Gene/Protein Disease Symptom Drug Enzyme Compound
Pivot Concepts:   Target Concepts:
Query: UMLS:C0024141 (systemic lupus erythematosus)
 44,322 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

AVANT Immunotherapeutics is developing TP-10, a recombinant soluble complement receptor type 1 (sCR1), for the potential treatment of reperfusion injury (following surgery, ischemic disease and organ transplantation), organ rejection, acute inflammatory injury to the lungs and autoimmune diseases [348669]. TP-10 has been awarded Orphan Drug status from the FDA for the prevention and reduction of adult respiratory distress syndrome (ARDS) and as a treatment for infants undergoing cardiac surgery [180849], [359588]. A placebo-controlled phase II trial, conducted at approximately 30 sites in the US and involving approximately 600 adult patients undergoing cardiac surgery utilizing cardiopulmonary bypass, was initiated in November 2000. This safety and efficacy study was designed to assess the ability of TP-10 to mitigate the injury to the heart, brain and other organs that occurs when patients are placed on cardiopulmonary bypass circuits, thus potentially improving postoperative outcomes [391437]. In September 2000, the company was planning a double-blind, placebo controlled phase IIb trial in infants undergoing cardiac surgery; AVANT expected to initiated in 30 infants in January 2001 [395086]. The data from this trial will enable the company to further define its clinical endpoints before inititating a pivotal phase III trial in 2001 [382529]. A phase I/II trial of TP-10 involving 15 infants, under 12 months of age, undergoing cardiac surgery for congenital heart defects was initiated by the company in September 1999. The trial will evaluate the ability of TP-10 to mitigate the injury to the heart and other organs when patients are placed on cardiopulmonary bypass circuits [340602]. Enrollment was complete by January 2000 [352458]. Phase I safety trials of TP-10, including studies in adult patients at risk for adult respiratory distress syndrome (ARDS), adult patients with first-time myocardial infarction (heart attack), and pediatric patients undergoing cardiac surgery demonstrated that TP-10 is well tolerated. However, after completion, in December 1997, of a phase IIa trial in nine patients with ARDS, AVANT decided to cease development for this indication. TP-10 was licensed to Novartis AG for use in xeno- and allotransplantation in July 1999. Extensive animal studies have shown TP-10 to have potential in a wide variety of complement-mediated conditions, including organ transplantation, multiple sclerosis, rheumatoid arthritis and lupus [238093]. Early work demonstrated favorable results in animal models of reperfusion injury [180849] and hyperacute xenograft rejection in guinea pig to rat and pig to primate organ transplants [191552]. AVANT has received Notices of Allowance (July 1998) from the USPTO for three separate patent applications covering pharmaceutical compositions of TP-10, methods of purification and methods of certain TP-10 glycoforms for treating diseases or disorders resulting from inappropriate complement activation [291776]. In January 1999, the company was awarded US-05856297 which covers pharmaceutical compositions of TP-10. US-05856300 was also awarded covering compositions and methods of producing the drug [312267].
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PMID:TP-10 (AVANT Immunotherapeutics). 1157 6

Genelabs is developing GL-701 (prasterone), oral dehydroepiandrosterone (DHEA), for the potential treatment of systemic lupus erythematosus (SLE) [154020]. In September 2000, the company completed submission of its rolling NDA, begun in May 2000 [340361], [355642], [361381], [380239], [383545]. In October 2000, the FDA granted the company's NDA Priority Review designation [387020]. Genelabs began its NDA submission for GL-701 in May 2000, by submitting the complete clinical, statistical and human pharmacokinetic sections to the FDA. This includes all the human efficacy and safety data for the NDA [368932]. In March 1999, Genelabs received Fast Track designation for GL-701 from the US FDA, allowing the development and review of an NDA to be expedited [319963]. Genelabs met with the US FDA in November 1999 to present the data from the two phase III trials in women and was advised by the FDA that its NDA proposal appeared adequatefor submission [348192], [361381]. Because of the public domain nature of DHEA, Genelabs was not certain that it would obtain patent protection. In the US it received Orphan Drug designation, providing seven years of exclusive marketing rights, and in October 1996, Genelabs received US-05567696, covering the use of GL-701 in lupus patients to reduce their dosage of concomitant corticosteroids [222741], [329646]. The US FDA has also granted Subpart E designation to GL-701, which permits expedited development [169754], [222741]. Genelabs licensed the product exclusively worldwide from Stanford University, which performed the early-stage clinical studies. The Asian marketing rights have been licensed to Genelabs Biotechnology Ltd (GBL), a joint investment with the government of Taiwan [229812]. In January 2001, analysts at UBS Warburg predicted that GL-701 would be launched in 2001, and reach sales of US $ 90 million by 2004 [398731].
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PMID:GL-701 Genelabs. 1181 36

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].
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PMID:Abetimus (La Jolla pharmaceuticals). 1202 52

Genelabs is developing oral dehydroepiandrosterone (DHEA), for the potential treatment of systemic lupus erythematosus (SLE) in women. Results of a second phase III study, due for completion in March 1999, will determine whether Genelabs files an NDA in the US. Because of the public domain nature of DHEA, Genelabs is not certain that it will obtain patent protection. In the US it received Orphan Drug designation, providing seven years of exclusive marketing rights, and, in October 1996, Genelabs received US-05567696, covering the use of DHEA in lupus patients to reduce their dosage of concomitant corticosteroids. The US FDA has also granted Subpart E designation to DHEA, which permits expedited development. Genelabs licensed the product exclusively worldwide from Stanford University, which performed the early stage clinical studies. The Asian marketing rights have been licensed to Genelabs Biotechnology Ltd (GBL), a joint investment with the government of Taiwan.
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PMID:DHEA (Leland Stanford Junior University). 1618 Jan 72