• Aastrom Biosciences Inc., of Ann Arbor, Mich., and its wholly owned subsidiary, Berlin-based Zellera AG, started a bone grafting clinical trial to be conducted by the Institut de Terapia Regenerativa Tisular at Hospital General de l'Hospitalet, Hospital de Barcelona and Centro Medico Teknon, located in Barcelona, Spain. The feasibility trial is designed to demonstrate the safety and effectiveness of Aastrom's Tissue Repair Cells to regenerate new, healthy bone in the repair of non-union large bone fractures.

• Affymetrix Inc., of Santa Clara, Calif., and IBM Corp., of Somers, N.Y., plan to combine their technologies and services to create a worldwide system for integrating genomic research data with patient clinical data, reducing health care costs and improving patient care. The collaboration will use Affymetrix's GeneChip technology and IBM's professional services in areas such as regulatory compliance, and business and systems integration. The H. Lee Moffitt Cancer Center & Research Institute at the University of South Florida is working with the companies to design trials with the latest genetic research findings and determine tailored treatment options for patients.

• Alta Partners, of San Francisco, closed its latest funds, Alta BioPharma Partners III and ACP IV, with more than $475 million in commitments. The funds will be invested exclusively in life sciences companies, from start-ups to advanced clinical-stage companies. The investors include the California Public Employees' Retirement System, TIAA-CREF, Teachers' Merchant Bank and clients of Shott Capital Management, as well as new investments from Adams Street Partners, Auda Ventures, Commonfund Capital, Diamond Capital Management, FLAG Capital Management and Omers. Alta has funded more than 90 companies since its 1996 founding.

• Amphora Discovery Corp., of Research Triangle Park, N.C., entered a two-year research agreement focused on chemical biology and lead generation at global research sites belonging to Aventis SA, of Strasbourg, France. Amphora will employ its drug discovery capabilities to identify small-molecule kinase inhibitors for multiple potential therapeutic targets. The agreement also includes high-content profiling, ion channel research and technology enhancement. Aventis, which agreed to pay Amphora research funding, milestones and royalties on future products, also has an option to extend the collaboration. The total value of the deal could be substantial if all milestones are achieved, the partners said, though specific financial terms were not disclosed.

• Amylin Pharmaceuticals Inc., of San Diego, began a Phase II study of exenatide LAR in Type II diabetes and a Phase I study of AC162352 in obesity. It also completed enrollment of a Phase II study of AC137 for obesity. Exenatide LAR, the long-acting-release formulation of exenatide being developed with Eli Lilly and Co., of Indianapolis, and Alkermes Inc., of Cambridge, Mass., will be evaluated in up to 60 diabetes patients. The study of AC162352 will enroll up to 80 healthy volunteers. And the study of AC137, a pramlintide, is designed to evaluate safety and tolerability of rising doses in about 200 obese patients with and without diabetes. Data are expected in the second half of this year.

• Biofrontera AG, of Leverkusen, Germany, reported positive interim Phase II results showing that BF-Derm1 reduced urticaria symptoms by 30 percent to 40 percent, on average, with no relevant side effects. The product is a histidine decarboxylase inhibitor.

• Cardiome Pharma Corp., of Vancouver, British Columbia, began its second Phase III study of RSD1235 for the acute treatment of atrial fibrillation. The study, called ACT 2, will evaluate the efficacy and safety of intravenous RSD1235 in patients who have developed transient atrial fibrillation following cardiac surgery. The 210-patient, placebo-controlled study will be conducted in 25 centers in the U.S., Canada and Europe. ACT 2 is the second of an expected three Phase III studies that Cardiome will undertake prior to filing for U.S. approval in conjunction with Fujisawa Healthcare Inc., of Deerfield, Ill. At the same time, Cardiome said its ACT 1 study has progressed more quickly than expected, and it now expects to report results prior to the end of this year. It began last August, just months after Cardiome detailed plans for the pivotal program. (See BioWorld Today, May 15, 2003.)

