• Argos Therapeutics, of Durham, N.C., said an article in the online journal PLoS ONE supports the company's approach to stimulating a patient-specific immune response to HIV infection. The study describes the adaptation of Argos' Arcelis technology platform to create a personalized immunotherapy product that is matched to each patient's unique viral load. That overcomes the extreme patient-to-patient viral diversity that Argos researchers believe is a primary factor in the failure of other HIV immune-based therapies.

• Cytomedix Inc., of Rockville, Md., said it submitted additional data to the Centers for Medicare & Medicaid Services' (CMS) concerning its proposal not to pay for autologous blood-derived products for chronic nonhealing wounds, such as the company's AutoloGel. The company asked that CMS establish coverage for the treatment of chronic diabetic foot ulcers with autologous PRP produced by a device cleared by the FDA

• Lux Biosciences Inc., of Jersey City, N.J., announced Wednesday that the FDA has granted fast-track designation for LX201, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye to prevent corneal transplant rejection. LX201 is being tested in the one-year pivotal LUCIDA clinical trial program, comprising two controlled studies investigating the use of LX201 in patients at elevated immune-mediated risk of rejection or graft loss subsequent to cornea transplantation. LX201 has received orphan drug status in both the U.S. and Europe.

• MiddleBrook Pharmaceuticals Inc., of Germantown, Md., closed its previously announced private placement of common stock and warrants, resulting in $21 million in gross proceeds to the company to support the manufacture of Moxatag, its once-daily amoxicillin product, and for working capital and general corporate purposes. (See BioWorld Today, Jan. 28, 2008.)

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said the FDA has granted priority review for Velcade in patients with newly diagnosed multiple myeloma (MM). The supplemental new drug application submitted to the FDA for that indication included data from the Phase III VISTA study comparing a Velcade-based regimen to a traditional standard of care. The VISTA trial randomized 682 patients with newly diagnosed MM ineligible for stem cell transplantation and was conducted by the company and its co-development partner New Brunswick, N.J.-based Johnson & Johnson Pharmaceutical Research & Development LLC. The trial compared Velcade, melphalan and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. VcMP achieved a statistically significant improvement across all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression and survival (progression-free survival and overall survival). VcMP demonstrated an immunofixation-negative CR rate of 35 percent, which is the highest rate reported in a Phase III trial in patients with newly diagnosed MM, compared to 5 percent in the MP arm.

• Phosphagenics Ltd., of Melbourne, Australia, announced positive results of a preclinical study demonstrating that the combination of its APA-01 product candidate and the statin atorvastatin (Lipitor, Pfizer Inc.) significantly reduced serum lipids and inflammatory proteins involved in the development of atherosclerosis. The results indicated that among animals treated with the APA-01 and atorvastatin combination, total cholesterol levels fell by up to an additional 12 percent compared to animals treated with atorvastatin alone. Total HDL-C (good cholesterol) levels increased by up to 37 percent in combination drug-treated animals, while LDL-C (bad cholesterol) levels were further reduced by up to 24 percent with the combination, as opposed to atorvastatin alone. The combination also caused a decrease of 92 percent in triglycerides levels compared to 72 percent with atorvastatin alone.

• Plexera Bioscience LLC, of Bothell, Wash., has entered into an option agreement with Harvard University spinout company Auguron Biosciences Inc. giving it exclusive access to use Auguron's Nucleic Acid Programmable Protein Array technology on the Plexera Kx Array Platform. The technology enables fresh, functional proteins to be generated on high-density microchips from surface printed DNA.

• Point Therapeutics Inc., of Wellesley Hills, Mass., has adjourned its annual meeting of stockholders until Feb. 12 when stockholders will vote on several proposals in connection with the proposed merger with Dara Biosciences Inc., of Raleigh, N.C. The meeting was adjourned to allow for the solicitation of additional votes in favor of the proposals. While proxies received to date have been overwhelmingly in favor of the merger-related proposals, approval of a majority of the outstanding Point shares is necessary for some of the proposals.

• Sequenom Inc., of San Diego, will conduct a multicenter fetal Rhesus D (RhD) genotype study at centers affiliated with the North American Fetal Therapy Network, a nonprofit research network with expertise in the care for pregnancies at high risk of complex fetal disorders. RhD testing will be conducted at the Medical Genetics Laboratory at Houston-based Baylor College of Medicine, using a laboratory test developed with Sequenom's MassARRAY system and SEQureDx Technology. The prospective, multicenter study, which will enroll 550 pregnant women who are RhD-negative, has two primary goals, to validate the assay for RhD for use as a clinical service offering, and to collect samples for use in later clinical studies to support an FDA application.