• Active Biotech, of Lund, Sweden, completed three Phase I studies of Anyara to treat advanced non-small-cell lung cancer, renal-cell cancer (RCC) and pancreatic cancer. The upcoming Phase II/III trial is a randomized study of Anyara in combination with interferon A vs. interferon A alone in patients with advanced stage RCC. The primary endpoint is overall survival and the trial will include about 500 patients.

• BioMimetic Therapeutics Inc., of Franklin, Tenn., reported positive results from its 20-patient feasibility trial of GEM OS1 Bone Graft in foot and ankle fusion indications, showing that the product is as effective as autograft for the stimulation of bone healing, without the pain and morbidity associated with the harvesting of the autograft. Assessment of computerized tomography (CT) scans of the fusion site by an independent reviewer blinded to the treatment found that at six weeks, 39 percent of GEM OS1 patients as compared to 34 percent of autograft patients exhibited osseous bridging of greater than 50 percent of the fusion surfaces. Based on that data, plus earlier results from a Canadian study, an independent data monitoring committee recommended expansion of the GEM OS1 U.S. program into pivotal trials.

• Crucell NV, of Leiden, the Netherlands, said the rabies monoclonal antibody product it is developing has entered a Phase I study in the U.S. Crucell has developed the product using its MAbstract and PER.C6 technology. The U.S. trial will be a randomized, double-blind, placebo-controlled study in 60 healthy volunteers that will test the antibody product alone in a dose-escalation study as well as in combination with a rabies vaccine.

• Cyclacel Pharmaceuticals Inc., of Short Hills, N.J., submitted an investigational new drug application to the FDA to begin clinical trials of CYC116, the company's orally available inhibitor of aurora kinases A and B and VEGFR2. CYC116 is the third targeted drug candidate from Cyclacel to enter clinical development in cancer.

• GlaxoSmithKline, of Philadelphia, the U.S. subsidiary of London-based GlaxoSmithKline plc, and Massachusetts General Hospital Cancer Center started a landmark international breast cancer trial, TEACH (Tykerb Evaluation After Chemotherapy). This will be the first Phase III study to investigate whether adjuvant treatment with Tykerb (lapatinib) will improve disease-free survival in women with early stage HER2-positive breast cancer, including those with positive and negative node involvement. An adjuvant therapy is one that is administered in addition to primary surgical or radiation treatment to lower risk of disease progression. About 3,000 women will be enrolled from more than 450 centers in more than 30 countries.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said results from an interim safety analysis of its ongoing Phase IIb PROVE 1 trial of telaprevir (VX-950), a protease inhibitor against hepatitis C virus, showed 65 of 74 patients (88 percent) demonstrated undetectable HCV RNA (less than 10 IU/mL) at week 12, compared to 17 of 33 (52 percent) in the control arm. The incidence of treatment discontinuations due to adverse events was 9 percent and the incidence of serious adverse advents was 3 percent. Based on those results, Vertex earned a $15 million milestone payment from partner Janssen Pharmaceutica NV, a unit of New Brunswick, N.J.-based Johnson & Johnson. A total of 250 patients were enrolled in the study, and Vertex anticipates reporting further results from the trial at a medical forum in 2007.