British Biotech plc, of Oxford, UK, experienced setbacks with two of its four products in clinical development, stopping a Phase II study of E21R in acute myeloid leukemia (AML) after new preclinical data failed to support the previous high incidence of apoptosis in AML, and closing recruitment in a Phase II study of MG98 in head and neck cancer and renal carcinoma, after patients failed to show a clinical response as defined by the protocols. E21R, a modified form of granulocyte macrophage-colony stimulating factor being developed in collaboration with the Australian company Bresagen Ltd., also is in Phase II in chronic myelomonocytic leukemia, and that trial is continuing. MG98, a second-generation antisense compound designed to inhibit the expression of DNA methlytransferase, an enzyme implicated in tumor growth, was licensed from the Canadian company MethylGene Inc. in February. A Phase I trial of MG98 in advanced myelodysplasia and AML, being carried out by MethylGene, is continuing recruitment, and British Biotech is planning a Phase I study to begin before the end of 2002 in the treatment of solid tumors.
Entomed SA, of Strasbourg, France, announced the imminent departure of its CEO, Mario Thomas. Thomas informed the company that he is to return to his native Canada at the end of September for "personal reasons." He has been with Entomed for two years, during which time he successfully negotiated a second, €20 million (US$19.9 million) funding round. The company develops therapies to treat drug-resistant infections in humans using antimicrobial peptides extracted from insects' immune systems.
ExonHit Therapeutics SA, of Paris, has been given leave by the U.S. Patent and Trademark Office to file a patent application for a process and kits permitting the early in vitro detection of a range of diseases. The company, which uses proprietary gene profiling technology to develop novel diagnostics and therapeutics, said the new method demonstrates that it is possible to use the genomic signatures derived from blood cells both to diagnose disease and to monitor its progress. CEO Bruno Tocqué said that "with this new method, we are able to detect the existence of a disease before the clinical symptoms are observed." It would thus "meet the growing need . . . for tools permitting the early, simple and reliable detection and monitoring of diseases such as cancer and neurodegenerative diseases."
GeneMedix plc, of Newmarket, UK, agreed to a collaboration with SkyePharma plc, of London, to develop an extended-release version of interferon alpha 2b, using SkyPharma's DepoFoam injectable drug delivery technology. SkyePharma already has formulated interferon alpha 2b with DepoFoam and said it has the possibility to deliver therapeutic doses in a controlled manner for up to 28 days from a single injection. Patients currently receiving the drug for the treatment of hepatitis B and hepatitis C must receive injections every few days. GeneMedix is paying SkyePharma US$5 million in the form of an unsecured convertible note and will make milestone payments. The companies will share equally in future development costs.
Isogenica Ltd., of Cambridge, UK, agreed to a research collaboration with Graseby Dynamics Ltd., a manufacturer of nuclear, biological and chemical detection equipment for military and civil defense applications. The collaboration will assess the utility of Isogenica's Covalent Display Technology for rapidly identifying molecules that will bind with high affinity and specificity, in Graseby's detection equipment. More often, the CDT technology is applied to drug discovery and development.
KS Biomedix Holdings plc, of Guildford, UK, said it received FDA approval for a Phase I study of TransMID in children with malignant brain tumors. The study will assess increasing doses of the product, which delivers diphtheria toxin to selectively kill tumor cells, in up to 30 children aged 5 to 18 years. In addition, a pivotal Phase III trial in adult patients is due to start in the second half of 2002.
LION bioscience AG, of Heidelberg, Germany, published a study reporting that comprehensive IT solutions in pharmaceutical research and development could save as much as $264 million and one year of development time for each new drug. The study, undertaken for LION by the Boston Consulting Group, said that the greatest savings would come from integrating information across disciplines, departments and research projects. Last week, the company released a new software product, SRS Evolution, and announced that Pfizer Inc., of New York, had purchased a world license of its predictive ADME simulation software, iDEA.
Morphochem AG, of Munich, Germany, and Migragen AG, of Tuebingen, Germany, began a collaboration to identify, optimize and produce small-molecule drug candidates through a joint discovery and development program. The companies will initially focus on nerve regeneration in spinal cord injury and traumatic brain injury. The firms will share ownership and revenues for any molecules discovered by the joint program.
NicOx SA, of Sophia Antipolis, France, reported positive results from a Phase I/II trial of an inhaled formulation of NCX 950, a nitric oxide-donating salbutamol salt that the company is developing for the treatment of respiratory infections. Salbutamol is a beta-2 agonist used to treat acute episodes of asthma, inducing bronchial dilation through its activity on receptors in bronchial tissues. The trial confirmed animal studies in which NCX 950 was found to be a better bronchial-dilating agent than regular salbutamol and to have an anti-inflammatory activity that does not exist in the beta 2-agonist class of drugs. NCX 950 is the first of several compounds incorporating nitric oxide-donating salt technology being developed by NicOx to have been tested in the clinic.
Proteome Sciences plc, of Cobham, UK, said it completed the acquisition of Xzillion Proteomics GmbH of Co KG, the proteomics division of Aventis Research and Technologies GmbH and Co KG. Proteome paid £12.6 million in new shares, giving Aventis 15.8 percent of the enlarged share capital of Proteome.
Qiagen NV, of Venlo, the Netherlands, announced a profit warning for the second half of 2002. The company expects sales of $300 million in the rest of the year, 13 percent below the previous estimates. On that basis, profits are expected to be $56 million to $58 million, instead of the previously estimated $86 million. Following the announcement on July 3, the stock dropped more than 40 percent to just above €6 per share, less than half of its previous 52-week low. Through July 8, the stock recovered to just above €7. The company cited sinking sales in the United States, due to falling investments by American firms, as the primary reason for the expected drop. Analyst opinions ranged from SES Research's "outperform" to HSBC Trinkaus & Burkhardt's "sell."
ReGen Therapeutics plc, of London, said it is seeking funds to continue development of Colostrinin in the treatment of Alzheimer's disease, following positive results in the open-label phase of a 30-week trial, carried out in Poland. In the second 15-week phase, all patients received Colostrinin, following an initial 15-week placebo-controlled phase. Approximately 40 percent of patients on Colostrinin were stabilized or improved after 15 weeks, and 33 percent of patients continued to show stabilization or improvement at 30 weeks.