|By PR Newswire||
|February 4, 2014 07:30 AM EST||
QUÉBEC CITY, Feb. 4, 2014 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that an article on Phase 2 results for zoptarelin doxorubicin (AEZS-108) in endometrial cancer has been published in the February issue of the International Journal of Gynecological Cancer. Zoptarelin doxorubicin, is the Company's cytotoxic peptide conjugate which specifically targets luteinizing hormone-releasing hormone ("LHRH") receptors. The article, "Efficacy and Safety of AEZS-108 (LHRH Agonist Linked to Doxorubicin) in Women With Advanced or Recurrent Endometrial Cancer Expressing LHRH Receptors: A Multicenter Phase 2 Trial (AGO-GYN5)", Emons G., Gorchev G., Harter P., Wimberger P., Stähle A., Hanker L., Hilpert F., Beckmann M.W., Dall P., Gründker C., Sindermann H., Sehouli J., outlines results of this study which had been previously presented at the European Society of Gynaecological Oncology's ("ESGO") annual meeting in September 2011. The article is currently available at this link.
"These encouraging results were the basis for our current Phase 3 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with advanced, recurrent or metastatic endometrial cancer who have progressed and have received one chemotherapeutic regimen with platinum and taxane", stated David Dodd, President and CEO of Aeterna Zentaris. "This compound's innovative targeted approach potentially offers a much needed novel treatment option for women with endometrial cancer and could provide the Company with a significant market opportunity."
Phase 2 Study Results and Conclusion
Forty-four patients were entered onto the study at 8 centers in Germany and 3 centers in Bulgaria. Forty-three of these patients were eligible. Two patients had a complete remission (5%) and 8 achieved a partial remission (18%). Stable disease for at least 6 weeks was observed in 44%. The median time to progression (TTP) was 7 months and median overall survival (OS) was 15 months. The most frequently reported grade 3 or 4 adverse effects were neutropenia (12%) and leucopenia (9%).
Data showed that zoptarelin doxorubicin has clinically meaningful activity with low toxicity in women with advanced or recurrent LHRH receptor positive endometrial cancer, supporting the principle of receptor mediated targeted chemotherapy.
Current ZoptEC Phase 3 trial in endometrial cancer
This is an open-label, randomized, multicenter Phase 3 trial currently being conducted under a Special Protocol Assessment, comparing zoptarelin doxorubicin with doxorubicin as second line therapy for advanced, recurrent or metastatic endometrial cancer. The first patient was dosed in July 2013 and recruitment is ongoing at multiple sites in North America, Europe and Israel. The primary efficacy endpoint is improvement in median Overall Survival. Lead investigators are David Scott Miller, MD, from the University of Texas Southwestern Medical Center, in Dallas, Texas, and Hani Gabra, MD, from the Imperial College London Hammersmith Campus in London, England.
Selected as the contract clinical development organization, Ergomed has agreed to assume 30% (up to US$10 million) of the clinical and regulatory costs for this trial. Details for this trial are available at www.clinicaltrials.gov (NCT01767155).
About Zoptarelin Doxorubicin
Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a Phase 3 trial in endometrial cancer under a Special Protocol Assessment, while zoptarelin doxorubicin is also in an investigator-initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound.
About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, an estimated 49,560 new cases of endometrial cancer in the U.S., and 35,600 in Europe were expected during 2013, with about 20% of recurring disease.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology. The Company's pipeline encompasses compounds from drug discovery to regulatory approval. For more information, visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to
the safe harbour provisions of the U.S. Securities Litigation Reform
Act of 1995. Forward-looking statements involve known and unknown risks
and uncertainties that could cause the Company's actual results to
differ materially from those in the forward-looking statements. Such
risks and uncertainties include, among others, the availability of
funds and resources to pursue R&D projects, the successful and timely
completion of clinical studies, the risk that safety and efficacy data
from any of our Phase 3 trials may not coincide with the data analyses
from previously reported Phase 1 and/or Phase 2 clinical trials, the
ability of the Company to efficiently commercialize one or more of its
products or product candidates, the ability of the Company to take
advantage of business opportunities in the pharmaceutical industry,
uncertainties related to the regulatory process and general changes in
economic conditions. Investors should consult the Company's quarterly
and annual filings with the Canadian and U.S. securities commissions
for additional information on risks and uncertainties relating to
forward-looking statements. Investors are cautioned not to rely on
these forward-looking statements. The Company does not undertake to
update these forward-looking statements. We disclaim any obligation to
update any such factors or to publicly announce the result of any
revisions to any of the forward-looking statements contained herein to
reflect future results, events or developments, unless required to do
so by a governmental authority or by applicable law.
