• aaiPharma Inc., of Wilmington, N.C., received its anticipated income tax refund of $11.3 million and reached an agreement with the lenders under its senior credit facilities to permit the proceeds of the refund to be used for working capital expenses and other general corporate purposes subject to certain restrictions detailed in the agreement. Also subject to conditions, aaiPharma's senior lenders also agreed not to take any action with respect to existing defaults under aaiPharma's senior credit facilities until April 30. The company also confirmed that it did not make the April 1 interest payment on its 11.5 percent senior subordinated notes due 2010. The company has said that it is "highly likely" that it will seek protection under Chapter 11 of the U.S. Bankruptcy Code.

• Access Pharmaceuticals Inc., of Dallas, entered a standby equity distribution agreement (SEDA) with Cornell Capital in which Cornell Capital agreed to finance up to $15 million to support the company's products. In additional, Access has sold an aggregate of $2.6 million in secured convertible debentures, which are convertible into Access common stock at the holders' option at a price equal to $4. Access said the SEDA will allow it to raise capital as required in amounts deemed suitable by the company, with certain limitations, during a two-year period. The company is developing polymer platinates for cancer and focuses on drug delivery technologies including vitamin-mediated targeted delivery, oral delivery and nanoparticle aggregates.

• Acorda Therapeutics Inc., of Hawthorne, N.Y., launched Zanaflex capsules (tizanidine hydrochloride), a capsule formulation of tizanidine, a leading treatment for spasticity in the U.S., the company said. Acorda acquired Zanaflex capsules and tablets from Elan Corp. plc, of Dublin, Ireland.

• American Pharmaceutical Partners Inc., of Schaumburg, Ill., said American BioScience Inc. initiated enrollment in a Phase II study of Abraxane administered weekly with Herceptin (Genentech Inc., of South San Francisco) in the first-line treatment of metastatic breast cancer. The International Oncology Network will conduct the open-label, non-randomized study with 70 patients. The primary endpoint is response rate and the secondary endpoints are time to tumor progression, overall survival and toxicities.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., completed its 12-week pivotal Phase III trial of Bio-E-Gel (bioidentical estradiol transdermal gel) to treat moderate to severe hot flashes in menopausal women. The multicenter, randomized, double-blind, placebo-controlled trial evaluated three doses of the product and enrolled 483 patients. Top-line results should be available by the end of the second quarter, and the company is preparing to file a new drug application.

• Cel-Sci Corp., of Vienna, Va., said its CEL-1000 immune-modulating peptide was shown in mice to protect against viral encephalitis, during a presentation at the American Association of Immunologists' annual meeting in San Diego. The work, supported by two grants from the National Institute of Allergy and Infectious Diseases, adds to earlier studies that showed the peptide modulated the immune system to fight diseases such as herpes simplex virus, malaria and cancer. CEL-1000 is a modified version of a human immune-based protein known to bind to both human and mouse immune cells.

• Clearant Inc., of Los Angeles, completed its reverse merger with Vancouver, British Columbia-based Bliss Essentials Corp., previously traded under the symbol "BLSE." As part of the transaction, Clearant has raised about $11 million through the sale of its common stock, of which about $2.8 million will be used to repay debt, with the balance being used for working capital and general corporate purposes. Clearant focuses on developing pathogen-inactivation methods for biological products and has the Clearant Process, a method designed to sterilize allograft implants in their final packing.

• Cytogen Corp., of Princeton, N.J., said it is undertaking a development initiative for a candidate that uses DOTA-based bifunctional chelant technology to radiolabel Cytogen's monoclonal antibody to prostate-specific membrane antigen (PSMA) with a therapeutic radionuclide. The antibody, called 7E11-C5.3, is directed against an intracellular epitope of PSMA. The technology was not licensed to the PSMA Development Co. LLC, the company's joint venture for PSMA product development.

