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Th1236 details
Primary information
ID10876
Therapeutic IDTh1236
Protein NameSipuleucel-T
SequenceNA
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeNA
DescriptionSipuleucel-T is a personalized, autologous, cellular immunotherapy. Sipuleucel-T is a therapeutic cancer vaccine for prostate cancer. Sipuleucel-T selectively targets the prostate-specific antigen (PSA) known as prostatic acid phosphatase (PAP) that is expressed in around 95% of prostate cancers. It must be prepared specifically for each patient. In metastatic prostate cancer, it has extended survival by median 4.1 months (IMPACT Phase III trial data). Sipuleucel-T is marketed under the brand name Provenge by Dendreon Corporation. Sipuleucel-T was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2010, to treat asymptomatic or minimally symptomatic metastatic Hormone-Refractory Prostate Cancer (HRPC). The treatment initially cost $93,000 at the time of FDA approval, but rose to over $100,000 in 2014.
Indication/DiseaseSipuleucel-T is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
PharmacodynamicsNA
Mechanism of ActionSipuleucel-T is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers. During ex vivo culture with PAP-GM-CSF, APCs take up and process the recombinant target antigen into small peptides that are then displayed on the APC surface. The precise mechanism remains unknown, however.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
ClearanceNA
CategoriesAntineoplastic and Immunomodulating Agents
Patents NumberUS8153120
Date of Issue4-Oct-2012
Date of Expiry22-03-2027
Drug InteractionThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with 2-Methoxyethanol, 9-(2-phosphonylmethoxyethyl)-2,6-diaminopurine, Abatacept, abetimus, ABR-215757, Acteoside, Adalimumab, Adefovir Dipivoxil, Afelimomab, Alefacept.
TargetProstatic acid phosphatase
Brand NameProvenge
CompanyNA
Brand DescriptionNA
Prescribed ForProvenge® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer
Chemical NameNA
FormulationNA
Physical Appearance Solution
Route of AdministrationIntravenous
Recommended DosageThe recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals. In controlled clinical trials, the median dosing interval between infusions was 2 weeks (range 1 to 15 weeks); the maximum dosing interval has not been established
ContraindicationHypersensitivity to the active substance
Side Effectsfever;gredness, swelling, oozing, or other signs of infection where the IV needle was placed; orgsigns of infection around the veins your cells were collected from.
Useful Link 1Link
Useful Link 2NA
RemarksNA