Welcome!

News Feed Item

VentiRx Pharmaceuticals Announces the Completion of Patient Enrollment in Randomized, Placebo-controlled Phase 2 Trial of VTX-2337 in Combination with Pegylated-Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer

Company also announces designation of Orphan Drug Status by FDA for VTX-2337 in Ovarian Cancer

SEATTLE, April 17, 2014 /PRNewswire/ -- VentiRx Pharmaceuticals, Inc. today announced that enrollment has been completed in GOG-3003 (NCT01666444), a randomized, placebo-controlled Phase 2 trial of VTX-2337 in combination with Pegylated Liposomal Doxorubicin (PLD) in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who have failed prior platinum-based chemotherapy.

VentiRx Pharmaceuticals Logo

VTX-2337 is a novel, investigational small molecule that targets Toll-like receptor 8 (TLR8). PLD is the standard of care for the treatment of platinum-resistant ovarian cancer and encouraging data have been reported with PLD and VTX-2337 in a recently completed Phase 1b study (GOG-9925, NCT01294293).

The Phase 2 GOG-3003 study has reached its target enrollment with more than 290 patients randomized at over 85 institutions throughout North America. The study is being performed in collaboration with the Gynecologic Oncology Group (GOG) Partners Program. Women were randomized to receive PLD plus VTX-2337 or PLD plus placebo. The primary endpoint of the trial is overall survival.

"There are limited treatments available for women with platinum-resistant ovarian cancer and completion of this study brings us closer to validating new cancer immunotherapies like VTX‑2337 as a new treatment option. We are hopeful that this novel approach of combining a selective modulator of the innate immune system with chemotherapy may extend survival for woman with ovarian cancer," said Bradley Monk, M.D., University of Arizona Cancer Center at St. Joseph's Hospital and Medical Center, chair of the study.

"Completion of enrollment in the large, randomized GOG-3003 trial and receipt of orphan drug designation for VTX-2337 in ovarian cancer are important milestones for VentiRx in the development of our novel immunomodulator VTX-2337," said Robert Hershberg, M.D., Ph.D., President and Chief Executive Officer of VentiRx. "We appreciate the tremendous effort of the GOG in the enrollment of this trial ahead of schedule, and look forward to the event-driven analysis in late 2015."

GOG-3003 is one of two Phase 2 clinical trials of VTX-2337 currently underway. The second trial, called Active8, is a company-sponsored, randomized, Phase 2 placebo-controlled trial in patients with locally advanced and metastatic squamous cell carcinoma of the head and neck. The study is evaluating VTX-2337 in combination with cetuximab and chemotherapy vs. cetuximab and chemotherapy alone. Progression-free survival is the primary endpoint. The Active8 trial is currently enrolling patients in the U.S. More information on this trial is available at clinicaltrials.gov (NCT01836029).

The company also announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to VTX-2337 for the treatment of ovarian cancer. Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products and is given to drugs that meet certain criteria and are designed to treat a rare disease or condition affecting fewer than 200,000 people in the U.S.

About VTX-2337

VTX-2337 is a novel Toll-like Receptor 8 (TLR8) agonist that directly activates multiple components of the innate immune system. This includes activation of human myeloid dendritic cells (mDCs), monocytes and natural killer (NK) cells resulting in the production of high levels of mediators known to orchestrate the integration of innate and adaptive antitumor responses. 

Results from preclinical models suggest that combining VTX-2337 with PLD may provide a synergistic effect in stimulating a variety of immune pathways associated with antitumor activity. A recently completed Phase 1 trial in this same study population demonstrated that the combination was safe and well-tolerated.

About Ovarian Cancer

There will be an estimated 22,240 new cases of ovarian cancer in the United States and over 40,000 new cases in the European Union in 2014. Ovarian cancer is one of the most lethal gynecologic cancers. Women with recurrent or persistent ovarian cancer recur within 6-12 months of completion with a platinum-containing regimen and there remains a high unmet need for improved treatment options.

About The Gynecologic Oncology Group

The GOG is a national non-profit organization dedicated to clinical research in the field of gynecologic cancer. The purpose of the GOG is to improve the treatment of gynecologic cancer. These goals are addressed through research encompassing surgery, radiation therapy, chemotherapy, pathology, immunology and/or gynecologic nursing. To promote this mission, the GOG receives support from the National Cancer Institute (NCI) of the National Institutes for Health. The GOG has a history of establishing treatment standards for ovarian cancer, demonstrating improved survival with platinum therapy in the early 1980s and again with the combination of paclitaxel and platinum in the mid-1990s.

