• aaiPharma Inc., of Wilmington, N.C., said the Nasdaq National Market appended a fifth character "E" to the company's trading symbol, "AAII," to denote its delinquency in filing its annual report for the year ended Dec. 31. Earlier this month, the company received an anticipated income tax refund of $11.3 million, which it will use for working capital expenses and general corporate purposes. The company expects to file for Chapter 11 bankruptcy, and it plans to file its annual report by April 30.

• Acusphere Inc., of Watertown, Mass., met with FDA authorities to discuss the Phase III trial design to evaluate AI-700 and has decided to increase enrollment from 600 patients to 700 patients. The company has enrolled more than 350 patients to date and enrollment should be complete by early 2006. The new drug application for AI-700 is expected to be filed later that year. AI-700 is designed to enable ultrasound to compete more effectively with nuclear stress testing in detecting coronary heart disease.

• AEterna Zentaris Inc., of Quebec, presented new data on the safety and efficacy of Impavido (miltefosine) at the Third World Conference on leishmaniasis held in Palermo, Italy. Among the data presented were results from a Phase IV study of 1,100 patients that confirmed safety and efficacy of previous studies, but showed fewer cases of vomiting and diarrhea. In a study that supported approval of Impavido in Colombia, about 90 percent of patients showed at least a major improvement of their mucocutaneous lesions and no patients have shown progression of the disease.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its partner, Boston Life Scientific Corp., of Natick, Mass., has received FDA approval for its Liberte bare-metal coronary stent system, which will serve as the platform for BSC's next-generation U.S. paclitaxel-eluting stent system, Taxus Liberte.

• Avanir Pharmaceuticals Inc., of San Diego, said data from its Phase III trial examining Neurodex showed patient improvement during the first week of treatment for pseudobulbar affect in patients with multiple sclerosis. Results indicated after 90 days of treatment, 84 percent of patients receiving Neurodex on a 12-hour dosing schedule reported that their condition improved, as compared to 49 percent of patients who received placebo. Those findings were presented at the 2005 American Academy of Neurology meeting in Miami. Avanir submitted a rolling new drug application for Neurodex in December and expects to receive priority review upon completion of the submission.

• Berlex Inc., of Montville, N.J., and Chiron Corp., of Emeryville, Calif., said preliminary results of the first 16-year, long-term follow-up study of patients with multiple sclerosis from the Betaseron (interferon eta-1b) pivotal trial show that long-term treatment with Betaseron is safe. Data were presented at the American Academy of Neurology meeting in Miami. The study is expected to be completed this year. Betaseron, the first therapy approved in the U.S. to treat relapsing-remitting MS, is manufactured by Chiron and sold in the U.S. by Berlex.

• Caliper Life Sciences Inc., of Hopkinton, Mass., entered a new two-year multi-million dollar minimum purchase agreement with Amphora Discovery Corp., of Research Triangle Park, N.C. Under the new agreement, Amphora has agreed to purchase a minimum total dollar amount per year in LabChip products, with the majority of the yearly purchase commitment to be met through data point purchases. Amphora uses Caliper's microfluidics-based screening systems to screen against drug target classes such as kinases, proteases, phosphatases, ion channels and GPCRs. Further financial details were not disclosed.

• Carrington Laboratories Inc., of Irving, Texas, said the National Institute of Allergy and Infectious Diseases awarded a second year of SBIR funding to its wholly owned subsidiary DelSite Biotechnologies Inc. The $463,000 grant will be used to evaluate the feasibility of using the GelVac system to deliver nasally several different types of antigens associated with common infectious diseases. DelSite said the grant will complete the funding of the $888,000 two-year BioDefense grant awarded in March 2004.

• Celera Genomics Group, of Rockville, Md., and Abbott Laboratories, of Abbott Park, Ill., said two Celera antigen targets have been selected for investigation by Abbott for therapeutic development. They are the first targets to be selected in their collaboration to find cancer therapies. Abbott is screening a number of protein antigens identified and validated by Celera, which might elect to jointly fund clinical development and commercialization of any resulting products.

• Chiron Corp., of Emeryville, Calif., said the South African National Blood Service plans to initiate testing of whole-blood donations using the fully automated Procleix Tigris System with the Procleix Ultrio Assay beginning in September. About 800,000 units annually will be screened individually for HIV-1, hepatitis C and hepatitis B. Financial terms were not disclosed. Procleix assays and systems detect viral RNA and DNA in donated blood and plasma during the very early stages of infection.

• Clarient Inc., of San Juan Capistrano, Calif., entered an agreement with Translational Oncology Research International under which Clarient's BioAnalytical Services business unit will provide various research services for TORI-sponsored studies. TORI is focused on evaluating agents for cancer treatment, while Clarient, formerly ChromaVision Medical Solutions, provides automated cell-imaging systems and oncology laboratory services.

• Crucell NV, of Leiden, the Netherlands, has signed a €21.4 million (US$27.6 million) manufacturing contract with the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases, for the manufacture of vaccines against Ebola infections. Under the terms of the agreement, Crucell will manufacture up to 10 batches of clinical material of the PER.C6-based Ebola vaccine in its own manufacturing facility. Those materials are expected to be used for Phase I and early Phase II studies.

