A Phase I Study of Multiple doses of NSC-Based Oncolytic Virotherapy Administered Intracerebrally to Patients with Recurrent High-Grade Gliomas
Grant Award Details
Grant Type:
Grant Number:
CLIN2-13162
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$11,999,984
Status:
Active
Grant Application Details
Application Title:
A Phase I Study of Multiple doses of NSC-Based Oncolytic Virotherapy Administered Intracerebrally to Patients with Recurrent High-Grade Gliomas
Public Abstract:
Therapeutic Candidate or Device
Neural stem cells that are genetically engineered to express a cancer-killing virus that specifically targets brain tumor cells
Indication
Recurrent brain tumors in adults: high grade gliomas (HGG), such as glioblastoma (GBM)
Therapeutic Mechanism
The neural stem cells will act as carriers to deliver a cancer-killing virus to brain tumors (at the main area of tumor and distant sites) while also protecting the virus from being destroyed by the body’s immune system during transit to the cancer cells. Virus that is released by the neural stem cells at tumor sites will specifically infect, replicate in, and kill tumor cells, while sparing normal, non-tumor tissue.
Unmet Medical Need
GBM (a type of HGG) is the most common malignant adult primary brain tumor. GBM is an aggressive cancer, and survival of GBM patients is typically less than two years after diagnosis despite current therapies. Thus, there is an urgent need for new therapies to improve survival of GBM patients.
Project Objective
Phase I trial completed
Major Proposed Activities
Neural stem cells that are genetically engineered to express a cancer-killing virus that specifically targets brain tumor cells
Indication
Recurrent brain tumors in adults: high grade gliomas (HGG), such as glioblastoma (GBM)
Therapeutic Mechanism
The neural stem cells will act as carriers to deliver a cancer-killing virus to brain tumors (at the main area of tumor and distant sites) while also protecting the virus from being destroyed by the body’s immune system during transit to the cancer cells. Virus that is released by the neural stem cells at tumor sites will specifically infect, replicate in, and kill tumor cells, while sparing normal, non-tumor tissue.
Unmet Medical Need
GBM (a type of HGG) is the most common malignant adult primary brain tumor. GBM is an aggressive cancer, and survival of GBM patients is typically less than two years after diagnosis despite current therapies. Thus, there is an urgent need for new therapies to improve survival of GBM patients.
Project Objective
Phase I trial completed
Major Proposed Activities
- Manufacture cGMP clinical lots of the therapeutic agent to supply the proposed clinical trial.
- Complete a phase I clinical trial to determine safety and the recommended number of weekly doses of the therapeutic agent.
- Determine biologic activity, biodistribution, immunogenicity, and preliminary clinical efficacy.
Statement of Benefit to California:
GBM is incurable and has a devastating, short course of disease. This neural stem cell-mediated virotherapy could improve survival of patients with HGG, including GBM, and thus quality-of-life of their family and caregivers. Because of its “off-the-shelf” nature, this therapy is lower cost than autologous cell-based therapies and could be rapidly made available throughout CA, and beyond, thus bringing value to the healthcare system and giving diverse patient populations access to this treatment.
