• Adolor Corp., of Exton, Pa., submitted the second section of its new drug application for Entereg for postoperative ileus. The submission of the chemistry, manufacturing and controls section was made under the FDA's Continuous Marketing Application Pilot 1 Program. Partnered with GlaxoSmithKline plc, of London, the product began the filing process last month. (See BioWorld Today, May 10, 2004.)

• Advanced Magnetics Inc., of Cambridge, Mass., said the National Cancer Institute in Bethesda, Md., began a clinical study of ferumoxytol under its cancer imaging program. The trial, which will evaluate the product in both angiographic imaging and delayed imaging in patients with primary or metastatic brain tumors, is designed to determine optimal imaging time and magnetic field strength to visualize the extent of brain tumors.

• Adventrx Pharmaceuticals Inc., of San Diego, began cGMP production of the antiviral drug Thiovir in preparation for an investigational new drug application filing with the FDA. Thiovir is being manufactured by Reykjavik, Iceland-based DeCode Genetics Inc. at its chemistry facility based in Lemont, Ill. Thiovir is an orally delivered prodrug of the broad-spectrum antiviral drug foscarnet, which is an IV-delivered treatment for opportunistic infections in HIV-infected patients.

• Array BioPharma Inc., of Boulder, Colo., received a $420,000 research milestone from Amgen Inc., of Thousand Oaks, Calif., as part of their January 2002 drug discovery agreement. Array collaborated with Amgen on the discovery of lead compounds for an Amgen therapeutic target. Array is entitled to milestone payments if the program continues to advance.

• Atrix Laboratories Inc., of Fort Collins, Colo., said its Latin America licensee, Tecnofarma International Ltd., of Buenos Aires, Argentina, received Mexican approval of its one- and three-month prostate cancer products, Eligard 7.5 mg and 22.5 mg. The one-month product was launched last month.

• AVI BioPharma Inc., of Portland, Ore., presented results of a study showing inhibition of Dengue virus with its Neugene antisense compounds at the Seventh International Symposium on Positive-Strand RNA Viruses held in San Francisco May 27-June 1. The study, conducted in cooperation with the Centers for Disease Control and Prevention in Atlanta, evaluated the ability of AVI's Neugene compounds to inhibit replication of Dengue virus strains I through IV.

• BASF Plant Science GmbH, of Ludwigshafen, Germany, licensed the enzyme database Brenda from BioBase GmbH, of Wolfenbuttel, Germany. The electronic encyclopedia contains data on 83,000 enzymes from 9,800 organisms and additional metabolic data.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said preclinical results to be published in the June 11, 2004, issue of the International Journal of Pharmaceutics detail positive findings from a study of its BioOral calcium phosphate nanoparticle (CAP) delivery system for the oral delivery of insulin. Specifically, insulin delivered with CAP in a formulation called CAPIC reduced blood glucose levels in fasted diabetic mice by 80 percent within the first hour and maintained the reduction for 12 hours. In contrast, insulin delivered without CAP reduced blood glucose about 20 percent for four to five hours.

• Biotech Holdings Ltd., of Richmond, British Columbia, signed an agreement for marketing its Sucanon diabetes drug in Mexico with an unnamed company. The insulin-sensitizing drug, which is designed to treat symptoms of Type II diabetes and impaired glucose tolerance, is approved in that country and Peru.

• Calypte Biomedical Corp., of Alameda, Calif., raised $9.3 million in a private placement to accredited investors. It is issuing about 23.6 million shares of its common stock at 40 cents per share and five-year warrants to purchase about 8.1 million shares of its common stock at 50 cents per share. The investors were led by SF Capital Partners Ltd. and also included Marr Technologies BV, which participated in the company's last two financing rounds and remains its largest stockholder. The proceeds are expected to be used for the commercialization of the company's rapid tests for HIV-1/2 diagnosis that are in development.

