Welcome!

News Feed Item

Tennessee Oncology Announces Participation in DARA BioSciences Breast Cancer CAPTURE Registry

DARA BioSciences Studying Patient Adherence to Tamoxifen Therapy Through CAPTURE: Compliance and Preference for Tamoxifen Registry

RALEIGH, NC and NASHVILLE, TN -- (Marketwired) -- 08/09/13 -- Tennessee Oncology, PLLC, one of the nation's leading teams of cancer care specialists, is participating in CAPTURE (Compliance and Preference for Tamoxifen Registry) with DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology supportive care products. The CAPTURE registry is designed to gain valuable insight into adherence to prescribed tamoxifen treatment; patient preference for a liquid formulation of tamoxifen; and prevalence of difficulties in swallowing among breast cancer patients taking tamoxifen tablets.

CAPTURE was initiated to support the recent launch of Soltamox® (tamoxifen citrate) oral solution, the only liquid form of tamoxifen available for patients who prefer or need a liquid formulation of tamoxifen. Participating patients currently on tamoxifen therapy for breast cancer are asked to complete an online questionnaire.

Tennessee Oncology is one of 10 leading oncology centers now enrolling patients for this registry.

"We are pleased to participate in CAPTURE as this registry explores breast cancer adherence issues and patient preferences relative to long-term tamoxifen therapy," said Dr. Nancy Peacock, Medical Oncologist of Tennessee Oncology at St. Thomas Midtown Hospital in Nashville, Tenn. "CAPTURE data could potentially help physicians better understand challenges faced by their breast cancer patients and develop ways to help tamoxifen patients stay on therapy to maximize its effectiveness."

The American Society of Clinical Oncology recently updated its guidelines, recommending that tamoxifen (20mg per day for 5 years) should be discussed as an option to reduce the risk of estrogen receptor (ER) positive breast cancer. Soltamox® is bioequivalent to tamoxifen and has the same indications. See full prescribing information.

CAPTURE's key objectives are to:

  • Understand patient preference for tamoxifen tablets or an oral tamoxifen liquid solution: Some patients may prefer one dosage form over another for ease of use or for other reasons;
  • Ascertain whether patient participation in choosing their preferred dosage form may lead to better adherence;
  • Correlate adherence to tamoxifen therapy with factors such as, age, ethnicity, history of smoking, alcohol intake, surgery, and radiation therapy;
  • Understand patient adherence to long-term tamoxifen therapy and how it may be affected by swallowing difficulties; and
  • Identify factors that might drive patient preference for the oral liquid form of tamoxifen therapy.

Soltamox (tamoxifen citrate, oral solution) is bioequivalent to, and has the exact same label indications as, the tablet form of tamoxifen. Tamoxifen is indicated for the treatment of ductal carcinoma in situ (DCIS); as adjuvant treatment of node-positive breast cancer; in the treatment of metastatic breast cancer; and for breast cancer risk reduction in high risk women. Currently, there are more than 1.8 million prescriptions of tamoxifen written on an annual basis in the United States. Existing FDA-approved tamoxifen product labeling supports up to five years of treatment.

About DARA BioSciences, Inc.

DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products.

DARA increased its focus in oncology through its January 2012 acquisition of Oncogenerix, Inc., which holds the exclusive U.S. marketing rights to Soltamox®, a novel oral liquid formulation of tamoxifen citrate, which is widely used in the treatment and prevention of breast cancer. Soltamox is the only FDA-approved oral liquid version of tamoxifen citrate and fulfills a vital clinical need for patients who prefer a liquid formulation or cannot tolerate existing solid tablet formulations of this drug. DARA has exclusive U.S. rights to Soltamox through a license from Rosemont Pharmaceuticals, Ltd.

