• Ablynx NV, of Ghent, Belgium, said the European Patent Office upheld key claims for its Nanobodies platform in response to proceedings initiated by Domantis Ltd., of Cambridge, UK. Nanobodies, a class of antibody-derived therapeutic proteins, are functional antigen-binding domains derived from an antibody-heavy chain. Ablynx retains access to Nanobody property through its Hamer patent portfolio.

• Ascentia Biomedical Corp., of Bellevue, Wash., said preclinical compounds that were included in an option agreement with the University of Washington in Seattle have been shown to induce tumor rejection responses in a mouse model of breast cancer. The company plans to file an investigational new drug application to begin human testing in cancer, and has plans to expand evaluation to indications such as sepsis, autoimmune disorders and as an adjuvant for vaccines.

• Astex Therapeutics Ltd., of Cambridge, UK, signed a new alliance with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to discover, develop and commercialize drug candidates against undisclosed targets in different therapeutic areas. Under the agreement, Astex will provide drug candidates to Boehringer, which will move the candidates through development and into the market. Astex will receive an up-front payment in return for access to its fragment-based discovery technology, and could get research funding, milestone payments and royalties.

• Biacore International AB, of Uppsala, Sweden, launched its Biacore A100 and Flexchip systems. Both systems offer array-based protein interaction analysis.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said that one of its investigators at the University of Texas M.D. Anderson Cancer Center in Houston has initiated a Phase II trial of oral Fodosine (forodesine hydrochloride), the company's lead transition-stage analogue inhibitor of purine nucleoside phosphorylase. The trial is designed to evaluate the efficacy and safety of Fodosine in patients with advanced, fludarabine-refractory chronic lymphocytic leukemia.

• Biogen Idec Inc., of Cambridge, Mass., and Genentech Inc., of South San Francisco, submitted a supplemental biologics license application with the FDA for a new indication for Rituxan (rituximab) in patients with active rheumatoid arthritis who inadequately respond to an anti-TNF therapy. The submission is based on the 24-week results of a randomized, double-blind, placebo-controlled Phase III study. Rituxan received FDA approval in November 1997 to treat relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma.

• Cardiome Pharma Corp., of Vancouver, British Columbia, said a Phase I study of its orally administered RSD1235 found the drug to be safe and well tolerated across all dose levels. The company anticipates initiating Phase II studies of the drug in patients with atrial arrhythmia. Results indicated that oral RSD1235, which is designed to be used as chronic therapy, also could be used as a follow-on treatment to the intravenous formulation, which is in Phase III trials for acute conversion of atrial fibrillation.

• Cephalon Inc., of Frazer, Pa., received approval in Germany to market modafinil tablets to treat moderate to severe chronic shift-work sleep disorder. Modafinil is the only medication in a new class of wake-promoting agents believed to work selectively through the sleep/wake centers to activate the cortex of the brain. The drug has been approved in more than 20 countries.

• Connetics Corp., of Palo Alto, Calif., said the SEC declared effective the resale registration statement covering its 2 percent convertible senior notes due 2015, and the shares of common stock into which the notes are convertible. The notes were placed privately in March.

• CoTherix Inc., of South San Francisco, received approval from the FDA to modify the Ventavis inhalation solution label to include the safe use of the drug with Tracleer, an oral endothelin receptor antagonist for pulmonary arterial hypertension. The label also will include the use of Murrysville, Pa.-based Respironics Inc.'s hand-held I-neb AAD device for the delivery of Ventavis. The label changes were based on results from a trial in which PAH patients treated with Tracleer and Ventavis had common adverse reactions.

• CytRx Corp., of Los Angeles, will advance a small interfering RNA against RIP140 into animal studies for the treatment of Type II diabetes and obesity. An independent study found that suppression of RIP140 by gene deletion or siRNA resulted in the acceleration of fat burning in animals and fat cells. CytRx is developing RNAi therapeutics against the drug target.

• Forbes Medi-Tech Inc., of Vancouver, British Columbia, submitted an investigational new drug application with the FDA to initiate a Phase II trial of its cholesterol-lowering drug, FM-VP4. FM-VP4 is a cholesterol absorption inhibitor, a new class in cholesterol-lowering drugs.

• Illumina Inc., of San Diego, began commercial shipment of two Sentrix BeadChips that enable multi-sample whole-genome or RefSeq-based expression profiling of mouse samples. The BeadChip is designed to analyze six discrete mouse RNA samples on one chip, interrogating in each sample nearly 48,000 sequences from the mouse transcriptions.

