News Story: Full Text
Sponsored By
Cleveland Clinic Brain Tumor and Neuro-Oncology Center
Please Click On The Above Banner For More Details
Braintumor Website


FDA Grants Orphan Drug Designation for Tocagen`s Toca 511 & Toca FC, an Investigational Immuno-Oncology Treatment for Glioblastoma


Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)

 Great news for brain tumor patients!



Website: http://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-for-tocagens-toca-511--toca-fc-an-investigational-immuno-oncology-treatment-for-glioblastoma-300132737.html

Posted on: 08/25/2015

FDA Grants Orphan Drug Designation for Tocagen's Toca 511 & Toca FC, an Investigational Immuno-Oncology Treatment for Glioblastoma

Glioblastoma is the most common form of primary brain cancer, with over 10,000 people diagnosed every year in the United States. The disease is extremely aggressive; newly diagnosed patients have a five-year survival rate of less than 5 percent, and the tumor typically recurs following standard-of-care treatment. Median survival following recurrence is approximately eight months. Toca 511 & Toca FC is an investigational treatment that is designed to program cancer cells to convert the prodrug 5-FC into the anticancer drug 5-FU, killing tumor cells and leading to activation of the immune system via a combination of mechanisms.

"There's an extraordinary need for new treatment options for patients with this devastating disease," said Harry Gruber, M.D., chief executive officer of Tocagen. "We believe FDA's granting of both orphan drug and Fast Track designations to Toca 511 & Toca FC will enable us to more efficiently advance our program, which we hope will ultimately offer physicians and patients a new option in the fight against brain cancer."

The FDA's orphan drug designation is intended to encourage development of treatments for diseases that affect fewer than 200,000 individuals in the United States. Orphan drug designation qualifies the drug developer for various development incentives, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee for the condition for which the drug was designated. Orphan designation does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.

About Toca 511 & Toca FC

Toca 511 & Toca FC is designed to program cancer cells to convert the prodrug 5-FC into the anticancer drug 5-FU, killing tumor cells and leading to activation of the immune system selectively against the tumor via a combination of mechanisms. Toca 511 is a retroviral replicating vector (RRV) that selectively delivers a gene for the enzyme cytosine deaminase to the tumor. Patients then take oral cycles of Toca FC, a novel formulation of an antifungal drug, which is converted within infected cancer cells into the FDA-approved anticancer drug, 5-fluorouracil (5 FU). As a result, in addition to direct 5-FU mediated killing the immune system is activated to recognize and kill cancer cells, leaving healthy cells unharmed. Immune activation locally in the tumor occurs through a combination of mechanisms that together break the barrier of immune tolerance and may lead to durable tumor response.

About Tocagen

Tocagen is a clinical-stage biopharmaceutical company pursuing the discovery, development and commercialization of products built upon a broadly applicable, highly tumor-selective immuno-oncology platform. The company's lead combination product, Toca 511 & Toca FC, is advancing into a pivotal Phase 2/3 study in 2015 for patients with recurrent glioblastoma or anaplastic astrocytoma. The FDA has granted Toca 511 & Toca FC both Fast Track and orphan drug designations. A study evaluating Toca 511 & Toca FC in five additional metastatic solid tumor indications is planned for 2016.

Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer (VABC). For more information about Tocagen or Toca 511 please visit www.tocagen.com or www.clinicaltrials.gov using the identifiersNCT01470794NCT01156584NCT01985256, or NCT02414165. For more information about Tocagen please visitwww.tocagen.com or follow @Tocagen.

Media Contact: 
Monica May  
Canale Communications 
619-849-5383

 

 

SOURCE Tocagen Inc.



RELATED LINKS
http://www.tocagen.com

 

 




Click HERE to return to brain tumor news headlines


Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740