• Advitech Inc., of Quebec City, reported promising results of its open clinical study of XP-828L to treat psoriasis. The results relate to seven patients who have completed 16 weeks of treatment in an initial and extension phase, suggesting the product has a positive impact over a longer period of time. In the extension phase of the study, the PASI (Psoriasis Area and Severity Index) score improved by 6.7 percent to 78.4 percent. Advitech, which develops bioactive products derived from milk proteins, is preparing for the next study, a double-blind, placebo-controlled trial, in a larger group in 2005.

• Affymetrix Inc., of Santa Clara, Calif., said that both its instrument and microarray manufacturing facilities, located in Bedford, Mass., and West Sacramento, Calif., were audited by TUV America and received ISO certification. The achievement of ISO certification confirms that quality systems were implemented in product development, operations, shipping and service and will support CE marking of future Affymetrix products that will be labeled for in vitro diagnostic use.

• Agencourt Bioscience Corp., of Beverly, Mass., said the National Institutes of Health in Bethesda, Md., renewed its contract with Agencourt for genomic sequencing services. Under the two-year contract, Agencourt will continue to provide expressed sequence tags and serial analysis of gene-expression sequencing for two NIH initiatives, the Mammalian Gene Collection project and the Cancer Genome Anatomy project.

• Akorn Inc., of Buffalo Grove, Ill., entered an option agreement to license a patent and related technology rights invented by Issam Raad and Robert Sheretz. The agreement is between Akorn and the University of Texas M.D. Anderson Cancer Center in Houston and grants Akorn an option to evaluate the invention and to determine an appropriate regulatory pathway based on discussion with the FDA.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said findings reported at the European Society of Cardiology meeting in Munich, Germany, support previous safety data in the Taxus clinical program. The new findings, reported by Boston Scientific Corp., of Natick, Mass., provide further evidence that the Taxus Express(2) stent system is used by physicians in treating lesions and cases, especially in diabetic patients. Angiotech supplies the product's drug coating.

• AVI BioPharma Inc., of Portland, Ore., plans to start a clinical trial with AVI-4020, its Neugene antisense drug candidate, to treat patients with acute West Nile virus infection who have serious neurological impairment. A number of clinical sites in Arizona and Southern California are expected to participate in the study, which will randomize 50 patients into two cohorts. A pilot trial last fall met its primary safety endpoints and the pharmacokinetic profile of AVI-4020 indicated that delivery across the blood-brain barrier was achieved in all patients.

• Cell Therapeutics Inc., of Seattle, said the underwriters of its recent common stock public offering exercised their overallotment option and purchased about 1.4 million additional shares at $4.75 apiece, minus the underwriting discounts. The company sold a total of about 10.4 million shares in the offering, including the shares covered by the overallotment, for gross proceeds of about $49.2 million. UBS Securities LLC and CIBC World Markets acted as joint book-running managers, along with co-managers WR Hambrecht + Co., Delafield Hambrecht Inc. and Punk, Ziegel & Co.

• Celsion Corp., of Columbia, Md., said the FDA approved a Phase I study of ThermoDox, its investigational therapy for liver cancer. The trial, to be conducted at the National Institutes of Health in Bethesda, Md., and to be funded under a Collaborative Research and Development Agreement, will investigate ThermoDox in combination with radiofrequency ablation. ThermoDox is a temperature-sensitive liposomal encapsulation of doxorubicin that allows concentrated delivery of the drug to the tumor target. Celsion hopes to begin the study before the end of the year.

• Crucell NV, of Leiden, the Netherlands, said an HIV vaccine produced with its PER.C6 technology would advance to its next phase of clinical trials in the near future. Merck & Co. Inc., of Whitehouse Station, N.J., made the announcement at the AIDS Vaccine 2004 conference in Lausanne, Switzerland. Crucell's agreement with Merck dates to October 2000, when it granted Merck an exclusive commercial license to the PER.C6 technology for the development of an HIV vaccine. The deal provides for up-front and ongoing fees and royalty and milestone payments.

• diaDexus Inc., of South San Francisco, said findings reported at the European Society of Cardiology meeting in Munich, Germany, demonstrate that elevated levels of lipoprotein-associated phospholipase A2 (Lp-PLA2) are independently associated with the presence of stable coronary artery disease. The privately held company's PLAC test was used to measure Lp-PLA2 levels in nearly 800 men and women.

