SBIR-STTR Award

Spheramine: a Cell-Based Therapy for Parkinson's Disease
Profile last edited on: 5/5/2021

Program
SBIR
Agency
NIH | NINDS
Total Award Amount
$1,279,611
Award Phase
2
Principal Investigator
Richard C Allen
Activity Indicator

Company Information

Titan Pharmaceuticals Inc (AKA:TTNP)

400 Oyster Point Boulevard Suite 505
South San Francisco, CA 94080
   (650) 244-4990
   busdev@titanpharm.com
   www.titanpharm.com
Multiple Locations:   
Congressional District:   14
County:   San Mateo

Phase I

Phase I year
1999
Phase I Amount
$120,000
Parkinson's disease (PD) is a disease of the central nervous system characterized by the reduction of dopamine (DA)-producing nerve cells in the substantia nigra, which results in chronic and progressive motor impairment. As late stage PD patients become intolerant of or resistant to the standard pharmacological therapies, surgical grafting of fetal ventral mesencephalic tissues in brains of PD patients have met with good success. However, the use of human fetal cells remains problematic due to the limited availability of tissue and the associated ethical, legal and social concerns. Xenotransplantations brings a potential risk for zoonotic and xenogeneic infections and potential serious side effects from a lifetime immunosuppressant regimen post-surgery. Spheramine(TM) is a novel, implantable cell based potential therapy for PD, consisting of cultured DA- producing human retinal pigmented epithelial (hRPE) cells on gelatin microcarriers which enhance their survival in vivo. Toxicology studies in nonhuman primates have demonstrated the safety of Spheramine. A pivotal preclinical study has established the efficacious dose range for Spheramine implantation in the MPTP hemiparkinsonian monkey without need for immunosuppression. The primary objective of this study is to test the safety and efficacy of intrastriatal implantation of Spheramine in Hoehn and Yahr stage III and IV Parkinson's patients. PROPOSED COMMERCIAL APPLICATIONS: There are approximately 2 million Parkinson's patients worldwide. At the later stages of the disease there is a decreased response to medication. Spheramine(TM) is a human cell-based therapy being developed for the treatment of Parkinson's Disease (PD). It is believed that the stereotaxic implantation of Spheramine in the striata of Parkinson's patients will be efficacious and more consistent in restoring function than current transplant procedures, and that concurrent immunosuppression will not be required. The proposed research will facilitate the development of this novel therapy for PD.

Phase II

Phase II year
2000 (last award $$: 2001)
Phase II Amount
$1,159,611
Parkinson's disease (PD) is a disease of the central nervous system characterized by the reduction of dopamine (DA)-producing nerve cells in the substantia nigra, which results in chronic and progressive motor impairment. As late stage PD patients become intolerant of or resistant to the standard pharmacological therapies, surgical grafting of fetal ventral mesencephalic tissues in brains of PD patients have met with good success. However, the use of human fetal cells remains problematic due to the limited availability of tissue and the associated ethical, legal and social concerns. Xenotransplantations brings a potential risk for zoonotic and xenogeneic infections and potential serious side effects from a lifetime immunosuppressant regimen post-surgery. Spheramine(TM) is a novel, implantable cell based potential therapy for PD, consisting of cultured DA- producing human retinal pigmented epithelial (hRPE) cells on gelatin microcarriers which enhance their survival in vivo. Toxicology studies in nonhuman primates have demonstrated the safety of Spheramine. A pivotal preclinical study has established the efficacious dose range for Spheramine implantation in the MPTP hemiparkinsonian monkey without need for immunosuppression. The primary objective of this study is to test the safety and efficacy of intrastriatal implantation of Spheramine in Hoehn and Yahr stage III and IV Parkinson's patients. PROPOSED COMMERCIAL APPLICATIONS: There are approximately 2 million Parkinson's patients worldwide. At the later stages of the disease there is a decreased response to medication. Spheramine(TM) is a human cell-based therapy being developed for the treatment of Parkinson's Disease (PD). It is believed that the stereotaxic implantation of Spheramine in the striata of Parkinson's patients will be efficacious and more consistent in restoring function than current transplant procedures, and that concurrent immunosuppression will not be required. The proposed research will facilitate the development of this novel therapy for PD.