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TraferminCAB 2001, KCB 1, Fiblast®

 

作者: &NA;,  

 

期刊: Drugs in R & D  (ADIS Available online 1999)
卷期: Volume 1, issue 1  

页码: 40-41

 

ISSN:1174-5886

 

年代: 1999

 

出版商: ADIS

 

数据来源: ADIS

 

摘要:

Trafermin (KCB 1, CAB 2001, Fiblast®), a recombinant form of basic fibroblast growth factor known as 2-155-basic fibroblast growth factor (human clone &lgr;KB7/&lgr;HFL1 precursor reduced), is a potent angiogenic, heparin-binding peptide with a molecular weight of 17 124D. It has potential in the treatment of conditions requiring the stimulation of blood vessels and tissue repair. Scios was the first company to clone and produce recombinant human basic fibroblast growth factor and holds patents in the US and Europe covering its manufacture, use and sale.Scios has an agreement with Wyeth-Ayerst (American Home Products) for the development and commercialisation of trafermin in the US in the treatment of neurological and cardiovascular disorders. Under the agreement, the 2 companies will share development costs and profits. Wyeth-Ayerst also receives exclusive marketing rights outside of North America and certain Pacific Rim countries. Scios is leading development of trafermin in vascular indications, whereas, Wyeth-Ayerst is leading its development in the treatment of stroke. In 1988 Kaken (Japan) licensed trafermin from Scios for development and marketing rights in China, Hong Kong, Japan, Korea and Taiwan for all indications. Trafermin is also licensed to Merck KGaA who is conducting preclinical studies for treatment of soft tissue ulcers.A phase III trial in the US for the treatment of stroke was terminated because of an unfavourable risk:benefit ratio in trafermin-treated patientsvsthose receiving placebo. Interim results from an ongoing trial in Europe, which has a different dosing regimen (24hvs8h infusion), have raised no such concerns. Trafermin is also in phase II trials in the US for peripheral vascular disease and coronary artery disease. Kaken has submitted an NDA in Japan for the treatment of intractable skin ulcers. Kaken is investigating trafermin in preclinical trials for the treatment of bone fractures, periodontosis and osteoporosis in Japan.Clinical investigation into the use of locally administered pellets containing trafermin, in patients undergoing coronary artery bypass surgery, is continuing at the Montefiore Medical Center in the US.

 

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