Le Lézard
Classified in: Health, Science and technology
Subjects: CCA, TRI

Tocagen Reports Results of Toca 5 Phase 3 Trial in Recurrent Brain Cancer


SAN DIEGO, Sept. 12, 2019 /PRNewswire/ -- Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today announced that the Toca 5 Phase 3, randomized, multi-center clinical trial evaluating Toca 511 & Toca FC in patients with recurrent high grade glioma (HGG) undergoing resection missed the primary endpoint of overall survival compared to standard of care treatment (11.1 months median compared to 12.2 months, HR=1.06, p=0.6154). In addition, all secondary endpoints showed no meaningful difference between the arms of the trial. The safety, tolerability and adverse event profile of Toca 511 & Toca FC was as expected for this patient population.

Tocagen Inc. (PRNewsfoto/Tocagen Inc.)

Further analysis of the Toca 5 trial data is currently underway and presentation of the results is planned at an upcoming medical conference.

"Recurrent brain cancer represents a very high unmet medical need and patients with this disease have very few treatment options," said Marty Duvall, chief executive officer of Tocagen. "While the Toca 5 trial results are disappointing, we will be conducting a thorough analysis of the data including molecular analyses and pre-planned subgroups. In addition, we will be conducting an operational review. We sincerely appreciate the exceptional support from patients and their families as well as patient advocates, physicians and our employees who have been committed to the rigorous study of Toca 511 & Toca FC in the Toca 5 trial."

Conference Call and Webcast
Tocagen will host a conference call today, September 12, at 8:30 a.m. Eastern (5:30 a.m. Pacific) to discuss the Toca 5 clinical trial. The live call may be accessed by dialing 1-877-270-2148 for domestic callers or 1-412-902-6510 for international callers. A live webcast of the conference call will be available online from the Investors section of Tocagen's website at www.tocagen.com. The webcast will be archived on Tocagen's website for 60 days.

About Toca 511 & Toca FC
Tocagen's lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

More information about the Toca 5 trial can be found on ClinicalTrials.gov using the clinical trial identifier NCT02414165. The Toca 5 trial was funded in part by a grant awarded by the FDA Office of Orphan Products (FD-R-5732).

About Tocagen
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 Phase 2/3 trial for patients newly diagnosed with glioblastoma, sponsored by the NCI and conducted by NRG Oncology, and a Phase 1 trial in patients with non-muscle invasive bladder cancer. Tocagen is advancing preclinical programs from its versatile gene therapy platform that represents a new approach in cancer immunotherapy. For more information about Tocagen, visit www.tocagen.com.

Forward-Looking Statements
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 expectations and plans regarding further data analysis and regulatory agency engagement. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of our product candidate development activities and planned clinical trials; our ability to execute on our strategy; regulatory developments in the United States and foreign countries; and our estimates regarding expenses, future revenue and capital requirements. 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.

Media Contact:
Pam Lord
Canale Communications
(619) 849-6003
pam@canalecomm.com

Investor Contact:
Pete Rahmer
Endurance Advisors
(415) 515-9763
prahmer@enduranceadvisors.com

 

SOURCE Tocagen Inc.


These press releases may also interest you

at 08:00
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the randomized Phase 2 GRIFFIN (MMY2004) study showing that the addition of DARZALEX® (daratumumab) to bortezomib, lenalidomide and dexamethasone (VRd) induced...

at 06:08
Kodiak Sciences Inc. , a clinical-stage biopharmaceutical company specializing in novel therapeutics to treat chronic, high-prevalence retinal diseases, today announced emerging durability data in patients with wet age-related macular degeneration...

14 sep 2019
Worldwide Business with kathy ireland® is pleased to announce an exclusive interview with Cold Daddy CEO Hobby Howell to discuss their game-changing water therapy that doesn't require ice. Cold Daddy is an innovative company that has developed a...

14 sep 2019
Gold Coast Traditions, a family-owned certified organic food production company today announces the unveiling our latest products?Organic Cornbread Mix, Organic Oat Muffin Mix, and Organic Classic Pancake and Waffle Mix. Gold Coast Traditions...

14 sep 2019
More than 9,400 Torontonians took a giant step forward for youth mental health today, crossing the finish line of the seventh annual RBC Race for the Kids at Mel Lastman Square and raising $2.6 million in support of the Family Navigation Project...

14 sep 2019
ImPACT Applications, a world leader in concussion management software, and HeadCheck Health, Inc., a mobile App and web-based technology company specializing in concussion safety and protocol management, announced today they are partnering to deliver...



News published on 12 september 2019 at 06:00 and distributed by: