Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF) has received confirmation from the Independent Data Monitoring Committee (IDMC) of the safety and importance of the HER-Vaxx cancer immunotherapy.
The IDMCs role is to review study data and conduct a formal independent review of key data such as deaths, adverse reactions and laboratory results, enabling the IDMC to clearly weigh the benefits and risks of continued study participation.
As a result of the review, the IDMC chair confirmed the IDMC members had no safety concerns and that the study should continue without modification.
The IDMC has encouraged Imugene to push ahead with this important study.
Imugene managing director and CEO Leslie Chong said: “I am happy to report that we have achieved this significant milestone and Im highly encouraged by the positive outcome of this first IDMC meeting.
“I am truly pleased with the study progress to date.”
Imugenes HER-Vaxx is a B-cell peptide cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.
The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu.
It has been shown in pre-clinical studies and in Phase I studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.
Benefit of IDMC review
The IDMC ensures the interests of patients entered on the trial are being well-served (ie, that the risk-benefit ratio is appropriate) and that the scientific integrity of the trial is maintained between trial initiation and completion.
A key benefit of IDMC review of trial data is an independent assessment to assure that study participants are not exposed to unnecessary or unreasonable risks because of their trial participation.
The IDMC is a key process by which the highest scientific and ethical standards are maintained in a clinical trial.
It conducts business in “closed sessions” with meetings attended only by members of the IDMC, thereby maintaining independence from the sponsor.
IDMCs analyse ongoing data for randomised studies, including those that involve multiple sites and when statistically required per protocol, analyse important clinical endpoints such as survival or diseaRead More – Source