A combination of Tiziana Life Sciences‘ milciclib and the intravenous chemotherapy Gemzar (gemcitabine) stabilized tumor growth in a small group of patients with advanced solid tumors, including mesothelioma, according to a Phase 1 clinical trial.
All the patients had metastatic cancer that had failed to respond to other treatments. Among those who responded to the milciclib-Gemzar combo treatment, a patient with peritoneal mesothelioma had a stable disease for nearly 14 months.
The study, “Phase I Dose-Escalation Study of Milciclib, A Novel Inhibitor of Cyclin Dependent Kinases (CDKs), in Combination with Gemcitabine in Patients with Refractory Solid Tumors,” was published in the journal Cancer Chemotherapy and Pharmacology.
Sixteen patients were included in the study, three of them with mesothelioma. They received various oral doses of milciclib, seven days on and seven days off, for four weeks. In addition, they received intravenous Gemzar on days 1, 8, and 15 in a four-week cycle.
Interestingly, the combination treatment was also effective in patients who had previously shown resistance to Gemzar.
“Following the generation of encouraging Phase I clinical data with milciclib … we are rapidly moving forward with further evaluation of the drug as an oral treatment in Phase IIa clinical trials for patients with refractory hepatocellular carcinoma (HCC), which is a significant unmet medical need,” Gabriele Cerrone, chairman of Tiziana Life Sciences, said in a press release.
The study was mainly concerned with the safety of the treatment. Results showed that milciclib triggered toxic reactions in only one of nine patients who received the highest dose. The adverse effects in this patient were low platelet counts, ataxia, and tremor. The most common side effects seen in the trial were low counts of neutrophils and platelets.
“It is noteworthy that the combination treatment regimen used in the Phase I study also exhibited positive clinical activity in patients who were previously resistant to treatment with gemcitabine, a drug widely used as a partner in combination therapies for treatment of refractory cancers. This suggests that milciclib may have therapeutic potential in combination with other existing therapies,” Cerrone said.
The company has yet to disclose its plans for the continuing develop and marketing of milciclib as a mesothelioma therapy.