Tumor stem cell-targeted immunotherapy for metastatic melanoma –a randomized phase 3 clinical trial.
Grant Award Details
Grant Type:
Grant Number:
CLIN2-08239
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Cell Line Generation:
Award Value:
$3,000,000
Status:
Closed
Grant Application Details
Application Title:
Tumor stem cell-targeted immunotherapy for metastatic melanoma –a randomized phase 3 clinical trial.
Public Abstract:
Therapeutic Candidate or Device
Tumor stem cell-targeted immunotherapy.
Indication
Metastatic melanoma.
Therapeutic Mechanism
Destruction of host tumor stem cells by adaptive humoral cellular immunity will eradicate the origin of melanoma which will extend patient survival.
Unmet Medical Need
There is no effective treatment for metastatic melanoma. This treatment is the only one to target tumor stem cells in melanoma patients.
Project Objective
Complete Phase 3 trial to support BLA approval.
Major Proposed Activities
Tumor stem cell-targeted immunotherapy.
Indication
Metastatic melanoma.
Therapeutic Mechanism
Destruction of host tumor stem cells by adaptive humoral cellular immunity will eradicate the origin of melanoma which will extend patient survival.
Unmet Medical Need
There is no effective treatment for metastatic melanoma. This treatment is the only one to target tumor stem cells in melanoma patients.
Project Objective
Complete Phase 3 trial to support BLA approval.
Major Proposed Activities
- Assessment of clinical safety and efficacy of the therapeutic candidate.
- Manufacturing of tumor stem cell-targeted immunotherapy.
- Enrollment of metastatic melanoma patients in phase 3 clinical trial.
Statement of Benefit to California:
Metastatic melanoma is a disease with no effective treatment and estimated 9,710 deaths in USA in 2014. An effective treatment will keep afflicted individuals productive, enhance State tax revenues and defray the healthcare cost burden to taxpayers. It will also lead to robust industry developments in the fields of stem cell treatments and biomarker discovery, effectively leading to job creation and tax benefits to the State as a result of consumption of research and clinical goods and services.