Active Biotech AB, of Lund, Sweden, presented new data at the Medicon Valley BioConference in Malmö, Sweden, last week indicating that its candidate oral multiple sclerosis treatment, SAIK-MS (Laquinimod), inhibits progression of the disease in various animal models. The company said the compound was 100 times more effective than Linomide (Roquinimex) in inhibiting the progress of disease in an MS disease model, based on the level of free substance in plasma, and that infiltration of the central nervous system by white blood cells was completely inhibited. A Phase II trial of SAIK-MS involving 180 patients at 20 centers throughout Europe is ongoing.
Cambridge Antibody Technology Group plc, of Melbourne, UK, saw its shares rise by 45 pence last week to £5.45 after partner Abbott Laboratories, of Abbott Park, Ill., announced an expanded access program for D2E7, a rheumatoid arthritis (RA) treatment. D2E7, the first fully human monoclonal antibody against RA, is under review by the FDA and the European Agency for the Evaluation of Medicinal Products. The expanded access is for patients with moderate to severely active disease who have failed other treatments. The expanded access will generate more data to help underpin a claim on the effectiveness of D2E7 in inhibiting the progression of RA.
Cyclacel Ltd., of Dundee, UK, said it was awarded £1.2 million (US$1.9 million) in government grants to support cell cycle research focused on disrupting mitosis in cancer cells. One grant will fund a collaboration with the department of genetics at Cambridge University to carry out a genome-wide screen of the fruit fly Drosophila, to identify genes involved in mitosis. A second grant will enable Cyclacel to expand its structure-based drug design capabilities.
Enact Pharma plc, of Salisbury UK, said New Opportunities Investment Trust plc, of London, had subscribed for 2.1 million shares at 19.5 pence, raising £400,000 (US$620,000). The money will enable Enact to start a Phase I study of its lead product, NQ02, in the treatment of hepatoma and/or colorectal cancer. NQ02 consists of two elements, a vitamin derivative that activates nitroreductase enzymes at the tumor site, to convert the second element, a harmless prodrug CB1954, to a cytotoxic. The trial will be carried out under the auspices of the charity, Cancer Research UK.
Evotec Technologies GmbH, of Hamburg, Germany, launched a new cell analyzer for high-content analysis of drug activity with subcellular resolution. Called "Opera" by the company, the device combines the resolution of cofocal laser scanning microscopy with a design that allows it to process more than 200,000 images per day. Software that accompanies the device allows investigators to design assays for drug screening based on their own specifications. Evotec Technologies is a subsidiary of Evotec OAI AG, also of Hamburg, which focuses on technology development and instrumentation.
KS Biomedix Holdings plc, of Guildford, UK, said it received approval for a Phase I/II trial of KSB303, a radiolabeled sheep antibody, in the treatment of pancreatic cancer. The trial, in patients with advanced disease, will evaluate safety and the maximum tolerated dose. The Phase I imaging study of the antibody alone showed specific targeting and prolonged retention of the antibody at the tumor site.
ML Laboratories plc, of Warrington, UK, is looking for a new CEO following the resignation of the founding executive chairman, Kevin Leech, after he was declared personally bankrupt. Stuart Sim, the current CEO, will take on the post of chairman. The company announced several other changes to the board, which it said had been "under discussion for some time" and unconnected to the fact that Leech, who has a substantial shareholding in ML Labs, was bankrupt. ML's share price fell 13 percent to 11.5 pence last week following the news.
Modex Therapeutics Ltd., of Lausanne, Switzerland, said the FDA granted its autologous skin product EpiDex humanitarian use device designation for a defined chronic wound indication. That will enable the company to achieve accelerated market approval to begin selling EpiDex in the U.S., once it has demonstrated the safety profile of the product. Modex plans to file a humanitarian device exemption dossier that will draw on safety data accumulated during European clinical studies of EpiDex, a human skin equivalent derived from adult stem and precursor cells taken from the patient's own hair follicles. Subject to shareholder approval, Modex plans a stock-based merger with tissue engineering firm IsoTis NV, of Bilthoven, the Netherlands.
NeuTec Pharma plc, of Manchester, UK, said Aurograb, its antibody-based treatment for the hospital superbug, methicillin-resistant Staphylococcus aureus, commenced a multicenter Phase II trial in systemically ill patients. The company believes the product also will be effective against vancomycin-resistant forms of S. aureus, the first recorded UK case of which was diagnosed earlier this year. NeuTec has a second product, Mycograb, for the treatment of invasive yeast infections, which is in Phase II.
Onyvax Ltd., of London, a cancer vaccines specialist, announced a collaboration with Asterand, of Detroit, to produce and distribute Onyvax's prostate cancer cell lines. While there are only three prostate cancer cell lines in general use, Onyvax has derived many more over several years of developing prostate cancer vaccines, and the deal with Asterand will make them available for academic and commercial research.
Oxxon Pharmaccines Ltd., of Oxford, UK, said its therapeutic melanoma vaccine has entered Phase II, following a successful Phase I trial showing the product was safe and immunogenic in melanoma patients. The vaccine involves sequential immunization with two different vectors carrying the same antibodies, enhancing the immune system's ability to recognize and destroy cancer cells.
Pharming Group NV, of Leiden, the Netherlands, said the district court in the Hague approved its recently proposed settlement to creditors. The offer fulfills the necessary legal requirements, Pharming said. If no appeals are forthcoming, the legal moratorium the company entered in August last year will be lifted Saturday, as will the bankruptcy status of its subsidiary, Pharming Intellectual Property BV.
Wilex AG, of Munich, Germany, began a Phase Ib/IIa trial of a small molecule that inhibits a system that plays a role in the progression and metastasis of some solid tumors. The compound, WX-UK1, works against urokinase-type plasminogen activators (uPA), and will be tested in patients with advanced gastric, pancreatic and ovarian cancers. Preliminary results are expected in the second half of 2003. The study will evaluate dosage toleration and biological activity, and follows a Phase Ia trial that showed the compound was safe and well tolerated in healthy volunteers. Wilex was founded in 1997 by clinical oncologists from the Technical University of Munich, with venture backing from investors that include Apax Partners, TVM Techno Venture Management and Merlin Biosciences. The privately held company develops cancer therapies and has three products in clinical trials.