• Adnavance Technologies Inc., of Vancouver, British Columbia, completed a Series B financing of C$3.7 million (US$3.77 million) to fund continued development and expansion of its ultra-sensitive metallized-DNA technology. That technology is designed to provide advantages over existing DNA testing methods and might eliminate the need for target amplification for a large number of molecular diagnostic tests. The financing was led by Working Opportunity Fund, managed by GrowthWorks Capital Ltd., JovInvestment Management and Business Development Bank of Canada. The company also appointed V. Randy White CEO.

• Alimera Sciences Inc., of Atlanta, entered a second agreement with Emory University to explore oxidative stress management, specifically the reduction of reactive oxygen species, as a treatment for ophthalmic diseases. The deal gives Alimera the exclusive option to license a class of small-molecule compounds called triphenylmethanes, for use in treating ocular disorders, such as diabetic retinopathy and the dry form of age-related macular degeneration. If the option is exercised, Alimera will be responsible for both development and commercialization, while Emory will receive milestone payments and royalties from net sales. In a September 2007 deal with Emory, Alimera gained an option to license nicotinamide adenine dinucleotide phosphate (reduced form) inhibitors for similar treatments.

• Althea Technologies Inc., of San Diego, said it spun out an independent company to commercialize its genetic testing technology through laboratory services and gene expression products for use in monitoring and managing cancer treatment. The new firm, Althea Diagnostics, will be located within Althea's campus and will build upon commercialized technology for quantitative measurement of multiple genes in a single reaction, as well as new technologies and bioinformatics applications designed to speed development of molecular diagnostic tests.

• Arpida Ltd., of Reinach, Switzerland, reported that the rolling new drug application submission for intravenous iclaprim in complicated skin and skin structure infections will be completed within the next few weeks. The company said there were a few delays due to data being delivered later than expected, as well as additional processing steps required for electronic filing format.

• Axcan Pharma Inc., of Mont-Saint-Hilaire, Quebec, completed the transaction involving the acquisition of all of its common shares by an affiliate of the investment firm TPG Capital. Under the terms of the deal reported in November, Axcan shareholders are entitled to receive $23.35 for each share of Axcan stock held, or about $1.3 billion, and the firm's stock ceased trading on Nasdaq and on the Toronto Stock Exchange. (See BioWorld Today, Nov. 30, 2007.)

• Chembio Diagnostics Inc., of Medford, N.Y., acquired a worldwide, nonexclusive sublicense from Hercules, Calif.-based Bio-Rad Laboratories Inc. for patents relating to HIV-2, which will allow Chembio to manufacture and market its rapid HIV test and support development of its Dual Path Platform HIV oral fluid test. Financial terms of the deal were not disclosed.

• CombiMatrix Corp., of Mukilteo, Wash., said its subsidiary, CombiMatrix Molecular Diagnostics, completed clinical validation and has commercially launched the HerScan test, a Bacterial Artificial Chromosome (BAC) Comparative Genomic Hybridization array-based test for breast cancer. The HerScan test is designed to detect amplification of the HER2 gene in early breast cancer, while simultaneously giving clinicians a complete profile of a patient's tumor genome.

• Genentech Inc., of South San Francisco, said the Patent and Trademark Office issued a final action rejecting the patentability of claims of the company's Cabilly patent (U.S. Patent No. 6,331,415) relating to certain methods used to make antibodies and antibody fragments by recombinant DNA technology. Genentech said it intends to file a response to that action and, should the rejection be maintained, will appeal the decision. In the meantime, the patent will remain enforceable through the appeals process, which might take one to two years, or longer. If the rejection is upheld, Genentech faces losing a royalty stream from other companies making use of that recombinant DNA production technology.

• Lixte Biotechnology Holdings Inc., of East Setauket, N.Y., and collaborator, the Surgical Neurology Branch at the National Institute of Neurological Disorders and Stroke, reported that its lead compound, LB-1, showed anticancer activity against medulloblastoma cells growing in culture and in a mouse model of cancer. Data were presented at the International Conference on Drug Discovery and Development in Dubai, United Arab Emirates.

The National Institutes of Health (NIH) said its eye institute will move forward with a multicenter head-to-head clinical trial comparing the relative safety and effectiveness of South San Francisco-based Genentech Inc.'s Lucentis (ranibizumab) and Avastin (bevacizumab) in treating advanced, or wet, age-related macular degeneration (AMD) in 1,200 patients. Lucentis was approved by the FDA in June 2006 to treat wet AMD. Genentech's cancer drug Avastin, which is chemically similar to Lucentis but costs much less, has been widely used off-label to treat wet AMD. Avastin is thought to remain in the eye longer than Lucentis and therefore possibly allow for less frequent injections. Genentech has opposed the study. The Senate Special Committee on Aging is investigating Genentech's pricing practices related to Lucentis, but the committee recently said it has no plans to hold a hearing on the matter. (See BioWorld Today, Dec. 3, 2007.)

• Neurobiological Technologies Inc., of Emeryville, Calif., amended its license and cooperation agreement with Merz Pharmaceuticals GmbH, of Merz, Germany, and Children's Medical Center Corp. relating to memantine, which is sold in the U.S. as Namenda and in Europe as Ebixa for Alzheimer's disease. Modified terms call for the discontinuation of paying royalties on sales of memantine outside of the U.S. as of the fourth quarter of 2007 and provide for a staged reduction in the royalty rates to be paid to the company and CMCC on sales of memantine in the U.S. beginning the third quarter of 2008. The amendment also provides that neither CMCC nor Merz will give notice of termination of the agreement before July 1, 2009, or to be effective before Jan. 1, 2010. Neurobiological Technologies also reported that it received the payment from Merz due Jan. 30 of royalties, which totaled $2.2 million.

