• Alliance Pharmaceutical Corp., of San Diego, intends to pursue a proof-of-concept study on the use of Oxygent for organ protection during major surgery. The company has an agreement that gives LEO Pharma A/S, of Ballerup, Denmark, the right to enter a definitive license agreement for the development and commercialization of Oxygent upon the results of a proof-of-concept study.

• BioInvent International AB, of Lund, Sweden, obtained approval in the UK to start the first trial of BI-201, a human antibody selected from the company's n-CoDeR antibody library for its ability to bind to the TAT protein. The Phase I/IIa trial will include 36 HIV-infected patients who have not received any previous treatment. Results should be available in the second quarter of 2006.

• BioMimetic Pharmaceuticals Inc., of Franklin, Tenn., announced the second closing of its Series C round, raising an additional $11.8 million. The first closing brought in $25.7 million, and the round now totals about $38 million. Proceeds are expected to be used to support the final phases of FDA approval and the market launch of BioMimetic's lead product, GEM 21S, in development for the treatment of bone defects in the jaw and maxillofacial region. Funds also will go toward advancing other products from the company's orthopedic pipeline into clinical development. Investors in the round include Noro-Moseley, of Atlanta; PTV Sciences, of Houston; Axiom Ventures, of Hartford, Conn.; and HSS Ventures, of New York. With the financing, BioMimetic has raised a total of $51 million.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said preclinical results of using BioVant in bacterial and viral vaccine candidates suggest that the approach might lead to the creation of highly specialized vaccines for emerging viruses and bioterrorism applications. The company presented the data on BioVant, its calcium phosphate nanoparticle technology, at the 2nd International Conference on Immunopotentiators in Modern Vaccines meeting in Malaga, Spain. The presentation included a conceptualization of the functional efficacy of BioVant, highlighting its use to selectively elicit Th1 or Th2 T-helper immunity.

• Bolder BioTechnology Inc., of Wheat Ridge, Colo., has been awarded a $99,000 Phase I Small Business Innovation Research grant from the National Institutes of Health's Institute of Allergy and Infectious Diseases. The grant is intended to support research to improve the pharmacological properties of a human protein, gamma interferon, to enhance its ability to stimulate the body's immune system against infections. If Bolder meets the goal of the Phase I grant, the company will be eligible to apply for an additional $750,000 in Phase II grant support.

• Bridge Pharmaceuticals, of Beijing, and the National Foundation for Cancer Research in Bethesda, Md., formed a collaborative research program designed to accelerate cancer drug discovery and development. The partnership will allow NFCR and Bridge Pharmaceuticals to jointly fund, manage and direct cancer research programs in both the U.S. and Asia.

• Cell Genesys Inc., of South San Francisco, received a special protocol assessment from the FDA for its second Phase III trial of GVAX vaccine for prostate cancer. The trial is expected to enroll about 600 symptomatic patients with cancer-related pain, and will compare GVAX vaccine plus Taxotere chemotherapy to Taxotere plus prednisone with respect to a survival benefit. Cell Genesys is looking for a 33 percent improvement rate in survival among patients treated with GVAX. The company's GVAX cancer vaccines, also in development for lung and pancreatic cancer, leukemia and myeloma, are whole-cell vaccines designed to stimulate an immune response against a patient's tumor. The first Phase III study in prostate cancer was initiated last year. (See BioWorld Today, May 11, 2004.)

• CepTor Corp., of Hunt Valley, Md., filed an application with the American Stock Exchange to make its common stock eligible for listing. CepTor is a development-stage biopharmaceutical company involved in the discovery, development and commercialization of cell-targeted therapeutic products for the treatment of neuromuscular and neurodegenerative diseases with a focus on orphan diseases.

• Cytos Biotechnology AG, of Zurich, Switzerland, said its partner, Novartis Pharma AG, of Basel, Switzerland, obtained approval from the Swedish health authority to begin a Phase I trial with Immunodrug candidate CAD106, an immunotherapeutic for the treatment of Alzheimer's disease. Expecting to enroll about 60 patients, the study will assess the safety and tolerability of the product's ß-amyloid-specific antibody response. The achievement of that milestone will trigger an undisclosed payment to Cytos.

