• Aeolus Pharmaceuticals Inc., of Research Triangle Park, N.C., said the FDA approved the company's investigational new drug application to begin Phase I trials of AEOL 10150 for amyotrophic lateral sclerosis. An initial study will consist of a single dose given to Lou Gehrig's disease patients to evaluate its safety, tolerability and pharmacokinetics. The doses will be increased as the trial progresses, and the company said it is negotiating with several centers to begin the trials. The company's stock (OTC BB:AOLS) gained 19 cents Tuesday, or 10.8 percent, to close at $1.97.

• Agencourt Bioscience Corp., of Beverly, Mass., celebrated the opening of its new corporate headquarters in Beverly. The facility occupies 30,000 square feet, more than doubling the size of its former facility. Agencourt provides genomic services and nucleic acid-purification products.

• American Pharmaceuticals Partners Inc., of Schaumburg, Ill., established a $100 million unsecured, three-year, senior revolving credit facility, which is expandable to $150 million. The facility replaces an existing, five-year, senior-secured $50 million revolving credit facility put in place in December 2001. The new facility is being funded by Fifth Third Bank, Wachovia Bank, Merrill Lynch & Co. Inc. and CIBC World Markets. The company will record a non-cash charge of about $1.2 million, or 2 cents per diluted share, as a result of the early termination of the prior credit facility.

• AspenBio Inc., of Castle Rock, Colo., completed and terminated its offering under a private placement of unregistered securities totaling an aggregate of about $2.5 million, with about $1.2 million having closed on July 21 and about $1.3 million having closed on Aug. 19. Each unit sold consisted of 20,000 common shares and 20,000 warrants exercisable for three years at $1.50 a share, at a total price of $17,500 per unit. The offering was completed through Westminster Securities Corp., the company's placement agent for the offering.

• Callisto Pharmaceuticals Inc., of New York, signed an agreement with the University of Texas M.D. Anderson Cancer Center in Houston for the licensing of Annamycin, an anthracycline drug for leukemia therapy. Callisto expects to initiate a Phase IIb trial in relapsed acute lymphocytic leukemia and relapsed acute myeloid leukemia patients in the first half of 2005. Financial terms were not disclosed.

• Cell Therapeutics Inc., of Seattle, said the audit committee of the board will engage a new independent audit firm after Ernst & Young LLP notified CTI that they resigned as the company's independent auditor effective Aug. 31. Cell Therapeutics is developing cancer products.

• Cephalon Inc., of West Chester, Pa., received a subpoena from the U.S. Attorney's Office in Philadelphia requesting documents from 1998 to the present regarding the sales and promotional practices relating to the company's products. Cephalon said it would cooperate with the request. Cephalon is focused on products to treat sleep and neurological disorders, cancer and pain.

• Curis Inc., of Cambridge, Mass., received a $5.4 million, three-year grant from the Spinal Muscular Atrophy Foundation to identify therapeutic compounds to treat spinal muscular atrophy. The study will use Curis technologies and expertise to develop and refine motor neuron assays and to use those assays to screen for potential drug candidates. SMA is a genetic motor neuron disease caused by progressive degeneration of nerve cells in the spinal cord and brainstem, leading to muscle weakness, respiratory complications and premature death.

• Cyclacel Group plc, of Dundee, Scotland, began patient enrollment in a third Phase I trial of CYC682, a cancer drug acting on the cell cycle. CYC682, an orally available small-molecule nucleoside analogue drug, is Cyclacel's second candidate to enter clinical trials. The new trial is an open-label Phase Ib study testing CYC682 in patients with solid tumors or lymphoma. In addition to determining its safety profile, secondary objectives are to analyze the pharmacokinetics of CYC682 and its metabolite together with investigating the use of biomarkers to predict tumor sensitivity.

• Cylex Inc., of Columbia, Md., raised $6.4 million after closing its second round of private financing. The company, which was founded in 1998, has secured $12.4 million in venture funding to date. Its ImmuKnow product is a cellular immunology assay. Investors included Early Stage Enterprises LP, which led the funding; Roche Venture Fund; NJTC Venture Fund; and The Nikko New Wave 2001 Investment Enterprise.

• Generex Biotechnology Corp., of Toronto, presented data on Oralin, the company's buccal spray insulin formulation, at the 40th annual meeting of the European Association for the Study of Diabetes, held in Munich, Germany. In the randomized, crossover study, seven healthy volunteers were assessed during five test periods seven days apart and received four different doses of buccal spray. The purpose of the study was to evaluate the pharmacodynamic and pharmacokinetic properties and the dose-ranging effects of Oralin in comparison to regular insulin and a placebo spray in healthy subjects.