About VentiRx Pharmaceuticals

VentiRx Pharmaceuticals Inc. is a clinical stage biopharmaceutical company committed to the development and commercialization of novel Toll-like receptor 8 (TLR8) immunotherapies for the treatment of cancer, respiratory and inflammatory diseases. The Company's lead product candidate is VTX-2337, a small molecule TLR8 agonist for the treatment of cancer. VentiRx has an exclusive, world-wide collaboration with Celgene Corporation for VTX-2337. VentiRx is a privately held organization based in Seattle, Washington. For additional information, please visit www.ventirx.com.

Logo - http://photos.prnewswire.com/prnh/20120123/SF39404LOGO

SOURCE VentiRx

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
To Really Work for Enterprises, MultiCloud Adoption Requires Far Better and Inclusive Cloud Monitoring and Cost Management … But How? Overwhelmingly, even as enterprises have adopted cloud computing and are expanding to multi-cloud computing, IT leaders remain concerned about how to monitor, manage and control costs across hybrid and multi-cloud deployments. It’s clear that traditional IT monitoring and management approaches, designed after all for on-premises data centers, are falling short in ...
When applications are hosted on servers, they produce immense quantities of logging data. Quality engineers should verify that apps are producing log data that is existent, correct, consumable, and complete. Otherwise, apps in production are not easily monitored, have issues that are difficult to detect, and cannot be corrected quickly. Tom Chavez presents the four steps that quality engineers should include in every test plan for apps that produce log output or other machine data. Learn the ste...
The deluge of IoT sensor data collected from connected devices and the powerful AI required to make that data actionable are giving rise to a hybrid ecosystem in which cloud, on-prem and edge processes become interweaved. Attendees will learn how emerging composable infrastructure solutions deliver the adaptive architecture needed to manage this new data reality. Machine learning algorithms can better anticipate data storms and automate resources to support surges, including fully scalable GPU-c...
A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to great conferences, helping you discover new conferences and increase your return on investment.
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
Containers and Kubernetes allow for code portability across on-premise VMs, bare metal, or multiple cloud provider environments. Yet, despite this portability promise, developers may include configuration and application definitions that constrain or even eliminate application portability. In this session we'll describe best practices for "configuration as code" in a Kubernetes environment. We will demonstrate how a properly constructed containerized app can be deployed to both Amazon and Azure ...
Everyone wants the rainbow - reduced IT costs, scalability, continuity, flexibility, manageability, and innovation. But in order to get to that collaboration rainbow, you need the cloud! In this presentation, we'll cover three areas: First - the rainbow of benefits from cloud collaboration. There are many different reasons why more and more companies and institutions are moving to the cloud. Benefits include: cost savings (reducing on-prem infrastructure, reducing data center foot print, redu...
SYS-CON Events announced today that Silicon India has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Published in Silicon Valley, Silicon India magazine is the premiere platform for CIOs to discuss their innovative enterprise solutions and allows IT vendors to learn about new solutions that can help grow their business.
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
You want to start your DevOps journey but where do you begin? Do you say DevOps loudly 5 times while looking in the mirror and it suddenly appears? Do you hire someone? Do you upskill your existing team? Here are some tips to help support your DevOps transformation. Conor Delanbanque has been involved with building & scaling teams in the DevOps space globally. He is the Head of DevOps Practice at MThree Consulting, a global technology consultancy. Conor founded the Future of DevOps Thought Leade...
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5–7, 2018, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buye...
Founded in 2000, Chetu Inc. is a global provider of customized software development solutions and IT staff augmentation services for software technology providers. By providing clients with unparalleled niche technology expertise and industry experience, Chetu has become the premiere long-term, back-end software development partner for start-ups, SMBs, and Fortune 500 companies. Chetu is headquartered in Plantation, Florida, with thirteen offices throughout the U.S. and abroad.
DXWorldEXPO LLC announced today that "IoT Now" was named media sponsor of CloudEXPO | DXWorldEXPO 2018 New York, which will take place on November 11-13, 2018 in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
The technologies behind big data and cloud computing are converging quickly, offering businesses new capabilities for fast, easy, wide-ranging access to data. However, to capitalize on the cost-efficiencies and time-to-value opportunities of analytics in the cloud, big data and cloud technologies must be integrated and managed properly. Pythian's Director of Big Data and Data Science, Danil Zburivsky will explore: The main technology components and best practices being deployed to take advantage...