SA News • Wed, Jul. 16
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Wed, Jul. 16, 10:23 AM
- The USPTO issues patent No. 8,771,701 entitled "Compositions for immunotherapy and uses thereof" protecting Prima BioMed's (PBMD +9.8%) CVac technology. CVac is a personalized immunotherapy. The patent's term extends to August 2022.
- The patent covers the method of composition and the method of use of CVac, which uses the patient's own dendritic cells that are reinjected back into the patient to generate a cytotoxic T cell response against the mucin 1 antigen.
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- Prima Biomed (PBMD +29.9%) says multiple jurisdictions have approved its amended CAN-004 protocol including regulators in Latvia, Lithuania, Bulgaria, Ukraine and Belarus.
- As previously announced, the CAN-004 trial was approved by the Belgian regulators in January.
- PBMD says the CAN-004 amendment also has been approved by ethics committees and institutional review boards in the U.S., Australia, Belgium, Bulgaria, Latvia and Lithuania.
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- Prima BioMed (PBMD -31.3%) plummets after releasing a topline analysis of the CVac epithelial ovarian cancer Phase 2 study.
- PFS data prove "inconclusive" as "the estimate of median progression-free survival for all randomized patients resulted in no observed difference between the CVac and control groups."
- When estimated separately for patients in first and second remission, median PFS favored the control arm for first remission and CVac for second remission (no statistical significance for either result).
- It's too early to draw OS conclusions.
- The company says the recent MAGE-A3 melanoma trial results might "indicate that PFS (and similar endpoints like disease-free survival) may not be useful markers of clinical benefit for cancer immunotherapeutics." (PR)
Sep. 18, 2013, 12:49 PM
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