• Helsinn Healthcare SA, of Lugano, Switzerland, agreed to grant exclusive license and distribution rights for Palonosetron in the UK to Cambridge Laboratories Ltd., of Dublin, Ireland. The product, which is under registration in Europe, is a serotonin receptor antagonist used for the prevention of nausea and vomiting induced by chemotherapy in the U.S. It is marketed there as Aloxi by MGI Pharma Inc., of Minneapolis. Financial terms were not disclosed.

• Hemispherx Biopharma Inc., of Philadelphia, began clinical testing of Alferon N injection for West Nile virus. The trial will follow a double-blinded, placebo-controlled design to test the alpha-interferon therapy.

• Isolagen Inc., of Houston, appointed Robert Bitterman to succeed Michael Macaluso as president and CEO. Macaluso will continue to serve on the board. Bitterman recently concluded 10 years of service as president of Aventis Pharmaceuticals' dermatology division, Dermik Laboratories. Isolagen specializes in the development and commercialization of autologous cellular therapies for soft- and hard-tissue regeneration.

• Lynx Therapeutics Inc., of Hayward, Calif., announced the acceptance for publication of two peer-reviewed manuscripts that describe the use of its Massively Parallel Signature Sequencing gene-expression technology to document gene-activity data for nearly every gene in the experimental plant species Arabidopsis thaliana. The data were generated through a National Science Foundation-sponsored project. Arabidopsis thaliana is a plant in the mustard family with one of the smallest genomes and the highest gene density so far identified in a flowering plant. The manuscripts are in the August 2004 issue of Nature Biotechnology and the September 2004 issue of Molecular Biology and Evolution.

• MannKind Corp., of Valencia, Calif., presented research at the annual meeting of the European Association for the Study of Diabetes in Munich, Germany, that described features of insulin delivery and glucose control with its Technosphere/Insulin system. The MannKind product is in late-stage Phase II trials in the U.S. and Europe and is being developed to treat Type I and Type II diabetes mellitus. The system produces a rapid increase in blood-insulin levels similar to the normal early release of insulin that is observed in healthy individuals following a meal.

• Metabasis Therapeutics Inc., of San Diego, plans to present data this week at the 40th annual meeting of the European Association for the Study of Diabetes concerning CS-917, its oral gluconeogenesis inhibitor, to treat Type II diabetes mellitus. The results will include data on combination of the drug in animal studies with glyburide. Another presentation will discuss results from preclinical studies designed to delineate the mechanism of action of CS-917, which has moved through two initial Phase II studies and was shown to significantly lower blood-glucose levels in patients. Metabasis expects its second-generation candidate, MB07803, to enter the clinic next year.

• Micrologix Biotech Inc., of Vancouver, British Columbia, received Canadian regulatory authorization to begin a Phase IIa study of MBI-3253 (celgosivir), an oral first-in-class therapy for chronic hepatitis C virus infections. The company has selected sites for the trial, which it expects to begin enrolling patients within the next few weeks. About 60 treatment-naive or interferon-intolerant hepatitis C patients will be divided into three dosing groups and treated for 12 weeks. Its objective is to evaluate viral loads at various time points during the study and at 12 weeks, and it also will assess the drug's safety. Results are expected in the second quarter of next year.

• Nektar Therapeutics, of San Carlos, Calif., said data reported at the European Association for the Study of Diabetes meeting in Munich, Germany, showed that Exubera (inhaled insulin) was effective and well tolerated in controlling blood glucose levels over a two-year period in Type II diabetics. The findings were reported by Pfizer Inc., of New York, and Sanofi-Aventis, of Paris. Nektar develops and provides the inhalers and the powdered insulin for the Exubera product.

• Nucleonics Inc., of Horsham, Pa., requested that the Australian commissioner of patents re-examine Benitec Ltd., of Queensland, Australia, and Australian Patent No. 743316, "Control of Gene Expression." The request cites 24 prior art publications showing that the patent claims are invalid because they lack novelty and do not involve an inventive step. Benitec filed an infringement suit in March against Nucleonics and others, citing its U.S. issued Patent No. 6,573,099. It also has filed an opposition in Australia to the grant of a patent for the seminal invention in RNA interference. Nucelonics believes the Benitec intellectual property portfolio is flawed, and Nucleonics will defend its right to develop therapeutics for chronic viral diseases, said the company CEO Robert Towarnicki.

