Comments
SParikh wrote: This article speaks true to the importance and capitalizing of the cloud. Me having experience dealing with cloud based tech and consulting and integration services, I realize the need for a secure and consistant cloud service. Many people are concerned with the privacy, or lack thereof, that could occur with storing personal documents into a non-physical storage unit. I can see, though with companies such as ours and Metacloud, we are working toward a more secure and easy to use cloud system for both personal and professional use. Spursh Parikh www.sererra.com
Cloud Expo on Google News

2008 West
DIAMOND SPONSOR:
Data Direct
SOA, WOA and Cloud Computing: The New Frontier for Data Services
PLATINUM SPONSORS:
Red Hat
The Opening of Virtualization
GOLD SPONSORS:
Appsense
User Environment Management – The Third Layer of the Desktop
Cordys
Cloud Computing for Business Agility
EMC
CMIS: A Multi-Vendor Proposal for a Service-Based Content Management Interoperability Standard
Freedom OSS
Practical SOA” Max Yankelevich
Intel
Architecting an Enterprise Service Router (ESR) – A Cost-Effective Way to Scale SOA Across the Enterprise
Sensedia
Return on Assests: Bringing Visibility to your SOA Strategy
Symantec
Managing Hybrid Endpoint Environments
VMWare
Game-Changing Technology for Enterprise Clouds and Applications
Click For 2008 West
Event Webcasts

2008 West
PLATINUM SPONSORS:
Appcelerator
Get ‘Rich’ Quick: Rapid Prototyping for RIA with ZERO Server Code
Keynote Systems
Designing for and Managing Performance in the New Frontier of Rich Internet Applications
GOLD SPONSORS:
ICEsoft
How Can AJAX Improve Homeland Security?
Isomorphic
Beyond Widgets: What a RIA Platform Should Offer
Oracle
REAs: Rich Enterprise Applications
Click For 2008 Event Webcasts
SYS-CON.TV
Top Links You Must Click On


Adherex Reports Positive Preliminary Interim Phase II Results for Eniluracil plus 5- Fluorouracil and Leucovorin at the CTRC-AACR San Antonio Breast Cancer Symposium

RESEARCH TRIANGLE PARK, NORTH CAROLINA -- (Marketwire) -- 12/10/12 -- Patients who had rapid disease progression on capecitabine treatment(1) (N=9) and crossed over to take eniluracil/5-FU/leucovorin (EFL) experienced the following:


--  89% had clinical benefit(2) 
--  33% had tumor responses(3) 
--  Ongoing median progression-free survival of 117 days vs. 42 days while
    taking capecitabine 

Adherex Technologies Inc. (TSX:AHX)(OTCQB:ADHXF) today announced preliminary interim results from the ongoing Phase 2 clinical study evaluating EFL in metastatic breast cancer patients. The results were presented in a poster at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas, by Edgardo Rivera, MD, Medical Director, Banner MD Anderson Cancer Center, Gilbert, Arizona. The poster can be found on the www.adherex.com website under the Investors and Media section.

"EFL could potentially allow patients who rapidly fail capecitabine to continue with another oral 5-FU therapy rather than switching to the less well-tolerated intravenous microtubule-interfering agents," said Edgardo Rivera, MD. "We are hopeful that a small clinical trial in patients with metastatic breast cancer who failed capecitabine may be an attractive path to rapidly demonstrate the clinical usefulness of EFL."

EFL was also well tolerated and active in the main study that compares safety and anti-tumor activity of EFL (Arm 1) vs. capecitabine (Arm 2) in metastatic breast cancer patients who had been previously treated with an anthracycline and taxane. Arm 2 patients who have disease progression on capecitabine may crossover to take EFL in Arm X. All study drugs are taken orally.

The EFL regimen was optimized according to the methods covered in Adherex patent filings and are presented on the Adherex website.

As of Oct. 29, 2012, 122 patients had tumor assessments. Approximately 20% of patients were treated as 1st-line for metastatic disease (80% as 2nd-line) and 70% had previous 5-FU treatment(s). The preliminary interim results were based upon 68 patients in Arm 1, 54 patients in Arm 2 and 18 patients on Arm X. Clinical benefit was 76%, 74% & 61%, and tumor response rate was 25%, 26%, & 17% in Arms 1, 2, & X, respectively. One CR occurred in Arm 1. For patients in Arm X who had rapidly failed capecitabine, 89% had clinical benefit and 33% had tumor responses.

The final efficacy and safety data from the study, including progression-free survival (PFS), are expected to be released during the second quarter of 2013.