SOURCE Aeterna Zentaris Inc.
Who are you? How do you introduce yourself? Do you use a name, or do you greet a friend by the last four digits of his social security number? Assuming you don’t, why are we content to associate our identity with 10 random digits assigned by our phone company? Identity is an issue that affects everyone, but as individuals we don’t spend a lot of time thinking about it. In his session at @ThingsExpo, Ben Klang, Founder & President of Mojo Lingo, discussed the impact of technology on identity. Sho...
Jan. 18, 2017 03:45 AM EST Reads: 3,993
Technology vendors and analysts are eager to paint a rosy picture of how wonderful IoT is and why your deployment will be great with the use of their products and services. While it is easy to showcase successful IoT solutions, identifying IoT systems that missed the mark or failed can often provide more in the way of key lessons learned. In his session at @ThingsExpo, Peter Vanderminden, Principal Industry Analyst for IoT & Digital Supply Chain to Flatiron Strategies, will focus on how IoT depl...
Jan. 18, 2017 02:30 AM EST Reads: 1,820
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at Dell EMC, introduced a methodology for capturing, enriching and sharing data (and analytics) across the organization...
Jan. 18, 2017 02:15 AM EST Reads: 3,215
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Jan. 18, 2017 01:30 AM EST Reads: 4,202
WebRTC is about the data channel as much as about video and audio conferencing. However, basically all commercial WebRTC applications have been built with a focus on audio and video. The handling of “data” has been limited to text chat and file download – all other data sharing seems to end with screensharing. What is holding back a more intensive use of peer-to-peer data? In her session at @ThingsExpo, Dr Silvia Pfeiffer, WebRTC Applications Team Lead at National ICT Australia, looked at differ...
Jan. 18, 2017 01:15 AM EST Reads: 4,891
"Splunk basically takes machine data and we make it usable, valuable and accessible for everyone. The way that plays in DevOps is - we need to make data-driven decisions to delivering applications," explained Andi Mann, Chief Technology Advocate at Splunk and @DevOpsSummit Conference Chair, in this SYS-CON.tv interview at @DevOpsSummit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 18, 2017 01:00 AM EST Reads: 2,015
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
Jan. 18, 2017 01:00 AM EST Reads: 6,046
"Logz.io is a log analytics platform. We offer the ELK stack, which is the most common log analytics platform in the world. We offer it as a cloud service," explained Tomer Levy, co-founder and CEO of Logz.io, in this SYS-CON.tv interview at DevOps Summit, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 18, 2017 12:45 AM EST Reads: 6,254
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
Jan. 18, 2017 12:45 AM EST Reads: 5,953
In his session at @DevOpsSummit at 19th Cloud Expo, Robert Doyle, lead architect at eCube Systems, will examine the issues and need for an agile infrastructure and show the advantages of capturing developer knowledge in an exportable file for migration into production. He will introduce the use of NXTmonitor, a next-generation DevOps tool that captures application environments, dependencies and start/stop procedures in a portable configuration file with an easy-to-use GUI. In addition to captur...
Jan. 18, 2017 12:30 AM EST Reads: 2,787
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 18, 2017 12:00 AM EST Reads: 2,259
Due of the rise of Hadoop, many enterprises are now deploying their first small clusters of 10 to 20 servers. At this small scale, the complexity of operating the cluster looks and feels like general data center servers. It is not until the clusters scale, as they inevitably do, when the pain caused by the exponential complexity becomes apparent. We've seen this problem occur time and time again. In his session at Big Data Expo, Greg Bruno, Vice President of Engineering and co-founder of StackIQ...
Jan. 18, 2017 12:00 AM EST Reads: 7,741
One of the hottest areas in cloud right now is DRaaS and related offerings. In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.
Jan. 17, 2017 11:30 PM EST Reads: 4,369
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of D...
Jan. 17, 2017 11:15 PM EST Reads: 4,947
In 2014, Amazon announced a new form of compute called Lambda. We didn't know it at the time, but this represented a fundamental shift in what we expect from cloud computing. Now, all of the major cloud computing vendors want to take part in this disruptive technology. In his session at 20th Cloud Expo, John Jelinek IV, a web developer at Linux Academy, will discuss why major players like AWS, Microsoft Azure, IBM Bluemix, and Google Cloud Platform are all trying to sidestep VMs and containers...
Jan. 17, 2017 11:00 PM EST Reads: 637