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


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
SYS-CON Events announced today that MathFreeOn will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. MathFreeOn is Software as a Service (SaaS) used in Engineering and Math education. Write scripts and solve math problems online. MathFreeOn provides online courses for beginners or amateurs who have difficulties in writing scripts. In accordance with various mathematical topics, there are more tha...
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this ...
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm ...
Although it has gained significant traction in the consumer space, IoT is still in the early stages of adoption in enterprises environments. However, many companies are working on initiatives like Industry 4.0 that includes IoT as one of the key disruptive technologies expected to reshape businesses of tomorrow. The key challenges will be availability, robustness and reliability of networks that connect devices in a business environment. Software Defined Wide Area Network (SD-WAN) is expected to...
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
OnProcess Technology has announced it will be a featured speaker at @ThingsExpo, taking place November 1 - 3, 2016, in Santa Clara, California. Dan Gettens, OnProcess’ Chief Analytics Officer, will discuss how Internet of Things (IoT) data can be leveraged to predict product failures, improve uptime and slash costly inventory stock. @ThingsExpo is an annual gathering of IoT and cloud developers, practitioners and thought-leaders who exchange ideas and insights on topics ranging from Big Data in...
Developing software for the Internet of Things (IoT) comes with its own set of challenges. Security, privacy, and unified standards are a few key issues. In addition, each IoT product is comprised of (at least) three separate application components: the software embedded in the device, the back-end service, and the mobile application for the end user’s controls. Each component is developed by a different team, using different technologies and practices, and deployed to a different stack/target –...
Virgil consists of an open-source encryption library, which implements Cryptographic Message Syntax (CMS) and Elliptic Curve Integrated Encryption Scheme (ECIES) (including RSA schema), a Key Management API, and a cloud-based Key Management Service (Virgil Keys). The Virgil Keys Service consists of a public key service and a private key escrow service. 

SYS-CON Events announced today that CDS Global Cloud, an Infrastructure as a Service provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. CDS Global Cloud is an IaaS (Infrastructure as a Service) provider specializing in solutions for e-commerce, internet gaming, online education and other internet applications. With a growing number of data centers and network points around the world, ...
Big Data has been changing the world. IoT fuels the further transformation recently. How are Big Data and IoT related? In his session at @BigDataExpo, Tony Shan, a renowned visionary and thought leader, will explore the interplay of Big Data and IoT. He will anatomize Big Data and IoT separately in terms of what, which, why, where, when, who, how and how much. He will then analyze the relationship between IoT and Big Data, specifically the drilldown of how the 4Vs of Big Data (Volume, Variety,...
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will present at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said “No to LUNs.” With Tintri they manag...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...