Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INTERCEPT treated platelets · 2 trials · 1 indication
Recovery of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero.
Survival of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 \* Control) in survival is greater than or equal to zero.
| Arm | Type | Description |
|---|---|---|
| Stage 1 | EXPERIMENTAL | The study will be performed in two stages. Stage 1 is a randomized, 2-period crossover design. Test platelets stored for 7 days will be radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods will be compared with each other and against the fresh platelet Control. With agreement from the FDA (BQ200481, July 8, 2020), completion of Stage 1 is not required. |
| Stage 2 | EXPERIMENTAL | Stage 2 is a single arm design. Test platelets from 24 healthy subjects, stored for 7 days, will be prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets will be compared against the fresh platelet Control. Stage 1 subjects with evaluable Variant 1 method data will contribute to the requirement of the 24 subjects for Stage 2. |
| Amicus platelet components | EXPERIMENTAL | The two stages of this pilot study consist of the following: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). In Stage 1, apheresis platelets will be collected using the Amicus separator and stored for 7 days in 35% Plasma and 65% InterSol |
| Trima platelet components | EXPERIMENTAL | The two stages of this pilot study consist of the following: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). In Stage 2, apheresis platelets will be collected using the Trima separator and stored for 7 days in 100% plasma. |
| Name | Type | Description |
|---|---|---|
| INTERCEPT Treated Platelets | DEVICE | Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) will be simultaneously administered intravenously into the subject. |
Inclusion Criteria: * Age greater than or equal to 18 years, of either gender. * Normal health status (as determined by the Investigator review of medical history and blood donor physical exam). * Meet FDA, AABB, and site guidelines for blood donation and apheresis platelet donation. Travel, tattoo...
INTERCEPT treated platelets are apheresis platelet components that receive a pathogen reduction treatment developed by Cerus Corporation. The process is studied in healthy adult volunteers to assess how radiolabeled treated platelets recover and survive in the body after storage. The program is in Phase 2 clinical development.
INTERCEPT treated platelets are developed by Cerus Corporation, which trades on the Nasdaq under the ticker CERS. Cerus is the sponsor of the clinical studies evaluating the treated platelet components.
INTERCEPT treated platelets are in Phase 2 clinical development. The program is investigational and has not been approved by the FDA. Two Phase 2 trials have been completed, and no trials are currently active.
Two completed Phase 2 trials have evaluated INTERCEPT treated platelets. NCT04022889 studied recovery and survival of radiolabeled autologous INTERCEPT apheresis platelets stored up to 7 days in 100% plasma, enrolling 37 healthy volunteers. NCT02310412 compared 7-day stored platelets in 35% plasma and 65% InterSol versus 100% plasma, enrolling 14 healthy volunteers.
Across the two completed Phase 2 trials, 51 participants have been enrolled. NCT04022889 enrolled 37 healthy volunteers in the United States, and NCT02310412 enrolled 14 healthy volunteers. Both studies used controlled, randomized designs and enrolled adults aged 18 years and older.