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Name | Symbol | Market | Type |
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SPDR S&P Telecom ETF | AMEX:XTL | AMEX | Exchange Traded Fund |
Price Change | % Change | Price | High Price | Low Price | Open Price | Traded | Last Trade | |
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-0.1279 | -0.18% | 70.3592 | 70.997 | 70.4285 | 70.79 | 6,127 | 01:00:00 |
XTLbio's HepeX-B Receives Orphan Drug Designation from the FDA Rehovot, Israel, 4 August 2003 - XTL Biopharmaceuticals Ltd. (XTLbio) reported today that the U.S. Food and Drug Administration (FDA) has granted its investigational therapeutic product, HepeX-B(tm), Orphan Drug Designation (see Notes to Editors) for prevention of hepatitis B infection in liver transplant patients. Hepatitis B is the most common form of hepatitis and one of the world's leading causes of death. About 5% of chronic hepatitis B patients will develop end-stage liver disease, a condition which necessitates liver transplantation. During the liver transplantation procedure the diseased liver is removed and a healthy liver from a donor is transplanted. Without proper treatment, the newly transplanted liver can become re-infected by residual virus in the patient's serum , leading to rapid disease progression and graft failure in many cases. The current market for prevention of hepatitis B infection following liver transplant is estimated to be worth $100 million. HepeX-B is a combination of two fully human monoclonal antibodies acting on the hepatitis B virus surface antigen, which were selected based on their strong activity against the virus in XTLbio's pre-clinical Trimera(tm) model. In a recently reported study, HepeX-B maintained serum levels similar to or higher than the current first-line treatment (polyclonal preparation of hepatitis B immunoglobulin) , while using 1,000 times less drug. Dr. Norah Terrault, assistant professor of medicine, Gastroenterology Division, University of California, San Francisco, said, "HepeX-B potentially holds several significant advantages over other products - to patients, clinicians and healthcare payers. It is an important addition to the armamentarium of treatments for liver transplant patients." Dr. Martin Becker, XTLbio's Chief Executive Officer, commented, "XTL bio is pursuing a vigorous commercialization program for HepeX-B, with Phase 2b studies scheduled to commence later this year. The receipt of Orphan Drug Designation from the FDA is a significant step in our effort to introduce this novel therapy as rapidly as possible for liver transplant patients." Contacts: XTLbio Dr. Martin Becker, President and CEO, Tel: +972-8-930-4440 Financial Dynamics David Yates, Sarah MacLeod, Tel: +44 (0) 20 7831 3113 Notes to Editors Orphan Drug Designation The grant of Orphan Drug Designation Status for HepeX-B entitles XTLbio to exclusive marketing rights in the United States for seven years following marketing approval. Other benefits include the Company being eligible to apply for certain grants from the FDA to provide funding for development. There is also a fee waiver when XTLbio submits its Biological Licence Application (BLA) to the FDA for approval to market the product. About XTLbio XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing drugs against hepatitis. XTLbio's HepeX(tm) product line - now in clinical trials - has the potential to introduce revolutionary therapies for viral hepatitis, including prevention of re-infection in transplanted livers, the Company's primary focus, and a longer-term cocktail approach in treating chronic illness. XTLbio believes its primary competitive advantage lies in its patented Trimera(tm) technology, which enables the development of fully human monoclonal antibodies and models of human disease for pre-clinical drug validation. Established in 1993, XTLbio became a public company in 2000 with shares traded on the London Stock Exchange under the symbol XTL. END
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