• Ablynx, of Ghent, Belgium, has achieved a second milestone in its collaboration with Proctor & Gamble Co., of Cincinnati, by the discovery of novel Nanobodies against a second target for possible new treatments in the musculoskeletal area. The first milestone was achieved in December 2006 and was also a target for musculoskeletal diseases. In the collaboration, Ablynx is responsible for discovering Nanobodies that meet an agreed product profile and P&GP is responsible for the pre-clinical and clinical development and commercialization of any resulting drug products.

• Algeta ASA, of Oslo, Norway, is extending its research agreement with the Norwegian Radium Hospital on development of new cancer therapeutics based on target-seeking alpha-emitting molecules. The partnership is focused on studying the effects of targeted radiotherapy treatment on lymphoma. The monoclonal antibody rituximab was linked to the alpha emitter Thorium-227 and tested in preclinical lymphoma models. The new agreement also will include development of Thorium-227 linked products aimed at treating breast cancer, for which highly characterized molecular targets already exist (such as HER2) and against which treatments have and are being developed.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said treatment has begun on the first patient in an expanded access program for Kuvan (sapropterin dihydrochloride), an investigational oral small molecule phenylketonuria (PKU), a rare genetic metabolic disorder. BioMarin submitted a new drug application for Kuvan to the FDA in May, and, if granted priority review status, Kuvan could receive approval by the end of 2007. Kuvan is being developed in partnership with Merck Serono, a division of Merck KGaA, of Darmstadt, Germany. In clinical trials, Kuvan has been shown to reduce blood Phe levels and increase Phe tolerance in some PKU patients with mild, moderate and severe disease.

• BioServe, of Beltsville, Md., said it was selected by the Specialized Clinical Center of Research in Houston for a study aimed at identifying genetic cause of thoracic aortic disease. BioServe will provide researchers from various universities in Texas access to certain sample sets from its repository of more than 600,000 human DNA, tissue and serum samples linked to clinical and demographic data. The study is underwritten by a five-year grant from the National Heart, Lung and Blood Institute.

• Evogene Ltd., of Rehovot, Israel, and Bayer CropScience, of Monheim am Rhein, Germany, have formed a collaboration to increase the productivity and yield of a Bayer CropScience core crop, especially with regard to stress conditions such as drought. Under the agreement, Bayer CropScience has exclusively licensed the rights to certain genes discovered by Evogene that have demonstrated improved plant yield and other performance enhancements in various plant species. Evogene is to receive an initial fee, success-based milestone payments and royalties on sales. No specific terms were announced.

• Gene Logic Inc., of Gaithersburg, Md., said a study between its Genomics Division and the Mayo Clinic found biomarkers that predict susceptibility to Parkinson's disease and age of disease onset. They used bioinformatic analysis methods to compare gene sequence variations called single nucleotide polymorphisms in the genomes of Parkinson's disease patients to those of their disease-free siblings. They targeted variants of genes related to the axon guidance pathway. The work also may provide a model for the study of other diseases such as Alzheimer's.

• GeneThera Inc., of Wheat Ridge, Colo., entered a collaboration with the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna, or IZSLER, an Italian government institution in Brescia. They previously had a memorandum of understanding on the deal. GeneThera will continue its Italian operations and build a lab in IZSLER's facilities. The program is focused on detection of transmissible spongiform encephalopathy in animals. GeneThera said separately it plans to develop a vaccine for mad-cow disease.

• Geron Corp., of Menlo Park, Calif., and the Biotechnology Research Corp., of Hong Kong, said Geron has increased its stake in their joint venture entity, TA Therapeutics Ltd. (TAT), from 50 percent ownership to 75 percent ownership. TAT is a Hong Kong company that conducts research and develops therapeutics based on telomerase activator drugs to restore the functional and regenerative capacity of cells. BRC, which was established by the Hong Kong University of Science and Technology, continues to hold the remaining 25 percent of the shares. The company is expanding its pre-clinical development and working toward filing an investigational new drug application with the FDA for a small molecule compound for the treatment of HIV/AIDS.

• Immtech Pharmaceuticals Inc., of New York, said the FDA granted orphan drug designation to pafuramidine (DB289) for the treatment of malaria. The oral drug candidate is in Phase II clinical trials in malaria patients. Prior trials have demonstrated 96 percent cure rates with five-day treatment, Immtech said. The current trial is assessing three-day treatment with an increased dose, and is testing the product in combination with artesunate.

• Immunicon Corp., of Huntingdon Valley, Pa., said J. William Freytag was elected chairman. Freytag has been a director at Immunicon since 1999. He succeeds Edward Erickson, who earlier announced he would not seek re-election. Freytag was president and CEO of Myogen Inc. until it was acquired last year by Gilead Sciences Inc., of Foster City, Calif.

• Janssen-Cilag International NV, of Beerse, Belgium, has submitted a marketing authorization application to the European Medicines Agency for ceftobiprole, an investigational antibiotic for the treatment of complicated skin and soft tissue infections including diabetic foot infections. Ceftobiprole, the first broad-spectrum, anti-MRSA cephalosporin antibiotic to complete Phase III clinical trials, has demonstrated clinical activity against Gram-positive as well as Gram-negative pathogens. In clinical trials, ceftobiprole demonstrated high cure rates in patients with complicated skin infections, including those caused by the potentially deadly methicillin-resistant Staphylococcus aureus. Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd., of Basel, Switzerland, and Cilag GmbH International, of London. Janssen-Cilag companies will market the product in European countries and co-promote the product with Basilea in the major European markets. A new drug application for ceftobiprole has been submitted in the U.S.

