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 IDMC’s 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 I’m highly encouraged by the positive outcome of this first IDMC meeting.
“I am truly pleased with the study progress to date.”
Imugene’s 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.
IDMC’s 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 disease progression.
Phase-2 HER-Vaxx study
The Phase 2 HER-Vaxx study is designed to measure the efficacy, safety and immune response in 68 patients with metastatic gastric cancer overexpressing the HER-2 protein.
This study is randomised into two arms of either HER-Vaxx plus standard-of-care chemotherapy or standard-of-care chemotherapy alone.
The primary endpoint is overall survival and secondary endpoint will be progression-free survival.
Safety, tolerability and immune response will also be measured.
The Phase 2 trial is being conducted at multiple sites across Eastern Europe and India where clinicians have difficulty accessing approved antibody treatments such as Herceptinâ and Perjetaâ marketed by Swiss multinational Roche Holding AG.
There is also a high prevalence of gastric cancer in the countries selected.