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
The Jevons Paradox suggests that when technological advances increase efficiency of a resource, it results in an overall increase in consumption. Writing on the increased use of coal as a result of technological improvements, 19th-century economist William Stanley Jevons found that these improvements led to the development of new ways to utilize coal. In his session at 19th Cloud Expo, Mark Thiele, Chief Strategy Officer for Apcera, compared the Jevons Paradox to modern-day enterprise IT, examin...
DXWorldEXPO LLC announced today that ICC-USA, a computer systems integrator and server manufacturing company focused on developing products and product appliances, will exhibit at the 22nd International CloudEXPO | DXWorldEXPO. DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City. ICC is a computer systems integrator and server manufacturing company focused on developing products and product appliances to meet a wide range of ...
The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities. In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, posited that disruption is inevitable for comp...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
Sanjeev Sharma Joins November 11-13, 2018 @DevOpsSummit at @CloudEXPO New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders.
Headquartered in Plainsboro, NJ, Synametrics Technologies has provided IT professionals and computer systems developers since 1997. Based on the success of their initial product offerings (WinSQL and DeltaCopy), the company continues to create and hone innovative products that help its customers get more from their computer applications, databases and infrastructure. To date, over one million users around the world have chosen Synametrics solutions to help power their accelerated business or per...
One of the biggest challenges with adopting a DevOps mentality is: new applications are easily adapted to cloud-native, microservice-based, or containerized architectures - they can be built for them - but old applications need complex refactoring. On the other hand, these new technologies can require relearning or adapting new, oftentimes more complex, methodologies and tools to be ready for production. In his general session at @DevOpsSummit at 20th Cloud Expo, Chris Brown, Solutions Marketi...
At the keynote this morning we spoke about the value proposition of Nutanix, of having a DevOps culture and a mindset, and the business outcomes of achieving agility and scale, which everybody here is trying to accomplish," noted Mark Lavi, DevOps Solution Architect at Nutanix, in this SYS-CON.tv interview at @DevOpsSummit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Bill Schmarzo, author of "Big Data: Understanding How Data Powers Big Business" and "Big Data MBA: Driving Business Strategies with Data Science," is responsible for setting the strategy and defining the Big Data service offerings and capabilities for EMC Global Services Big Data Practice. As the CTO for the Big Data Practice, he is responsible for working with organizations to help them identify where and how to start their big data journeys. He's written several white papers, is an avid blogge...
HyperConvergence came to market with the objective of being simple, flexible and to help drive down operating expenses. It reduced the footprint by bundling the compute/storage/network into one box. This brought a new set of challenges as the HyperConverged vendors are very focused on their own proprietary building blocks. If you want to scale in a certain way, let's say you identified a need for more storage and want to add a device that is not sold by the HyperConverged vendor, forget about it...
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. ...
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
DXWorldEXPO LLC, the producer of the world's most influential technology conferences and trade shows has announced the 22nd International CloudEXPO | DXWorldEXPO "Early Bird Registration" is now open. Register for Full Conference "Gold Pass" ▸ Here (Expo Hall ▸ Here)
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory?