NewVac Reports Primary Endpoint Met in the Phase II Clinical Trial of Quisinostat in Combination with Paclitaxel and Carboplatin in Platinum-Resistant Ovarian Cancer

SAN DIGEO, CA, January 3, 2017 – NewVac LLC reported meeting all primary endpoints in the Phase II Clinical Trial of quisinostat, novel selective oral histone deacetylase (HDAC1) inhibitor, which NewVac licensed from Janssen Pharmaceutica NV. 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 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 CMC activities were initiated to support a Phase III clinical trial.

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 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 is consisted of screening period of 3 weeks before the beginning 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 determination of progression-free survival, time to disease progression and overall survival rate in the study population.

 About Ovarian cancer

Ovarian cancer ranks 5th in the world list of causes of death of women from malignant tumors. Among the countries are USA, West and North Europe. Ovarian cancer is also a leading cause of death from tumors of gynecological nosologies, i.e. it causes more deaths per year than any other type of female reproductive system cancer. The average age at diagnosis is 58 years, and 90% of diagnoses are established in women who are older than 40 years. In the case of ovarian cancer the median 5-year survival rate is 36.3%.   After debulking surgery, the standard of care for first line diagnosed ovarian cancer is platinum- and paclitaxel based chemotherapy. However, there is still a very high risk of recurrence, with a very poor outcome. There is an urgent need to develop new and better treatment options both for first line patients and those that relapse.  The populations of patients who progress within 1-6 months are considered to be platinum-resistant patients. For these patients, retreatment with the same chemotherapy regimen is futile (<10% response rate). However, by adding a potential resistance modifier such as Quisinostat, a re-treatment with the original regimen in combination with the experimental agent is the best test of proof of concept.

About NewVac

NewVac LLC, a ChemRar Group company, focuses on novel therapeutic and diagnostic approaches to detecting and treating cancer. NewVac, a privately owned biotech, is a member of Skolkovo innovative biocluster in Moscow, Russia.

Media Contacts:

Ronald Demuth

+1(858)-794-4860 x321

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