• Ark Therapeutics plc, of London, said that following a recent independent data and safety monitoring board review of the Phase III trial of Cerepro, its gene therapy treatment for glioma, patients in the study will be followed until the end of June. At that point there will be enough data to provide reliable statistical evaluations of the clinical effects. In trials completed to date Cerepro produced an average extension of 7.5 months of life, giving around 15.5 months survival, whereas controls survived on average for about nine months.
• BioAlliance Pharma SA, of Paris, will move into new European headquarters in February. Located just down the road from its existing head office, it has more than double the floor space and will enable the company to bring together its entire staff at a single site.
• Cancer Research Technology Ltd., of London, the technology transfer arm of the charity Cancer Research UK, said it granted Glycart Biotechnology AG, of Zurich, Switzerland, rights to develop a preclinical antibody discovered by CRT. The antibody selectively binds to an unnamed cell surface protein that is overexpressed in certain types of cancer, including colorectal cancer. Glycart will use its GlycoMAB technology to enhance the efficacy of the antibody. A collaboration has been set up between CRT, Glycart and Oxford University to carry out preclinical studies on the glyco-engineered antibody.
• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, said a preclinical study of CF101 for uveitis conducted by the NIH's National Eye Institute demonstrated that the drug reduced ocular disease symptoms. Can-Fite and the NIH signed a cooperative research and development agreement to continue preclinical work.
• Cobra BioManufacturing plc, of Keele, UK, said David Thatcher is leaving his post as CEO after 15 years with the company. He is not being replaced, but Simon Saxby has been appointed chief operating officer and will join the board. Thatcher became CEO in 2002 when the company dropped its in-house development programs to focus on manufacturing DNA-based products for third parties. He was manufacturing director of the company when it was spun out of the UK Medical Research Council in 1992 as Therexsys Ltd. Thatcher will become a nonexecutive director and also will act as consultant for Cobra's oral vaccine project. Saxby most recently was CEO of Alpha Biologics Sdn Bhd, a Malaysian contract manufacturing organization.
• Daiichi Sankyo Inc., of Tokyo, said the FDA has approved WelChol (colesevelam hydrochloride), a polymer-based therapy that targets cholesterol, as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes mellitus.
• Eisai Co. Ltd., of Tokyo, and MGI Pharma Inc., of Bloomington, Minn., said the Federal Trade Commission granted early termination of the statutory waiting period applicable to the firms' acquisition deal announced last month. Eisai agreed to purchase all outstanding shares of MGI for $41 per share, or about $3.9 billion.
• Eurofins Scientific, of Nantes, France, has brought forward by two years its objective of achieving annual revenues of €600 million (US$876.7 million). It now expects to reach that milestone this year and to increase its annual revenues to €720 million in 2009 and to €1 billion by 2011. When it raised its revenue forecast for 2007 from €450 million to €460 million last November, it said its revenues would increase by a further 20 percent to €550 million in 2008. Eurofins pointed out that over the past decade the company doubled in size every two years on average. For the future, it is hoping for 20 percent a year revenue growth through a 50:50 combination of organic and external growth.
• ExonHit Therapeutics SA, of Paris, created separate business units to manage molecular diagnostics and therapeutics. In the coming year, the company expects to launch new whole-genome microarrays for rats and mice, commercialize a blood-based diagnostic for Alzheimer's disease and partner EHT0202 based on Phase II data in neurodegenerative disorders.
• Galapagos NV, of Belgium, has been awarded a €4.4 million (US$6.6 million) grant by the Flanders government for rheumatoid arthritis drug development. The three-year project is entitled "Kinases in Inflammation," and will build on new biological models already developed to evaluate the effectiveness of small molecules to treat RA, as well as to develop and validate biomarkers to monitor disease progression and therapeutic response.
• Henderson Morley plc, of Birmingham, UK, signed a collaborative research agreement with the Australian Centre for Vaccine Development, part of the Queensland Institute of Medical Research, to jointly develop a vaccine targeted against cytomegalovirus disease, the most important preventable infectious disease of unborn children in the developed world. The collaboration will use a combination of technologies from Henderson Morley and the center, with each party bearing its own development costs and sharing any new intellectual property.
• MolMed SpA, of Milan, Italy, said AIFA, the Italian Health authority, authorized the a Phase III trial of its TK cell therapy in patients affected by high-risk acute leukemias and receiving hematopoietic stem cell transplantation from a partially compatible family donor, the first such approval in the country. The multicenter, randomized Phase III trial builds on the Phase I/II trial TK007, which showed improved survival and demonstrated the feasibility of transplantation from partially incompatible family donors. The product uses ex vivo gene delivery technology licensed from Oxford BioMedica plc, of Oxford, UK, and the start of the trial triggers an undisclosed milestone payment to the company.
