¿ Axxima Pharmaceuticals AG, of Martinsried, Germany, completed a $27.3 million private financing round led by Bear Stearns Health Innoventures LLC, of New York. The company said the funding will help progress its pipeline, establish a U.S. presence and move drug candidates towards commercialization. Axxima was the first European investment for Bear Stearns.
¿ Cell Genesys Inc., of Foster City, Calif., initiated a Phase II trial of GVAX vaccine in patients with pancreatic cancer who have undergone surgical resection of their tumor. The trial will evaluate GVAX used in combination with surgical resection of pancreatic cancer followed by standard adjuvant radiation and chemotherapy. The trial is expected to enroll up to 60 patients. GVAX cancer vaccines are comprised of tumor cells that have been irradiated and genetically modified to secrete GM-CSF.
¿ DoubleTwist Inc., of Oakland, Calif., reported that NV Organon, of Oss, the Netherlands, licensed the Prophecy database and tools suite, the Prophecy ToolKit and Genomatix Promoter Resource Database (GPR). Prophecy provides Organon access to DoubleTwist¿s annotated and assembled human genome database, as well as data mining and visualization tools. The Prophecy ToolKit facilitates the integration of the company¿s in-house sequence data with DoubleTwist¿s database and enables high-throughput data extraction. The GPR database is a data module that provides additional capabilities for locating and characterizing genes by providing the only available polymerase II promoter annotation of the whole human genome.
¿ Centocor Inc., of Malvern, Pa., placed a hold on further development of Remicade (infliximab) for the treatment of patients with advanced congestive heart failure (CHF), based on preliminary results of an ongoing Phase II trial. Results showed there was no improvement in patients¿ clinical status and also showed a higher incidence of mortality and hospitalization for worsening heart failure in patients treated with Remicade, especially those treated at the higher dose of 10 mg/kg. The trial evaluated three infusions of Remicade 5 mg/kg, Remicade 10 mg/kg or placebo over six weeks in patients with NYHA class III-IV congestive heart failure. The patients typically experienced a limitation in or a complete inability to carry on any form of physical activity, the company said. Over the next several weeks Centocor will continue to follow patients who participated in the trial to judge the risks posed to patients with advanced CHF. Remicade is approved to treat Crohn¿s disease and rheumatoid arthritis. (See BioWorld Today, Aug. 25, 1998, and Nov. 11, 1999.)
¿ Galapagos Genomics NV, of Mechelen, Belgium, and Procter & Gamble Pharmaceuticals, a division of The Procter & Gamble Co., of Cincinnati, entered a collaboration under which P&GP will use Galapagos¿ adenovirus technology as a tool to validate the utility of genes as new drug targets. Galapagos will supply P&GP with adenoviral vectors containing human genes selected by P&GP researchers. Galapagos will construct the recombinant adenoviruses using its PhenoSelect expression platform. P&GP will use these viruses to introduce and express newly discovered genes into human cells in vitro and to evaluate the function of the proteins encoded by the genes. Financial terms were not disclosed.
¿ Generex Biotechnology Corp., of Toronto, reported promising data from studies presented at the 2001 annual meeting of the Canadian Diabetes Association and Canadian Society of Endocrinology and Metabolism in Edmonton, Alberta. The six studies released at the meeting indicate that Oralin, Generex¿s proprietary oral insulin formulation, may be used safely and effectively in place of injected insulin to treat Type I and Type II diabetes. Oralin is delivered as a fine spray to the buccal (oral) cavity via Generex¿s Rapidmist device, where the formulation is rapidly absorbed through the buccal mucosal lining.
¿ Hybridon Inc., of Cambridge, Mass., reported a recent $3 million payment in full and final satisfaction of its 8 percent convertible note due November 2003. According to its terms, the notes were convertible into Hybridon common stock at $2.40 per share until Sept. 30, 2001, and at 50 cents per share thereafter. ¿Hybridon has reduced its outstanding debt obligation from $62 million in 1997 to less than $2 million in current debt obligations,¿ CEO Stephen Seiler said.
¿ Icagen Inc., of Research Triangle Park, N.C., renewed its research and development agreement with Bristol-Myers Squibb Co., of New York, for the discovery and development of small-molecule drugs targeting a specific ion channel involved in atrial fibrillation. The renewal provides for continued research and development funding by Bristol-Myers. The original deal, signed in 1997, was valued at up to $75 million. (See BioWorld Today, Oct. 1, 1997.)
¿ ImmunoGen Inc., of Cambridge, Mass., introduced a product candidate for acute myelogenous leukemia (AML). My9-6-DM1, a tumor-activated prodrug (TAP), showed robust activity against human tumors in studies conducted in mice. Results were announced at Strategic Research Institute¿s ¿Engineered Antibodies Accelerating Drug Discovery & Development Conference¿¿ in Philadelphia. My9-6-DM1 is a TAP produced by linking the monoclonal antibody My9-6, which targets myeloid leukemia cells, to DM1, a maytansinoid drug and potent antimitotic agent. In the study, complete elimination of human tumor xenografts was seen in mice treated with My9-6-DM1. No recurrence or toxicity had been observed so far in the 100 days of the study.
¿ MedImmune Inc., of Gaithersburg, Md., said data on Synagis (palivizumab) and the economic impact of respiratory syncytial virus disease were presented at the American Academy of Pediatrics 2001 National Conference and Exhibition in San Francisco. Data from MedImmune¿s 2000-2001 Synagis Outcomes Registry reaffirmed that prophylaxis with Synagis reduces the rate of RSV-related hospitalization among high-risk infants, the company said. A total of 2,116 infants were enrolled in the study, which included patients with a range of gestational ages and risk factors.
