• Alfacell Corp., of Bloomfield, N.J., said nearly 90 percent of patients are enrolled in its confirmatory Phase IIIb malignant mesothelioma trial for Onconase (ranpirnase) being conducted in the U.S., Canada, Germany, Italy, Poland, Australia and New Zealand. Earlier this year, Alfacell said regulatory changes had delayed the opening of new sites for the study, but government approvals have been obtained and sites recently opened in Russia, Romania, Mexico and Brazil.

• Altea Therapeutics Corp., of Atlanta, completed a Phase II dose-ranging study for its hydromorphone transdermal patch for acute pain. The patch is designed for the rapid onset of analgesia, consistent drug blood levels and fast drug elimination. The patch was tested for three days on 14 patients following knee or hip replacement surgery, and patients had steady serum hydromorphone levels within four hours that remained constant for the test period. Altea focuses on products based on transdermal patches that give continuous delivery of proteins and highly water-soluble drugs through the skin.

• AMDL Inc., of Tustin, Calif., conducted the second closing of a combined Regulation D/Regulation S private offering of shares and warrants. The offering generated total gross proceeds of $1 million, and consisted of the sale of about 2.1 million shares at 32 cents per share and about 1.1 million shares at 31.5 cents per share, along with three-year warrants to purchase an additional about 1.3 million shares at 44 cents each. Proceeds are expected to fund the costs of regulatory approval of products, including the DR-70 cancer blood test, and for general working capital.

• AmpliMed Corp., of Tucson, Ariz., said the FDA granted orphan drug designation to its lead drug, Amplimexon (imexon injection) for the treatment of ovarian cancer. That designation would allow the company seven years of marketing exclusivity following approval. Amplimexon previously received orphan drug status for the treatment of metastatic malignant melanoma, multiple myeloma and pancreatic cancer. The drug is completing a Phase I safety trial and Phase I/II studies in pancreatic cancer with gemcitabine and in metastatic melanoma in combination with dacarbazine.

• Cerenis Therapeutics, of Ann Arbor, Mich., entered a license agreement with Nippon Chemiphar Co. Ltd., of Tokyo, to develop new small-molecule therapies based on PPAR (peroxisome proliferators activated receptor) delta agonists. The agonists have been shown to play a role in elevating levels of HDL. Cerenis will have access to a broad range of PPAR delta agonists for use in research and development of HDL therapies with the potential to help reduce cholesterol buildup through a natural process known as reverse lipid transport.

• Cognetix Inc., of Salt Lake City, reported that the FDA granted orphan drug designation to Cognetix's lead compound, CGX-1160, for the intrathecal treatment of neuropathic pain associated with spinal cord injury. CGX-1160 has completed a Phase Ib trial for the treatment of chronic, intractable pain at Brigham and Women's Hospital in Boston. CGX-1160 is based on a peptide synthesized from marine cone snails.

• Emergent BioSolutions Inc., of Gaithersburg, Md., reported positive results from its Phase II study evaluating a simplified dosing regimen for the next-generation, single-dose oral typhoid vaccine. The 32-subject study demonstrated that a simpler, more rapid dosing schedule did not affect the vaccine's safety profile or the magnitude of the immune response stimulated by the vaccine. Results were published in the August 2005 issue of the Journal of Infectious Diseases.

• Gilead Sciences Inc., of Foster City, Calif., reduced the price for the HIV drugs Viread (tenofovir disoproxil fumarate) and Truvada (emtricitabine and tenofovir disoproxil fumarate) made available through its access program in the developing world. The price decreases are due to increased economies of scale, production at a new plant in the Bahamas that manufactures active ingredient for both products, and continued improvements in the manufacturing process. The new prices of $17 and $26.25 for a 30-day supply represent a 31 percent and 12 percent reduction, respectively.

• IMI International Medical Innovations Inc., of Toronto, completed its previously announced bought-deal private placement, raising C$9.25 million (US$7.6 million). The syndicate of underwriters is being led by Orion Securities Inc., of Toronto, and includes Loewen Ondaatje McCutcheon Ltd., also of Toronto. Net proceeds will be used to fund working capital purposes, including the development of the company's portfolio in cancer detection.

• InforSense Ltd., of London, said the National Cancer Institute selected the company's InforSense technology for high-throughput genetic data analysis in its oncology research.

• Invitrogen Corp., of Carlsbad, Calif., announced the availability of an expanded set of technologies for protein electrophoresis, highlighted by its NuPage Novex Midi-Gels and XCell4 SureLock Midi-Cell apparatus. The technologies will enable researchers to add a high-throughput, large-sample volume compatible solution to their traditional protein separation applications, it said.

• Millennium Biologix Corp., of Kingston, Ontario, entered an exclusive license agreement with the Massachusetts Institute of Technology in Cambridge for commercialization rights on their patents related to "Use of Growth Factors for Expansion of Mammalian Chondrocytes and Engineering of Cartilaginous Tissues." The agreement will allow Millennium to develop and use a specific combination of growth factors in its Autologous Clinical Tissue Engineering Systems for cartilage repair, a point-of-care regeneration product for production of cartilage from the patient's own cell sample.