• Encysive Pharmaceuticals Inc., of Houston, presented Phase IIb/III data from a clinical study of Thelin (sitaxsentan) in pulmonary arterial hypertension at the European Society of Cardiology annual meeting in Munich, Germany. Long-term evaluation results suggest that patients might continue to benefit from Thelin with chronic therapy. Following a mean treatment duration of 26 weeks, 56 percent of the 79 patients on 100 mg and 44 percent of the 91 patients on 300 mg improved at least one New York Heart Association functional class. Thelin is a small molecule that blocks the action of endothelin. Side effects seen to date include liver dysfunction, headache, edema, constipation, nasal congestion and flushing.

• Epimmune Inc., of San Diego, presented data from its ongoing SIV rhesus macaque vaccine study at the AIDS Vaccine 2004 conference in Lausanne, Switzerland, showing the vaccine induced immune responses specific for multiple cytotoxic T-lymphocyte (CTL) and helper T-lymphocyte epitopes. CTL-specific responses were increased by fivefold to 10-fold following SIV viral challenge. SIV is the virus equivalent of HIV in many non-human primate species. Epimmune is focused on the development of vaccines using multiple epitopes to specifically activate the body's immune system.

• Generex Biotechnology Corp., of Toronto, applied for Ecuadorian approval for the manufacturing, marketing, distribution and sale of Oralin, its oral insulin spray formulation, as well as its RapidMist Diabetes Management System. Generex has a distribution agreement in place through a joint venture with PharmaBrand SA, of Quito, Ecuador.

• Genetronics Biomedical Corp., of San Diego, was awarded a grant by the National Institutes of Health in Bethesda, Md., to conduct research in the field of vascular gene therapy. The $100,000 Phase I grant was awarded through the Small Business Innovation Research grant program, and it could be followed, upon evaluation, by a Phase II award of up to $1 million. Genetronics is a late-stage biomedical company focused on building an oncology franchise based on its electroporation therapy.

• LION bioscience AG, of Heidelberg, Germany, released LION Target Engine 1.1. LION Target Engine 1.1 is designed to enable scientists in target identification and validation to access all available life science data through a simplified web interface.

• Micrologix Biotech Inc., of Vancouver, British Columbia, completed the acquisition of MitiKor Inc., of San Diego, a company focused on the treatment of degenerative diseases related to mitochondrial dysfunction. The company created by the merger has a portfolio of clinical and preclinical development programs including five clinical-stage product candidates in hepatitis C, Alzheimer's disease, catheter-related infections, acne and human papillomavirus.

The National Institute of General Medical Sciences (NIGMS), part of the National Institutes of Health in Bethesda, Md., established its fifth center of excellence for Complex Biomedical Systems Research. The new center, headed by David Botstein of Princeton University, will explore how biological molecules interact with each other and their environment to create dynamic systems. NIGMS will award $3 million to the center this year and expects the project to total $14.8 million over five years.

• New River Pharmaceuticals Inc., of Radford, Va., said the FDA designated its NRP104 investigational drug a fast-track product for treatment of cocaine dependence. The company said it is collaborating with officials at the National Institute on Drug Abuse to design preclinical and clinical programs for the drug, which already is in clinical development for attention deficit hyperactivity disorder in pediatric populations.

• Power3 Medical Products Inc., of The Woodlands, Texas, entered a research agreement with Baylor College of Medicine to discover biomarkers in serum and plasma that are of use in the diagnosis and drug targeting for metabolic syndrome and associated disorders, such as diabetes, cardiovascular disease, hypertension and stroke. Initial results should shed new light on metabolic syndrome as researchers seek more definitive blood tests about what is happening at the protein level.

• Quaker BioVentures, of Philadelphia, entered a 10-year limited partnership agreement with the New Jersey Economic Development Authority to create and manage the $10 million Garden State Life Sciences Venture Fund that will make investments in emerging life sciences companies in New Jersey. The $10 million commitment, which will come from the state's residual Business Employment Incentive Program funds, will leverage at least $30 million from other funds managed by the venture capital firm.

• Sequenom Inc., of San Diego, agreed to provide the Translational Genomics Research Institute (TGen) access to its candidate gene portfolio of targets associated with an individual's predisposition for skin cancer in a research agreement. TGen will further validate the candidate genes against its expression databases to assess their use as diagnostic markers for skin cancer risk and the clinical prognosis of skin cancer patients. Products developed will be jointly owned and commercialized.

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