�Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) proclaimed that the Company has reached arrangement with U.S. and E.U. regulatory government to go forward with the REALIZE test, a pivotal Phase 3 clinical trial with the hepatitis C virus (HCV) protease inhibitor telaprevir in combination therapy for patients with chronic HCV infection who failed to accomplish a sustained viral response (SVR) with prior therapy. The trial will be conducted in the U.S. and E.U. and will enroll just about 650 genotype 1 HCV patients world Health Organization failed prior treatment with pegylated-interferon (peg-IFN) and virazole (RBV). The trial is designed to evaluate 2 48-week telaprevir-based regimens in comparison with a 48-week control sleeve. Telaprevir volition be dosed for 12 weeks. The primary termination of the trial is SVR, defined as undetectable HCV RNA (
"In Phase 2 clinical trials, telaprevir-based regimens own demonstrated the potential to increase sustained viral response rates across a broad spectrum of patients infected with the hepatitis C virus, including patients wHO failed to achieve SVR with previous pegylated interferon and virazole therapy, many of whom are at high risk of exposure for serious HCV-related complications," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Medical College of Cornell University. "The REALIZE trial of telaprevir is a turning point Phase 3 trial of an investigational HCV proteinase inhibitor in null responder and other patients wHO failed prior treatment and will seek to give additional data to certify the benefit of telaprevir in this difficult to treat patient population."
"Approximately 6 one thousand thousand patients ar chronically septic with hepatitis C in the U.S. and E.U. today, and approximately 650,000 of these patients have failed previous treatments of pegylated interferon and ribavirin therapy and are in pauperism of a new curative option to treat their disease," aforementioned Kurt C. Graves, Vertex's Executive Vice President, Chief Commercial Officer and Head, Strategic Development. "Data generated from this Phase 3 trial in treatment-failure patients, as well as information from the ongoing Phase 3 ADVANCE trial in treatment-na�ve patients, may farther contribute to the rising profile of telaprevir to address the significant aesculapian need in both treatment-na�ve and treatment-failure patients."
Global Phase 3 Trial in Patients world Health Organization Failed to Achieve SVR with Prior Therapy
The REALIZE Trial (Re-treatment of Patients with Telaprevir-based Regimen to Optimize Outcomes) volition enroll some 650 genetic constitution 1 HCV patients and will be conducted by Tibotec at more than 100 centers in the U.S. and E.U. Tibotec expects to complete enrollment of the REALIZE trial in the first quarter of 2009. The trial will include the following patient groups:
- Null responders (defined as patients who achieved less than 2 log reduction in HCV RNA at Week 12 of prior therapy);
- Partial responders (defined as patients who achieved at least a 2 log reduction at Week 12, merely failed to achieve undetectable HCV RNA by Week 24 of prior therapy); and
- Relapsers (outlined as patients who had undetectable HCV RNA at the completion of at least 42 weeks of prior treatment, but relapsed during review).
The REALIZE trial will dose telaprevir in combination with pegylated interferon alfa-2a (PEGASYS) and ribavirin. The REALIZE test will enter three 48-week trial munition:
1. Telaprevir dosed at 750 mg every ashcan School hours (q8h) for 12 weeks in combination with standard doses of peg-IFN and RBV, followed by 36 weeks of discourse with peg-IFN and RBV alone;
2. Delayed start arm, comprised of 4 weeks of treatment with peg-IFN and RBV, followed by telaprevir dosed at 750 mg q8h for 12 weeks in combination with criterion doses of peg-IFN and RBV, followed by another 32 weeks of peg-IFN and RBV alone; and
3. A control sleeve with standard doses of peg-IFN and RBV dosed for 48 weeks
Patients in all treatment arms will be followed for 24 weeks after pass completion of treatment to assess SVR.
Updates on the status of Vertex and Tibotec's clinical trials of telaprevir are available at http://www.clinicaltrials.gov.
Pivotal Trial in Treatment-Na�ve Patients
Vertex and Tibotec are besides conducting the global 3-arm pivotal Phase 3 ADVANCE trial in treatment-na�ve genotype 1 HCV patients that is focused on 24-week telaprevir-based regimens for patients achieving speedy viral response (HCV RNA
About Telaprevir
Telaprevir (VX-950) is an investigational oral inhibitor of HCV peptidase, an enzyme essential for viral reverberation, and is one of the most advanced investigational antiviral agents in growth that specifically targets HCV. The types of untoward events that were seen across all treatment munition in Phase 2b trials of telaprevir are those that have been normally observed with peg-IFN and RBV. The most common adverse events, regardless of treatment assignment, were fatigue, rash, head ache and nausea, with roseola being the most common reason for treatment discontinuation in patients treated with telaprevir. There have been reports of severe rashes in clinical trials of telaprevir-based therapy. Gastrointestinal disorders, skin contrary events (blizzard, pruritus) and anemia were more common in the telaprevir coat of arms compared to the control arm all over the dosing period.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of citizenry with the disease. HCV, a dangerous public health concern touching 3.4 million individuals in the United States, is spread through point contact with the blood of infected people. Though many people with HCV infection whitethorn not receive symptoms, others may get symptoms such as jaundice, abdominal hurting, fatigue and fever. Chronic HCV significantly increases a person's risk of infection for development long-term infection, chronic liver disease, cirrhosis or demise. The loading of liver disease associated with HCV infection is increasing, and current therapies typically put up sustained benefit in less than half of patients with genotype 1 HCV, the well-nigh common song of the virus.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotech company attached to the discovery and development of breakthrough modest molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaborationism with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and cystic fibrosis. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline mathematical group of companies.
Pegasys is a registered trademark of Hoffman-La Roche Ltd.
Safe Harbor Statement
This press release contains forward-looking statements, including statements that (i) Vertex will start the REALIZE tryout, which will enroll about 650 genetic constitution 1 HCV patients wHO failed prior treatment with pegylated-interferon (peg-IFN) and virazole (RBV); (ii) the REALIZE trial and the ADVANCE trial testament generate information that will contribute to the emerging profile of telaprevir to address both treatment-na�ve and treatment-failure patients; (iii) Tibotec expects to complete registration of the REALIZE trial in the first quarter of 2009 and Vertex is on track to complete registration of the ADVANCE trial during the fourth quarter of 2008; d (iv) Vertex expects to take sustained viral response (SVR) data from the ADVANCE trial in the low gear half of 2010. While we believe the advanced statements contained in this press release are precise, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among former things, that the outcomes for each of our ongoing or planned clinical trials, and in special the ADVANCE and REALIZE clinical trials may non be prosperous or may not confirm results from earlier clinical trials, that there whitethorn be variable interpretations of data produced by unitary or more than of those clinical trials, that registration in the ADVANCE or REALIZE clinical trials may be more difficult or slower than we currently anticipate, that unexpected contrary events experient by patients in whatsoever of these trials crataegus oxycantha slow enrollment or lead to regulative action, and other risks listed under Risk Factors in our annual reputation on Form 10-K, which was filed with the Securities and Exchange Commission on February 11, 2008. We disclaim any obligation to update the information contained in this press out release as new information becomes available.
Vertex Pharmaceuticals Incorporated
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