• Cell Signaling Technology Inc., of Beverly, Mass., entered a distribution and co-marketing agreement with ProQinase GmbH, of Freiburg, Germany, for the full line of ProQinase purified enzymes. Cell Signaling will distribute the 70 kinases on a scale for high-throughput screening and research, and in validated kinase assays for the drug discovery market. ProQinase's enzymes together with Cell Signaling's phospho-specific antibody reagents will create assay systems enabling kinase inhibitor drug discovery, lead optimization and profiling.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, extended its collaboration agreement with Lonza Biologics plc, of Slough, UK. Lonza researchers gain continued nonexclusive access to Chromos' ACE System for evaluation in its contract manufacturing business. Chromos' chromosome-based technology enables the rapid engineering of cell lines to express specific genes. The collaboration is extended until the fourth quarter of this year, and it includes an option to license Chromos' ACE System with Lonza's GS System for use in cellular protein production.

• Commonwealth Biotechnologies Inc., of Richmond, Va., entered a two-year agreement with DynPort Vaccine Company LLC, of Frederick, Md., in which both companies will compete for new biodefense vaccine development funding. They have a long-standing relationship wherein Commonwealth has provided DynPort with research, development and production capabilities in support of DynPort's biodefense programs, including three contract proposals valued at more than $30 million.

• Corixa Corp., of Seattle, agreed to license and supply its RC-529 adjuvant to Aventis SA, of Strasbourg, France, in the development of several infectious disease vaccines. The agreement calls for Aventis Pasteur, the vaccines business of Aventis, to pay Corixa up-front license fees, as well as success-based milestone and royalty payments. Aventis Pasteur, which committed to placing annual orders for supply of the adjuvant based on clinical trial and commercial forecasts, could add additional nonexclusive vaccine fields in the future, subject to availability and future payments to Corixa by Aventis Pasteur. More specific details were not disclosed.

• Crucell NV, of Leiden, the Netherlands, said it would receive up to about $3.5 million from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., to support the development of a malaria vaccine candidate. The funds will cover process development of the AdVac-based malaria vaccine, including the production of clinical trial material and an investigational new drug filing.

• CV Therapeutics Inc., of Palo Alto, Calif., filed for European approval of Ranexa (ranolazine) in chronic angina. To support current and potential activities in Europe, the company established a UK-based subsidiary called CV Therapeutics Europe Ltd., naming Huw Jones president and David Rowley-Jones nonexecutive director. CV's product has been in the FDA regulatory review process, most recently receiving a panel recommendation for another trial. (See BioWorld Today, Dec. 10, 2003.)

• DOV Pharmaceutical Inc., of Hackensack, N.J., raised $10 million after entering a definitive agreement with an unaffiliated institutional investor for a private placement of 666,667 common shares at $15 apiece. The company, which is developing drugs for central nervous system and cardiovascular disorders, said the additional funds, together with existing cash on hand, would support operations well into next year. The offering is expected to close within two days.

• Eidogen Inc., of Pasadena, Calif., agreed to provide a pilot license to its Target Informatics Platform (TIP) software to Boehringer Ingelheim GmbH, of Ingelheim, Germany. TIP is a structural informatics enterprise software solution that bridges the gap between bioinformatics and cheminformatics, Eidogen said.

• Entelos Inc., of Foster City, Calif., agreed to provide the Massachusetts Institute of Technology in Cambridge a biological modeling platform that MIT will use to build in silico models for immunology research. A collaborative team from MIT and Entelos will work to understand how and why intracellular signaling breaks down in certain immune system cells.