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., appointed N. Anthony Coles president, CEO and board member, effective March 31. He will succeed Hollings C. Renton, who announced his retirement last fall. As a result, Coles will step down from his position as president, CEO and director at Bedminster, N.J.-based NPS Pharmaceuticals Inc., effective March 17. Francois Nader, who currently serves as executive vice president and chief operation officer at NPS, then will take over as that company's president and CEO.

• Polydex Pharmaceuticals Ltd., of Toronto, completed a trial of Ushercell, a cellulose sulphate, cotton-based gel in development for preventing sexually transmitted infections, in rhesus monkeys, in which data showed that none of the six animals in the Ushercell gel group were infected following exposure to simian-human immunodeficiency viruses compared to five of the six macaques to be infected in the placebo group. Those data suggested that the vaginal application of Ushercell gel effectively reduced the infectivity of the virus, and those results contrast with interim results from halted Phase III trials after analysis showed a higher-than-expected seroconversion rate among participants at some trial sites. The company is in the process of further exploring all Ushercell data. The product also is part of an ongoing Phase I trial to assess the safety of several vaginal products.

• PolyMedix Inc., of Radnor, Pa., said data showed that its antimicrobial polymer compounds had activity against certain biowarfare pathogens, including Salmonella typhimurium, Listeria monocytogenes, Yersinia enterocolitica and E. coli 0157:H7, and demonstrated enhancement of activity of the polymers by sesquiterpenoid agents. Those data were presented at the American Society of Microbiology's biodefense and emerging diseases meeting in Baltimore. PolyMedix has filed a patent application for use of sesquiterpenoids to enhance the activity of its polymers.

• PrimeGen Biotech LLC, of Irvine, Calif., said its researchers successfully used purified proteins and DNAs in nonviral methods to reprogram adult human cells - cells derived from adult human tissues such as skin - into stem cells. Relying on a high efficiency particle delivery system to transport proteins and DNA molecules directly into cells, researchers found that after one week, stem cell colonies arose that exhibited the markers of embryonic stem cells and pluripotent cells. Those data were reported at the Stem Cell Summit in New York.

• Sigma-Aldrich Corp., of St. Louis, signed a licensing agreement for a leading marker, developed by NeuroSurvival Technologies Ltd., of Petach-Tikva, Israel, for molecular imaging of apoptosis in vitro and in vivo in animals. The marker, a member of a family of small molecules aimed at targeting apoptosis, will be manufactured and marketed by Sigma-Aldrich under the commercial name Apo-TRACE. Financial terms were not disclosed.

• StemCyte Inc., of Arcadia, Calif., and Rutgers, the State University of New Jersey, reported at the Stem Cell Summit in New York that they entered a research and licensing deal for a spinal cord injury therapy that uses StemCyte's human umbilical cord blood stem cells in conjunction with lithium. Under the terms, StemCyte will provide financial sponsorship for work at Rutgers' W.M. Keck Center for Collaborative Neuroscience and will receive exclusive commercialization rights to the therapy. If a product is commercialized successfully, Rutgers will receive royalties. Specific financial terms were not disclosed.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said the Department of Defense approved a $1.9 million grant to M. Ross Bullock, of the University of Miami Miller School of Medicine and principal investigator for the company's planned Phase IIb trial of Oxycyte in traumatic brain injury. Oxycyte is a perfluorocarbon therapeutic oxygen carrier and blood substitute. The company said the DoD grant will allow it to double the planned enrollment in the Phase IIb study to 200 patients. The trial is expected to start in April.

• Theravance Inc., of South San Francisco, and GlaxoSmithKline plc, of London, expanded the Horizon program into development of a next-generation combination treatment for patients with chronic obstructive pulmonary disorder, starting a large Phase IIb COPD dose-optimization study of GW642444, a long-acting beta agonist. It's expected to enroll about 600 patients with moderate to severe COPD to be randomized to receive a once-daily dose of placebo or drug via a novel inhaler throughout the 28-day treatment period. The primary endpoint will be efficacy, evaluated by change from baseline FEV1 (pre-bronchodilator and pre-dose). That Phase IIb study is in addition to the four Phase IIb asthma studies testing GW642444 and inhaled corticosteroid GW685698 and will be used to guide future development plans and progression into Phase III combination studies in COPD.

• VioQuest Pharmaceuticals Inc., of Basking Ridge, N.J., and the National Cancer Institute entered a clinical trial agreement for VQD-002 (triciribine phosphate monohydrate), the company's small-molecule candidate designed to inhibit activation of protein kinase B, a component of the phosphoinositide 3 kinase (P13K) signaling pathway known to promote cancer cell growth and survival and resistance to chemotherapy. Under the agreement, the NCI will sponsor a trial of VDQ-002 in combination with erlotinib (Tarceva, OSI Pharmaceuticals Inc. and Genentech Inc.), an EGFR inhibitor, based on recent reports suggesting that VioQuest's drug might be useful in enhancing response to erlotinib.