• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix unit and the Computational Biology Research Center, a division of the Japanese National Institute of Advanced Industrial Science and Technology, developed a method for the preparation and measurement of DNA methylation in tissue biopsies. The technique uses CombiMatrix's customizable microarrays for the detection of methylation at any CpG dinucleotide position in DNA.

• Advanced Life Sciences Inc., of Woodridge, Ill., relocated its operations to a 41,000-square-foot building in the Argonne Biotechnology Corridor. The facility houses the company's headquarters as well as expanded research and development space. Advanced Life Sciences is working to discover drugs for infection, cancer and inflammation.

• Amersham Biosciences, the life sciences business of Amersham plc, of London, released the MegaBACE 4500 DNA sequence analyzer, a next-generation version of the MegaBACE 4000. The new product is designed to improve the average sequencing read length by about 150-200 base pairs.

• Applied Biosystems Group, of Foster City, Calif., introduced the 8500 Affinity Chip Analyzer, a product intended to aid the drug discovery process by identifying and characterizing antibody diagnostics and therapeutic candidates. The analyzer is designed to deliver comparative quantitative affinity ranking of biologically relevant binding events in a high-throughput format and enables researchers to detect and measure up to 400 antibody binding interactions in less than two hours.

• AVI BioPharma Inc., of Portland, Ore., reported positive Phase II data at this week's Transcatheter Cardiovascular Therapeutics meeting in Washington, showing that use of its Neugene antisense drug Resten-NG resulted in a statistically significant, 75 percent reduction in the rate of restenosis (p=0.02). The multicenter Avail trial randomized 57 patients into three groups: a control arm, a subtherapeutic dose (3 mg) treatment arm and a therapeutic dose (10 mg) treatment arm. In measuring the primary efficacy endpoint, angiographic analysis at six months, data showed the restenosis rate was 33.3 percent in both the control and subtherapeutic dose treatment arms, and 8.3 percent in the therapeutic dose treatment arm.

• Axonyx Inc., of New York, said it would provide Phenserine treatment to Alzheimer's disease patients in its ongoing Phase IIb and Phase III trials, which involve 75 and 375 people respectively, through a formal six-month extension study. Phenserine, a dual-action acetylcholinesterase and beta amyloid precursor protein inhibitor, is in development for mild to moderate Alzheimer's disease. Patients previously treated with Phenserine can receive it for an additional six months, while patients previously treated with placebo can receive their initial six-month treatment period with Phenserine.

• Axxima Pharmaceuticals AG, of Munich, Germany, said it is using a drug discovery research software platform produced by IDBS, of Guildford, UK. Axxima is using the ActivityBase product as its software platform for managing chemical and biological drug discovery data. Axxima is developing small-molecule drugs to combat infection and related diseases, such as inflammation, by blocking signal transduction pathways required by pathogens for their survival.

• CancerVax Corp., of Carlsbad, Calif., set the price range for its initial public offering at $12 to $14 per share and its number of shares at 6 million. At that range, the offering would raise between $72 million and $84 million. The company, which also added Citigroup Global Markets Inc. to its group of underwriters, filed for its IPO last month. (See BioWorld Today, Aug. 18, 2003.)

• Corgentech Inc., of South San Francisco, completed patient enrollment in a pivotal Phase III trial of its lead product, CGT003, for the prevention of graft failure following coronary artery bypass graft surgery. The trial, called Prevent 4, began just more than a year ago and includes 2,400 patients in more than 100 U.S. sites. CGT003 is an E2F decoy, an oligonucleotide that binds to and inactivates the pivotal cell-cycle transcription factor E2F. It also is in a Phase III trial for the prevention of peripheral arterial bypass graft failure, as the FDA will require both trials for approval. The agency has granted fast-track status to CGT003, which is administered through a drug delivery device that belongs to Corgentech. (See BioWorld Today, Aug. 15, 2002.)

