• Advanced Cell Technology, of Worcester, Mass., appointed William Caldwell CEO and named Michael West chairman, president and chief scientific officer of the company. Caldwell has worked with technology companies, both public and private, and served in executive positions in marketing and finance. West, who founded the Menlo Park, Calif.-based Geron Corp., previously served as chairman and CEO of Advanced Cell Technology, which focuses on discovering and advancing stem cell technology.

• Advanced Viral Research Corp., of Yonkers, N.Y., presented final results of its Phase I/II trial of AVR118 in patients with AIDS at the 2005 annual assembly of the American Academy of Hospice and Palliative Medicine and Hospice and Palliative Nurses Association in New Orleans. All dose groups showed an improvement in weight, strength, body-mass index and calf circumference.

• Altana AG, of Bad Homburg, Germany, launched Alvesco (ciclesonide) in the UK. The product is an inhaled corticosteroid for the treatment of adults suffering from persistent asthma. Its small particle size allows for greater lung deposition and lower oral deposition, the company said, and it is converted to its active form by esterases in the lung. The company, which also has received approval in Germany, plans to begin marketing it there next month. Further launches worlwide will follow later this year.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, raised A$8.2 million (US$6.2 million) through a 15 percent placement of ordinary shares to existing and new shareholders. Shares were sold at A$0.55 each. Funds will be used to accelerate the clinical development programs for ChemGenex's targeted cancer compounds in Phase II trials: Ceflatonin for leukemia and Quinamed for solid tumors. The company also said it expects to advance its preclinical pipeline of therapeutics in the fields of oncology, diabetes, obesity and depression.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., said findings from a 674-subject study, published in the December 2004 issue of Atherosclerosis, suggested that women with a genetic predisposition to protective levels of C-reactive protein (CRP) lose that benefit when taking hormone-replacement therapy. The results are the first published data from the company's STRENGTH (Statin Response Examined by Genetic Haplotype Markers) trial, a prospective pharmacogenetic study undertaken to find genetic markers responsible for differential response to statin drugs for lowering cholesterol. The eight-month trial of 315 men and 359 women also was designed to find genetic markers responsible for pre-treatment levels of biomarkers such as low-density lipoprotein, high-density lipoprotein and CRP.

• ImClone Systems Inc., of New York, reached agreements, in principle, to settle its previously disclosed consolidated securities class action and consolidated shareholder derivative action, both of which are pending in the U.S. District Court for the Southern District of New York. As a result, the company expects to recognize a one-time charge of about $55.4 million against its earnings last quarter. The charge is net of insurance reimbursement and the net amount received by the company in the settlement of the derivative action. Both arose from lawsuits that originally were filed in early 2002. Late in 2001, the FDA issued a "refusal to file" letter on a new drug application for Erbitux (cetuximab), leading to a scandal that sent ImClone's former CEO to prison. (See BioWorld Today, Jan. 3, 2002.)

• Immtech International Inc., of Vernon Hills, Ill., began enrollment in a Phase I trial to evaluate two new formulations of DB289, its first oral drug candidate. The 42-patient study will compare the current capsule formulation to two new formulations of pressed tablets. The company expects it to take about seven weeks to complete, including enrollment, collection and analysis of blood samples, as well as data evaluation. The three formulations are being tested to determine which has the most consistent absorption in the blood, and if there is an absorption difference between the capsule and tablets. Findings will be used to select the best formulation for pivotal Phase III studies in trypanosomiasis and Pneumocystis pneumonia.

• The International Genomics Consortium in Phoenix said its Expression Project for Oncology released clinically annotated gene-expression profiles for 60 tumor specimens, completing the initial phase of the nation's first, and eventually largest, public database dedicated to standardized gene-expression data. The dataset is available through the National Center for Biotechnology Information website at www.ncbi.nlm.nih.gov/geo/.

• Marshall Edwards Inc., of Washington, said the findings reported in the current issue of Oncology Research showed that its investigational cancer drug, phenoxodiol, considerably enhances the ability of docetaxel (Taxotere, Sanofi-Aventis Group) to kill human ovarian cancer cells in the laboratory. Researchers from Yale University School of Medicine used cancer cell lines established from patients who had failed to respond to standard cancer drugs. Phenoxodiol was able to restore sensitivity to docetaxel in those resistant cells, and the researchers also found that the synergistic effect of phenoxodiol was so great that, when added to the treatment mix, phenoxodiol allowed 1 percent of the amount of docetaxel to be used.

