• Archemix Corp., of Cambridge, Mass., entered into a collaboration with New York-based Pfizer Inc. to discover aptamers - single-stranded nucleic acids that combine desirable characteristics of small molecules and antibodies. Archemix will use its SELEX technology to discover the aptamer product candidates, which Pfizer will develop and commercialize. Archemix will receive an undisclosed up-front payment, research funding, milestones and royalties.

• Asuragen Inc., of Austin, Texas, entered into a license agreement with Yale University for exclusive access to rights in inventions developed by Frank Slack for the regulation of oncogenes by microRNAs. Slack's inventions derive from his efforts to characterize the microRNA let-7 in both mammalian and nonmammalian organisms. A collaboration between scientists in the Slack laboratory and at Asuragen revealed that human let-7 regulates the expression of ras and that misregulation of let-7 in human lung cells likely contributes to the development of lung cancer via altered expression of ras. A number of recent microRNA discoveries, including those by Slack, have potential clinical implications. In addition to the exclusive license agreement, Asuragen also has entered into a sponsored research agreement with Slack to fund his miRNA research.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, announced that the second pivotal ceftobiprole phase III study in complicated skin infections met its primary endpoint of statistical non-inferiority versus combination therapy. Ceftobiprole is an anti-MRSA, broad-spectrum cephalosporin developed in collaboration with Cilag GmbH International, a London-based Johnson & Johnson company. The double-blind study treated 828 patients with either ceftobiprole or the combination of ceftazidime plus vancomycin in a 2:1 randomization. Almost one-third of patients had diabetic foot infections, of which three-quarters were moderate to severe cases. Ceftobiprole demonstrated high cure rates in patients with complicated Gram-positive as well as Gram-negative skin infections, including diabetic patients with foot infections. A first regulatory submission is planned this year.

• Biopure Corp., of Cambridge, Mass., received a provisional opinion letter from the United Kingdom Commission on Human Medicines containing comments and questions based on its review of the company's marketing authorization application for Hemopure for the treatment of acutely anemic adult orthopedic surgery patients younger than 80 years of age. Issues the commission labeled as "major" relate to toxicology, quality, clinical efficacy and safety, including the product's benefit-risk balance in the proposed indication when blood is readily available. Topics captioned as "other" include several dozen issues primarily relating to chemistry, manufacturing and controls. Under UK regulations the company has up to six months to respond to the questions, and can request an extension. If marketing authorization is granted, the company could seek registration of the product in other member states in the European Economic Area through the Mutual Recognition Procedure.

• Cell Therapeutics Inc., of Seattle, filed for a special protocol assessment with the FDA to get guidance on the design of a Phase III trial of Xyotax in women with advanced lung cancer. Labeled PGT306, the trial will focus exclusively on women with normal estrogen levels, the patient subset in which the drug demonstrated the greatest survival advantage in past studies known as STELLAR. The latest trial is expected to enroll 300 poor performance status (PS2) women who have advanced-stage, non-small-cell lung cancer and have not received prior chemotherapy. Only women with normal estrogen levels either as a result of premenopausal age or hormone replacement therapy will be randomized. The company hopes to begin the study next quarter pending FDA feedback in the next 30 to 45 days. It also plans to file for Xyotax's European approval this year as a single-agent, first-line treatment for non-small-cell lung cancer in PS2 patients.

• Cleveland BioLabs Inc., of Cleveland, saw its shares rise more than 40 percent on news that a single administration of CBLB612, the lead compound in its Protectans 600 series, resulted in a threefold increase in the number of progenitor stem cells in mouse bone marrow within 24 hours. The number of those stem cells in peripheral blood was increased tenfold within four days of administration, suggesting that the 600 series can promote mobilization and proliferation of stem cells throughout the blood. Shares of Cleveland Biolabs (NASDAQ:CBLI) gained $2.38 Wednesday to close at $7.38.

