• Adventrx Pharmaceuticals Inc., of San Diego, filed an investigational new drug application with the FDA to begin its clinical program for BlockAide/CR for HIV. Adventrx plans to test the drug in patients who have evidence of HIV replication despite ongoing highly active antiretroviral therapy (HAART). The Phase Ib/IIa multidose trial is designed to examine the safety, pharmacokinetics and effect on viral load of BlockAide/CR. The product is intended to inhibit HIV infection, while HAART is used to interrupt viral replication after HIV has gained entry into immune system cells.

• Agilent Technologies Inc., of Palo Alto, Calif., released the Agilent 1100 Series liquid chromatography micro-collection/spotting system, a software-controlled separation solution for proteomics. The product features direct spotting on matrix-assisted laser desorption/ionization mass spectrometry targets. Separately, Agilent formed a new unit within its Life Sciences and Chemical Analysis business group, the Integrated Biology Solutions unit, consolidating management of its gene-expression, proteomics and reagents businesses.

• Australian Cancer Technology Ltd., of Sydney, Australia, opened its U.S. headquarters in Rochester, N.Y. Its U.S. division, known as ACT (USA) Inc., plans to employ 15 to 20 people by the end of this year. The parent company is developing pharmaceuticals and other technologies directed toward the unmet needs of cancer patients.

• Biosite Inc., of San Diego, entered a license and collaboration agreement with DMI BioSciences Inc., of Englewood, Colo., through which Biosite will perform antibody development and marker validation of cysteinylated albumin (cys-albumin), a biomarker that is elevated in blood when a patient is undergoing ischemia. Biosite, which obtained certain exclusive and semi-exclusive diagnostic rights to the biomarker, together with specified sublicensing rights, will pay DMI milestones and royalties for any resulting diagnostic products. Biosite will receive royalties for any products that DMI commercializes.

• Columbia Laboratories Inc., of Livingston, N.J., received UK regulatory approval to market its Striant SR 30 mg Mucoadhesive Buccal Tablet, the first transbuccal for testosterone replacement therapy in men with primary or secondary hypogonadism. It is marketed as Striant in the U.S.

• Connetics Corp., of Palo Alto, Calif., said the FDA accepted its filing of a new drug application for Actiza. The investigational new drug formulation of 1 percent clindamycin is delivered by the company's VersaFoam delivery system as a potential topical treatment for acne.

• CyDex Inc., of Lenexa, Kan., entered an agreement to allow limited use of its Captisol formulation system to Gilead Sciences Inc., of Foster City, Calif. The delivery technology improves a compound's solubility, stability and bioavailability, CyDex said. Financial terms were not disclosed.

• DOR BioPharma Inc., of Miami, generated gross proceeds of about $3.25 million after entering definitive agreements for the private placement of about 4.1 million common shares and warrants to purchase an additional 1.6 shares to institutional investors. The warrants will be exercisable at 87 cents per share for a period of five years, subject to accelerated expiration if the price of the common stock is at or above $1.74 per share for 20 consecutive trading days. The company plans to use the proceeds to complete its ongoing Phase III trial of orBec (oral beclomethasone dipropionate), to further develop its biodefense vaccines for ricin and botulinum toxins, for potential acquisition and/or in-licensing of additional clinical-stage products and for general corporate purposes. Separately, DOR completed the conversion of all of its previously outstanding shares of Series B preferred stock into common shares. The preferred shares were issued as part of a 1997 joint venture with Elan Pharmaceutical Investments Ltd., a unit of Elan Corp. plc, of Dublin, Ireland. Elan voluntary converted 128,203 preferred shares, worth about $12.8 million, into about 2.9 million common shares, equivalent to a conversion price of $4.44 for each share of common stock. DOR no longer has any preferred stock issued or outstanding.

• Eyetech Pharmaceuticals Inc., of New York, presented Macugen data that showed 70 percent of patients lost less than three lines of vision on the eye chart, compared with 55 percent of those receiving sham injection. The new findings, which were presented at the Aspen Retinal Detachment Society Meeting, suggest that the overall efficacy is independent of lesion size and patient age. The data came from two pivotal Phase II/III trials in patients with all subtypes of wet age-related macular degeneration. Macugen is a selective inhibitor of vascular endothelial growth factor.

• GeneMax Corp., of Blaine, Wash., said its contract manufacturer expects to complete this month the first phase of production of the gene vector used in GeneMax's immunotherapy to treat cancer. The initial phase will deliver a number of vector clones to GeneMax for evaluation. The vector is a bioengineered, nonreplicating virus that is designed to deliver the TAP gene to the tumor cells without negatively affecting the patient. GeneMax expects to begin Phase I/IIa trials following FDA approval of an investigational new drug application.

