¿ AVI BioPharma Inc., of Portland, Ore., presented data on its antisense compound, Resten-NG, at the 7th Local Drug Delivery Meeting and Cardiovascular Conference on Radiation and Molecular Strategies in Geneva, Switzerland. The data showed that the compound prevented balloon-induced restenosis in advanced preclinical models of restenosis in stented coronary arteries in pigs.
¿ Biopure Corp., of Cambridge, Mass., signed a letter of intent with Sumter Realty Group LLC, of Sumter, S.C., for the construction and financing of a state-of-the-art biopharmaceutical manufacturing facility in Sumter. The facility, to produce the oxygen-carrying pharmaceutical solution Hemopure, is expected to cost Biopure about $85 million.
¿ Cell Therapeutics Inc., of Seattle, initiated the first of several company-sponsored multicenter clinical trials with Trisenox injection for the treatment of multiple myeloma. The first trial began Monday and will enroll up to 55 patients who have relapsed following up to three prior treatments for multiple myeloma. The study will be conducted at the Scripps Clinic and other cancer centers. A second trial is scheduled to begin soon.
¿ Celsion Corp., of Columbia, Md., said the National Institutes of Health intends to conduct preclinical evaluations using Celsion's temperature-sensitive liposomes in addition to radio frequency ablation hyperthermia for the local control of liver tumors. Celsion entered a material transfer agreement in connection with the project to supply quantities of temperature-sensitive, drug-laden liposomes.
¿ Genetronics Biomedical Ltd., of San Diego, entered into three cooperative research and development agreements with two Naval Medical Centers to further assess the feasibility of using electroporation for in vivo gene delivery. Financial terms were not disclosed.
¿ Gilead Sciences Inc., of Foster City, Calif., initiated a limited expanded-access program to provide tenofovir disoproxil fumarate to people with advanced HIV infection in the United States and certain countries in Europe. Tenofovir DF is an investigational reverse transcriptase inhibitor being evaluated in combination with other agents in multinational Phase III clinical studies as a potential treatment for HIV.
¿ HCC De Facto Group plc, of London, opened a wholly owned subsidiary, HCC De Facto GmbH, based in Munich. The office will build on the company's existing German business and will be headed initially by Richard Cripps, managing director of HCC De Facto Group.
¿ Inex Pharmaceuticals Corp., of Vancouver, British Columbia, began screening patients for its pivotal Phase II/III trial evaluating its lead product, Onco TCS, as a treatment for second or later relapsed aggressive non-Hodgkin's lymphoma. The screening began within U.S. Oncology Inc.'s network of community-based physician practices and cancer centers. Inex aims to enroll 100 patients by the end of the year.
¿ ImaRx Therapeutics Inc., of Tucson, Ariz., signed an agreement with Elan Corp. plc, of Dublin, Ireland, to form a research joint venture to develop and commercialize HydroPlex drug delivery technology for an oncology product. Elan has made an equity investment in ImaRx and provided a credit facility to facilitate funding of the joint venture. ImaRx focuses on ultrasound-activated drug delivery systems and gene therapy technologies. Its HydroPlex drug delivery systems wrap non-water-soluble drugs by polymer strands, making the drugs more water soluble, easier to administer and less toxic. ImaRx also has developed energy-activated delivery systems using ultrasound to help release drug payloads from ImaRx's patented microscopic "smart bubbles."
¿ Inspire Pharmaceuticals Inc., of Durham, N.C., filed an investigational new drug application with the FDA for INS37217 Ophthalmic for the treatment of retinal detachment and retinal edema. It plans to initiate a Phase I/II trial in patients with detached retinas due to breaks or tears in the retina.
¿ Introgen Therapeutics Inc., of Austin, Texas, said a preclinical study demonstrating that INGN 201 can stimulate human immune cells to selectively kill cancer cells overexpressing the p53 gene was published in the January issue of Clinical Cancer Research. INGN 201 is a gene-based drug in Phase III trials for patients with head and neck cancer by direct tumor injection. Introgen's stock (NASDAQ:INGN) moved up $1.812 Wednesday, or about 30 percent, to close at $7.812.
