• Advancis Pharmaceutical Corp., of Germantown, Md., said it expects to start enrolling 600 patients later this month for a new Phase III trial of Amoxicillin Pulsys in adults and adolescents with pharyngitis/tonsillitis. The company concluded a pre-Phase III meeting with the FDA, and the regulatory strategy was acceptable to the agency. If the trial is successful, it will support a new drug application filing in late 2006. The product missed in two pivotal trials earlier this year, leading to a staff reduction and a dropped partnership. (See BioWorld Today, Sept. 16, 2005.)

• Amazon Biotech Inc., of New York, is preparing an investigational new drug for a cancer drug candidate believed to be useful in early stage breast cancer. Some of the active ingredients have shown anticancer efficacy in in vitro studies. Amazon Biotech is a natural plant pharmaceutical company primarily developing immune modulator drugs.

• American BioScience Inc., of Santa Monica, Calif., said clinical data of Abraxane showed high response rates in patients with non-small-cell lung cancer, metastatic malignant melanoma and head and neck cancer. Abraxane is an albumin-bound drug designed to work by using tumors' attraction to albumin to kill the cancer. The data were presented at the Chemotherapy Foundation Symposium XXIII in New York.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, entered a definitive agreement to acquire the Lifespan ePTFE vascular graft business in Laguna Hills, Calif. from Edwards Lifesciences Corp. for $14 million in cash. The agreement includes an arrangement in which Edwards will retain certain rights to distribute the existing Lifespan product line globally for up to five years, as well as become the exclusive distributor of Angiotech's Vascular Wrap paclitaxel-eluting mesh products in the European Union for up to three years following regulatory approval.

• Bayer Pharmaceuticals Corp., of West Haven, Conn., and Onyx Pharmaceuticals Inc., of Emeryville, Calif., said that Bernard Escudier provided an update on the Nexavar (sorafenib tosylate) Tablets Phase III trial in patients with advanced renal-cell carcinoma (RCC), or kidney cancer during the 13th European Cancer Conference (ECCO) in Paris. Escudier reported, based on an interim analysis, that there was an estimated 39 percent improvement in survival for patients receiving Nexavar vs. those receiving placebo (p=0.018, hazard ratio 0.72). More than 900 patients with advanced kidney cancer participated in the international Phase III study.

• Celgene Corp., of Summit, N.J., said preliminary Phase II data comparing the efficacy and safety of the combination of thalidomide and topotecan vs. topotecan alone show that the addition of thalidomide could slow the growth of recurrent epithelial ovarian cancer in patients who had received prior treatments. Results showed that patients in the topotecan plus thalidomide arm reported an overall response rate of 50 percent, compared to 22 percent of patients receiving topotecan alone, and 32 percent of patients receiving both products showed a complete response vs. 16 percent of those in the topotecan arm. These data were presented at the XXIII Chemotherapy Foundation Symposium in New York.

• Chromos Molecular Systems, of Burnaby, British Columbia, said it entered a definitive agreement under which it will acquire Targeted Molecules Corp., of San Diego, which is focused on the development of antibody product candidates for treatment of multiple sclerosis and acute thrombosis. Chromos also will complete a private placement to raise not less than $6 million, the proceeds of which will be used to finance operations. As a result of the acquisition, Chromos will gain two humanized monoclonal antibody product candidates, TMC-2003 for inflammatory diseases and NHAT for acute thrombosis. TMC has demonstrated efficacy of those candidates in preclinical proof of principle studies. TMC-2003 (to be re-designated CHR-1103) is a humanized monoclonal antibody directed to VLA-2, an integrin involved in maintenance of inflammation.

• Corautus Genetics Inc., of Atlanta, said the FDA granted fast-track designation to its vascular endothelial growth factor (VEGF)-2 for the treatment of severe angina associated with cardiovascular disease. The company is conducting the GENASIS (Genetic Angiogenic Stimulation Investigational Study) trial to evaluate the safety and efficacy of VEGF-2 in that indication.

• Critical Therapeutics Inc., of Lexington, Mass., said data demonstrate that its Zyflo (zileuton tablets) improved the lung function of patients with severe asthma, while reducing their need for rescue medication and oral corticosteroids. Data showed that both moderate and severe asthmatic patients in the zileuton group experienced rapid and sustained improvements in pulmonary function, compared to placebo, as early as 30 minutes after receiving zileuton. Results of the study were presented at the American College of Chest Physicians 2005 meeting in Montreal.

• DiscoveRx Corp., of Fremont, Calif., signed an agreement with the National Institutes of Health that will provide initial access to its PathHunter technology for small-molecule screening against selected targets of interest to the Molecular Libraries Roadmap Initiative. PathHunter is a cell-based assay technology ideally suited to high-throughput screening that monitors cell-signaling pathways.

• DOV Pharmaceutical Inc., of Hackensack, N.J., presented new data at the Third Annual Scientific Symposium in New York of the company's non-opiate analgesic bicifadine as a treatment for chronic low back pain. It showed that the efficacy of bicifadine 800 mg/day in reducing pain and improving behavioral functioning is at least equivalent to the standard of care. The open-label trial data also showed that the subset of patients who rolled over following completion of a prior three-month Phase III trial had a mean pain score of about 40 on a visual analogue scale, compared with 70 for newly enrolled patients.

• Emisphere Technologies Inc., of Tarrytown, N.Y., received permission from the regulatory authorities in India to begin a Phase II trial for its oral insulin product. The company intends to initiate patient enrollment later this month for a 90-day, four-arm study trial to evaluate the safety and efficacy of low and high doses of oral insulin tablets vs. placebo in 120 subjects with Type II diabetes mellitus, who have inadequate glycemic control with their existing oral antidiabetic monotherapy. The primary efficacy endpoint is related to the change in hemoglobin A_1C.