Rosty Raykov, Chief Executive Officer of Adherex, said, "Thanks to the scientific leadership of Dr. Tom Spector, we are pleased to see these avenues opening up to potentially provide benefit to cancer patients. Adherex is focused on finishing enrollment of the study by the end of this year. The Company does not intend to raise capital until final data is available from the study and partnering opportunities are fully explored."

(1)Patients who rapidly failed capecitabine treatment had disease progression (PD) within 70 days (one scan). (2)Clinical benefit = (significant (partial, PR) + complete (CR) tumor reduction + stable disease (SD)).(3)Tumor response = PR or CR.

About Eniluracil

Eniluracil is a mechanism-based inactivator of DPD, the enzyme that rapidly breaks down 5-FU. Accordingly, Eniluracil increases the 5-FU elimination half-life from about 15 minutes to 5 hours and enables 5-FU to be administered orally, making it 100% orally bioavailable. In addition, Eniluracil prevents the formation of alpha-fluoro-beta-alanine (F-Bal), the 5-FU-breakdown product. F-Bal appears to cause hand-foot syndrome and neurotoxicity. It also decreases the antitumor activity of 5-FU in laboratory animals. Furthermore, because DPD is present in variable levels, the highly variable and nonlinear pharmacokinetics of 5-FU become predictable and linear when DPD is inactivated by Eniluracil in cancer patients.

The weekly regimen used in the current Phase 2 trial is based on a Phase 1 Eniluracil/5-FU/Leucovorin trial that produced durable tumor responses and no hand-foot syndrome in advanced colorectal cancer patients who were refractory to intravenous 5-FU/Leucovorin. In a similar Phase 2 study with capecitabine, no tumor responses occurred and 87% of the patients experienced hand-foot syndrome, a painful condition that may require dosing interruptions and dose reductions.

About Metastatic Breast Cancer

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. During 2012, American Cancer Society estimates that 226,870women will be diagnosed with breast cancer, while 39,510 women likely will die from the disease. FDA-approved therapies used to treat late-stage, refractory breast cancer include capecitabine (Xeloda®) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; ixabepilone (Ixempra®) for patients with late-stage disease after failure of an anthracycline, taxane and capecitabine; ixabepilone plus capecitabine for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy; eribulin mesylate (Halaven®) for patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Xeloda® is a registered trademark of Genentech, a member of the Roche Group.

Ixempra® is a registered trademark of Bristol Myers Squibb

Halaven® is a registered trademark of Eisai Pharmaceuticals

Forward Looking Statements

Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs, and its ability to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2011. Adherex Technologies, Inc. disclaims any obligation to update these forward-looking statements except as required by law.

For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.

Contacts:
Adherex Technologies Inc.
Rosty Raykov
Chief Executive Officer
(919) 636-5144

About Marketwire .
Copyright © 2009 Marketwire. All rights reserved. All the news releases provided by Market Wire are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Enterprise Open Source Magazine Latest Stories . . .
The personal cloud will be the main catalyst in bringing services otherwise unavailable to developing nations. While businesses have been deploying cloud technology for some time, it's only recently that personal cloud services have emerged. The rise of the personal cloud means conten...
Over the weekend Barron’s put out a piece touting AMD’s chances of taking share in the mainstream server market that belongs to Intel with its SeaMicro microserver acquisition, a development that would tickle its tiny stock price, if it ever happened. But even the thought of it, althou...
Cloud computing is the game changer for the life sciences industry, according to an article on PharmaBiz.com. Globally, pharma majors are deploying cloud technology because it provides data security, compliance and transparency, according to Vikram Anand, associate vice president, clo...
OpenStack is easily installed using a package called Packstack. Redhat is one of the primary contributors to packstack and my install experience is similar to the installation of RDO, described here The procedure is quite simple: Install Redhat, Fedora or Centos on one or more x86 se...
n the cloud doesn't matter whether you are running on an Open Source platform or not - it is NOT free because you pay for the service. And for long Open Source project have been funded through the services premiums that you pay. I would argue that Open Source vendors have mastered the ...
Metacloud plays hardball. It has no patience with pilots or proofs-of-concept. It’ll only do production Infrastructure-as-a-Service installations, which is kind of uppity for a start-up that only hit the radar last October – even if it did come out of the closet with an unidentified ...
Subscribe to the World's Most Powerful Newsletters
Subscribe to Our Rss Feeds & Get Your SYS-CON News Live!
Click to Add our RSS Feeds to the Service of Your Choice:
Google Reader or Homepage Add to My Yahoo! Subscribe with Bloglines Subscribe in NewsGator Online
myFeedster Add to My AOL Subscribe in Rojo Add 'Hugg' to Newsburst from CNET News.com Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)sys-con.com!

Advertise on this site! Contact advertising(at)sys-con.com! 201 802-3021


SYS-CON Featured Whitepapers
ADS BY GOOGLE