• Alfacell Corp., of Somerset, N.J., said in vitro data showed that a combination of Onconase (ranpirnase) and Avandia (rosiglitazone), marketed by GlaxoSmithKline plc, of London, decreased cell viability and increased cell apoptosis in several cancer cell lines, including lung, breast, prostate and ovarian, due to decreased Fra-1 and Survivin expression. The results, published in Molecular Cancer Therapeutics, suggested that combined therapeutic use may overcome the resistance produced in some cancer cells by the activation of survival pathways and their targets.

• Curis Inc., of Cambridge, Mass., said it has selected CUDC-305, an orally available, synthetic small-molecule inhibitor of heat-shock protein 90, as a development candidate from its targeted cancer drug development platform. The firm said it expects to initiate investigational new drug-enabling studies soon and anticipates that, assuming the outcome of those studies is favorable, it will file an investigational new drug application for CUDC-305 in mid-2009. Curis said that CUDC-305 demonstrated potent efficacy across a broad range of cancers in preclinical cancer models and has exhibited promising pharmacological features, particularly its high oral bioavailability, high tumor penetration and extended tumor retention.

• Exelixis Inc., of South San Francisco, initiated a pivotal Phase III trial of XL184 for medullary thyroid cancer. The randomized, double-blind, placebo-controlled, single-agent study is being conducted under a special protocol assessment with a primary endpoint of progression-free survival. XL184 is a small molecule targeting the MET, RET and VEGFR2 kinases. (See BioWorld Today, June 17, 2008.)

• Gamida Cell Ltd., of Jerusalem, has entered into a licensing agreement with Amgen Inc., of Thousand Oaks, Calif., for the use of a number of proprietary cytokines in the manufacturing of StemEx for Gamida Cell's pivotal registration study of StemEx and its subsequent commercialization. Under the terms of the agreement, Amgen will receive a minority equity interest in Gamida Cell in addition to royalty payments from future sales of StemEx for hematological diseases. Gamida Cell will receive a nonexclusive license to manufacture and use a number of cytokines for StemEx manufacturing. Financial details were not disclosed.

• Ikaria Holdings Inc., of Clinton, N.J., said through its subsidiary, INO Therapeutics, that Japan's Ministry of Health, Labor and Welfare approved INOflo (nitric oxide) for hypoxic respiratory failure with concurrent pulmonary hypertension in neonates. INOflo (marketed as INOmax in the U.S.) is the first pharmaceutical gas to be approved in Japan and has received orphan drug status in that country. INOflo will be imported and distributed via a partnership with Air Water Inc., of Fountain Valley, Calif., and Sumitomo Seika Chemicals, of Japan.

• Isotechnika, of Edmonton, Alberta, said F. Hoffmann-LaRoche Ltd., of Basel, Switzerland, has given up its licensing rights to voclosporin for solid organ transplant. Roche had acquired those rights as part of a 2002 deal. Isotechnika said it will open licensing talks to potential partners for both transplant and autoimmune indications. Voclosporin, a next-generation calcineurin inhibitor, recently completed a Phase IIb trial for the prevention of kidney rejection following transplantation. An extension to the Phase IIb trial and a combined Phase III European/Canadian trial for the treatment of moderate to severe psoriasis are ongoing. Isotechnika is partnered with Lux Biosciences Inc., of Jersey City, N.J., in three separate Phase II/III pivotal trials investigating voclosporin for the treatment of uveitis.

• Sound Pharmaceutics, of Seattle, said it received an additional contract from the Office of Naval Research for about $1.6 million to continue research and development of its lead drug candidate for hearing regeneration. The ONR's new funding of that project, which was begun in 2005, brings the total to about $3 million. The company has developed a technology involving p27Kip1, a cyclin-dependent kinase inhibitor, in the inner ear of mammals.

• Tekmira Pharmaceuticals Corp., of Vancouver, British Columbia, said it has selected ApoB SNALP and PLK1 SNALP as its two lead product candidates and plans to advance both into clinical development in 2009.