• Evotec AG, of Hamburg, Germany, said that Boehringer Ingelheim GmbH, of Ingelheim, Germany, extended the scope of their collaboration to identify and develop therapeutics acting on G protein-coupled receptors. Boehringer research sites in Biberach, Germany, and Laval, Quebec, now will collaborate with Evotec under a fee-for-service agreement. For selected Boehringer target proteins, Evotec will apply its skills in biochemical and cellular assay development, as well as in ultra-high-throughput screening to identify promising hit molecules.

• Hemispherx Biopharma Inc., of Philadelphia, said its immunomodulator Ampligen demonstrated strong therapeutic synergy with Relenza (zanamivir) against an influenza H5N1 infection in MDCK cells, as determined by a cytopathic effect inhibition assay. Zanamivir had zero inhibitory activity against the avian flu virus when given alone, but when co-administered with Ampligen at low doses, it was shown to be 100 percent inhibitory. The study was supported by the National Institutes of Health.

• Isotechnika Inc., of Edmonton, Alberta, said it will separate the position of chairman and CEO, currently held by Robert Foster, and it will reduce the number of insiders on its board. Foster is resigning as CEO and will take on the position of executive chairman, while Randal Yatscoff will assume the CEO and president position. Yatscoff will resign from his position on the board.

• Lexicon Genetics Inc., of The Woodlands, Texas, received expanded rights to Edinburgh, Scotland-based Stem Cell Sciences plc's Internal Ribosome Entry Site (IRES) technology for genetically modified mice. The technology is used to enhance the accuracy of gene expression in genetically altered mice and cultured stem cells. As part of that expansion, SCS granted Lexicon an exclusive license to the IRES technology, and provides Lexicon with the right to grant sublicenses in the U.S. and Europe. In exchange, Lexicon will pay an up-front fee and share with SCS future revenues generated by sublicenses. Lexicon also granted SCS certain nonexclusive rights to its gene targeting technology for use in stem cell and progenitor cell lines.

• NexMed Inc., of Robbinsville, N.J., entered a research and development agreement with a Japanese pharmaceutical company to develop a new patch product for treating severe chronic pain. The partner will fund the development costs for a new fentanyl patch, and NexMed has received an up-front payment of $100,000 with potential milestone payments in the future.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said the U.S. Department of Defense Prostate Cancer Research Program has awarded a grant totaling $582,988 to the University of Texas Southwestern Medical Center at Dallas to study the use of vascular targeting antibodies in combination with chemotherapy agents for prostate cancer. Peregrine's lead antibody, Tarvacin, will be studied under the grant to assess its use in combination with other cancer agents. Tarvacin is in a Phase I trial for advanced refractory solid tumors.

• Prolexys Pharmaceuticals Inc., of Salt Lake City, said data of the first extensive description of the protein interaction network of the malarial parasite Plasmodium falciparum, elucidated by employing a high-throughput version of the yeast 2-hybrid assay, show that interactions can be identified using engineered yeast strains, integrated robotics, LIMS system, Quality Assurance/Quality Control checkpoints and bioinformatics analysis tools. The company reported that groups of interacting proteins involved in chromatin modification, transcription, ubiquitination and host cell invasion were identified. The results were published in the Nov. 3, 2005, issue of Nature, and are part of a collaboration between Prolexys scientists and the academic laboratory of Howard Hughes Medical Institute.

• Rigel Pharmaceuticals Inc., of South San Francisco, said two publications in the Oct. 24, 2005, issue of Methods of Enzymology featured its program on ubiquitin ligases. The first publication highlights a fluorescence resonance energy transfer (FRET)-based assay that can monitor the kinetics of enzymatic activity across a range of ligases, while the second article details a high-throughput screening process that Rigel has developed to screen the anaphase-promoting complex, an E3 ubiquitin ligase under scrutiny as an cancer target.

• Santhera Pharmaceuticals AG, of Liestal, Switzerland, started a collaborative clinical trial with the U.S. National Institutes of Neurological Disorder and Stroke at the National Institutes of Health to evaluate SNT-MC17 (idebenone) in patients affected by Freidreich's ataxia. Results from the Phase II study are expected to supplement previous clinical work that suggests SNT-MC17 is effective in treating cardiac complications that are the main cause of death in FRDA patients. The NIH will conduct the 48-patient trial, expected to last about six months, and will evaluate the reduction of oxidative stress markers as its primary endpoint. Santhera plans to start a pivotal Phase III trial in Europe later this year.

• SIGA Technologies, of New York, reported that on Nov. 2, the company entered a Securities Purchase Agreement for the issuance and sale to institutional investors of 2 million shares of the company's common stock at $1 per share and warrants to purchase 1 million shares. The warrants are exercisable at any time and from time to time through and including the seventh anniversary of the closing date at an exercise price equal to 110 percent of the closing stock price on Nov. 2. The investors are also entitled to purchase additional shares of the company's common stock for a gross amount of $2 million at an initial purchase price of $1.10 per share for a period of 90 trading days following the effectiveness of a registration statement.

• The Immune Response Corp., of Carlsbad, Calif., a biopharmaceutical company focused on immune-based therapy company in HIV and multiple sclerosis, said that it received a notice from the staff of The Nasdaq Stock Market that the company did not demonstrate compliance with the $1 bid price requirement for continued listing on The Nasdaq Capital Market, prior to the expiration of the 180-day compliance period on Oct. 26. On Sept. 30, the company received notice from Nasdaq that it no longer satisfied the requirement that it maintain a market value of listed securities of at least $35 million and that it was subject to delisting based on that deficiency.