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Pentrix vaccine trial advances to evaluation stage.
2002 OCT 16 - (NewsRx.com & NewsRx.net) -- Australian Cancer Technology (AustCancer) (ACU) has announced that the phase 1b/2a clinical trial of the Pentrix anticancer vaccine, being undertaken at St Vincent's Hospital, Sydney, has advanced to the evaluation and interpretation of results stage and it is expected that interim results from the first group of patients will be announced by early November 2002.
An important aspect of the trial is the continued demonstration of good patient tolerance (no adverse toxicity) confirming the outcome of the phase 1a trial that was completed in January.
Recruitment to the phase 1b/2a trial commenced in February, with administration commencing in April. A spectrum of cancers, which to date include colorectal, prostate, renal, lung, head and neck and esophageal, are covered by the trial.
It is envisaged that up to 16 patients will be enrolled in this phase of the trial which is scheduled for formal completion by the end of 2002. Patients receive four doses of the vaccine over 3 months with a follow-up period of a further 3 months. It can take up to 3 months to assess a patient's suitability for the trial.
To date six patients have completed the vaccine course and have commenced the follow-up and evaluation phase.
Rather than measuring clinical outcomes such as survival, which can take 12-24 months, the body's immune response to the vaccine is also being used as the indicator of expected clinical outcomes. One of the major tasks in the current study has been to develop reliable and meaningful assays to evaluate a patient's immune response to Pentrix. Discussions with several potential partners from the global pharmaceutical industry have indicated that positive assay results would be ...
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Source: HighBeam Research, Pentrix vaccine trial advances to evaluation stage.