• Corixa Corp., of Seattle, began a Phase I trial to test the safety and immune response activity of an investigational vaccine for patients with non-small-cell lung cancer. The vaccine is designed to trigger patient immune responses against an antigen expressed by certain lung cancer cells and, if successful, would be used to prevent disease recurrence in patients following prior treatment.

• Dendreon Corp., of Seattle, reported final audited findings from a Phase III study called D9901, confirming preliminary data that showed treatment with its Provenge immunotherapy did not achieve the pre-specified endpoint of the prostate cancer study. Comparison of the Provenge-treated group to placebo using the Kaplan-Meier method revealed a clinical benefit, as measured by a delay in time to disease progression, in the Provenge treated group (p=0.061) that fell short of the target (p=0.05). The preliminary analysis reported late last year also revealed an insufficient p value (p=0.085). Final results confirmed the significant clinical benefit of delay in time to disease progression from Provenge treatment for men with androgen independent prostate cancer with a Gleason score of 7 or less (p=0.001), an improvement from that previously reported in the preliminary analysis (p=0.002). Preliminary data gleaned from the double-blinded study showed a median survival of 26.3 months in the patients randomized to the Provenge treated group, compared to 19.3 months for placebo. Also, 75 percent of patients randomized to placebo whose disease progressed went on to receive active therapy in a crossover salvage protocol that accompanied the D9901 trial, producing a median survival of 23.9 months. The results originally were scheduled for release at this week's Prostate Cancer Foundation's scientific retreat in Washington, which was postponed due to Hurricane Isabel. Dendreon's stock (NASDAQ:DNDN) dropped 83 cents Thursday, or 7.9 percent, to close at $9.63. (See BioWorld Today, Dec. 6, 2002.)

• Flamel Technologies SA, of Lyon, France, will have its options traded on the Pacific Exchange beginning today. Flamel's options (PCX: FLU) will trade on the March expiration cycle, with exercise limits set at 31,500 contracts. Flamel is developing a recombinant human insulin product, Basulin.

• Generex Biotechnology Corp., of Toronto, began a Phase IIb trial of Oralin, its oral insulin spray formulation, in 80 Type II diabetic patients with poorly controlled blood glucose who, at entry to the study, are maintained on one or two injections of insulin plus one or more oral anti-hyperglycemic agents. The Canadian-based study is designed to determine Oralin's metabolic effect using Generex's RapidMist Diabetes Management System, which is designed to provide needle-free administration of insulin via a liquid pharmaceutical formulation.

• Graffinity Pharmaceuticals AG, of Heidelberg, Germany, entered a long-term research and development collaboration to identify and develop small-molecule therapeutics with Genentech Inc., of South San Francisco. Genentech will provide a number of drug targets to Graffinity, which will deliver lead structures for the targets after using its RAISE (rapid affinity informed structure evolution) technology. Thereafter, Genentech can either license the programs exclusively or the parties may choose to enter into a joint research program. Graffinity will receive an undisclosed up-front fee, as well as research funding and success milestones upon delivery of lead compounds. Also, it may receive either development milestone payments and royalties or non-U.S. rights to products resulting from any joint programs.

• ID Biomedical Corp., of Vancouver, British Columbia, said preliminary data from its most recent influenza challenge study of FluINsure showed significant reductions in clinical illness across all vaccine regimens tested when compared with placebo. The trial compared subjects who had received placebo with subjects who had received the same one-and two-dose regimens studied previously, and also a two-dose regimen in which the vaccine dose was halved. The latter reduced-dose regimen proved to be as effective as the higher two-dose regimen. Also, ID said the one-dose regimen was efficacious in protecting against fever. It said it plans to study the reduced-dose, two-dose regimen, as well as the one-dose regimen, in a field study scheduled to begin next month.

