Tocagen Inc continues enrollment into Phase I/II study in Recurrent, High Grade Glioma (HGG)
Last year, NBTS announced it had awarded an Innovation Research Grant to Tocagen Inc., which is developing an innovative therapeutic approach to the treatment of brain cancer. NBTS remains excited about this award to Tocagen, believing it represents an important step forward in our mission to drive brain tumor research towards therapies. The NBTS grant demonstrates NBTS’s fierce commitment to improving the lives of those affected by brain tumors.
In November, 2011 NBTS attended Tocagen’s annual meeting and is pleased to report that Tocagen has made significant progress. Currently they have enrolled the first three patients in their Phase I/II clinical trial with their investigational combination therapy, referred to as "Toca 511 & Toca FC". Tocagen plans to continue enrollment into this study in the coming months and has made some important changes to the inclusion criteria:
- Subjects with a single, recurrent High Grade Gliomas (HGG), including Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, and Glioblastoma Multiforme (GBM) are now eligible.
- There is no upper age limit, however KPS score for patients greater than 75 year of age must be at least 70.
- The tumor size limit has been increased to ≤ 9.0 cm2 in its greatest cross sectional area.
For more information about Toca 511 & Toca FC, please see these FAQ:
Q: What is Toca 511 & Toca FC?
A: Toca 511 & Toca FC is an investigational combination treatment that is designed to deliver high amounts of cancer killing drug to the cancer tissue while leaving healthy tissue unharmed. In preclinical brain cancer studies in animals, Toca 511 & Toca FC was able to destroy tumors and prolong life in most animals treated.
Q: What is Toca 511?
A: Toca 511 is an investigational biologic drug containing a cytosine deaminase (CD) gene.
Q: What is Toca FC?
A: Toca FC is an investigational extended-release oral drug containing 5-FC (flucytosine). It is intended to be used in combination with, and after administration of Toca 511.
Q: How is Toca 511 & Toca FC administered?
A: Toca 511 is given by injection into the tumor. Toca FC is taken orally.
Q: How many days of hospitalization are required?
A: Subjects will be admitted to the hospital for the administration of Toca 511 and are expected to go home the next morning. All subsequent tests will be performed on an out-patient basis and Toca FC can be taken at home.
Q: What side effects can be expected?
A: Since Toca 511 & Toca FC is an investigational therapy, a complete safety profile has not been established. However, Toca 511 & Toca FC has not shown significant toxicity in animal safety studies and has been well tolerated by the human subjects dosed in the clinical study to date.
Q: What results are expected from the Toca 511 & Toca FC trial?
A: The trial is designed to assess the safety and tolerability of Toca 511 in combination with Toca FC. Additionally, response to treatment will be assessed by measuring tumor size by brain scan (MRI) and progression free survival at 6 months (PFS-6).
Q: If I participate in this study, can I then participate in a vaccine trial?
A: Generally yes, but you should discuss your individual case with your doctor.
Q: How many sites will participate and where are the sites located?
A: Locations include Los Angeles (UCLA), San Francisco (UCSF), Cleveland (CCF). We are currently expanding the trial to sites in the west, mid west, and east coast. For an updated site list please visit: http://clinicaltrials.gov/ct2/show/NCT01156584?term=Tocagen&rank=1.
Q: How can someone with a recurrent HGG participate in the clinical trial?
If you are a patient and would like more information regarding your eligibility for this study, please contact the study site location nearest you or contact Tocagen through the Patient Inquiry Form. For more information about this study and a complete listing of inclusion/exclusion criteria, please visit http://clinicaltrials.gov/ct2/show/NCT01156584?term=Tocagen&rank=1.
Q: How can a physician refer a patient with a recurrent HGG?
If you are a physician who would like more information regarding the eligibility of one of your patients, please contact Tocagen through the Physician Inquiry Form.
