AVI BioPharma Inc., of Portland, Ore., completed oral delivery studies in a Phase I human trial of its Neugene antisense drug, designed to inhibit cardiovascular restenosis, cancer and polycystic kidney diseases. The study did not identify any drug-related safety issues. The company is in a Phase II clinical trial with the drug for the same indication, and additional trials in cancer and polycystic kidney disease are planned for later this year.
Cell Therapeutics Inc., of Seattle, said at the 11th annual NCI-EORTC-AACR Symposium on New Drugs in Cancer Therapy in Amsterdam, the Netherlands, that a newly defined gene linked to cancer may provide a target for developing selective therapies for cancer. The gene, LPAAT-B, codes for an enzyme important in cell-signaling pathways and the synthesis of phospholipids, and has been linked to the function of the ras oncogene. LPAAT-B is overproduced in numerous human cancers, including breast, lung, prostate and ovarian.
Entelos Inc., of Menlo Park, Calif., said Aventis Pharma AG, of Frankfurt, Germany, subscribed to the Entelos Asthma PhysioLab disease-simulation system. Under the terms, Aventis will have access to the system through a three-year, non-exclusive subscription. Financial terms were not disclosed.
EntreMed Inc., of Rockville, Md., gave data from its Phase I human trial and two National Cancer Institute-sponsored Phase I trials on recombinant human Endostatin protein at the NCI-EORTC-AARC Symposium. Endostatin has shown in preclinical testing to inhibit both the formation of new blood vessels and the growth of primary and metastatic tumors without toxicity. EntreMed said the results of the trials are encouraging and that it plans to continue clinical development. EntreMed's stock (NASDAQ:ENMD) climbed $4.125 Thursday, or about 14 percent, to close at $33.375.
Esperion Therapeutics Inc., of Ann Arbor, Mich., initiated a Phase I clinical trial of ApoA-I Milano (AIM), a variant of ApoA-I, the major HDL protein. The clinical testing of AIM is a first for a human recombinant variant protein as a possible therapeutic agent. AIM is present in a small population of Northern Italians with low levels of HDL cholesterol.
Guilford Pharmaceuticals Inc., of Baltimore, said the Giladel Wafer, its FDA-approved treatment for glioblastoma multiforme, produced prolonged survival and improved neurological outcomes in patients in a Phase III trial investigating the drug's benefit when administered at the time of initial surgery for malignant glioma. Guilford said it plans to submit a supplemental new drug application to the FDA to expand the label indication to include first-line therapy in patients newly diagnosed with malignant glioma.
Insmed Inc., of Richmond, Va., said underwriters exercised their overallotment option in connection with the company's recent public offering, purchasing an additional 975,000 shares offered by selling shareholders. Robertson Stephens Inc. led the underwriting, with Banc of America Securities LLC and Prudential Vector Healthcare Group serving as co-managers. The overallotment option brings the total offering to 6.475 million shares at $11.875 per share for proceeds of $76.89 million. (See BioWorld Today, Oct. 30, 2000.)
Interleukin Genetics Inc., of Waltham, Mass., entered a collaboration with Brigham and Women's Hospital, of Boston, to research the genetic control of inflammation. Interleukin will provide its proprietary screening platform, the Inflammatory Response Induction System, which evaluates the inflammatory responses in humans with specific Il-1 genetic variations, to the collaboration.
Kreatech Biotechnology BV, of Amsterdam, the Netherlands, raised 8.8 million guilders (US$3.41 million) in a private placement of stock with Alafi Capital and Life Sciences Partners. Kraetech said it plans to use the funding for expansion. Both investors are committed to a further investment of 4.4 million guilders. Bank Ten Cate & Cie N.V. led the placement.
Ligand Pharmaceuticals Inc., of San Diego, presented Phase I/II trial results at the NCI-EORTC-AACR Symposium, demonstrating that Targretin capsules, in conjunction with chemotherapy, may be effective in treating patients with non-small-cell lung cancer. These results add to Phase II/III results recently reported by Ligand and suggest Targretin therapy may delay some forms of solid tumor cancer.
