The first patient has been dosed in a phase II study investigating the safety and tolerability of the novel agent LiPlaCis for the treatment of advanced or refractory prostate cancer.
The first patient has been dosed in a phase II study investigating the safety and tolerability of the novel agent LiPlaCis for the treatment of advanced or refractory prostate cancer (NCT01861496).
LiPlaCis is a target-controlled liposome formulation of cisplatin, one of the most widely used chemotherapies. The agent’s tumor triggered release mechanism allows for delivery of the therapeutic directly to the tumor, and the investigators also believe the agent will have fewer serious toxicities that are typically associated with cisplatin, including neurotoxicity, nausea, and vomiting.
The formulation has already shown promising interim results in an ongoing phase II trial in patients with heavily pretreated metastatic breast cancer. The purpose of this phase II study is to determine if patients with prostate cancer will respond in the same way that has been seen in patients with breast cancer.
Oncology Venture, the company developing the formulation, has received clearance from health authorities in Denmark to treat up to 15 patients with LiPlaCis. The company will use its messenger RNA-based drug response prediction technology, DRP, to identify the patients most likely to respond to the treatment. Only patients who have a LiPlaCis DRP higher than 33% are eligible to be included in the trial.
“It is known that platin products are active in prostate cancer, but previous clinical studies have not been able to show sufficient effect to obtain marketing approval. We believe this is mainly due to treating a too broad patient population and will examine if the DRP can identify the individuals who benefit from the LiPlaCis treatment as we can do in breast cancer,” said Peter Buhl Jensen, MD, CEO of Oncology Venture, in a statement.
Oncology Venture announced that the first patient has been dosed at the University Hospital in Herlev, Denmark. The phase II portion of the trial will enroll approximately 50 patients, including patients with metastatic breast cancer, prostate cancer, and skin cancer.
Patients will receive escalating doses of LiPlaCis intravenously every 3 weeks on day 1 and day 8. Patients may continue on treatment for more than 3 cycles if investigators determine they are benefiting from the treatment.
To be included in the study, patients must have relapsed on 2 or more prior therapies, and must have an ECOG performance status of 0 or 1.
The primary endpoint of the study is to determine the maximum tolerated dose and recommended dose, and to assess adverse events and laboratory abnormalities. Secondary endpoints include pharmacokinetics, efficacy, and progression-free survival.
LiPlaCis demonstrated a 50% objective response rate in the upper one-third of patients with metastatic breast cancer selected with DRP (5 of 10 patients) and a 24% objective response rate in the upper two-thirds of DRP-selected patients (6 of 25 patients). Investigators noted these data compare favorably with historical objective response rates of 10% to 12% with eribulin, vinorelbine, and gemcitabine and 10% with conventional cisplatin.