¿ MethlyGene Inc., of Montreal, published results in Bioorganic & Medicinal Chemistry Letters 11 (2001) on the design and synthesis of a novel class of potent inhibitors against a family of histone deacetylases enzymes (HDACs). HDACs have been identified as playing a key role in the regulation of gene expression, or epigenetics, the company said. The compounds described in the publication represent initial work done by MethylGene to discover HDAC inhibitors in a chemical series.
¿ Nexell Therapeutics Inc., of Irvine, Calif., began patient enrollment in a Phase III trial of hematopoietic stem cells for treatment of chronic granulomatous disease. Nexell said it plans to enroll 45 patients in the trial. The principal clinical endpoint is a reduction in the incidence of catalase-positive infections in the patients treated with the stem cell product. The program has received fast-track designation by the FDA. Nexell said it expects to complete patient enrollment in 2003. The trial is being conducted at the National Institutes of Health, of Bethesda, Md., under a cooperative research and development agreement.
¿ Novuspharma SpA, of Monza, Italy, released preliminary results of two Phase II studies of BBR 3464 in ovarian and non-small-cell lung cancer. The results, part of a series of international, multicenter Phase II studies to assess the drug¿s efficacy and safety as a monotherapy in five different types of cancer, were presented at a conference in Lisbon, Portugal. One study included 23 patients who had failed one prior course of platinum-based chemotherapy. One partial response and several other signs of biological activity were seen. The drug was well tolerated in these patients. In light of this and the preliminary signs of activity, an additional cohort of patients will be treated at a higher (1 mg/sqm) dose in the same study. In the other study, two groups of patients who failed prior treatment with platinum and a taxane were studied, with objective partial responses observed in one group and a transient partial response in one patient in the second group.
¿ Progen Industries Ltd., of Brisbane, Australia, received approval of a A$3.1 million (US$1.6 million) grant under the Australian federal government¿s AusIndustry Research and Development Start program. Progen will use the funding to develop its drug design technology platform over the next three years. It initially will focus on an anticancer drug.
¿ Proneuron Biotechnologies Ltd., of Ness-Ziona, Israel, initiated a second Phase I trial of autologous activated macrophage therapy for patients with complete spinal cord injury. The trial will be conducted at the Erasme Hospital in Brussels, Belgium. The use of autologous-activated macrophages for nerve regeneration is based on technology developed in the lab of Michal Schwartz and licensed to Proneuron. The trial is designed to complement Proneuron¿s first Phase I, also conducted in Israel.
¿ SangStat Medical Corp., of Fremont, Calif., is initiating two Phase II studies in the UK to evaluate RDP58, a rationally designed peptide, in the treatment of Crohn¿s disease and ulcerative colitis. RDP58, a novel inhibitor of tumor necrosis factor alpha synthesis discovered by SangStat in collaboration with France-based Synt:em, is being investigated for treatment of various autoimmune disorders. Each of the multicenter, prospective, double-blind, randomized, placebo-controlled studies will evaluate the safety and tolerability of a 28-day therapy of 100mg RDP58 oral solution. One study will evaluate RDP58 in the treatment of patients with moderately active Crohn¿s disease; the other will evaluate the compound in the treatment of moderately active ulcerative colitis. Each study is expected to enroll 45 patients.
¿ Seattle Genetics, Inc., of Bothell, Wash., entered into an agreement to license certain cell-killing drugs from Proacta Therapeutics, of Auckland, New Zealand. Seattle Genetics intends to evaluate the synthetic drugs as product candidates on their own as well as to use them in its antibody-drug conjugate program. Seattle Genetics will have exclusive development, manufacturing and worldwide commercialization rights to any products using the drugs. The licensed drugs were identified and developed in the Auckland Cancer Society Research Center. Antibody-drug conjugates combine the targeting capabilities of antibodies with cell-killing drug payloads, providing a means to selectively kill cancer cells while limiting damage to normal tissue.
¿ Sosei Co. Ltd., of Tokyo, raised $6.5 million in its latest round of financing. This follows an earlier fund raising from venture capitals and institutions in Japan and the West in October of last year, bringing the total amount it raised to over $12.2 million. Sosei will use the proceeds for drug development and to strengthen the management team. The company has one compound in clinical trials and will initiate clinical trials of a second compound shortly.
¿ Stemron Corp., of Rockville, Md., named Arthur Mandell president and CEO. He brings more than 20 years of experience in both the pharmaceutical and biotechnology sectors. Prior to joining Stemron, Mandell served as senior vice president and chief business officer for Human Genome Sciences Inc., also of Rockville.
¿ Third Wave Technologies Inc., of Madison, Wis., and Otsuka Pharmaceutical Co. Ltd., of Tokyo, signed a marketing and distribution agreement under which Otsuka will distribute Invader research products in Japan and other countries in the Far East, Southeast Asia and the Middle East. Otsuka will market, distribute and provide technical support for both existing catalogue and new custom-order Invader products for genotyping and gene expression analysis. Financial details were not disclosed.
¿ U3 Pharma AG, of Martinsried, Germany, was founded to explore the role of signal transduction in disease, initially focusing on the creation of new products for cancer and hyperproliferative diseases. U3 Pharma is beginning operations with an extensive portfolio of drug targets and a suite of discovery technologies. At the same time, U3 Pharma announced the closing of a $4.5 million first-round financing involving a group of investors led by Alta Partners and Medicis Ventures. The company was founded on the research of Axel Ullrich, making it his third biotech company after founding Sugen Inc., of South San Francisco, and Axxima AG, of Munich, Germany.