• Discovery Laboratories Inc., of Warrington, Pa., said Pediatrics published results from its Select and Star Phase III trials that concluded that Surfaxin provided potential advantages over existing surfactant therapy in preterm infants at risk for respiratory distress syndrome (RDS). Surfaxin recently received an approvable letter from the FDA for the prevention of RDS in premature infants. The trials showed that Surfaxin significantly increased survival compared with Exosurf and Survanta, and that more Surfaxin-treated babies survived without developing chronic lung disease. (See BioWorld Today, Feb. 15, 2005.)

• Duska Therapeutics Inc., of Bala Cynwyd, Pa., said the first patient was enrolled in a Phase II trial of its lead drug, ATPace, a liquid formulation of adenosine 5'-triphosphate (ATP) in development as a diagnostic drug for identifying patients with bradycardic syncope who might benefit from pacemaker therapy. Three hundred patients with various types of syncope and 250 control subjects are expected to be enrolled.

• Emisphere Technologies Inc., of Tarrytown, N.Y., retired its remaining debt due to an affiliate of Dublin, Ireland-based Elan Corp. plc in a $13 million cash payment, plus issuance of a warrant to purchase 600,000 shares of the company's common stock at $3.88 per share. Emisphere said that payment finalizes the transaction and eliminates the debt at a significant discount. In December, the companies agreed to reduce the amount due under the note in exchange for an accelerated repayment schedule, with Emisphere paying a total of $26 million and up to 1.2 million shares of stock. The first half of the payment was made Dec. 27. The final half follows a $15.7 million common stock offering completed by Emisphere March 31. (See BioWorld Today, April 4, 2005.)

• Genetronics Biomedical Corp., of San Diego, changed its name to Inovio Biomedical Corp. Effective Monday, Genetronics' American Stock Exchange ticker symbol changed from "GEB" to "INO." Inovio focuses on developing oncology and other therapies using electroporation to deliver drugs and nucleic acids. Separately, Inovio reported the initiation of a Phase I/II trial in prostate cancer undertaken in the UK in collaboration with the University of Southhampton. The trial will use Inovio's DNA delivery technology.

• Helsinn Healthcare SA, of Lugano, Switzerland, said the European Commission granted marketing authorization for Aloxi to prevent acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. Aloxi belongs to the second generation of serotonin subtype 3 receptor antagonists and has shown efficacy during the acute and delayed phases after chemotherapy treatment. Helsinn's partner, MGI Pharma Inc., of Minneapolis, received FDA approval for Aloxi in September 2003.

• Hemosol Corp., of Toronto, agreed to produce two separate iron-binding drugs, 40SD02 and 25SD04, for Biomedical Frontiers Inc., of Minneapolis. The injectable drug formulations will be used for preclinical and clinical studies for treatment of iron poisoning, iron overload and diabetic complications. Production is scheduled to begin in the second quarter.

• Interleukin Genetics Inc., of Waltham, Mass., said annual report filing will be delayed while the company conducts a review of the accounting treatment of its March 2003 sale of Series A convertible preferred stock and convertible long-term debt in previously reported financial statements. Interleukin develops gene-based products for cardiovascular disease, osteoporosis, rheumatoid arthritis, endometriosis and periodontal disease using a functional genomics platform.

• Ipsat Therapies, of Helsinki, Finland, closed a €7 million (US$9 million) private placement, bringing the total amount raised since inception to €19 million. The round was led by Bio Fund Management Oy, with Finnish Industry Investment Ltd., the Varma Mutual Pension Insurance Co. and Sitra also investing. Ipsat said proceeds are expected to fund research and development activities involving its product portfolio, primarily its Phase IIb proof-of-concept trial for P1A, a recombinant enzyme for the prevention of antibiotic-associated diarrhea, antibiotic resistance and gut disturbance. The company also is pursing alliances with partners to expedite commercialization. Along with the financing, Ipsat added new board members Wolfgang Pieken, of MWG Biotech AG and founding partner of Ventac Partners; Aki Prihti, of Bio Fund; Ritta Jaaskelainen, of Finnish Industry Investment Ltd.; Pauli Marttila; and Kai Lindevall.

• IsoTis OrthoBiologics SA, of Lausanne, Switzerland, received 510(k) clearance from the FDA for its DynaGraft II product family for orthopedic applications. DynaGraft II is derived from demineralized bone matrix and delivered in a reverse phase medium for optimal graft containment. The company had orthobiology sales of more than $25 million in 2004.

• Manhattan Pharmaceuticals Inc., of New York, acquired Tarpan Therapeutics Inc., also of New York, in an all-stock transaction that resulted in Tarpan shareholders owning about 20 percent of Manhattan on a fully diluted basis. Through that acquisition, Manhattan adds a Tarpan-developed peptide, PTH (1-34) to its pipeline. The product, designed to regulate epidermal cell growth to treat psoriasis and other dermatological conditions, is expected to begin Phase II trials this year. Tarpan's former CEO, Douglas Abel, has been named president and CEO of Manhattan, as of the completion of the transaction. He also has been appointed to the company's board.

• NexMed Inc., of Robbinsville, N.J., completed enrollment for its Phase I study of NM100060, its nail lacquer treatment for onychomycosis. The double-blind, randomized, parallel study enrolled a total of 60 patients and is designed to assess the safety and pharmacokinetics of NM100060. The product is applied directly to the nail and delivers a low dose of terbinafine HCI into the nail bed. Terbinafine is the active ingredient in the leading oral product marketed for treating onychomycosis.

• Novavax Inc., of Malvern, Pa., named Gary Evans, a director of Novavax since 1998, chairman. Evans' role as chairman will be a nonexecutive position. Denis O'Donnell, former chairman, will remain on the board. The board also approved the promotion of Rahul Singhvi to senior vice president and chief operating officer. Novavax develops a drug delivery technology called Estrasorb.

• Oragenics Inc., of Alachua, Fla., said it has developed a manufacturing process for its antibiotic drug candidate, Mutacin 1140, a peptide that had been difficult to produce. The company said it now can manufacture the product in sufficient quantities to enable preclinical studies needed to file an investigational new drug application.

• Oxford Genome Sciences UK, of Oxford, UK, closed a second round of venture capital investment. The South East Growth Fund led the round, following an initial investment in July, and Oxford Capital partners joined as a new investor. The second tranche has allowed the company to move into a large proteomic facility near Oxford and will be used to accelerate the company's growth, primarily through partnerships, the company said.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., and the National Institute of Allergy and Infectious Diseases have agreed to a collaboration in which NIAID's testing laboratories will screen Peregrine's Anti-Phospholipid Therapy agents, including Tarvacin, for activity against a broad spectrum of enveloped viral pathogens of health and bioterrorism concern. Virus types to be screened as part of the collaboration include herpes viruses, respiratory viruses and pox viruses. Peregrine also announced that, during the first year of an ongoing three-year, $1.7 million grant from NIAID, scientists at the University of Texas Southwestern Medical Center at Dallas, determined that Tarvacin binds to virally infected cells and viral particles such as Pichinde virus, which causes a fatal hemorrhagic fever. Researchers also determined that Tarvacin significantly protected animals challenged with a lethal dose of Pichinde virus. Results from those studies are being presented this week at the American Association of Immunologists' meeting in San Diego.

• Perlegen Sciences Inc., of Mountain View, Calif., received a biodefense partnership grant from the National Institute of Allergy and Infectious Diseases to analyze the genomes of about 150 Yersinia pestis and Yersinia pseudotuberculosis strains. Perlegen will use high-density oligonucleotide array technology to discover a genome-wide set of single nucleotide polymorphisms in the Yersinia species, which will aid in distinguishing strains and understanding their biology. Yersinia pestis is the causative agent of the plague, while Yersinia pseudotuberculosis is a genetically similar species that also can cause infection.

• Protein Polymer Technologies Inc., of San Diego, said a small group of institutional and accredited investors committed $4.2 million in return for about 12.7 million shares of common stock and warrants to purchase up to about 6.4 million shares. About $1.2 million of the committed capital represents the conversion of short-term promissory notes previously issued by the company. The company focuses on protein design and synthesis and has a portfolio of biomaterials.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., raised about $3.2 million through the placement of a convertible debenture with an investor group led by Network 1 Financial Securities Inc. and DC Opportunity Fund Ltd. The new debenture instruments are convertible into common stock at 75 cents per share. The holders also will receive five-year warrants to purchase 4.2 million shares of Provectus' common stock at $1.06 per share. Proceeds will fund the company's Phase II psoriasis trial and its Phase I breast cancer trial.