• ImaRx Therapeutics Inc., of Tucson, Ariz., began clinical trials of its SonoLysis technology for blood clots in kidney dialysis patients whose access grafts have become blocked. The technology uses gas-filled lipid microbubbles and ultrasound. In the presence of ultrasound, the microbubbles cavitate, releasing energy that could dissolve the blood clot.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said interim Phase IIa results showed that ISIS 104838 reduced TNF-alpha mRNA levels in synovial tissue and stabilized levels of TNF-alpha in blood in rheumatoid arthritis patients that received 300 mg of the drug. The randomized, placebo-controlled trial was designed to evaluate the second-generation antisense compound's ability to reach synovial tissue and reduce the level of TNF-alpha in blood and in the tissue. The study also evaluated the pharmacological effect of TNF-alpha inhibition by ISIS 104838 in rheumatoid arthritis patients. Isis plans to release final results and additional data analyses at next month's American College of Rheumatology meeting in Orlando, Fla.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said that treating high-risk acute coronary syndrome patients with an anti-platelet medicine known as glycoprotein IIb-IIIa inhibitor, before interventional procedures such as angioplasty, significantly reduced the in-hospital incidence of combined death or subsequent heart attacks, according to research presented at the Transcatheter Cardiovascular Therapeutics meeting in Washington. The data were collected from Crusade, a national quality improvement initiative that examines the treatment of high-risk chest pain disorder patients at hospitals in the U.S.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said findings published in the current issue of Cancer Research show that different antibody-based targeting agents can be used to effectively deliver the coagulation protein truncated tissue factor to tumors in treating cancer. The study also pointed to the effectiveness of delivering agents to tumors that block blood flow to the tumor resulting in therapeutic effects, which is the concept behind Peregrine's vascular targeting agent technology. Peregrine said it is researching the use of truncated tissue factor as an anticancer compound.

• QLT Inc., of Vancouver, British Columbia, said the FDA granted fast-track status to Visudyne therapy for both the occult with no classic and the minimally classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). QLT co-developed Visudyne with Ciba Vision, of Atlanta, and the eye health care unit of Novartis AG, of Basel, Switzerland, which share profits evenly. The companies completed enrollment of 360 patients in the Phase III trial of Visudyne therapy for the treatment of occult CNV due to AMD.

• Replidyne Inc., of Louisville, Colo., entered two collaborative agreements. With Array BioPharma Inc., of Boulder, Colo., Replidyne will work to create small-molecule therapeutics targeting bacterial infections and will be responsible for all preclinical and clinical development and commercialization of compounds discovered during the collaboration, and will fund lead optimization at Array. Separately, Replidyne will gain access to libraries of plant-isolated compounds that belong to Sequoia Sciences Inc., of San Diego. Replidyne will be responsible for high-throughput screening of the libraries, lead optimization, development and commercialization, and will work with Sequoia on compound identification. The companies did not disclose financial terms from either agreement.

• Schering AG, of Berlin, reported findings from the first stage of its Phase III multiple sclerosis program at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Milan, Italy, showing that both the approved Betaferon dose and a double-dose regimen were safe and well tolerated. No new or unpredictable side effects were reported from the Beyond trial, a multinational study that involves more than 2,000 relapsing and remitting multiple sclerosis patients. Schering said its next step would be to determine if a Betaferon dose higher than any available beta interferon could exert a greater therapeutic effect. Betaferon is marketed in the U.S. and Canada as Betaseron by Schering's subsidiary, Berlex Laboratories Inc., of Montville, N.J.

• Transgene SA, of Strasbourg, France, said it would begin clinical development of its anticancer candidate MVA-FCU1, a virus-directed enzyme prodrug therapy designed to cause the production of a chemotherapeutic drug within the tumor. MVA-FCU1 uses the attenuated MVA vaccinia virus vector to express the FCU1 gene, which was constructed at Transgene by fusing the Saccharomyces cerevisiae cytosine deaminase gene and the uracil phosphoribosyltransferase gene.

No Comments