• MorphoSys AG, of Martinsried, Germany, revealed that the human cytokine granulocyte macrophage-colony stimulating factor (GM-CSF) is the target of MOR103, a HuCAL-derived antibody for rheumatoid arthritis. MorphoSys also said it acquired patents covering GM-CSF inhibitors from the University of Melbourne in exchange for undisclosed up-front payments, milestone payments and royalties. MorphoSys is planning a randomized, double-blind, placebo-controlled, single-ascending dose Phase I trial of the drug, which it anticipates could provide an alternative to antitumor necrosis factor approaches to treating inflammatory disease.
• Nycomed, of Zurich, Switzerland, received FDA approval of its inhaled corticosteroid, Alvesco (ciclesonide), for prophylactic and maintenance treatment of asthma. The company said it is in negotiations with potential U.S. marketing partners. Alvesco previously had been approved in 44 countries.
• PamGene International BV, of s-Hertogenbosche, the Netherlands, signed a deal with Carlsbad, Calif.-based Invitrogen Corp. to co-market Invitrogen's Nuclear Hormone Receptor proteins and Lanthascreen assay technology with its portfolio of microarray-based Nuclear Hormone Receptor screening tools, namely its PamChip applications and PamStation instrumentation. Financial terms were not disclosed.
• Pharmaxis Ltd., of Sydney, Australia, said the Korean regulatory agency granted marketing approval of Aridol in asthma. The product will be distributed by Korean firm BL&H Co. Ltd. Pharmaxis said it will begin premarketing activities while seeking reimbursement approval through the national health scheme. The approval process is expected to conclude in the third quarter.
• Protherics plc, of London, said its licensee AstraZeneca plc, also of London, treated the first patient in an expanded Phase II trial of CytoFab in severe sepsis. The Phase II program will consist of two separate studies, with the first designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CytoFab produced by a revised, scaled-up manufacturing process enrolling up to 70 patients at multiple sites in the U.S. The study is expected to report in approximately 12 months. A second study then will assess the safety and the efficacy of the antibody in a larger patient group. Protherics previously reported encouraging phase IIb study results in an 81 patient trial.
• Senexis Ltd., of Cambridge, UK, was awarded £2.9 million (US$5.7 million) from the research charity the Wellcome Trust for the optimization and preclinical development of small molecules that have potential as a potential disease-modifying treatment for Alzheimer's disease. The compounds were licensed from the technology commercialization company BTG plc in 2006. The award comes from the Wellcome's Seeding Drug Discovery initiative.
• ThromboGenics NV, of Leuven, Belgium, and co-development partner BioInvent International AB, of Lund, Sweden, have received approval from the regulatory authorities in Denmark to initiate a Phase I clinical trial of the anticancer agent TB-403, a monoclonal antibody that targets the angiogenic factor PlGF. The first Phase I clinical study will be performed in Denmark, to monitor tolerability and safety after three single escalating intravenous doses.
• Trophos, of Marseille, France, completed the enrollment of the first 90 patients for a Phase IIa clinical trial of its lead product, TRO19622, in the indication of painful diabetic neuropathy. The company plans to test the drug on 180 patients, and the primary endpoint will be symptomatic pain relief. The trial is taking place at centers in Germany, Serbia, Croatia and Latvia, and the results are expected in the second half of 2008. Preclinical studies of in vivo models of diabetic and chemotherapy-induced neuropathic pain have demonstrated that TRO19622 is an effective treatment for both the pain and the underlying neuropathy associated with those diseases. The drug already has completed a successful Phase I/Ib trial in amyotrophic lateral sclerosis, for which it has been granted orphan drug status in both Europe and the U.S., and currently is undergoing a Phase Ib trial in juvenile spinal muscular atrophy.
• ValiRx plc, of London, said its subsidiary, Cronos Therapeutics Ltd., in conjunction with Cancer Research Technology Ltd., also of London, completed the final part of the first phase of preclinical studies on one of its cancer programs, a GeneICE therapeutics molecule. That research, to date, has shown the molecule to trigger cell death in ovarian, pancreatic and prostate cancer cells. Treatments based on that GeneICE compound now will be investigated, with work being fully funded by a development grant. Upon success of the next phase of preclinical work, ValiRx anticipates beginning its regulatory filings to start Phase I testing in the fourth quarter.