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Human Clinical Trials Initiated for Topotecan Using Transmembrane Carrier System
VANCOUVER, April 16 /PRNewswire-FirstCall/ -- Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) announced today that GlaxoSmithKline ("GSK"; LSE and NYSE: GSK) has filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) asking for approval to begin human clinical trials evaluating GSK's anticancer drug topotecan encapsulated in INEX's proprietary drug delivery technology, known as Transmembrane Carrier System (TCS).
David Main, President and CEO of INEX, said INEX earned US$1.5 million in the first quarter of 2003 in milestone payments to support the filing of the IND and the ongoing development of the product. Since the two companies entered their partnership in late 2001, GSK has paid INEX a total of US$4.5 million in upfront and milestone payments.
INEX will qualify for additional milestone payments as GSK's drug moves through clinical development and commercialization. GSK is responsible for all development costs and INEX will receive a royalty on the drug's sales upon commercialization.
Encapsulating anticancer drugs inside INEX's proprietary TCS drug delivery technology may provide prolonged blood circulation, accumulation in tumors and extended drug release of the encapsulated drug at the cancer site.
Topotecan is the second chemotherapeutic agent to be encapsulated using INEX's TCS technology. The company's lead product, Onco TCS, is the encapsulation of the anticancer drug vincristine. INEX plans to file in the third of quarter of 2003 a New Drug Application for Onco TCS as a treatment for relapsed aggressive non-Hodgkin's lymphoma. Onco TCS is also being evaluated in several phase II clinical trials in combination and stand-alone therapy for several other cancers.
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer.
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