• Sangamo BioSciences Inc., of Richmond, Calif., said Nature published data that demonstrate the use of the company's zinc finger DNA-binding protein technology to achieve permanent correction of a disease-causing gene in primary human cells. In the study, Sangamo scientists demonstrated the use of engineered zinc finger nucleases to correct errors in the DNA sequence of the IL2Rgamma gene.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., presented results at the annual meeting of the American Association of Immunologists that showed that the effects of Zadaxin result from the intracellular pathway. That suggested that Zadaxin is able to elicit changes in gene expression, in both the immune system and virally infected cells, by promoting the activity of the nuclear transcription factor NF-kB through a pathway that includes the stimulation of Toll-like receptors and their signaling pathway through the molecules TRAF-6 and IKKB.

• Sigma-Aldrich Corp., of St. Louis, completed its acquisition of the Proligo Group from Degussa AG, of Dusseldorf, Germany. Terms of the proposed purchase were not disclosed. Proligo, a global supplier of key genomics research tools including custom DNA, custom RNA and phosphoramidite raw materials used for DNA and RNA synthesis, had 2004 sales of about $40 million. Nine months of Proligo's operating results will be added to Sigma-Aldrich's performance in 2005, increasing overall sales growth by about 2 percent.

• Sonus Pharmaceuticals Inc., of Bothell, Wash., filed a shelf registration statement with the SEC that permits the company to offer and sell up to $50 million in common stock. The company is focused on the development of therapeutic drugs that may offer improved administration, safety, tolerability and effectiveness in treating cancer and related indications.

• Talecris Biotherapeutics Holdings Corp., of Research Triangle Park, N.C., a new corporation that acquired the contributed assets of the plasma business of Bayer HealthCare LLC Biological Products Division, a division of Bayer Group, of Leverkusen, Germany, launched its worldwide therapeutic proteins business, Talecris Biotherapeutics Inc. Private investment firms Cerberus Capital Management LP, of New York, and Ampersand Ventures, of Wellesley, Mass., provided the financial backing for Talecris.

• TolerRx Inc., of Cambridge, Mass., acquired certain intellectual property and material assets from Diabetogen Biosciences Inc., of London, Ontario, as well as access to technology under a patent application and a licensing agreement between Diabetogen and The L'Institut de La Sante et de La Recherche Medicale relating to the therapeutic use of anti-CD3 antibodies in autoimmune diseases. TolorRx also acquired rights to technology and material relating to a panel of fully human anti-CD3 antibodies under a licensing agreement between Diabetogen and Fremont, Calif.-based Abgenix Inc. Financial terms were not disclosed.

• Ventaira Pharmaceuticals, of Columbus, Ohio, completed a private placement of Series C preferred stock totaling $13.5 million. Ventaira is developing a best-in-class next-generation inhalation device using its electrohydrodynamic aerolization and formulation platforms. TL Ventures led the financing, which included a new investor, Battelle Ventures, and several existing investors.

• VioQuest Pharmaceuticals Inc., of Monmouth Junction, N.J., said that its subsidiary, Chiral Quest, introduced its chiral catalyst, DuanPhos, for commercial-scale shipping on a kilogram scale. VioQuest, in addition to acquiring oncologic, metabolic and anti-inflammatory therapeutic compounds for unmet medical needs, offers technologies in the manufacture of optically pure therapeutics for the pharmaceutical industry.

• ZymoGenetics Inc., of Seattle, said that Bruce L.A. Carter, president and CEO, was appointed chairman. Also, David MacCallum was appointed to the board and George Rathmann stepped down as chairman but will remain a member of the board. MacCallum currently is managing director of Outer Islands Capital, a hedge fund specializing in health care investments. ZymoGenetics is focused on the discovery, development and commercialization of therapeutic proteins for the prevention or treatment of diseases.