QBiotics Group has announced that its Phase 2a human clinical trial of tigilanol tiglate in Soft Tissue Sarcoma (STS) has completed recruitment. The final patient has received treatment and completed their 28-day follow-up.
The clinical trial is being conducted at Memorial Sloan Kettering Cancer Center in New York, with Dr Edmund Bartlett as its principal investigator.
The primary endpoint of the trial is to assess the drug efficacy of tigilanol tiglate in patients with a range of advanced and/or metastatic STS.
The single-centre, US‐based trial is an open‐label, single‐arm study to assess the preliminary efficacy and safety of silanol tailgate in 10 patients with advanced and/or metastatic STS.
Tigilanol tiglate was awarded Orphan Drug Designation for the treatment of STS by the US FDA earlier this year.
QBiotics’ executive director of strategic alliances and investor relations, Dr Victoria Gordon, said, “We are very pleased to have completed the recruitment phase of this tigilanol tiglate pilot study for patients with Soft Tissue Sarcoma which represents a key milestone in the Company’s development of its lead oncology asset. I would especially like to acknowledge the support of our Principal Investigators and their teams, as well as, the QBiotics’ clinical team, for their careful planning, oversight and input in reaching this achievement.”