In addition, MODERN is the first large Phase III trial that will compare the performance of a genotypic test with a phenotypic test in identifying patients appropriate for use of Celsentri/Selzentry®. Patients will be randomised to undergo screening with either the genotypic or phenotypic test. Genotypic tropism testing in the MODERN study is provided by Siemens Healthcare Diagnostics as part of this partnership and phenotypic testing (Trofile®) by Monogram Biosciences. Subject to FDA approval, Siemens Healthcare Diagnostics may commercialize their genotypic tropism diagnostic test.
"Our partnership with Siemens Healthcare Diagnostics is a valuable part of our commitment to addressing patient needs through developing innovative treatment approaches," said Dr. John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare. "Celsentri/Selzentry is an important treatment option for people living with CCR5-tropic HIV and we continue to support the evolution of tropism testing to provide physicians with accurate, accessible and affordable companion diagnostics."
Tocagen is enrolling patients in its clinical trials of Toca 511 (vocimagene amiretrorepvec), for injection & Toca FC (flucytosine), extended-release tablets. These multicenter, open-label studies(3) are in patients with recurrent high-grade glioma, such as those with glioblastoma multiforme (GBM, Grade 4), who have had prior surgery and chemoradiation. Toca 511 is a retroviral replicating vector (RRV) that is designed to deliver a cytosine deaminase (CD) gene selectively to cancer cells. After allowing time for the administered Toca 511 to spread through the tumor, those cancer cells expressing the CD gene may convert the antibiotic flucytosine into the anti-cancer drug 5-fluorouracil (5-FU). In these studies, patients receive multiple cycles of oral Toca FC. Tocagen plans to work with Siemens Healthcare Diagnostics on the assays used during these clinical studies. Subject to FDA approval, Siemens may commercialize diagnostic tests capable of monitoring patient levels of Toca 511 and Toca FC.
"We believe that developing the necessary diagnostic tests with the right diagnostic partner is an important component for the successful commercialization of Toca 511 & Toca FC," said Harry E. Gruber, CEO, Tocagen Inc. "Siemens' capabilities in developing commercial viral assays in addition to their market presence in the diagnostics space make them an excellent complement to Tocagen's focus on the development and commercialization of viral gene transfer products to treat advanced cancer."These partnerships reflect Siemens' efforts to expand its healthcare global presence by leveraging the power of in vivo and in vitro diagnostics to impact therapeutics – one goal of the recently launched Siemens Agenda 2013, a new two-year global initiative to further strengthen the innovative power and competitiveness of the Siemens Healthcare Sector.
(1) http://www.dddmag.com/article-Companion-Prospecting-91211.aspx (accessed on 10/6/11)(2) http://www.prnewswire.com/news-releases/companion-diagnostics-world-market-outlook-2011-2021-130615878.html, http://www.visiongain.com (accessed on 10/6/11)(3) http://clinicaltrials.gov/ct2/results?term=tocagenViiV Healthcare is a global specialist HIV company established by GlaxoSmithKline (LSE: GSK.L) and Pfizer (NYSE: PFE) to deliver advances in treatment and care for people living with HIV. Our aim is to take a deeper and broader interest in HIV/AIDS than any company has done before, and take a new approach to deliver effective and new HIV medicines as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit: www.viivhealthcare.com. Tocagen Inc. is a privately funded, clinical stage biopharmaceutical company pursuing the discovery, development and commercialization of gene transfer products for the treatment of cancer. Tocagen is initially focusing on treatments for patients with advanced cancer for whom no adequate treatments currently exist. Toca 511 & Toca FC, the company's lead investigational combination product candidate, is being evaluated in clinical trials in patients with recurrent high grade glioma (such as glioblastoma multiforme). Tocagen has received grant support from leading brain cancer foundations including, Accelerate Brain Cancer Cure ( ABC2), the American Brain Tumor Association ( ABTA), and the National Brain Tumor Society ( NBTS). For more information about Tocagen or Toca 511 please visit: www.tocagen.com. The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 51,000 employees worldwide and operates around the world. In fiscal year 2011 (to September 30), the Sector posted revenue of 12.5 billion euros and profit of around 1.3 billion euros. For further information please visit: www.siemens.com/healthcare.