• Curis Inc., of Cambridge, Mass., amended its first agreement with South San Francisco-based Genentech Inc. to extend funding for six months of the ongoing cancer therapeutic development collaboration. An additional $2 million will be provided to support Curis and other third-party resources that are developing Curis' Hedgehog inhibition technology for the treatment of solid-tumor cancers. The companies established their collaboration in June 2003 and the funding was scheduled to end in June.

• Cystic Fibrosis Foundation Therapeutics Inc., of Bethesda, Md., and Galapagos Genomics NV, of Mechelen, Belgium, initiated a two-year target discovery alliance. They will apply Galapagos' adenoviral siRNA and cDNA collections and expertise in assay design to discover and validate drug targets to develop new cystic fibrosis therapies. Galapagos will receive €1.3 million (US$1.7 million) from CFFT, and it has the option to develop the targets identified in its drug discovery programs.

• EntreMed Inc., of Rockville, Md., said the FDA granted orphan drug designation for its lead compound, 2-methoxyestradiol (2ME2, or Panzem) to treat ovarian cancer. In a Phase I study conducted by the National Cancer Institute with Entremed's initial formulation of 2ME2, an ovarian cancer patient experienced a durable partial response after failing three prior chemotherapy regimens. The product is in clinical trials for cancer and preclinical development for non-oncology indications.

• Human Genome Sciences Inc., of Rockville, Md., said results of a Phase II trial of Albuferon (albumin-interferon alpha) in patients with chronic hepatitis C who are native to interferon-alpha treatments demonstrated that the drug is well tolerated and has a prolonged half-life. The company also said results indicated Albuferon shows antiviral activity, with durable dose-dependent reductions in hepatitis C viral load. The mean reduction in HCV viral load of 3.2 log was observed after four weeks in the combined 900-mcg and 1,200-mcg dose cohorts. Those data were presented at the 40th annual meeting of the European Association for the Study of Liver in Paris.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported preliminary 24-week Phase IIa trial data for valopicitabine (NM283) in combination with pegylated interferon for the treatment of hepatitis C. Idenix said nine patients receiving the combination treatment have completed 24 weeks of treatment, and results showed that a mean viral load reduction of 4.5 log10, or more than 99.9 percent. The company also reported that the drug was well tolerated and no trial patients have discontinued treatment due to valopicitabine-related adverse events. Idenix has designed a Phase IIb program to further evaluate valopicitabine, an oral nucleoside analogue, in combination therapy.

• MethylGene Inc., of Montreal, presented preclinical data for MGCD0103 at the 96th American Association for Cancer Research annual meeting in Anaheim, Calif., that showed the compound's inhibitory activity on histone deacetylase (HDAC). The company described its Whole Cell HDAC Enzyme Assay that monitors the inhibitory activity of MGCD0103 both in vitro and in vivo. The product is in Phase I trials in solid tumors and hematological malignancies and the assay method is being used to monitor the pharmacodynamics of the drug.

• Orchid BioSciences Inc., of Princeton, N.J., is seeking stockholder approval to change its name to Orchid Cellmark Inc. The company said the new name will more accurately reflect its position as a leader in the provision of DNA identity testing services. The name combines the reputation of Orchid in the field of genetic variability analysis with the international brand name of Cellmark as a leading provider of DNA testing services. Orchid acquired Cellmark Diagnostics in 2001. (See BioWorld Today, Feb. 14, 2001.)

• Ortec International Inc., of New York, said it was informed by the FDA that the agency has received all the information required to complete its review and arrive at a recommendation for the company's pre-market approval application for OrCel in the treatment of venous ulcers. Ortec said the FDA is expected to communicate its recommendation within the next 30 days. OrCel is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., entered an exclusive agreement with Cura Pharmaceuticals Co. Inc. for the marketing and distribution of carboplatin injection. The exclusivity for Paraplatin, the branded form of carboplatin marketed by New York-based Bristol Myers Squibb Co., expired in 2004 and generic versions of the product have been approved. Spectrum plans to launch its product after receiving final FDA approval expected in the middle of this year.

• Unigene Laboratories Inc., of Fairfield, N.J., completed a $3 million private placement with Fusion Capital Fund II LLC. In conjunction, Unigene has decided to terminate its October 2003 common stock purchase agreement with Fusion. Under the private placement, Unigene sold about 2.1 million shares of common stock and a five-year common stock purchase warrant for 1.1 million shares at an exercise price of $1.8 per share. The company expects that its future financial requirements will be met through sales of its nasal calcitonin product, which is awaiting FDA approval, and milestone payments from its pharmaceutical partners.

• Xencor Inc., of Monrovia, Calif., said Indianapolis-based Eli Lilly and Co. exercised its option to develop one or more therapeutic proteins created by Xencor in an ongoing collaboration. Under terms of the agreement, Xencor granted Lilly an exclusive worldwide license to develop and commercialize certain therapeutic proteins optimized by Xencor using its Protein Design Automation technology. Xencor will receive an up-front license fee and is eligible to receive milestone payments in the event Lilly advances one or more candidates' development. Xencor also could receive royalties on potential sales of any licensed products.