• DeCode Genetics Inc., of Reykjavik, Iceland, began dosing patients in a Phase II trial in asthma. The company has isolated a gene that encodes a kinase, which is the target of the tested compound developed by a third party for a different indication. The randomized, double-blind, placebo-controlled trial will enroll about 160 asthma patients with at-risk variants of the gene.

• Discovery Laboratories Inc., of Warrington, Pa., said additional long-term data from its two Surfaxin (lucinactant) Phase III trials to treat respiratory distress syndrome in premature infants were presented at the Pediatric Academic Societies' annual meeting held in Washington. Premature infants treated with Surfaxin experienced a survival benefit through one year of life, corrected age, compared to those treated with animal-derived surfactants, Survanta and Curosurf. Discovery Laboratories received an approvable letter in February from the FDA for Surfaxin to prevent respiratory distress syndrome in premature infants. (See BioWorld Today, Feb. 15, 2005.)

• EraGen Biosciences Inc., of Madison, Wis., has licensed its MultiCode-PLx System to Research Triangle Park, N.C.-based Bayer HealthCare LLC, Diagnostics Division, a member of the Bayer Group, in an exclusive, worldwide agreement for cystic fibrosis. Bayer will provide laboratories with a cystic fibrosis assay capable of being automated for mutation carrier screening, as well as for neonatal and newborn testing.

• Fraunhofer USA's Center for Molecular Biotechnology in Newark, Del., has received a $1.2 million grant from the Bill & Melinda Gates Foundation for preclinical studies for the development of a vaccine against African trypanosomiasis. The center will apply its suite of technologies to engineer, produce and evaluate candidate vaccines, and will be part of a collaborative effort with the Institute of Parasitology at McGill University in Canada and Makerere University in Uganda.

• Genmab A/S, of Copenhagen, Denmark, acquired rights to 16 potential targets to treat non-steroid-dependent cancers of epithelial-cell origin, such as gastrointestinal cancers, from the insolvency administrator of Europroteome AG, of Berlin. Genmab purchased all of Europroteome's rights, and there are no milestone or royalty obligations. Genmab has started generating human antibodies to a unique target highly expressed on colon carcinomas.

• Ibex Technologies Inc., of Montreal, reported preliminary results from the first in vivo study of its kallikrein program in ovarian cancer to test the effect of overexpression and co-expression of certain serine proteases called kallikreins on the malignancy of human cancer in nude mice. Data showed that mice treated with two kallikrein-transfected cell lines had significantly longer survival times compared to controls. Full details of the study will be reported later this year, and Ibex said it intends to proceed with further preclinical work.

• InSite Vision Inc., of Alameda, Calif., signed a long-term commercial agreement with a global supplier of anti-infective drugs for the supply of azithromycin, the active drug in the company's AzaSite ocular anti-infective product. Azithromycin currently is not used in ophthalmology. InSite Vision is conducting two pivotal Phase III trials with AzaSite for the treatment of bacterial conjunctivitis.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said Nature Medicine published that the STAT-3 gene is required for the generation of B lymphomas in mice carrying a mutation implicated in some human lymphomas. The report also highlighted that reducing the expression of STAT-3 with a second-generation antisense drug targeted to STAT-3 resulted in impaired growth of human and mouse lymphoid tumors in animals. The drug, Isis 345794, is in preclinical development.

• LineaGen Research Corp., of Salt Lake City, along with IBM Healthcare and Life Sciences, of New York, and the University of Utah Health Sciences Center, announced a collaboration to create a clinical genomics infrastructure designed to accelerate the molecular understanding of complex diseases for developing molecular diagnostics and targeted treatments. Under the collaboration, IBM will leverage its Clinical Genomics Solution to develop the information infrastructure, while LineaGen will provide general oversight and administration of the project for the university.

• MethylGene Inc., of Montreal, reported preclinical results from its multi-kinase inhibitor program. The company has disclosed that its multi-kinase inhibitor targets c-met and VEGF receptor tyrosine kinases (RTK), as well as other non-disclosed angiogenic RTKs.