• Pharmos Corp., of Iselin, N.J., received a grant for 2004 of $482,000 from the Office of the Chief Scientist of Israel to support development of drug candidates from its CB2-selective family of compounds. The grant is in addition to a previously reported grant for 2004 of $3.1 million to support development of the company's lead neuroprotective drug candidate, dexanbinol.

• Quaker BioVentures in Philadelphia closed its inaugural fund with about $280 million under management. The venture firm said the fund was oversubscribed by $80 million and includes investments from state and city pension plans, corporate pension plans and university endowments. Founded in early 2002, Quaker is providing capital to life sciences companies in the mid-Atlantic region.

• Sinovac Biotech Ltd., of Beijing, said all 36 subjects in a Phase I trial of its inactivated vaccine for severe acute respiratory syndrome have been vaccinated with two doses of either the vaccine or placebo, completing its immunization schedule. No adverse side effects were observed during an observation period after the second inoculation, and blood sampling will be completed at the end of the month.

• Sirna Therapeutics Inc., of Boulder, Colo., filed an investigational new drug application with the FDA to begin trials of Sirna-027 in age-related macular degeneration (AMD) patients. The product, a chemically modified short interfering RNA targeting vascular endothelial growth factor receptor-1, is designed to shut down activation of pathologic angiogenesis initiated by both VEGF and placental growth factor. The open-label, dose-escalation study is enrolling patients with wet AMD, which is characterized by the growth of abnormal retinal blood vessels that leak blood or fluid to cause central vision loss. It is designed to measure Sirna-027's safety, tolerability and biological activity following a single intravitreal injection.

• Synthetic Blood International Inc., of Costa Mesa, Calif., submitted the first of a series of Phase II trial protocols for Oxycyte to the FDA. Oxycyte is the company's perfluorocarbon-based blood substitute and therapeutic oxygen carrier. The company also submitted the final Phase I safety study report for Oxycyte. Enrollment in the first Phase II trial is expected to begin this month. The study would involve orthopedic surgery patients who experience mild to moderate blood loss during surgery.

• Tercica Inc., of South San Francisco, said results of an analysis of more than 6,000 children showed that primary insulin-like growth factor-1 deficiency (IGFD) was 1.5 times more common than growth-hormone deficiency in children with short stature. The prevalence suggests that about 30,000 evaluated children in the U.S. have short stature due to primary IGFD. Detailed results of the study were presented at the 12th International Congress of Endocrinology meeting in Lisbon, Portugal, earlier this month. Of the children diagnosed with short stature in the study, 42 percent also had abnormally low IGF-1 levels. Tercica plans to file a new drug application in early 2005 for the use of rhIGF-1 in children with severe primary IGFD.

• Valentis Inc., of Burlingame, Calif., expanded its license agreement with Genzyme Corp., of Cambridge, Mass., allowing increased use of Valentis' GeneSwitch gene-regulation technology. In return, Valentis gains certain rights to Genzyme's static mixer intellectual property for use in plasmid DNA manufacturing. GeneSwitch allows researchers to control the level and duration of expression of selected genes by oral administration of a small-molecule drug. Valentis is focused on creating cardiovascular therapeutics.

• VaxGen Inc., of Brisbane, Calif., said the FDA cleared an investigational new drug application for the company's candidate smallpox vaccine, LC16m8. The effective IND will allow VaxGen to begin clinical development of LC16m8 with the objective of meeting the U.S. government's stated interest in acquiring an emergency stockpile of an attenuated smallpox vaccine and licensing the product for commercial sales. The U.S. government has indicated that it anticipates spending $1.9 billion to establish and maintain a stockpile of attenuated smallpox vaccine over a 10-year period. The IND clears the way for a Phase I/II trial to evaluate the safety and immunogenicity of LC16m8 and compare it to Dryvax, the smallpox vaccine licensed for use in the U.S.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., completed the dosing portion of a Phase Ia trial for VX-950, an oral protease inhibitor to treat hepatitis C virus infection. The study involves 35 healthy volunteers in Europe. It is designed to assess safety, tolerability and pharmacokinetics in escalating, single doses of VX-950. Vertex expects to begin a Phase Ib study in hepatitis C patients by the end of the year. Vertex owns development and commercialization rights to VX-950 everywhere but Japan and certain Far East countries, where Tokyo-based Mitsubishi Pharma Corp. holds the rights.

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