• Mergen Ltd., of San Leandro, Calif., launched a new service of original equipment manufacturing for companies looking to resell DNA microarrays for gene-expression analysis under their own trademark or co-branded with Mergen. The new OEM business is intended to complement Mergen's own Express Chip DNA microarray system.

• Perlegen Sciences Inc., of Mountain View, Calif., said it will conduct a high-density whole-genome association study in collaboration with AstraZeneca plc, of London, for an undisclosed trait of interest. It is the second project between the two companies; a study to research the genetics of myocardial infarction was announced in January 2004.

• Pharmacyclics Inc., of Sunnyvale, Calif., said preclinical data reported at the Society for Cardiac Magnetic Resonance meeting in San Francisco support the use of compounds based on the company's texaphyrin technology to enhance visualization of vulnerable atherosclerotic plaque. The findings showed that gadolinium-based texaphyrin compounds might be used as molecular imaging agents that selectively localize in atherosclerotic plaque and enable noninvasive magnetic resonance imaging of rupture-prone plaque, the company said.

• Pharming Group NV, of Leiden, the Netherlands, raised €7 million (US$9.1 million) from warrants and options exercised by the company's shareholders and management. Pharming said it secured total financing of €42 million in 2004 and 2005. The company, which develops protein therapeutics for genetic disorders, specialty products for surgical indications and intermediates for various applications, also completed the acquisition of ProBio International Holdings Pte. Ltd., of Melbourne, Australia, to expand commercial activities with recombinant human lactoferrin.

• Pharmos Corp., of Iselin, N.J., received a gross milestone payment of $12.1 million from Bausch & Lomb, of Rochester, N.Y. The payment was triggered by Bausch & Lomb's commercial launch of Zylet, which received FDA approval last month. The product is part of the loteprednol etabonate business sold to Bausch & Lomb in 2001 by Pharmos, which stands to receive up to $10 million in an additional milestone payment based on Bausch & Lomb sales of Zylet over the next two years.

• RNAi Co. Ltd., of Tokyo, licensed for its RNA interference drug discovery efforts the MetaCore technology of GeneGo Inc., of St. Joseph, Mich. MetaCore is an integrated platform for the analysis of different types of experimental data in drug discovery. The companies also agreed to collaborate in platform development. Financial terms were not disclosed.

• Serologicals Corp., of Atlanta, said its company, Upstate Group Inc., of Lake Placid, N.Y., introduced the Pathway Profiler, a service designed to measure cell-based signaling cascades that might help drug development companies determine compound efficacy in a variety of cellular environments.

• Serono Inc., of Rockland, Mass., completed enrollment in its second Phase III trial of Serostim (somatropin [rDNA origin] for injection) in the treatment of HIV-associated adipose redistribution syndrome. The primary goal of the trial is to assess whether Serostim induction therapy significantly reduces the marketed abnormal accumulation of visceral adipose tissue and fat maldistribution. The company reported in May that it had initiated the study. (See BioWorld Today, June 2, 2005.)

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., said the FDA has raised no objections that would preclude the company from entering Phase I trials of TPI 287, an investigational new taxane. The company expects to begin clinical testing in the first half of this year with a Phase I study in eligible patients with recurrent and/or refractory malignancies. It is designed to determine an appropriate dose, and is expected to enroll up to 50 patients.

• Telik Inc., of Palo Alto, Calif., said it plans to file a prospectus supplement with the SEC related to an underwritten offering of 5 million shares of its common stock under an existing shelf registration. In connection with the offering, Telik expects to grant the underwriters a 30-day option to purchase up to 750,000 additional shares to cover overallotments. The company's most advanced drug development candidates are for cancer treatment.

• Tercica Inc., of South San Francisco, filed a registration statement with the SEC covering a proposed offering of 6 million shares of its common stock. All of the shares are being offered by Tercica. Tercica is focused on the development and commercialization of recombinant human insulin-like growth factor-1 for the treatment of short stature and other metabolic disorders.

• Vasogen Inc., of Mississauga, Ontario, received Canadian regulatory approval to begin a Phase I trial of VP025, the lead drug candidate from its new class of drugs designed to target inflammation. The product is being developed to target the chronic inflammation within the brain and central nervous system associated with a number of neurological diseases, including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis. The trial is designed to examine the safety and tolerability of increased doses of VP025 in up to 24 healthy volunteers. It is expected to be completed next quarter.

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