• Morphotek Inc., of Exton, Pa., said it has entered an agreement with London-based GlaxoSmithKline plc to apply its Morphodoma technology to GSK's antibody-producer lines to generate cell lines that exhibit new or improved biological characteristics. Under terms of the nonexclusive agreement, Morphotek will receive funding to support research and development efforts for an initial project to be performed for GSK, with the option for GSK to retain Morphotek for two additional projects. Morphotek also could receive annual licensing fees and milestone payments upon the successful achievement of project goals and the advancement of resultant products through clinical development. GSK will conduct preclinical and clinical work, and handle subsequent commercialization of any products.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., has initiated bridging and consistency lot studies for its StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine) under development for the prevention of S. aureus bloodstream infections in at-risk adults. The bridging study is designed to compare the immune response and safety of the vaccine material produced by the company's contract manufacturer with the StaphVAX lot from the Phase III trial in end-stage renal disease.

• NeurogesX Inc., of San Carlos, Calif., reported positive results from a Phase III trial in 307 patients with HIV-associated sensory neuropathy (HIV-AN). The company said the study met its primary endpoint, with patients reporting statistically significant pain reduction over a 12-week period following a single application of NGX-4010, NeurogesX's high-concentration trans-capsaicin dermal patch. The company plans to initiate a second pivotal trial with NGX-4010 later this year. The product has been granted fast-track status, as well as orphan drug designation in HIV-AN.

• Neurologix Inc., of Fort Lee, N.J., licensed the humanin gene from Keio University in Tokyo as part of a strategic move to broaden its product portfolio. The license agreement provides Neurologix with exclusive, worldwide rights (excluding Japan) to develop and commercialize therapeutics to treat brain and other central nervous system disorders. The humanin gene will be used in combination with Neurologix's gene-transfer technology, and the resulting therapeutic is expected to become the company's lead compound in Alzheimer's disease.

• NexMed Inc., of Robbinsville, N.J., entered an agreement to sell an aggregate of 445 shares of convertible preferred stock and warrants to purchase about 1.2 million shares of common stock. The company expects to receive gross proceeds of about $4.5 million, which will be used for general corporate purposes. The preferred shares will have a liquidation preference of $10,000 per share and will be convertible into shares of the company's common stock at an initial conversion value of $1.36.

• Orion Acquisition Corp. II, of San Francisco, and its wholly owned subsidiary, Medivation Inc., said activities relating to a Phase II trial of Dimebon, a small-molecule compound aimed at treating Alzheimer's disease, are proceeding as scheduled and that the companies' team is expanding in anticipation of potential new programs in other disease indications. Based on the timeline, the Phase II trial should begin in the third quarter, and is expected to conclude in June 2006. Medivation said it also has initiated preclinical studies for a U.S. investigational new drug application for Dimebon, expected in June 2006.

• pSivida Ltd., of Perth, Australia, said that "excellent" results have been received from the proof-of-concept study being performed in collaboration with Epitan Ltd., of Melbourne, Australia. Recent data indicated that a single injection of pSivida's porous BioSilicon technology successfully released Melanotan over a sustained period. It is for the prevention of sunburn injury in fair-skinned people and/or the prophylactic treatment of photosensitive skin disorders.

• Sinovac Biotech Ltd., of Beijing, and LG Life Sciences, of Seoul, Korea, entered an agreement on May 12 to collaborate international and China sector marketing efforts and vaccine supply. The companies signed a letter of intent to pursue opportunities in three major areas: LG's international marketing of Sinovac's hepatitis A vaccine, Sinovac introducing LG's HepB vaccines into China and jointly working on Sinovac's influenza vaccine.

• Synta Pharmaceuticals Corp., of Lexington, Mass., presented data from an open-label Phase IIa trial of STA-5326 in patients with Crohn's disease. STA-5326 is the first oral, small-molecule and selective inhibitor of the interleukin-12 cytokine family, including IL-12 and IL-23, cytokines that may play a role in Crohn's disease. At daily doses of 35 mg and above, treatment with STA-5326 showed a clinically meaningful response and disease remission rates in patients with the disease. Of 73 patients, 82 percent showed a decrease of 70 points or more at week four in the Crohn's Disease Activity Index. The data were presented this week at Digestive Disease Week held in Chicago.