¿ British Biotech plc,of Oxford, UK, said its Australian development partner for E21R, BresaGen Ltd., has begun Phase II trials in chronic myelomonocytic leukemia. The trials will take place in four centers in Australia and will complement Phase II studies in acute myeloid leukemia, which British Biotech plans to begin later this year. British Biotech licensed worldwide rights to E21R in all indications from BresaGen in December, in a deal worth US$6 million in fees and milestones to BresaGen.
¿ CeNeS Pharmaceuticals plc, of Cambridge, UK, obtained U.S. approval to carry out a Phase II trial of CEE 03-310, a dopamine antagonist, for the treatment of alcohol abuse. The placebo-controlled study, to be carried out at Yale University, will assess if CEE 03-310 reduces craving and consumption of alcohol in subjects with a drinking problem. The dopamine system is involved in the craving that drives addiction. CeNeS is concentrating on alcohol abuse to establish proof of principle, and said CEE 03-310 also might have applications in nicotine, cocaine and heroine use. CEE 03-310, licensed in from Novo Nordisk in 1999, has completed Phase II in schizophrenia and sleep disorders. In schizophrenia there was evidence of improvement in psychotic symptoms. Development is continuing with an amended formulation. CEE 03-310 has the ability to modify rapid eye movement sleep, which is affected in a range of disorders including depression, schizophrenia and narcolepsy. The Phase II study, completed in May 2000, showed that CEE 03-310 delays the onset on REM sleep in a dose-dependent manner. The first follow-on trial is investigating efficacy in older subjects.
¿ Genmab A/S, of Copenhagen, Denmark, reported positive data from an extension of its Phase I/II study of its rheumatoid arthritis treatment HuMax-CD4. In an open-label study with 10 patients, the number of swollen joints, painful joints and physician's global assessment of disease activity were reduced with medians of 57 percent, 46 percent and 54 percent, respectively, the company said. The patients, who also received low-dose methotrexate, tolerated the treatment well and showed no serious adverse events and no depletion of CD4-positive T cells. Genmab last week reported a net loss of DKK36.3 million (US$4.45 million) for the year ended Dec. 31, 2000, compared with a net loss of DKK18.9 million for the prior year. It entered the new year with approximately DKK1.8 billion in cash.
¿ LION Bioscience AG, of Heidelberg, Germany, said animal health specialist Intervet International, of Boxmeer, the Netherlands, extended its use of LION's bioinformatics solutions. Financial details were not disclosed. Extension for Intervet includes extended licenses for the data integration technology SRS, the automated gene and genome annotation system bioSCOUT, new licenses to genome comparison software genomeSCOUT and SRS everEST, a soon-to-be-launched product for EST clustering, LION said.
¿ MediGene AG, of Martinsried, Germany, announced that its subsidiary, San Diego-based MediGene Inc., has submitted to the FDA a final study report of its Phase I clinical trial for G207, an anticancer therapeutic for the treatment of brain tumors. Prompted by the final analysis of the data, MediGene is preparing a Phase II trial for G207, the company said. The Phase II clinical studies will be designed to show the efficacy of G207 both alone and in combination with irradiation. Results from preclinical studies showed a benefit from the combination therapy, MediGene said. The therapy works on GM herpes simplex viruses to kill tumor cells selectively.
¿ Modex Therapeutics Ltd., of Lausanne, Switzerland, said it acquired an exclusive license for the use of fibrin glue-keratinocyte combinations for wound treatment from the Blood Transfusion Center of Lille, France. The Blood Transfusion Center is part of the Establissement Francais du Sang, which retains nonexclusive rights to the technology in France. But Modex has exclusive rights to the patented technology in all other territories. The deal will enhance the company's product portfolio in wound and skin management, said CEO Jacques Essinger. In addition, Vincent Ronfard, one of inventors of the technology, joined Modex as head of tissue engineering.
¿ MPB Cologne GmbH, of Cologne, Germany, which focuses on molecular farming, received U.S. Patent No. 6,194,201 covering an anaerobic gene expression system for recombinant proteins in plants. The protected technology enables researchers to switch on certain genes' expression in GM potato tubers by depleting them of oxygen. "This allows production of proteins, which may severely affect plant growth," MPB CEO Klaus D|ring said, adding that biosafety has high priority for his company. The patent is based on a promoter derived from maize.
¿ November AG, of Erlangen, Germany, received exclusive worldwide rights to a new transfection system that transports nucleic acids into cells. This license agreement is part of a widespread strategic cooperation with Halle, Germany-based ACGT ProGenomics AG. The transfection system is based on a protein called TmHU of a hyperthermophilic bacterium, and has applications in molecular medicine, functional genomic studies and high-throughput screening. ACGT ProGenomics will receive royalties on TmHU sales.
¿ Phytopharm plc, of Godmanchester, UK, started a Phase IIa trial of P57 for the treatment of obesity. P57, an orally administered appetite suppressant derived from an extract of a South African plant, was licensed to Pfizer Inc. in August 1998, in a worldwide exclusive deal worth up to US$32 million in license fees and milestones. CEO Richard Dixey said study results will be known by the third quarter. The study will recruit up to 62 healthy male volunteers and will consist of three stages. The concentration of P57 has been increased 10-fold since the Phase I study, and the first stage, in nonobese individuals, will ensure safety and tolerability, and confirm the drug is absorbed. The second stage will assess safety, tolerability and pharmacokinetics in healthy, overweight individuals. The data from the first two stages will be used to determine the dosing regimen for the third stage of the trial. The food consumption of healthy, overweight individuals will be measured before the trial starts. The effects of P57 on calorie intake, over 15 days, will be assessed. Pfizer will have the data in time to decide whether or not to extend the collaboration beyond the current term of August 2001. Phytopharm received $1 million last April on completion of Phase I.
¿ Rhein Biotech GmbH, of D|sseldorf, Germany, began a five-year joint project on development of new organisms for production of pharmaceuticals with funding of EUR6.6 million (US$6.2 million), including EUR2.3 million in government grants. Rhein Biotech currently produces a hepatitis B vaccine and develops processes for the thrombolytic compound hirudin and the antiviral compound interferon alpha in its proprietary yeast system Hansenula polymorpha. "We want to have more tools for processes in the future," said Rhein Biotech's managing director, Michael Piontek. Candidates to become new production organisms for the company are a dimorph yeast (which can grow single cells as well as in a filamentous way, depending on conditions of fermentation), two nonsporulating filamentous fungi, a chlamydomonas alga and the Gram-positive microbe Staphylococcus carnosus. Partners in the project include the German research institutions Technical University of Aachen; Forschungszentrum J|lich, Fraunhofer Gesellschaft/IUCT, of Schmallenberg; Ruhr University, of Bochum; and the Institute for Plant Genetics and Cultivated Plants Research, of Gatersleben. Rhein Biotech GmbH is the research and development unit of Maastricht, Netherlands-based Rhein-Biotech NV.
¿ Trega Biosciences Inc., of San Diego, said its stockholders approved its merger with LION Bioscience AG. The acquisition is expected to close this week, LION said. LION will acquire all of the outstanding stock of Trega in exchange for LION American depositary shares.