• Genentech Inc., of South San Francisco, said its board conditionally approved a 2-for-1 stock split in the form of a stock dividend. The split would occur if stockholders approve an increase in Genentech's authorized common stock at the annual meeting in April. As of Feb. 17, Genentech had about 527 million shares issued and outstanding. The company's stock (NASDAQ:DNA) rose $1.02 Thursday to close at $109.76.

• Human Genome Sciences Inc., of Rockville, Md., said the FDA selected LymphoStat-B to treat systemic lupus erythematosus (SLE) as part of the Continuous Marketing Application Pilot Two Program. Participation in the program is limited to one fast-track product for each review division within the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. LymphoStat-B, a human monoclonal antibody to B-lymphocyte stimulator, BlyS, is in Phase II trials in SLE patients and rheumatoid arthritis patients.

• Kosan Biosciences Inc., of Hayward, Calif., began a Phase Ib trial of KOS-862 (Epothilone D) to evaluate the product as a cancer therapy in combination with Gemzar (gemcitabine HCl, Eli Lilly and Co.) in patients with advanced solid tumors. They will be administered in a dose-escalating study designed to establish the combination's maximum tolerated dose, pharmacokinetics, safety and potential clinical benefit. Both KOS-862 and Gemzar will be given once weekly for three out of four weeks.

• Kucera Pharmaceutical Co., of Winston-Salem, N.C., said preliminary laboratory data support the continued development of an antiviral compound that has confirmed activity against the causative viral agent responsible for severe acute respiratory syndrome. The company, a 2001 spin-off of Wake Forest University Health Sciences and the University of North Carolina at Chapel Hill, said patents on that use and other antiviral applications were recently filed.

• Large Scale Biology Corp., of Vacaville, Calif., said it is developing a drug to treat a cardiovascular condition as part of its exclusive license agreement with Cincinnati Children's Hospital Medical Center. A recent article in the American Heart Association journal, Arteriosclerosis, described decreases in atherosclerotic plaque in mice on high-fat diets when lysosomal acid lipase (LAL) was administered. The initial research phase will be conducted at the hospital. The company will produce LAL for clinical applications and plans to seek commercial partners for the drug.

• Nektar Therapeutics, of San Carlos, Calif., said the European Medicines Evaluation Agency accepted the filing of an application for Exubera, an inhaled human insulin powder. Pfizer Inc., of New York, and Aventis SA, of Strasbourg, France, submitted the filing, seeking approval to market Exubera for adult patients with Type I and Type II diabetes. The companies are working with the FDA to determine the appropriate timing for submission of a new drug application. Pfizer and Aventis have a global agreement to co-develop, co-promote and co-manufacture inhaled insulin. Nektar, which is collaborating with Pfizer, developed the inhalation device and formulation. Its stock (NASDAQ:NKTR) gained $2.22 Thursday, or 11.4 percent, to close at $21.77.

• Oragenics Inc., of Alachua, Fla., gained exclusive worldwide rights to a platform technology from iviGene Corp., also of Alachua. More specifically, the technology enables the identification of potential therapeutic, vaccine or diagnostic targets implicated in the onset and progression of disease, and the company licensed rights in the areas of cancer and tuberculosis, as well as agricultural and other non-human uses. iviGene will receive royalties on revenues from any resulting products, including royalties on sublicense fees, milestone payments and future product sales. At the same time, Oragenics received a $100,000 Phase I Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., to support development of the technology to identify genes of Mycobacterium tuberculosis that are specifically induced during human infections with that pathogen.

• Vasogen Inc., of Mississauga, Ontario, raised about $57.7 million after closing its previously reported offering, in addition to proceeds generated by an overallotment option. The offering included 8.5 million common shares, as well as the underwriters' purchase of about 1.3 million shares pursuant to fully exercising their option. Vasogen said it would use the proceeds to advance development of Celacade (immune modulation therapy); to further fund its new drug development pipeline, including VP025; and for general corporate purposes. Lead managers for the offering are Needham & Co. Inc. and RBC Capital Markets Corp., with A.G. Edwards & Sons Inc. acting as a co-manager. (See BioWorld Today, March 1, 2004.)

• Zengen Inc., of Woodland Hills, Calif., said findings published in this month's issue of Pharmacological Reviews point to its discovery that activation of melanocortin receptors (MCR) subtypes MC1R and MC3R could be a new strategy to control inflammatory disorders. Researchers showed that MCR activation caused a collective reduction of the major molecules involved in the inflammatory process, and that treatment with melanocortin peptides doesn't abolish the inflammatory response, but instead modulates it.