¿ Actelion Pharmaceuticals Ltd., of Allschwil, Switzerland, said it will follow Phase III data filed with the FDA with a new drug application for Tracleer (bosentan), the company's oral therapeutic for pulmonary hypertension, by the end of the month. The Phase III data from the company's 32-patient, double-blind, placebo-controlled trial indicated that patients in the treated group experienced a 20 percent increase in exercise ability after 12 weeks (p=0.018), and that 43 percent of treated patients improved from severe to moderate.
¿ Antigenics Inc., of New York, said it won a patent battle related to a Whitehead Institute patent licensed to StressGen Biotechnologies Corp., of Victoria, British Columbia, for the use of heat shock proteins. StressGen said the ruling does not affect its core programs.
¿ AVI BioPharma Inc., of Portland, Ore., completed patient enrollment in a multicenter Phase II trial of its therapeutic vaccine Avicine in pancreatic cancer patients. The 50-patient, randomized trial is designed to evaluate the safety and efficacy of Avicine alone compared to the drug in combination with gemcitabine.
¿ Cell Therapeutics Inc., of Seattle, applied for marketing approval from the European Agency for the Evaluation of Medicinal Products for Trisenox for treatment of relapsed acute promyelocytic leukemia. Trisenox was approved in the U.S. in September. (See BioWorld Today, Sept. 27, 2000.)
¿ COR Therapeutics Inc., of San Francisco, and Schering-Plough Corp., of Madison, N.J., said a Phase II study of patients with ST-segment elevation myocardial infarction showed Integrilin, an antiplatelet agent, combined with half-dose alteplase significantly improved blood flow through blocked arteries compared to full-dose alteplase alone. Both compounds are approved by the FDA. The 300-patient trial indicated that the therapy restored normal blood flow through clogged arteries within an hour in 56 percent of patients compared with 40 percent in patients treated with full-dose alteplase alone (p=.04).
¿ Coulter Pharmaceutical Inc., of South San Francisco, and SmithKline Beecham plc, of London, said the FDA accepted a biologics license application for Bexxar for treatment of refractory, low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma. The acceptance triggers a $5 million equity investment in Coulter by SB. SB returned to Coulter all development and commercialization rights to Bexxar outside the U.S. last spring. Coulter's stock (NASDAQ:CLTR) gained 11 percent Tuesday, or $4, to close at $39.
¿ deCODE Genetics Inc., of Reykjavik, Iceland, said it discovered a chromosomal region carrying a putative gene whose molecular variants contribute to common forms of peripheral arterial occlusive disease (PAOD). deCode used a genome-wide analysis of 1,300 Icelandic PAOD sufferers and their family members to identify the region.
¿ Diversa Corp., of San Diego, entered a biodiversity access agreement giving it rights to obtain environmental samples from Russia. Diversa will work with Russia through the Department of Energy's Idaho National Engineering and Environmental Laboratory to obtain unique Russian habitat samples. The agreement also will create a Russian Ecological Biotrade Center, and U.S. and Russian scientists will work to discover novel bioactive compounds from select pristine and contaminated environments in Russia through a nonproliferation initiative sponsored by the Department of Energy.
¿ Epix Medical Inc., of Cambridge, Mass., said its contrast agent MS-325 can be used to produce detailed images of arterial plaque and vessel wall inflammation using a signal magnetic resonance exam. Preliminary results of an eight-patient trial of the agent in that usage indicate, Epix said, a dramatic improvement in imaging arterial walls and adjacent plaque with MS-325 compared to standard magnetic resonance angiography.
¿ Immunex Corp., of Seattle, completed what it called the largest biotech offering ever with the exercise of underwriters' overallotment option to purchase an additional 10.5 million shares from American Home Products Corp., of Madison, N.J. The overallotment option brings the total proceeds from the offering to $3.2 billion. Immunex will receive no proceeds from the overallotment option exercise. AHP will realize $2.4 billion from the sale of 60.5 million shares of Immunex, reducing its stake in the company to about 41 percent. Immunex expects to net about $795 million from its offering of 20 million newly issued shares, and will use those proceeds to expand its manufacturing capacity, design and construct new research and technology facilities in Seattle, and conduct product research, development and commercialization.
¿ Incyte Genomics Inc., of Palo Alto, Calif., and Galapagos Genomics N.V., of Mechelen, Belgium - a joint venture between Crucell NV, of Amsterdam, and Tibotec NV, of Belgium - entered a collaboration aimed at functional genomics studies of full-length genes from Incyte's LifeSeq Gold database. Galapagos will generate a recombinant adenoviral library of full-length genes selected from the database for use in discovering and validating gene function. Financial details were undisclosed.
¿ Kos Pharmaceuticals Inc., of Miami, said summary findings from a 16-week study of Niaspan in treating lipid abnormalities in adult-onset diabetes indicate the drug significantly improves the critical lipoprotein abnormalities in patients without adversely affecting their blood sugar levels. The double-blind, placebo-controlled trial indicated Niaspan therapy increased HDL up to 24 percent and decreased triglycerides as much as 30 percent.
¿ Myriad Genetics Inc., of Salt Lake City, was awarded several state contracts to determine the DNA identity of convicted violent or serial felons. The contract will reduce the backlog of genotyping in states across the country from convicted violent or serial felons, and the data will be included in a national database known as the Combined DNA Index System, managed by the FBI, Myriad said.
¿ Ophidian Pharmaceuticals Inc., of Madison, Wis., said shareholders approved a plan to sell substantially all of the company's assets to Promega Corp., also of Madison. Shareholders granted Ophidian's board authorization to liquidate, dissolve and otherwise wind up operations. Nasdaq has delisted the company from its SmallCap Market, effective Nov. 7, but the stock is still available through the OTC Bulletin Board quotation service. Ophidian suspended laboratory, product development and related operations in May. (See BioWorld Today, May 30, 2000.)
¿ Packard BioScience Co., of Meriden, Conn., launched Packard Pacific Limited, a wholly owned subsidiary in Hong Kong. Packard intends to increase its presence and its support for its products throughout Southeast Asia.
¿ Photogen Technologies Inc., of Knoxville, Tenn., said PH-10 and laser light or low-level radiation can selectively destroy localized, solid tumors, according to a case study on a dog and a separate study that produced complete remission in 10 of 14 mice that were given PH-10 orally. Mice receiving PH-10 by injection demonstrated complete remission in six of eight mice with renal adenocarcinoma tumors.
¿ PPL Therapeutics plc, of Edinburgh, Scotland, created a new subsidiary company aimed at extending PPL's non-embryonic stem cell platform into diabetes treatment. In doing so, the company said it split the role of commercial director, currently held by Martyn Breeze, and appointed Geoff Cook to the board as business development director
¿ Prana Biotechnology Ltd., of Melbourne, Australia, said it is testing in the clinic the FDA-approved Clioquinol as a treatment for Alzheimer's disease. The drug was last used in the 1970's, when it was linked to a rare Japanese neurological disorder.
¿ The Immune Response Corp., of Carlsbad, Calif., initiated a Phase I/II trial of its immune-based therapy in multiple sclerosis to evaluate T-cell receptor peptide vaccines for safety and the ability to increase anti-inflammatory immune responses and changes in neurologic evaluations. The multicenter, three-armed, randomized study of 60 patients over a 24-week period will determine whether a combination of peptides in Incomplete Freund's Adjuvant increases the anti-inflammatory immune response compared to administration of the same peptides in saline.
¿ Trinity Medical Group USA, of San Rafael, Calif., said it will continue a clinical trial using Remune as a treatment for HIV in Thailand for two more years. Protocol 2101B, as the study is known, will so become one of the longest scientific examinations of immune-based therapy for HIV. Remune will continue to be supplied for the trial by The Immune Response Corp., of Carlsbad, Calif.
¿ Xenometrix Inc., of Boulder, Colo., granted a worldwide license for gene expression profiling to Packard BioScience Company, of Meriden, Conn., giving Packard access to intellectual property covered by U.S. and European patents on gene expression profiles utilizing all platforms, including biochips and high-density microarrays. Financial details were undisclosed.
¿ XTL Biopharmaceuticals Ltd., of Rehovot, Israel, and Pharming Group N.V., of Leiden, the Netherlands, entered an agreement to jointly evaluate and co-develop recombinant human Lactoferrin as a treatment for hepatitis C. Financial details of the deal were undisclosed.