LION Bioscience AG, of Heidelberg, Germany, and Celera Genomics, of Rockville, Md., extended their existing collaboration and entered a new strategic alliance to develop and deliver software tools through the Celera Discovery System, a web-based portal. They will collaborate to create improved software tools to meet the bioinformatics needs of life science researchers. Further terms were not disclosed.
MGI Pharma Inc., of Minneapolis, gave results from a Phase II trial of its anticancer agent, irofulven, at the NCI-EORTC-AARC Symposium. Results showed 10 of the 53 patients with advanced pancreatic cancer who were refractory to gemcitabine, a chemotherapy agent, achieved six-month survival, the primary endpoint for the trial. Also, one patient experienced tumor shrinkage of 100 percent and a second experienced 84 percent shrinkage. Enrollment is expected to begin near the end of the year for a pivotal Phase III trial.
NeoTherapeutics Inc., of Irvine, Calif., presented eight studies of its lead compound, Neotrofin, at the 30th annual meeting of the Society for Neuroscience in New Orleans. Collaborative researchers at universities in the U.S. and Canada conducted the research and seven of the presentations covered preclinical studies of Neotrofin and its effects in models of neurodegenerative disease.
Neurochem Inc., of Saint-Laurent, Quebec, submitted an application to the Clinical Trials Unit of the Medicines Control Agency in the UK to initiate a pivotal Phase II/III study of Fibrillex, its anti-amyloid drug for treatment of secondary amyloidosis. A similar request was granted recently by the FDA. The Phase II/III trial is designed as a randomized, multinational, double-blind, placebo-controlled and parallel-design trial, and will evaluate safety and efficacy.
Neurocrine Biosciences Inc., of San Diego, said its scientists presented 17 abstracts at the Society for Neuroscience meeting held in New Orleans this week. The studies confirmed that the corticotrophin-releasing factor system plays a major role in a variety of stress-related disorders.
OSI Pharmaceuticals Inc., of Uniondale, N.Y., said data indicate that OSI-774, its lead anticancer candidate, produced either a partial response or evidence of disease stabilization after three months of daily oral dosing in 48 percent of 56 patients with advanced, refractory non-small-cell lung cancer and 42 percent of 78 evaluable patients with advanced head and neck cancer. The epidermal growth factor receptor inhibitor produced that data in a Phase II study in patients who failed a platinum-based chemotherapy regimen with epidermal growth factor receptor-positive tumors.
PPD Inc., of Menlo Park, said its subsidiary, PPD Discovery Inc., expanded its functional genomics alliance with Aventis Pharma AG, of Frankfurt, Germany, allocating increased personnel resources to the project in response to the achievement of the alliance's first milestone, the transfer of technology from PPD to Aventis. The joint research agreement is aimed at developing therapeutics in oncology, inflammation, cardiovascular disease and central nervous system disorders.
Ribozyme Pharmaceuticals Inc., of Boulder, Colo., reported results of an open-label Phase I/II trial with Angiozyme at the annual European Organization for Treatment of Cancer Conference in Amsterdam, the Netherlands, showing it was well tolerated. Angiozyme, an anti-angiogenic ribozyme, targets the high-affinity receptor for the vascular endothelial growth factor.
StressGen Biotechnologies Corp., of Victoria, British Columbia, gave preclinical data on the immune response to the HspE7 fusion protein at the International Symposium on Heat Shock Proteins in Biology and Medicine held in Woods Hole, Mass. The data are consistent with the clinical application of HspE7 as an immunotherapy for HPV-related diseases and will be published in an upcoming issue of Cell Stress and Chaperones.
United Therapeutics Corp., of Silver Spring, Md., said it will go before an FDA advisory committee in early 2001 concerning the new drug application for UT-15, known as Uniprost. UT-15 is a prostacyclin analogue for treatment of pulmonary hypertension.