• Cardiome Pharma Corp., of Vancouver, British Columbia, will report information today to the FDA Arthritis Drugs Advisory Committee related to its new drug application for oxypurinol as a treatment for allopurinol-intolerant gout patients. The company plans to use the meeting to advise the FDA on gout clinical trial design, review its NDA and other items. Cardiome said there will not be a vote on the application.

• CellCentric Ltd., of Cambridge, UK, completed its first round of venture funding. The company was founded to commercialize the intellectual property and research of Azim Surani at the Wellcome Trust/Cancer Research UK Gurdon Institute at the University of Cambridge. His findings have demonstrated that mature cells could be reprogrammed to cells that behave like stem cells. Avlar BioVentures Ltd. led the investment, which also included Providence Investment Co. Ltd.

• Celsion Corp., of Columbia, Md., said its common stock was listed on the Berlin-Bremen Stock Exchange in Germany without the company's prior knowledge, consent or authorization. The company, through its counsel, contacted the stock exchange and demanded a halt to trading, as well as a delisting. Celsion is focused on treatment systems for cancer and other diseases using focused-heat energy.

• Crucell NV, of Leiden, the Netherlands, said a dose of its vaccine protected monkeys against the Ebola virus in recent studies. Crucell and the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Md., produced a vaccine against Ebola, using Crucell's PER.C6 cell line as a production platform, confirming the results of a previous NIAID/U.S. Army Medical Research Institute of Infectious Diseases trial of a prototype adenoviral vaccine reported in Nature in August. Crucell has a Cooperate Research and Development Agreement with the VRC to develop PER.C6 and adenovirus vector-based vaccines against Ebola, Marburg and Lass viruses, as well as a contract to produce such vaccines for clinical studies in humans.

• Eiffel Technologies Ltd., of Sydney, Australia, established a Level 1 American depository receipt (ADR) program. Its ADR code is "EFFTY." The company uses its Supercritical Fluid technology to re-engineer existing drugs such as insulin and products for asthma to improve their effectiveness.

• Entropin Inc., of Indio, Calif., said its collaborators at RTI International Metals Inc., of Niles, Ohio, synthesized radiolabeled ENT-103, setting the stage for Entropin to evaluate a variety of enhanced topical formulations of ENT-103. The company intends to select the best as its candidate for initial human clinical trials. ENT-103 is designed as a therapy for pain.

• Gamida-Cell Ltd., of Jerusalem, said preclinical studies show that an injection of an expanded population of cord blood-derived AC133 cells directly into the pancreas reversed diabetes in mice. The data demonstrated that the expanded population of stem cells helped to restore normal blood glucose levels, as well as the ability to maintain a stable blood sugar level. The expression of the human C-peptide, the marker for the production of insulin, also appeared.

• GeneGo Inc., of St. Joseph, Mich., entered a multiyear licensing agreement with Invitrogen Corp., of Carlsbad, Calif., to develop new drug discovery capabilities. Invitrogen will license GeneGo's biological pathways to help make bioinformatics a part of the company's solutions set for life science research. Further details and financial arrangements were not disclosed.

• Generex Biotechnology Corp., of Toronto, said its wholly owned subsidiary, Antigen Express, established a collaboration with Saint Savas Cancer Center in Athens, Greece, to use modified peptide antigens to stimulate cancer patients' immune cells. Success in the test-tube studies should lead to clinical vaccine trials in patients with ovarian cancer. The company previously has shown that blood cells from patients with Her-2/neu positive breast cancer are stimulated by antigenic peptide epitopes, which have been modified by Antigen Express technology.

• Genmab A/S, of Copenhagen, Denmark, signed an agreement with DSM Biologics to produce a commercial supply of HuMax-CD4, its antibody to treat T-cell lymphoma. DSM will manufacture cGMP batches of HuMax-CD4 for clinical trials and commercial supply. It will be produced in DSM's facility in Groningen, the Netherlands.

• Hemispherx Biopharma Inc., of Philadelphia, said the Institutional Review Board of New York Hospital Queens approved the clinical protocol for therapy of West Nile virus using alpha-interferon (Alferon). Physicians can access the Alferon N injection for West Nile virus protocol at the hospital website. Alferon N (Interferon alfa-n3, human leukocyte derived) is a highly purified, natural source, glycosylated, multispecies alpha-interferon product.