• DiaDexus Inc., of South San Francisco, entered a collaboration with Mayo Validation Support Services, an affiliate of the Mayo Clinic in Rochester, Minn., to investigate a test featuring a select panel of tumor-specific genes to aid in patient risk stratification and assist in chemotherapy treatment decisions for breast cancer patients. The test uses gene expression profiling to predict recurrence of malignancy in patients diagnosed with primary invasive early stage breast cancer. The collaboration is part of diaDexus' molecular diagnostics program focused on developing tests to aid in the prognosis and staging of breast, colorectal and prostate cancers

• Diakine Therapeutics Inc., of Charlottesville, Va., entered an agreement to allow Mediatech Inc., of Herndon, Va., to market Lisofylline (LSF) to islet cell transplant centers worldwide. The synthetic small molecule is designed to block autoimmune damage to insulin-producing cells that are harvested prior to transplant, potentially improving the procedure's success rate. Terms of the deal call for DiaKine to supply LSF and access to an open investigational new drug application, and Mediatech will combine LSF with transplant media and sell the product. The two companies will share revenue.

• Epiphany Biosciences, of San Francisco, completed an exclusive, worldwide licensing agreement for the diagnostic and therapeutic use of the KSHV/HHV-8 sequence and related patents. Previously, the company had an exclusive option to the patent portfolio from Columbia University. KSHV or HHV-8 has been shown to cause serious and life-threatening disease such as cancer (Kaposi's sarcoma) especially in immunocompromised and HIV-positive patients. The virus also affects immunocompetent patients of Mediterranean, Jewish or African origin. KSHV can be transmitted through saliva, tissue, blood transfusions and bodily fluids. The virus was first discovered by Epiphany Scientific advisory board members Yuan Chan and Patrick Moore.

• Illumina, Inc., of San Diego, and Mayo Clinic in Rochester, Minn., signed a diagnostic collaborative agreement to enable the co-development of molecular diagnostic tests for the study of complex diseases. Illumina will contribute its VeraCode technology and development expertise for the BeadArray and BeadXpress instrument platforms. Mayo Clinic will bring broad knowledge in clinical practice and patient outcome management, along with proficiency in establishing clinical utility of new diagnostic technologies. Terms of the agreement enable the implementation of new clinical tests within Mayo's clinical practice and Mayo Medical Laboratories. Additionally, Illumina will manufacture and market tests worldwide on Illumina's BeadArray and upcoming BeadXpress Reader.

• Insmed Inc., of Richmond, Calif., said the Italian government is requesting that it make its drug Iplex (rhIGFI/rhIGFBP-3) available there for treating patients with amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease). Through an agreement with Cephalon Inc., of Frazer, Pa., which holds European patent rights to IGF-1 for treating ALS, Insmed will provide Iplex to physicians in Italy. The drug will be distributed through an expanded access program, with Insmed receiving payment from Italian health authorities. On Wednesday, the company's stock (NASDAQ:INSM) gained 23 cents, or 22.3 percent, to close at $1.26.

• InteKrin Therapeutics Inc., of Palo Alto, Calif., obtained worldwide development and commercialization rights through a licensing deal with Thousand Oaks, Calif.-based Amgen Inc. for AMG131, now called INT131, a PPAR gamma-selective modulator and partial agonist aimed at treating diabetes and insulin resistance. Financial terms were not disclosed.

• Omeros Corp., of Seattle, said it would receive up to $9 million in equity and grant funding to further develop its schizophrenia drug from the Stanley Medical Research Institute in Chevy Chase, Md. The funding is expected to advance the company's schizophrenia program through the completion of Phase I trials.

• Organon, of Oss, the Netherlands, signed a deal with San Diego-based Huya Bioscience International LLC to develop new drugs in three undisclosed indications. Huya specializes in identifying and licensing Chinese drug candidates for commercialization in Western markets. Financial terms were not disclosed.

• Poniard Pharmaceuticals Inc., of South San Francisco, expanded its research agreement with The Scripps Research Institute to include the discovery of focal adhesion kinase (FAK) inhibitors to treat cancer. The original agreement, signed in August 2005, covered the discovery of novel, small-molecule protein kinase inhibitors as therapeutic agents. The discoveries will be used to bolster Poniard's pipeline of specialty pharma oncology drugs, including lead product picoplatin, which will begin Phase III trials this year.

• S*BIO Pte. Ltd., of Singapore, entered a research collaboration with the Department of Tumorbiology and Microbiology at the Karolinska Institute in Sweden to evaluate the role of the company's histone deacetylase (HDAC) inhibitors in colorectal cancer and to investigate the underlying mechanisms of the development of gastrointestinal polyps and tumors. Terms of the collaboration were not disclosed.