|Tocagen Receives European Medicines Agency Orphan Medicinal Product Designation for Toca 511 & Toca FC for the Treatment of Glioma|
"The EMA's granting of orphan medicinal product designation to Toca 511 & Toca FC emphasizes the urgent need for new therapies that may benefit patients living with glioma," said
The EMA's orphan medicinal product designation aims to facilitate the development of medicines for rare diseases. To qualify for the designation, a medicine must meet a number of criteria, including its ability to treat, prevent or diagnose a disease that is life-threatening or chronically debilitating; prevalent in less than 5 in 10,000 people in the
Gliomas, particularly HGGs, are among the most common and aggressive primary brain cancers. The total number of patients with HGG expected to be diagnosed in 2018 is approximately 190,000 worldwide and approximately 36,000 in
About Toca 511 & Toca FC
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. Tocagen's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial for recurrent high-grade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration (
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our business plans and objectives, expectations regarding timing and success of our clinical trials and planned clinical trials, timing and substance of communications with the FDA and EMA, a commercialization of our product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: risks associated with our product candidate development activities including the risks of clinical trials; the risk that our product candidates will cause serious adverse events or otherwise fail to prove effective and safe; the risk that we are unable to execute on our strategy; and the risks associated with commercialization of our product candidates if approved for sale. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Tocagen's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Tocagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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