell, Wash., said the final results of its warrant exchange, which aimed to exchange 6.2 million warrants to purchase shares of common stock, concluded that 5.5 million warrants were properly tendered for stock shares. The aggregate shares of common stock purchased by holders of existing warrant shares totaled 4.9 million, and the aggregate to the company from proceeds is about $1.5 million. Helix BioMedix has about 20.2 million shares outstanding.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, entered a subscription agreement with a single institutional investor to raise $10 million in gross proceeds through the sale of common stock and warrants. The company has agreed to sell about 1.3 million shares of its stock at $7.50 a share and to issue a four-year warrant to purchase up to an additional 266,667 shares of common stock at an exercise price of $10 a share. The closing of the transaction is scheduled to occur on or before June 3.

• Human Genome Sciences Inc., of Rockville, Md., began dosing patients in a Phase IIb trial of Albuferon in combination with ribavirin to evaluate the efficacy and safety of the drug in chronic hepatitis C virus genotype 1 patients who are na ve to interferon alpha-based treatment regimens. The study will enroll at least 440 patients in Australia, Canada, Czech Republic, France, Germany, Israel, Poland and Romania.

• Insmed Inc., of Richmond, Va., said updated results from the pivotal trial evaluating SomatoKine (mecasermin rinfabate), a once-daily insulin-like growth factor I replacement therapy, delivered as a complex of rhIGF-I/rhIFGBP-3, in children with short stature due to growth hormone-insensitivity syndrome met the trial's primary endpoint of change in height velocity after six months on treatment. All patients in the study were treated with once-daily subcutaneous injections of SomatoKine, and average increase in annualized height velocity from pre-treatment to on-treatment at six months was 5 cm per year. Insmed said increases in height velocity also were related to both the dose received and the IGF-I blood levels reached during treatment. The company filed a new drug application for SomatoKine in January, though it remains in the midst of a patent-infringement lawsuit involving South San Francisco-based Tercica Inc. and Genentech Inc. (See BioWorld Today, Jan. 5, 2005.)

• MacroPore Biosurgery Inc., of San Diego, received $11 million in connection with the equity agreement announced in early May. The company will use the funds to support the research and development of its regenerative cell technology. The company is developing treatments for cardiovascular disease, spine and orthopedic conditions, gastrointestinal disorders and new approaches for aesthetic and reconstructive surgery using regenerative cells from adipose tissue.

• Metabolic Pharmaceuticals Ltd., of Melbourne, Australia, established a Level I American depository receipt program in the U.S., and its registration statement was declared effective May 31. The company is developing product candidates to target obesity, neuropathic pain and Type II diabetes.

• Northwest Biotherapeutics Inc., of Bothell, Wash., received clearance from the FDA to begin assessment of its dendritic cell-based product candidate, DCVax-Brain, in a Phase II trial with about 150 patients. DCVax-Brain is a personalized vaccine that is made from a patient's own cells and mobilizes the patient's immune system to attack brain cancer.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said a research article on the safety and feasibility of convection-enhanced delivery (CED) of Cotara to treat malignant glioma was published in Neurosurgery. The article demonstrated that CED of Cotara resulted in accurate delivery of the prescribed dose of radiation and resulted in favorable tumor coverage while minimizing additional exposure to surrounding healthy brain tissue in 51 patients.

• Protalex Inc., of New Hope, Pa., raised $5.1 million through a private placement of 2.6 million shares of common stock at $1.95 per share with warrants to purchase about 787,000 additional shares. The financing was led by vSpring Capital. Protalex will use the proceeds to finance the upcoming Phase I trials of its lead compound, PRTX-100, in rheumatoid arthritis and pemphigus.

• Sequenom Inc., of San Diego, appointed Harry Stylli president and CEO. He also was elected to the board. Most recently, Stylli served as president and CEO and continues to serve as a member of the board of Xencor Inc. Sequenom provides genetic analysis products that translate genomic science into molecular medicine and biomedical research.

• The Immune Response Corp., of Carlsbad, Calif., initiated a new arm of a Phase I/II trial investigating IR103 for the treatment of HIV. The study will enroll HIV patients who have not yet begun highly active antiretroviral therapy (HAART), and who will receive IR103, Remune or saline over 28 weeks. The trial, which originated in 2004, will evaluate the safety and the ability of IR103, which combines the company's HIV-1 immunogen with Aplivax, to generate HIV-specific immune responses to the drug in patients with and without HAART.

• TransMolecular Inc., of Birmingham, Ala., initiated a Phase II study of intracavitary administered 131I-TM-601 in adults with recurrent high-grade glioma. 131I-TM-601 is a radiopharmaceutical containing a synthetic version of chlorotoxin, a substance derived from scorpion venom, which seeks out and binds to a receptor expressed on tumor cells, but not on normal cells. The product has received orphan drug and fast-track designations. TransMolecular said the Phase II study will be conducted in two parts: first, a dose-escalation, multidose study done in four cohorts of postoperative patients and, second, an open-label, randomized study in a larger group of patients.

• Viventia Biotech Inc., of Toronto, said its lead anticancer drug, Proxinium, was designated as an orphan drug for the treatment of head and neck cancer by the European Medicines Agency for the Evaluation of Medical Products. Proxinium combines a cytotoxic protein payload with the tumor-targeting characteristics of a monoclonal antibody. Proxinium has completed two Phase I exploratory trials.