• HepaLife Technologies Inc., of Vancouver, British Columbia, extended the term and scope of its Cooperative Research and Development Agreement with the U.S. Department of Agriculture's agricultural research service. HepaLife will continue to collaborate toward optimizing the hepatic functionality of the patented PICM 19 cell line, and now will develop liver cell-specific in vitro toxicology and preclinical drug testing platforms based on the PICM 19 cell line to more accurately determine the potential toxicity and metabolism of new pharmacological compounds.

• Introgen Therapeutics Inc., of Austin, Texas, said data from its Advexin and INGN 241 programs were reported at the Okayama International Forum on Gene and Cell Therapy in Okayama, Japan. The event was held in conjunction with the inauguration of the Center for Gene and Cell Therapy at Okayama University.

• Medi-Hut Co. Inc., of Spring Lake, N.J., said the U.S. District Court for the District of New Jersey approved a class-action settlement reached last year, and the company settled its action against three former executives. Medi-Hut also said an insurance company is suing for alleged unpaid insurance premiums.

• Medtronic Inc., of Minneapolis, and Genzyme Corp., of Cambridge, Mass., formed a joint venture called MG Biotherapeutics to accelerate the development of new treatments for some of the most intractable forms of cardiovascular disease. The venture will work to develop therapies that leverage Medtronic's experience developing delivery devices for targeted therapy and leadership in treating heart disease, as well as imaging and navigational technologies, and Genzyme's experience developing biological approaches for cardiac repair and the treatment of heart disease. The parties will collaborate on an ongoing Phase II trial using cell therapy to repair damaged heart tissue, a portfolio of advanced delivery devices to deliver therapeutic cells to the heart in a less invasive manner and a long-term cell therapy research project into repairing heart tissue.

• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., began an exploratory research collaboration with Novartis Institutes for BioMedical Research Inc., also in Cambridge. Merrimack believes it can add value to Novartis' drug development efforts with its Network Biology platform by providing new insights into signaling pathways that are involved in certain diseases, and how those pathways are altered by various drug therapies.

• MicrosIslet Inc., of San Diego, now is trading on the American Stock Exchange under the ticker symbol "MII." MicroIslet is engaged in the research, development and commercialization of technologies in the field of transplantation for people with insulin-dependent diabetes.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., and Schering-Plough Corp., of Kenilworth, N.J., began a multicenter Phase IIIb trial to evaluate the benefit of Integrilin administered early to high-risk patients experiencing non-ST-segment elevation acute coronary syndrome. The trial will evaluate the benefit of Integrilin compared to placebo in reducing death and other adverse cardiac events, including heart attack, within 96 hours and up to 30 days following randomization. It will enroll 10,500 patients at 500 sites worldwide.

• Miravant Medical Technologies Inc., of Santa Barbara, Calif., said the FDA accepted its new drug application for SnET2 and granted the NDA a priority review designation in the process. The company is seeking approval for its drug as a treatment for patients with wet age-related macular degeneration. Its stock (OTC BB:MRVT) dropped 33 cents Tuesday, or 11.3 percent, to close at $2.60.

• Nanosphere Inc., of Northbrook, Ill., said findings published in the July 2004 issue of Nature Biotechnology detail the development of a colorimetric detection capability for its nanoparticle-based molecular detection systems. The company said such a development would further simplify the identification of genomic DNA, RNA and protein targets without the need for traditional signal or target amplification.

• Neuro3d, of Mulhouse, France, said ND1251 is being investigated in Phase I trials to treat depression. The product is an orally active phosphodiesterase-4 inhibitor. The goal of the trials is to establish safety, tolerability and pharmacokinetics, and to demonstrate activity in the brain.

