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It was still difficult to treat brain cancer and let a lot of failures go by, but Tocagen inevitably saw his attempt fail, leading to a re-examination of his operations.
Tocagen recently transferred its gene therapy assets, Toca 511 and Toca FC, into a phase 3 trial targeting patients with recurrent high-grade glioma (HGG) during resection.
But the so-called Toca 5 test was a failure: it missed the main criterion of overall survival compared to standard treatment (11.1 months on average compared to 12.2 months), with a p value greater than 0.6.
To add to the misfortune, all the secondary criteria "showed no significant difference between the arms of the trial," according to the brief update released this morning.
This could also cause deeper problems within the company, and its leader, Marty Duvall, said that in light of this data, "we will conduct an operational review."
RELATED, RELATED, RELATED: Kunkel Acting as Interim CMO at Tocagen Gene Therapy Company
Toca 511 is a selective cancer immunotherapy comprising an experimental biological product and a small experimental molecule, Toca FC, designed to be used together.
Toca 511 is an injectable retroviral replication vector that encodes an activator enzyme of the prodrug, cytosine deaminase (CD). CD is derived from yeast, and humans do not naturally possess this gene. Its selective delivery to cancer cells means that the infected cancer cells selectively carry the CD gene and produce the CD.
Toca FC, on the other hand, is an experimental oral prodrug, 5-fluorocytosine (5-FC), inactive as an anticancer drug. In animal models, Tocagen stated that 5-FC was converted to the anti-cancer drug, 5-FU, at high concentrations in Toca 511-infected and CD-producing cancer cells.
Things got better two years ago when the company got an IPO in April 2017 worth $ 85 million for its gene therapy tests.
Six months later, San Diego biotech said that after discussions with the FDA, it would "speed up" the development of its therapy immediately by removing its mid-term test and moving to a pivotal test of last phase: a Toca 5. trial.
It was in phase 2, but was modified and turned into a phase 3 even though it did not help in its outcome. That year, Toca 511 received the EMA's PRIME designation and a decisive FDA tag for its Phase 1 work.
The company is also conducting a Phase 1b exploratory study on the treatment of advanced solid tumors (Toca 6), is planning a trial on a newly diagnosed HGG (Toca 7) and is also working on a candidate targeting PD-L1 by the end of the year. # 39; year.
The shares of biotech were eviscerated early this morning, down 81%, in the territory of shares listed in cents.
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