¿ Centocor Inc., of Malvern, Pa., said that new data from the ADMIRAL study suggest significantly better clinical outcomes for patients undergoing primary stenting in acute myocardial infarction (AMI) when treated with ReoPro (abciximab). The trial showed that patients undergoing percutaneous transluminal coronary angioplasty and primary coronary stent implantation who were treated with ReoPro had a reduced risk of death, improved coronary artery patency, and improvement of global left ventricular function at 24 hours. The six-month data were presented at the Paris Course of Revascularization. The ADMIRAL (Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-term Follow-up) study is a double-blind, placebo controlled, multicenter trial of 300 AMI patients undertaken in 28 centers across France. ReoPro is marketed in Europe by Eli Lilly and Co., of Indianapolis.
¿ Immuno-Designed Molecules SA (IDM), of Paris, and Sanofi-Synthelabo, of Paris, signed a partnership agreement covering IDM's use of Sanofi-Synthelabo's protein interleukin 13. IL-13 will be used by IDM to prepare its therapeutic vaccines designed to treat a number of cancers, such as melanoma, prostate and colorectal. IL-13, when combined with a patient's white blood cells using IDM's VacCell Processor, allows for the production of dendritophages, engineered dendritic cells, which are the basis of IDM's therapeutic vaccines. Financial terms were not disclosed, but IDM did grant Sanofi-Synthelabo a right to an exclusive commercialization license of IDM IL-13 cellular vaccines in Europe.
¿ PathoGenesis Corp., of Seattle, started enrollment in an open-label, randomized Phase IV clinical trial of TOBI (tobramycin solution for inhalation) in cystic fibrosis patients with mild lung disease. Up to 400 people, ages 6 through 15, who have cystic fibrosis and Pseudomanas aeruginosa lung infections, but who have not yet experienced a major decline in lung function will be enrolled. The 14-month study will compare patients receiving TOBI and routine care to patients receiving routine care only.
¿ Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., reported the discovery of the binding site for HIV on CCR5, a receptor protein found on cells that plays a critical role in HIV entry and infection. Researchers observed that HIV bound a particular region or sequence of CCR5 and that it occurred only when the site contained sulfate groups at specific locations. Sulfate groups are added naturally to certain receptors such as CCR5 in vivo. The new structural data provide researchers with a better understanding of how HIV infects cells. The study was reported in the current issue of the Proceedings of the National Academy of Science.
¿ Schering-Plough Corp., of Madison, N.J., said Pegintron (peginterferon alfa-2b) a once-weekly monotherapy for the treatment of adults with chronic hepatitis C, was approved in Europe. Pegintron is a longer-acting form of Intron A that uses proprietary PEG technology developed by Enzon Inc. In a pivotal Phase III study, it was demonstrated that PEG-Intron is twice as active as Intron-A in achieving sustained loss of detectable hepatitis C virus (HCV) in adult patients. Schering-Plough submitted a biologics license application to the FDA in December. (See BioWorld Today, Jan. 6, 2000, p. 1.)
¿ Techniclone Corp., of Tustin, Calif., named John Bonfiglio president and CEO. He was vice president of technology and business development at the company before being named interim president in November.
¿ Vivus International Ltd., of Mountain View, Calif., a wholly owned subsidiary of Vivus Inc., filed for European marketing approval for Alibra for the treatment of male erectile dysfunction. The company filed for FDA approval in December.
¿ Xoma Ltd., of Berkeley, Calif., amended its original ophthalmic anti-infective product development agreement with Allergan Inc., of Irvine, Calif., to cover all ophthalmic anti-infective formulations, including stand-alone formulations of rBPI, and eye infections caused by all microbes. Allergan has an exclusive license from Xoma to develop ophthalmic anti-infective products that combine recombinant bactericidal/permeability-increasing protein (rBPI) with antibiotics to treat bacterial eye infections. The amended agreement calls for additional milestone payments beyond those in the original agreement. The companies signed the original deal, worth at least $11 million, last year. (See BioWorld Today, June 29, 1999, p. 1.)