Welcome!

News Feed Item

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

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired 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.

Latest Stories
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, provided an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data professionals...
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
In an era of historic innovation fueled by unprecedented access to data and technology, the low cost and risk of entering new markets has leveled the playing field for business. Today, any ambitious innovator can easily introduce a new application or product that can reinvent business models and transform the client experience. In their Day 2 Keynote at 19th Cloud Expo, Mercer Rowe, IBM Vice President of Strategic Alliances, and Raejeanne Skillern, Intel Vice President of Data Center Group and G...
"We are a modern development application platform and we have a suite of products that allow you to application release automation, we do version control, and we do application life cycle management," explained Flint Brenton, CEO of CollabNet, in this SYS-CON.tv interview at DevOps at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
Predictive analytics tools monitor, report, and troubleshoot in order to make proactive decisions about the health, performance, and utilization of storage. Most enterprises combine cloud and on-premise storage, resulting in blended environments of physical, virtual, cloud, and other platforms, which justifies more sophisticated storage analytics. In his session at 18th Cloud Expo, Peter McCallum, Vice President of Datacenter Solutions at FalconStor, discussed using predictive analytics to mon...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor – all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...