The results of the Phase 2 clinical trial of ITI-1000, a glioblastoma (GBM) cell therapy, of Immunomic Therapeutics (hereafter Immunomic), a US subsidiary of HLB, are expected to be announced this month. It was originally scheduled for release in early October, but has been delayed.
In response, HLB disclosed the reasons for the delay in the announcement of clinical trial results through its website on the 17th.
HLB explained, “As the data aggregation work of the University of Florida Hospital, a major clinical site, was suspended for a few days due to a hurricane, the data collection and presentation, which was originally expected in early October, is being delayed somewhat.”
He added, “It is expected that the top line analysis will be completed within this week as soon as work resumes.”
The full data and analysis results will be presented at the Neuro-Oncology Society (SNO) in mid-November.
On the other hand, HLB dismissed some rumors surrounding the clinical results, saying, “Even the Immunomic representative is not aware of the clinical results yet.”
HLB said, “In order to prevent an issue of undisclosed information about the top line results, as soon as the Immunomic CEO finds out, it is reported directly to the HLB CEO and is immediately announced.” All of the contents are 100% rumours,” he explained.
According to HLB, Immunomic started phase 2 in August 2016 for 150 GBM patients at Florida University Hospital and Duke University Hospital. Clinical participants were divided into ITI-1000 plus temozolomide and placebo plus temozolomide.
The primary evaluation index was OS (total survival), the secondary evaluation index PFS (progression-free survival period), and changes in immune response.
ITI-1000 is a therapeutic vaccine made by applying Immunomic’s cell therapy vaccine platform ‘UNITE’. It is a therapeutic vaccine candidate.
HLB said, “Glioblastoma is such a difficult cancer that there has been no successful new drug development in the past 20 years, so it is not an easy challenge for a new drug development company. Please support me,” he added.