• Labopharm Inc., of Laval, Canada, has received a notice of compliance from the Therapeutic Products Directorate of Health Canada for 100-mg, 200-mg and 300-mg tablets of its once-daily formulation of tramadol for the management of pain of moderate severity in adults who require treatment for several days or more. The NOC allows the marketing and sale of Labopharm's once-daily tramadol product in Canada. Labopharm is in discussions to complete a licensing and distribution agreement for its once-daily tramadol product in Canada, under which the company will retain the right to co-promote the product to certain specialties through its own sales force. Labopharm expects the product to be launched in Canada later this year.

• Lipid Sciences Inc., of Pleasanton, Calif., said scientific advisory board member Frank M. Sacks presented preclinical data on Reverse Cholesterol Transport (RTC) at the European Atherosclerosis Society meeting last week in Helsinki, Finland. According to the presentation, Lipid Sciences' HDL Selective Delipidation of plasma converted nearly all of the mature, cholesterol-rich HDL in monkey plasma to cholesterol-poor HDL. The resulting delipidated plasma, containing a high concentration of pre-beta HDL, was fully functional in activating RCT, which is the process of removing excess lipids from the arterial wall to reduce plaque buildup for transport to the liver by HDL for excretion from the body. RCT converts small cholesterol-poor HDL to large cholesterol-rich HDL particles. The company said this was the first demonstration in vivo in a primate of not only activation of RCT but efficient and complete utilization in RCT of all of the cholesterol-poor pre-beta HDL particles formed by Selective Delipidation.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., has eliminated 5 percent of its workforce, created a biologics strategic business unit to advance the company's protein and immunological products, and is seeking outside financial and consulting help for a continuing restructuring. The elimination of 32 jobs is expected to realize nearly $3 million on an annualized basis. Also, the company is pursuing a strategic alternatives process with Banc of America Securities with an eye toward selling all or a significant part of its business. In addition, the company said it has retained the Cato Research Ltd. consulting firm to help it work with the FDA to respond to the agency's request for data for Nabi-HB Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] for prevention of re-infection with hepatitis B disease in HBV-positive liver transplant patients. Nabi and Cato have had several discussions with the FDA to define the additional data the FDA is seeking from previously-completed clinical trials. As part of the restructuring, Raafat Fahim, senior vice president for research, technical and production operations, assumes the new position of chief operating officer and general manager of the Biologics SBU, and Jordan Siegel was promoted to senior vice president, finance and administration, chief financial officer and treasurer.

• PepTcell, of High Wycombe, UK, presented preclinical data showing how a new flu vaccine has the potential to protect against all strains of influenza, including pandemic and annual. The data were presented at the Options for the Control of Influenza VI Conference, in Toronto. The pre-clinical results, which will be published in the European Journal of Immunology, showed how mice vaccinated with PepTcell's novel flu vaccine, FLU-v, had a significantly increased survival rate when challenged with a lethal dose of influenza virus, compared with those that received a control vaccine. Following immunization with FLU-v the mice launched a specific T-cell immune response of the CD8+ subtype against the peptides. The CD8+ T-cells isolated from the mice showed activity against human cells infected with three unrelated influenza strains in in vitro tests. That experiment confirmed that the peptide sequences in Flu-V are highly conserved across strains, and that these peptides are naturally presented on the surface of flu-infected cells, and therefore can be recognized by the immune system, the company said.

• Telik Inc., of Palo Alto, Calif., said the FDA has converted the recently announced full clinical hold of Telcyta trials to a partial hold. That allows patients currently enrolled in the ASSIST-3 and ASSIST-5 trials to continue to receive study treatments, including Telcyta in combination with chemotherapy, subject to re-consenting procedures. Earlier this month the FDA initiated the clinical hold after the presentation of data from multiple failed Phase III trials of Telcyta at the American Society of Clinical Oncology annual meeting. Telik first announced last December that the ASSIST-1, -2 and -3 Phase III trials had not met their primary endpoints. Telik's shares fell 70 percent on the news. (See BioWorld Today, Dec. 27, 2006.) On June 5, Telik released the details of those trials, sending the stock down another 21 percent. (See BioWorld Today, June 6, 2007) In the ASSIST-1 trial, which compared Telcyta as a monotherapy to either doxorubicin or topotecan in third-line ovarian cancer, median survival was 8.5 months with Telcyta compared to 13.6 months in the control group. In the ASSIST-2 trial, which compared Telcyta as a monotherapy to Iressa (gefitinib, AstraZeneca plc) in third-line non-small-cell lung cancer, median survival was 4.6 months in the Telcyta arm and 6.1 months in the control arm. In the ASSIST-3 trial, which compared the combination of Telcyta and carboplatin to doxorubicin alone in second-line ovarian cancer, the primary endpoint of response rate was compromised due to premature discontinuations, but the secondary endpoint of median progression-free survival was 3.5 months for both groups. (See BioWorld Today, June 5, 2006.)

• Vegenics Ltd., of Melbourne, Australia, has licensed from CoGenesys Inc., of Rockville, Md., exclusive worldwide rights to human monoclonal antibodies that target vascular endothelial growth factor-C (VEGF-C). VEGF-C is believed to play an important role in promoting the formation of new blood vessels and the maintenance of existing blood vessels. In oncology, inhibition of VEGF-C is a promising new approach to restricting blood and nutrient supply that supports tumor growth. Terms were not disclosed. CoGenesys, Inc. was spun out of Human Genome Sciences, Inc. in June of 2006 when it obtained an exclusive worldwide license to human monoclonal antibodies to VEGF-C.