SAN DIEGO, June 26, 2017 -- NewVac, LLC today announced detailed primary results of Phase II clinical trial of quisinostat, a novel selective oral histone deacetylase (HDAC1) inhibitor, in advanced ovarian cancer. Results were presented at the ASCO 2017 Annual Meeting. The clinical trial demonstrated quisinostat's safety profile and high efficacy against platinum-resistant ovarian cancer in combination with paclitaxel and carboplatin. NewVac licensed quisinostat from Janssen Pharmaceutica NV.

The primary efficacy endpoint of the study - the objective response rate - was 51.6% and greatly exceeded the value of 30%, expected by the study protocol. Median duration of response was 5 months (4,2-5,7) with median progression free survival of 7 months (95%CI 4.8 - 9.2). SAE were observed in 16,1% of patients, mostly caused by background chemotherapy. The most frequent adverse events during the study were nausea and neutropenia.

As shown in previous preclinical studies, 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.

NewVac is preparing to study indications for quisinostat in combination with proteasome inhibitors to treat translocation-associated sarcomas in adolescents and young adults; and combination with checkpoint inhibitors to increase efficacy in solid tumors (gynecologic cancers and NSCLC).

About Phase II Trial
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. 

About Ovarian Cancer 
Ovarian cancer is one of the leading causes of death from malignant tumors amongst women in USA and Europe. With only 36.3% survival rate ovarian cancer takes more lives per year than any other female reproductive system cancer. The efficacy of the standard platinum- and paclitaxel-based chemotherapy is halted by 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, re-treatment 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 company, focuses on novel approaches to diagnosing and treating cancer. NewVac, is a private development stage biotech, a member of Skolkovo bio-cluster in Moscow, Russia. 

Media Contacts: 
Gelena Lifschitz
+1(858)-3534108
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