• Momenta Pharmaceuticals Inc., of Cambridge, Mass., filed an abbreviated new drug application to gain approval of M-Enoxaparin, a generic version of Lovenox. The company is developing the drug in collaboration with Sandoz, the generics division of Novartis AG, of Basel, Switzerland. Lovenox is approved for the prevention and treatment of deep vein thrombosis and acute coronary syndromes. Paris-based Sanofi-Aventis reported worldwide Lovenox sales of $2.4 billion in 2004.

• MultiCell Technologies Inc., of Lincoln, R.I., a supplier of immortalized non-tumorigenic human hepatocytes, received a new Small Business Innovation Research grant to create BioFactories that express a serine protease inhibitor recently implicated as a treatment for sepsis.

• Neuren Pharmaceuticals Ltd., of North Sydney, Australia, initiated a Phase II trial of its lead drug Glypromate. Recruitment has begun for the 30 patients involved in the trial, which is scheduled for completion at the end of 2005. The trial is aimed at confirming the pharmacokinetic profile and safety of Glypromate ahead of a Phase III trial that will assess the effectiveness of the compound as a protection from neurocognitive disturbance following coronary artery bypass graft surgery.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., extended its 2002 collaboration with NV Organon, of Oss, the Netherlands, through 2007. The partnership has delivered multiple lead drugs that are moving into or have completed preclinical toxicological studies. Organon elected to continue the collaboration by accepting the latest preclinical lead candidate generated by Pharmacopeia.

• Regeneration Technologies Inc., of Alachua, Fla., completed a private placement of its stock with a group of accredited investors. RTI sold 2.8 million shares of stock at $8.55 a share for an aggregate purchase price of about $23.9 million. The net proceeds are estimated to be $22.2 million and will be used for general working capital purposes. RTI processes allograft and xenograft tissue into shaped implants for use in orthopedic, cardiovascular and other surgeries.

• TAP Pharmaceutical Products Inc., of Lake Forest, Ill., is initiating Phase III studies for its investigational TAK-390MR for the treatment of acid-related disorders. The new product uses a new modified-release technology of an enantiomer of lansoprazole. TAP is a joint venture between Abbott Laboratories, of Abbott Park, Ill., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and markets Prevacid.

• Tripos Inc., of St. Louis, plans to work with French pharmaceutical company Les Laboratoires Servier, of Paris, to identify potential drugs. Servier, which validated compounds from Tripos' LeadQuest collection, will work with Tripos to further design and synthesize compounds for drug development, using Tripos' chemistry-based technologies. Financial terms were not disclosed.

• Verus Pharmaceuticals Inc., of San Diego, signed a multiyear agreement with Ventiv Commercial Services, a unit of Ventiv Health Inc., of Somerset, N.J., to use Ventiv's Total Data Solutions service to track, analyze and manage its field force activity in conjunction with the U.S. launch of Twinject. Verus acquired exclusive worldwide rights to Twinject, an epinephrine auto-injector for severe allergic reactions, in July from Hollister-Stier Laboratories LLC, of Spokane, Wash.

• ViaCell Inc., of Cambridge, Mass., licensed rights from Thousand Oaks, Calif.-based Amgen Inc. to the use of recombinant human granulocyte colony-stimulating factor for the development of a cellular product to treat hematological malignancies and genetic diseases. The agreement expands ViaCell's collaboration with Amgen, which previously provided ViaCell with nonexclusive rights to certain other growth factors. Under terms of the new agreement, ViaCell granted Amgen a warrant to purchase 200,000 shares of ViaCell stock. No additional terms were disclosed.

• Xechem International Inc., of New Brunswick, N.J., has formed Xechem UK Ltd., a wholly owned subsidiary based in the UK, to expedite the distribution of Nicosan/Hemoxin for the treatment of sickle cell disease. The drug has been designated an orphan drug in the U.S. and an application has been filed for designation in the European Union. Xechem is preparing the drug for application for investigational new drug status in the U.S.

• Xenova Group plc, of Slough, UK, expects its listing on the London Stock Exchange to be cancelled as of Sept. 1. Xenova board members agreed to a buyout in June for up to £26.1 million (US$47.5 million) by Celtic Pharma Group, a private equity business. Shareholders holding about 61 percent of Xenova - or 263 million shares - opted for the cash alternative. Shareholders with 2.7 percent, or 11.6 million shares, chose the cash and secured loan note alternative. Shareholders with 36 percent of the company, or 156.5 million shares, will receive secured loan notes. (See BioWorld Today, June 27, 2005.)

• YM BioSciences Inc., of Mississauga, Ontario, said its subsidiary, Delex Therapeutics Inc., received permission from Health Canada to initiate a randomized Phase IIb study with AeroLEF, its formulation of the opioid, fentanyl, to treat moderate to severe acute pain. AeroLEF is designed to provide personalized, patient-controlled analgesia to address the unpredictable variability in analgesic needs that are a hallmark of acute pain episodes, including breakthrough cancer pain.