¿ Kosan Biosciences Inc., of Hayward, Calif., was awarded a $1 million Phase II Small Business Innovation Research grant from the National Cancer Institute, of Bethesda, Md., to improve its production process for the potential anticancer agent epothilone D. Epothilones are polyketide natural products.
¿ Lexicon Genetics Inc., of The Woodlands, Texas, delivered to Abgenix Inc., of Fremont, Calif., 13 human antigens for antibody development as part of their drug discovery alliance. A joint steering committee formed from both companies selected the antigens from Lexicon's proprietary portfolio of novel, full-length human genes. (See BioWorld Today, Jan. 4, 2001.)
¿ Magainin Pharmaceuticals Inc., of Plymouth Meeting, Pa., and the Ludwig Institute for Cancer Research, of Hilden, Germany, entered a collaboration for the discovery and development of novel genes and proteins as pharmaceutical targets and therapeutics. The agreement calls for joint primary commercial rights to intellectual property for a number of novel genes and proteins discovered during joint genomics and biological research conducted under a 1996 agreement.
¿ Myriad Genetics Inc., of Salt Lake City, said researchers at Myriad and the University of Utah School of Medicine identified the first known gene - called HPC2, for Hereditary Prostate Cancer 2 - to put men at high risk for developing prostate cancer. The research was part of Myriad's cancer genetics collaboration with Schering-Plough Corp., of Madison, N.J., and the study was published in the February issue of the journal Nature Genetics.
¿ Nortran Pharmaceuticals Inc., of Vancouver, British Columbia, said its clinical candidate, RSD1235, showed efficacy in terminating atrial fibrillation. The studies evaluated the efficacy of the candidate in a canine model of atrial fibrillation and were performed at the Montreal Heart Institute.
¿ Nymox Pharmaceutical Corp., of Montreal, said it is collaborating with the Faculty of Veterinary Medicine at the University of Montreal to study animal treatments for E. coli 0157:H7.
¿ Phase-1 Molecular Toxicology Inc., of Santa Fe, N.M., released its rat toxicology database, TOXbank, including the upgraded gene expression data analysis software suite, MATRIXexpress. Phase-1 has identified 700 rat genes whose expression changes significantly and reproducibly as a function of toxic stimuli, and has used them to perform gene expression studies for rats exposed to toxic doses of selected compounds.
¿ Pherin Pharmaceuticals Inc., of Mountain View, Calif., said the FDA accepted an investigational new drug application for its lead compound for the treatment of a range of anxiety disorders in women. Pherin plans for Phase I trials with the compound in the United States to begin during 2001. Pherin's proprietary vomeropherins are administered locally into the nasal cavity, where they activate specific chemoreceptors in the vomeronasal organ.
¿ QLT Inc., of Vancouver, British Columbia, said a lawsuit was filed against it and two of its current or former officers in the United States District Court for the Southern District of New York. The plaintiff seeks class certification and alleges violations of U.S. federal securities laws during the period of Aug. 1 through Dec. 14, 2000, in connection with disclosures regarding its business and prospects.
¿ UCB Bioproducts Inc., of Cambridge, Mass., said it will provide commercial quantities of bivalirudin, the active pharmaceutical ingredient for Angiomax, a product of The Medicines Company, of Cambridge, Mass. UCB-Bio designed a process for producing the 20-amino-acid optimized natural peptide used in bivalirudin.
¿ Vasogen Inc., of Toronto, is planning a multicenter trial of its VAS972 therapy for the treatment of patients with moderate to severe psoriasis. The trial will enroll more than 100 patients at four sites.
¿ YM BioSciences Inc., of Mississauga, Ontario, and SR Pharma plc, of London, agreed to collaborate to investigate the use of YMB's proprietary cancer antigen, IPS-21, in conjunction with SR Pharma's SRL172, a vaccine adjuvant.