• Nucleonics Inc., of Malvern, Pa., said it raised an additional $8.3 million, bringing the total raised in its Series B venture round to $49.2 million. New investor Quaker BioVentures participated in the second close, as did previous investors New Enterprise Associates and S.R. One Ltd. The company elected James Barrett, a general partner at New Enterprise, as chairman, and appointed Giovanni Ferrara, of Burrill & Co., to its board. The company expects proceeds from the financing to support the development of its hepatitis B product candidate through Phase II testing. (See BioWorld Today, April 5, 2004.)

• Panacos Pharmaceuticals Inc., of Gaithersburg, Md., completed an escalating-dose Phase I trial of the first-in-class HIV-maturation inhibitor PA-457. Following oral administration to uninfected, healthy volunteers, PA-457 was well tolerated and exhibited favorable oral bioavailability and pharmacokinetics. PA-457 has a mechanism of action that is different from approved HIV drugs and shows activity against HIV strains resistant to current therapies.

• Pharsight Corp., of Mountain View, Calif., reached an agreement with Silicon Valley Bank to expand its secured revolving credit facility from $2 million to $3 million. The credit facility was renewed for an additional 12 months to May 27, 2005. Pharsight develops and markets products and services designed to help pharmaceutical and biotechnology companies improve their decision-making.

• Sanofi-Synthelabo SA, of Paris, said French regulatory authorities set June 30 as the expiration date of its revised offer for Aventis SA, of Strasbourg, France. The company's French, German and U.S. offers will expire simultaneously on that date.

• SIGA Technologies Inc., of New York, spun off its immunological bioinformatics technology and certain noncore vaccine development assets into Pecos Labs Inc., a privately held company recently formed as a wholly owned subsidiary of SIGA. Coincident with the transfer of the assets, Pecos completed a round of funding with a group of private investors, and Susan Burgess resigned as SIGA's president to become president and CEO of Pecos. SIGA, which will continue to develop its commensal-vectored vaccines for strep throat and biodefense targets, will retain a minority equity interest in Pecos and access to certain technology.

• SRI International, of Menlo Park, Calif., launched Bridge Pharmaceuticals Corp., a company focused on development of FDA-compliant therapeutic drugs in Asia for the U.S. and European Union markets. Bridge recently closed a $3.5 million Series A round led by WI Harper Group. Additional investors were Taiwan's Industrial Technology Research Institute ITIC Fund, the Development Center for Biotechnology, YFY Group and Singapore's Springboard Harper.

• Sumitomo Pharmaceuticals Co. Ltd., of Tokyo, acquired an exclusive license to develop and market licofelone in Japan to treat osteoarthritis. The company will begin clinical trials in Japan to confirm the efficacy and safety of licofelone, which is in late-stage clinical development by Merckle GmbH, of Ulm, Germany, and its EuroAlliance development partners, Alfa Wassermann SpA and Lacer SA. Clinical studies have shown that licofelone therapy is linked with lower incidences of gastrointestinal and other side effects than conventional nonsteroidal anti-inflammatory drugs.

• Tm Bioscience Corp., of Toronto, launched two new Tag-It Mutation Detection Kits for the P450-2C9 and P450-2C19 genes. The kits identify the presence or absence of important mutations in liver enzymes that are common in patients with atypical drug metabolism, which can lead to adverse drug reactions.

• Vical Inc., of San Diego, said the National Institute of Allergy and Infectious Diseases in Bethesda, Md., advised the company that it will support a Phase I trial of the company's plasmid DNA-based anthrax vaccine at two NIAID-funded Vaccine and Treatment Evaluation Units. Clinical trial materials are ready for shipment, and the trial is expected to begin within the next few weeks.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said it started a Phase II trial of Cloretazine at the Brain Tumor Center of the Duke University Comprehensive Cancer Center in Durham, N.C., to assess the activity and toxicity of the drug in adults with recurrent gliomas. The company said current treatments for glioma are inadequate and that Cloretazine has shown its ability to distribute into the brain, as well as advantages over other treatments. Cloretazine is a DNA-damaging alkylating agent. Vion plans additional Phase II trials in other solid tumors and has an ongoing program in hematologic malignancies.

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