• The Association of the British Pharmaceutical Industry has incorporated key recommendations from the Duff report into the TGN1412 clinical trial at Northwick Park, London, into revised guidelines for the conduct of Phase I trials, published this week. "The ABPI Guidelines for Phase I Clinical Trials" are the standard industry reference covering the responsibilities of the principal investigator, nurses and support staff, pharmacy, manufacture and site facilities. The updated guidelines follow consultation with industry, clinical experts and stakeholders, including advice on dosing calculations.

• Biopartners Holdings AG, of Baar, Switzerland, submitted a marketing authorization application for Biferonex (interferon beta-1a), a pH neutral and human serum albumin-free formulation, to the European regulatory agency for treating patients with relapsing-remitting multiple sclerosis. The Biferonex HAS-free formulation is designed to minimize the risk of injection-site reactions and has demonstrated a low incidence of neutralizing antibodies.

• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, said it successfully completed preclinical trials with CF102 and plans to submit an application with the FDA to begin Phase I trials. The product binds to the A3 adenosine receptor, which is overexpressed on the cell surface of liver cancer cells. Laboratory studies have shown that CF102 induces apoptosis of liver cancer cells, Can-Fite said. The nucleoside agent also may have applicability for hepatitis virus, it said.

• Celltran Ltd., of Sheffield, UK, announced the completion of a £1 million (US$1.98 million) funding round, enabling it to advance its range of cell therapies for treating wounds. The round, led by Yorkshire Fund Managers, was supported by all existing shareholders and including South Yorkshire Investment Fund, Innogenetics NV, Biofusion plc, White Rose Technology Seedcorn Fund and PUK Ventures. Celltran's portfolio includes the lead product, Myskin, which currently is generating revenues and is marketed in the UK. Lyphoderm, which will enter Phase III clinical trials shortly, consists of freeze-dried allogeneic skin cells with enhanced storage, shelf life and easy application properties. In addition, the company has two further therapies, Ulcodress and Cryoskin, that are close to obtaining marketing approval.

• EvoGenix Ltd., of Sydney, Australia, began a second project with GlaxoSmithKline plc, of London, under a 2005 research and collaboration agreement. The first project, which involved optimizing a GSK protein using EvoGene protein engineering technology, was completed in March. The second project will be similar to the first. EvoGenix receives research funding, milestone payments and potential royalties on each project.

• London Genetics Ltd., of London, a commercial company set up to provide a single point of contact for firms looking for genetics-related partnerships with London's seven leading research institutes, announced the formation of its scientific advisory board. The board, consisting of a leading expert from each institution, will provide advice on industrial partnerships that make best use of their institutions' resources. The members combine experience in basic, clinical and translational research, with insights into the facilities and expertise available within their respective institutions, enabling them to advise London Genetics on potential partnership opportunities and clinical study design. London Genetics is funded by the London Development Agency.

• Medical Marketing International Group plc, of Cambridge, UK, said it has been granted a Japanese patent on its cancer vaccine technology. The patent, covering vaccines for B cell lymphomas, also has been granted in other territories including the U.S. and Europe. The products recently completed a multicenter Phase I/II trial in patients with lymphoma which met all its endpoints.

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, said the Committee for Orphan Medical Products of the European Agency for the Evaluation of Medicinal Products adopted a positive opinion on granting orphan medicinal product designation to PI-88 for the treatment of hepatocellular carcinoma, or primary liver cancer. The opinion will be submitted to the European Commission for orphan designation determination. PI-88 is an agent designed to inhibit both angiogenesis factors and heparanase. Progen this year plans to launch a Phase III trial to evaluate disease-free survival in patients with post-operative primary liver cancer.

• Santhera Pharmaceuticals, of Liestal, Switzerland, and Takeda Pharmaceutical Co., of Osaka, Japan, said the European Medicines Agency (EMEA) has accepted the filing of the marketing authorization application for Santhera's lead compound SNT-MC17 (INN: idebenone, originally developed by Takeda) for the treatment of Friedreich's Ataxia. The compound, which has been granted orphan drug designation in the European Union, could become the first approved product for the treatment of FRDA and will be marketed in Europe by Takeda. SNT-MC17 has shown clinical efficacy in FRDA patients on neurological as well as cardiac endpoints in several clinical studies and proved to be well tolerated in all studies so far. The application acceptance triggers a milestone payment of €3 million to Santhera from Takeda.

• Sirtex Medical Ltd., of New South Wales, Australia, signed a licensing agreement with Synmosa Biopharma Corp., of Taiwan. The deal covers marketing in Taiwan of Sirtex's SIR-Spheres microspheres for treating advanced liver cancer. Sirtex estimated it would take one or two years to gain approval in Taiwan. Terms of the deal were not disclosed. Sirtex recently licensed the product for other areas of Asia.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and MediWound Ltd., of Yavne, Israel, formed a commercialization agreement regarding MediWound's Phase III burn debridement product, Debrase. Teva gained commercialization rights to the drug in certain countries in exchange for purchasing $10 million in shares from MediWound's shareholders and $5 million in newly issued shares. Teva retains an option to acquire commercialization rights in Europe and North America by purchasing 51 percent of MediWound's shares. Concurrently, MediWound sold $15 million in newly issued shares to certain institutional and private investors.

• TheraGenetics, of London, has named Heiner Dreismann chairman of the board, and Robert Forrester as director. Dreismann most recently was president and CEO of Roche Molecular Systems Inc., the division of Hoffmann-La Roche Ltd. that pioneered clinical molecular diagnostics. Forrester serves as executive vice president and CFO of CombinatoRx Inc., and formerly was senior vice president of finance and corporate development at Coley Pharmaceutical Group.

• Vernalis plc, of Winnerish, UK, and Endo Pharmaceuticals Inc., of Chadds, Ford, Pa., said the FDA is extending the Aug. 19 review date on the new drug application on Frova (frovatriptan succinate) 2.5 mg tablets, for the additional indication of short-term prevention of menstrual migraine. Endo said the FDA needed more time to review the supplemental NDA, and had not requested any additional information or clinical trial data. The FDA in March also asked for a three-month extension on the review. The original PDUFA date was May 19.