• Acrongenomics Inc., of Athens, Greece, said it has managed to reshape key IVD molecular applications such as PCR, ELISA and Real Time PCR through its Nano-JETA technology platform, by integrating nanotechnology into molecular biology. The company recently conducted a study to validate the Nano-JETA Real Time PCR via the detection of Ep-CAM gene and beta-actin in peripheral blood of patients suffering from breast and colon cancer and to evaluate the technology platform vs. conventional Real Time PCR methodology in regards to stability, sensitivity, specificity and reproducibility.

• Amgen Inc., of Thousand Oaks, Calif., has submitted a supplemental biologics license application for Aranesp (darbepoetin alfa). The sBLA is based on Phase III data that Amgen believes will demonstrate Aranesp administered every three weeks is safe and effective in the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. If approved, Aranesp will be the first therapy indicated in the U.S. for once-every-three-week dosing in the treatment of anemia. The drug already is approved for the treatment of anemia associated with chronic renal failure in patients both on and off dialysis, and for weekly dosing in chemotherapy-induced anemia in patients with non-myeloid malignancies. In other news, Amgen announced it had completed its offer to exchange up to $2.4 million aggregate principal amount at maturity of its outstanding liquid yield option notes due 2032 for an equal amount of its zero coupon convertible notes due 2032. The exchange offer expired May 5. As of the expiration date, $2.24 million, representing approximately 95 percent of the liquid yield option notes, had been tendered.

• BioPort Corp., of Lansing, Mich., was awarded a $122.7 million contract by the Department of Health and Human Services for the manufacture and delivery of 5 million doses of the anthrax vaccine Adsorbed. The supply of vaccine, which is being purchased under the Project BioShield program, will be placed in the nation's strategic national stockpile in the event of a bioterror anthrax incident.

• Bone Care International Inc., of Madison, Wis., announced plans to move its vitamin D hormone, LR-103, into human subjects with chronic kidney disease, following the filing of an investigational new drug application. The IND focuses on the use of LR-103 to treat secondary hyperparathyroidism in patients with CKD. The company said data available from preclinical research indicate that LR-103 has the same potency as calcitriol, but much lower toxicity. Bone Care, which markets vitamin D hormone, Hectorol, to treat secondary hyperparathyroidism in patients with moderate to severe CKD and end-stage renal disease, said last week it is being acquired by Cambridge, Mass.-based Genzyme Corp. for $600 million. (See BioWorld Today, May 5, 2005.)

• Copernicus Therapeutics Inc., of Cleveland, said studies showed that treating causes of blindness, including retinitis pigmentosa, macular degeneration, diabetic retinopathy and various viral infections may be possible due to a non-viral nucleic acid nanoparticle technology that introduces DNA into cells of the retina and other optic tissues. In collaborative studies with Muna Naash at the University of Oklahoma Health Sciences Center, gene transfer efficiencies of up to 99 percent were achieved, according to findings reported at the 2005 Association for Research in Vision and Ophthalmology meeting in Fort Lauderdale, Fla. Copernicus is advancing nucleic acid delivery systems with applications in therapeutics.

• Cytochroma Inc., of Markham, Ontario, received the first tranche of a C$15 million (US$12.1 million) financing. The company expects to use the funds to advance CTA018 toward a Phase II trial for psoriasis and to extend its pipeline of late-stage preclinical products. The round was led by Toronto-based VenGrowth Private Equity Partners Inc. and included participation from previous investors. Cytochroma is focused on developing and commercializing vitamin D analogues for indications such as psoriasis, secondary hyperparathyroidism, multiple sclerosis and cancer.

• Eyetech Pharmaceuticals Inc., of New York, reported that Health Canada granted approval for Macugen (pegaptanib sodium injection) for the treatment of subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration. Macugen is the first in a new class of ophthalmic drugs to specifically target vascular endothelial growth factor.

• Galileo Pharmaceuticals Inc., of Santa Clara, Calif., promoted Lloyd Kunimoto to CEO. He was previously president and chief financial officer. David Milligan of Bay City Capital was appointed chairman, replacing Guy Miller, who left Galileo to become chairman and CEO of Edison Pharmaceuticals, a subsidiary of Galileo, focused on the treatment of mitochondrial diseases. Miller remains a member of Galileo's board.

• NeoPharm Inc., of Lake Forest, Ill., said updated combined data from three Phase I studies of cintredekin besudotox (IL13-PE38QQR) in brain cancer patients showed that peritumoral Convection Enhanced Delivery of the drug following tumor resection results in a median survival of 44 weeks for the 45 patients who received the cintredekin besudotox infusion. Six patients from the studies remain progression free, with a survival range of 39+ to 190+ weeks (median 89+ weeks) after a single treatment. Data were presented at the Second Quadrennial Meeting of the World Federation of Neuro-Oncology, held in conjunction with the Sixth Meeting of the European Association for Neuro-Oncology, in Edinburgh, Scotland.

• NephroGenex Inc., of Cary, N.C., signed two licensing agreements that provide the company with a kidney-specific molecular profiling technology and inhibitors of a kinase therapeutic target for renal disease. NephroGenex has acquired exclusive commercial rights to the glomerular transcriptome profiling technology developed at the Karolinska Institute in Stockholm, Sweden.

• Reata Pharmaceuticals Inc., of Dallas, said that its lead development candidate, RTA 744, has received FDA clearance to begin testing in patients with advanced brain cancers. RTA 744 is an anthracycline derivative that crosses the blood-brain barrier and shows potential for the treatment of primary and metastatic brain cancers. Additionally, the company reported a change in its name from Reata Discovery Inc. to Reata Pharmaceuticals Inc. to reflect the clinical status of its drug development programs.