• ImmunoGen Inc., of Cambridge, Mass., said Aventis Pharmaceuticals Inc., a unit of Paris-based Sanofi-Aventis Group, exercised its right to extend a research collaboration and agreed to provide $18.2 million in research support to ImmunoGen beginning Sept. 1, 2006. The funding is in addition to the support committed in July 2003 for a three-year collaboration, ending Aug. 31, 2006, that centers on discovering, developing and commercializing antibody-based cancer products. Upon signing the initial deal, ImmunoGen anticipated receiving $62 million, plus milestone payments and royalties on compounds resulting from the agreement. (See BioWorld Today, Aug. 1, 2003.)

• Inyx Inc., of New York, completed the acquisition of all of the outstanding shares of Ashton, UK-based Celltech Manufacturing Services Ltd., from UCB Group SA, of Brussels, Belgium. The companies agreed on a purchase price of €27.5 million (US$33.8 million) to be financed through a non-dilutive, asset-based facility provided by Westernbank Business Credit Division, of Westernbank, Puerto Rico. Inyx said the acquisition is expected to contribute annual revenues in excess of $50 million over the first 12 months. As part of the agreement, Inyx received a five-year manufacturing contract from UCB, as well as a long-term product support and services contract. (See BioWorld Today, Aug. 29, 2005.)

• Medisyn Technologies Inc., of Minnetonka, Minn., said that Thomas Ingolia has joined the company as CEO. Ingolia's experience includes three decades of executive leadership at Indianapolis-based Eli Lilly and Co. and a number of biotechnology start-ups. Medisyn is a drug design and discovery company.

• Metabolex Inc., of Hayward, Calif., said the Sept. 1 issue of Diabetes published preclinical data showing that matrix metalloproteinases (MMPs) are involved in islet destruction and may contribute to the worsening of Type II diabetes. The study also found that an investigational compound that inhibits MMPs can prevent Type II diabetes in an animal model. MMPs are enzymes that, when highly activated, contribute to arthritis, cardiovascular disease and cancer.

• MicroIslet Inc., of San Diego, and The Scripps Research Institute (TSRI) extended for an additional two years their collaboration for islet-cell transplantation therapies to treat insulin-dependent diabetes. The parties will continue preclinical studies that should lead to an investigational new drug application and the start of human clinical trials. MicroIslet will provide financial support and technical assistance to TSRI, and it has the option to retain all commercial licensing rights to any discoveries made through the collaboration. In other news, MicroIslet learned hat it is not in compliance with the American Stock Exchange's requirements for its failure to file its Form 10-QSB for the period ended June 30. The company has until Sept. 8 to submit a plan of action. The financial filing is late due to errors in the accounting treatment of certain non-cash expenses in 2004.

• Nobex Corp., of Research Triangle Park, N.C., said a preclinical study using a modified human brain-type natriuretic peptide delivered by oral administration showed that the product activates cGMP, resulting in increased cGMP levels in plasma, as well as significant reductions in mean arterial pressure. Results of the study, conducted with the Mayo Clinic, were published in the Aug. 9, 2005, edition of Circulation.

• Pharmaxis Ltd., of Sydney, Australia, said results of its Phase II trial in cystic fibrosis patients showed that those receiving the company's Bronchitol had statistically significant improved lung function compared to placebo at the end of a two-week treatment period. The drug also demonstrated significantly better respiratory symptoms. Bronchitol, which received orphan drug designation by the FDA, is a formulation of mannitol administered in a hand-held inhaler.

• SK Corp., of Fairfield, N.J., said that the FDA completed its review of the investigational new drug application filed by its subsidiary, SK Bio-Pharmaceuticals, for the anxiety drug YKP3089, a small molecule under development as an anxiolytic therapeutic agent. The exact mechanisms by which YKP3089 exerts its effect remain under investigation. The FDA said that the first clinical trial may now be initiated.

• StemCells Inc., of Palo Alto, Calif., received a manufacturing license for its cell processing facility from the State of California Department of Health Services. That enables the company to use its neural-cell therapy product, HuCNS-SC, in clinical trials.

• ViaCell Inc., of Cambridge, Mass., published results of a study demonstrating administration of stem cells from umbilical cord blood significantly improved heart function during a heart attack. Four weeks after cell transplantation, engrafted human unrestricted somatic stem cells were detected in the infarct region of the heart, and the implanted cells were shown to improve regional perfusion and wall motion. Ejection fraction, a measure of global heart function, increased in the transplant group. The study was published in an Aug. 30, 2005, supplement of the Journal of the American Heart Association.

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