title: Abetimus (La Jolla pharmaceuticals).
abstract: La Jolla is developing abetimus (LJP-394), a tetrakis-oligonucleotide conjugate, for the treatment of lupus and in particular, lupus kidney disease. In September 2000, phase III trials were initiated [382931]. These trials were ongoing in July 2001 [415284]. In January 1999, analysts had predicted a US filing in mid-2000 [318933]. The drug was granted Orphan Drug status in the US in September 2000 and in the EU in November 2001 [381379], [431129]. Following a meeting with the FDA, La Jolla planned a phase III trial of abetimus and expected this to begin in the second half of 2000 [364916]. In September 2000, the company anticipated its commencement within a few months [381379]; in fact, it began shortly thereafter. The trial was designed to repeat the positive results from the phase II/III study and the company intended to enroll 300 patients [382931], [386254]. By October 2000, more than ten clinical sites had been initiated into the trial and thefirst patient had been dosed. The company planned to have more than 50 sites in North America enrolling patients by the end of the year and expected to add about 15 more sites across Europe early in 2001 [384402]. In September 1996, US-05552391, covering abetimus, was granted. In October 1996, the company announced that it has received a third US composition of matter patent on abetimus [222901]. In November 1997, the company was issued with broad patents covering its core Tolerance Technology in 16 European countries and in Japan. A US patent on the technology was issued in 1993. These patents cover toleragens, as any composition of matter which contain multiple copies of B-cell epitopes, conjugated to a multivalent platform, where the conjugates lack T-cell epitopes. The patents also cover methods of synthesis and use [269583]. In November 2001, Morgan Keegan & Co estimated sales to be US $150 million in 2003, rising to US $600 million in 2005 [439326].
authors.affiliation: University of Erlangen-Nuremberg, Department of Medicine III, Institute of Clnical Immunol/Rheumatology, Germany. Hannes.Lorenz@med3.imed.uni-erlangen.de
authors.forename: Hanns-Martin
authors.initials: HM
authors.lastname: Lorenz
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D004345:Drug Industry; D015507:Drugs, Investigational / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008181:Lupus Nephritis / Q000188:drug therapy; D009841:Oligonucleotides / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D013329:Structure-Activity Relationship; D016896:Treatment Outcome
chemical_list: D015507:Drugs, Investigational; D007166:Immunosuppressive Agents; D009841:Oligonucleotides; C094104:abetimus