• Human Genome Sciences Inc., of Rockville, Md., received a milestone payment from London-based GlaxoSmithKline plc for the start of Phase I trials of 677116 to treat cardiovascular disease. The drug is a small-molecule inhibitor of lipoprotein-associated phospholipase A2, an enzyme associated with the formation of atherosclerotic plaques. GSK discovered the compound, the third of its kind in clinical development, under a collaboration begun in 1993 with HGS. In addition to the milestone payment, HGS is entitled to an additional payment for regulatory filings, as well as royalties on sales.

• InterMune Inc., of Brisbane, Calif., announced results from an exploratory Phase II trial investigating the effects of Actimmune (interferon-gamma-1b) on the expression of biological markers associated with idiopathic pulmonary fibrosis, a disease characterized by progressive scarring or fibrosis of the lungs, which ultimately results in death. The results provide clues to the molecular mechanisms through which interferon-gamma-1b might affect patients with IPF. The study will be published in the American Journal of Respiratory and Critical Care Medicine. Actimmune is approved to treat severe, malignant osteopetrosis and chronic granulomatous disease.

• Medivir AB, of Huddinge, Sweden, and the Population Council in New York reported preclinical findings at the Microbicides 2004 International Congress in London on a combination of MIV-150 and Carraguard against HIV transmission. Developed by Medivir, MIV-150 is an inhibitor of HIV, while Carraguard is a microbicide gel developed by the nonprofit organization for women in order to prevent sexual transmission of HIV. Findings showed that MIV-150 inactivates HIV outside the cell, Carraguard prevents HIV from penetrating into a cell and MIV-150 blocks the multiplication of HIV that could have penetrated into a cell.

• Merck & Co. Inc., of Whitehouse Station, N.J., completed its acquisition of Aton Pharma Inc., of Tarrytown, N.Y. Founded in April 2001, Aton was focused on identifying and developing small-molecule inhibitors of chromatin-modifying enzymes. (See BioWorld Today, Feb. 24, 2004.)

• Nektar Therapeutics, of San Carlos, Calif., completed the redemption of all of its 3 percent convertible subordinated notes due June 2010. The outstanding principal amount of the notes at the time of the redemption was about $133.3 million. Holders of all of the notes converted them into common shares prior to the March 29 redemption date, and none of the notes were redeemed for cash. About 11.7 million shares will be issued as a result.

• OriGene Technologies Inc., of Rockville, Md., provided the TrueClone Collection of more than 20,000 full-length human cDNA clones to the Tokyo-based Riken Protein Research Group for use in structural proteomics and related protein functional analysis programs. Riken's mission is to establish a research system for genome- and proteome-based structural biology. OriGene is a molecular tool provider for system biology studies that uses high-throughput gene cloning and gene expression profiling to develop products.

• Pain Therapeutics Inc., of South San Francisco, began a second Phase III study of Oxytrex to evaluate the oral painkiller's ability to treat severe osteoarthritic pain. The randomized, double-blind, multicenter, 700-patient trial is designed to confirm the compound's efficacy and safety compared to placebo and oxycodone. The company expects to complete patient enrollment by early next year, with data to follow. Pain Therapeutics began a similarly sized study last summer in patients with severe low-back pain. (See BioWorld Today, July 1, 2003.)

• Peninsula Pharmaceuticals Inc., of Alameda, Calif., began patient enrollment in two concurrent Phase III trials of its lead product, doripenem, for complicated intra-abdominal infections (cIAI). The multicenter, international, double-blind, randomized trials will evaluate the safety and efficacy of intravenous doripenem with a primary endpoint of clinical response at four to six weeks following the completion of therapy in patients who have been enrolled with a confirmed bacterial pathogen. Also known as S-4661, the broad-spectrum antibiotic is a new member of the carbapenem class of beta-lactam antibiotics. The company began a Phase III study of the drug in urinary tract infections late last year. (See BioWorld Today, Dec. 29, 2003.)

• QLT Inc., of Vancouver, British Columbia, said it will acquire privately held Kinetek Pharmaceuticals Inc., also of Vancouver, in a deal approved by special resolution of Kinetek shareholders and the British Columbia Supreme Court. The transaction is expected to close today. Under the terms, QLT will make an aggregate cash payment to Kinetek shareholders of about $2.7 million. Since June 2001, QLT and Kinetek have collaborated on a research and early development program to develop signal transduction inhibitors for the treatment of eye, immune system and kidney diseases. QLT's stock (NASDAQ:QLTI) closed Tuesday at $26.60, up $1.99.

• Telik Inc., of Palo Alto, Calif., began a Phase III trial of Telcyta (TLK286) administered as a single agent in non-small-cell lung cancer patients who have failed two prior chemotherapy regimens. The multinational registration study, designated ASSIST-2 (Assessment of Survival in Solid Tumors-2), is expected to enroll about 520 patients who are being randomized to Telcyta treatment or to a control group receiving Iressa, the approved third-line treatment for that cancer. The trial is designed to evaluate whether Telcyta reduces the risk of death, leading to an increase in survival, as compared to the control group treatment. Additional endpoints include time to tumor progression and objective response rate. Telik's ASSIST-1 trial, a multinational Phase III study to assess Telcyta in women with resistant ovarian cancer, began last fall. (See BioWorld Today, Oct. 2, 2003.)

• The Immune Response Corp., of Carlsbad, Calif., started a new HIV clinical trial in Canada. Remune, the firm's lead product candidate, will be included in a study investigating the ability of therapeutic HIV vaccination to delay rebound in plasma viremia after scheduled interruption of antiretroviral therapy. The three-arm, double-blind, randomized trial will start in early April and will run for more than 18 months.

• V.I. Technologies Inc., of Watertown, Mass., has recruited 20 trial sites for the company's Phase III acute transfusion study with the Inactine Pathogen Reduction System for red blood cells. Fourteen of the sites are actively screening and enrolling patients and six hospitals currently are in the approval process with their institutional review boards, and are expected to start enrolling patients in the near future.

• Valentis Inc., of Burlingame, Calif., completed enrollment for its Phase II study of Deltavasc in patients with peripheral arterial disease. The randomized, double-blind, placebo-controlled study began in July and includes 100 patients at 20 U.S. centers. Patients are receiving either Deltavasc or placebo. The primary endpoint is improvement in exercise tolerance. Valentis expects preliminary data by the end of the third quarter. Deltavasc is a formulation of the angiogenesis gene Del-1 with a polymer delivery vehicle.

• Viragen Inc., of Plantation, Fla., entered an agreement to obtain rights to a gene delivery technology to be evaluated in its collaboration with Roslin Institute in Edinburgh, Scotland, to develop avian transgenic technology as a biomanufacturing platform. It acquired an option to purchase an exclusive worldwide commercial license to the electroporation technology for use within the field of avian transgenics. Viragen gained the rights from privately held RMR Technologies LLC, of Coral Gables, Fla., and the University of South Florida in Tampa. Financial terms were not disclosed.

• Zonagen Inc., of The Woodlands, Texas, said it would concentrate its resources on the clinical development of Progenta for uterine fibroids and completing a study of Androxal for male hormonal deficiency as part of a new near-term business strategy. As a result, the company said it plans to out-license its other product candidates, including its phentolamine-based products for sexual dysfunction, such as Vasomax for male erectile dysfunction, a female version called Bimexes, a combination oral treatment for male erectile dysfunction and Erxin, an injectable combination treatment for male erectile dysfunction. Its non-phentolamine-based products include two different chitosan-based vaccine adjuvants; zona pellucida and hCG immunocontraceptive vaccines; a therapy for the treatment of genital herpes and two prostate therapeutic vaccines, one for hormone-dependent tumors and the other for hormone-independent tumors. Vasomax was partnered with Schering-Plough Corp., of Kenilworth, N.J., until a mutual termination in 2002. (See BioWorld Today, July 16, 2002.)