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Clinical Trials

NewVac’s ovarian cancer combination meets primary endpoints in phase II trial

Published 04 January 2017

NewVac has met all primary endpoints in the Phase II Clinical Trial of Quisinostat, novel selective oral histone deacetylase (HDAC1) inhibitor, which the company licensed from Janssen Pharmaceutica.

The clinical trial is evaluating the efficacy and safety of Quisinostat in platinum-resistant ovarian cancer in combination with Paclitaxel and Carboplatin. The detailed results will be presented in an upcoming clinical research meeting in 2017.

The main advantage of Quisinostat – its unique pharmacokinetic (PK) properties, particularly the ability to selectively accumulate in target tissues, providing high potential in treatment of solid tumors, which has been demonstrated in the Phase II trial.

Quisinostat may present a safe and effective therapeutic solution to patients by restoring sensitivity to chemotherapy in platinum-resistant cases. The efficacy and safety of Quisinostat will be further explored in clinic. In 2016 chemistry, manufacturing, and control (CMC) activities were initiated to support a Phase III clinical trial.

The results of a Quisinostat Phase Ib clinical trial were recently presented at the European Society for Medical Oncology (ESMO) 2016 scientific congress in Copenhagen, Denmark. Quisinostat demonstrated good safety profile and promising efficacy in metastatic platinum-resistant ovarian cancer, showing the highest objective response rate (ORR) among other patient groups within the trial.

Preclinical studies have shown that Quisinostat amplifies HDAC-repressed expression of E-cadherin, leading to a reversal of epithelial to mesenchymal transition (EMT). The latter is associated with platinum-based chemotherapy resistance.

Quisinostat has been investigated in six clinical trials conducted by NewVac or Janssen Pharmaceutica in Europe and the US. Overall, it has been tested in more than 200 patients with hematological and solid malignancies.

NewVac is preparing to study additional indications of Quisinostat in combination with proteasome inhibitors to treat translocation-associated sarcomas in adolescents and young adults; and in combination with check-point inhibitors to increase efficacy in solid tumors (gynecologic cancers and NSCLC).

About Phase II Trial

This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy.

The study consists of a screening period of 3 weeks before the start of Quisinostat administration, followed by the treatment period of approximately 18 weeks (up to 6 cycles and 21 days for each cycle), a safety follow-up of 4 weeks after the last administration of the study therapy and post-treatment follow-up aimed at the determination of progression-free survival, time to disease progression and overall survival rate in the study population.

Source: Company Press Release