In June 2012, DARA launched its first product, Bionect®, a topical treatment for skin irritation and burns associated with radiation therapy. DARA has rights to market Bionect in the US oncology/radiology markets under license from Innocutis. Soltamox was launched formally as DARA's second commercial product in December 2012, coincident in timing with the 35th Annual San Antonio Breast Cancer Symposium. In late April, 2013, DARA launched its third product, Gelclair®, an FDA-cleared product for the treatment of oral mucositis for which DARA also has exclusive U.S. commercial rights through a license from Helsinn Group in Switzerland.

DARA is also developing a cancer-support therapeutic compound, KRN5500, for the treatment of chronic chemotherapy-induced peripheral neuropathy (CCIPN) in patients with cancer. This product is an excellent fit with DARA's strategic oncology focus, has successfully completed a Phase 2a clinical trial, and has been designated a Fast Track Drug by the FDA. DARA has created an improved, potentially commercializable formulation of this drug and is in active partnering discussions regarding further clinical development. DARA has also submitted an Orphan Drug Application to the FDA for the use of this drug in painful CCIPN.

For more information please visit our web site at www.darabio.com.

About Tennessee Oncology
Tennessee Oncology, PLLC is one of the nation's leading teams of cancer care specialists, nationally recognized for improving patient outcomes and innovative treatments. Its comprehensive range of cancer care services include specialized oncology nursing care, laboratory services, outpatient chemotherapy, PET/CT services and patient education and support services. Founded in 1976, Tennessee Oncology is one of the largest physician-owned practices in the country, employing more than 75 physicians in 30 locations throughout Middle Tennessee, Chattanooga, and Northwest Georgia. Visit www.tnoncology.com for more information.

Safe Harbor Statement

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Risk Factors" in DARA's most recent Annual Report on Form 10-K, filed with the SEC on March 28, 2013. Those factors include risks and uncertainties relating to DARA's ability to timely commercialize and generate revenues or profits from Bionect®, Soltamox®, Gelclair® or other products given that DARA only recently hired its initial sales force and DARA's lack of history as a revenue-generating company, FDA and other regulatory risks relating to DARA's ability to market Bionect, Soltamox, Gelclair or other products in the U.S. or elsewhere, DARA's ability to develop and bring new products to market as anticipated, DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, the current regulatory environment in which DARA develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property and the intellectual property of others, the potential delisting of DARA's common stock from the NASDAQ Capital Market, risks and uncertainties relating to DARA's ability to successfully integrate Oncogenerix and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.

Media Contacts:
David Connolly or Samantha Stenbeck
LaVoie Group
617-374-8800
[email protected]
[email protected]

Sherry Mistro-Henn
Director of Marketing
Tennessee Oncology
(615) 333-2481
[email protected]

Carol Fite Lynn
Lam-Andrews
(615) 297-7717, ext. 100
[email protected]

Corporate Contact:
Jenene Thomas
DARA BioSciences
908-938-1475
[email protected]

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
DevOpsSummit New York 2018, colocated with CloudEXPO | DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City. Digital Transformation (DX) is a major focus with the introduction of DXWorldEXPO within the program. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term.
What are the new priorities for the connected business? First: businesses need to think differently about the types of connections they will need to make – these span well beyond the traditional app to app into more modern forms of integration including SaaS integrations, mobile integrations, APIs, device integration and Big Data integration. It’s important these are unified together vs. doing them all piecemeal. Second, these types of connections need to be simple to design, adapt and configure...
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 ...
Cell networks have the advantage of long-range communications, reaching an estimated 90% of the world. But cell networks such as 2G, 3G and LTE consume lots of power and were designed for connecting people. They are not optimized for low- or battery-powered devices or for IoT applications with infrequently transmitted data. Cell IoT modules that support narrow-band IoT and 4G cell networks will enable cell connectivity, device management, and app enablement for low-power wide-area network IoT. B...
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.
"DevOps is set to be one of the most profound disruptions to hit IT in decades," said Andi Mann. "It is a natural extension of cloud computing, and I have seen both firsthand and in independent research the fantastic results DevOps delivers. So I am excited to help the great team at @DevOpsSUMMIT and CloudEXPO tell the world how they can leverage this emerging disruptive trend."
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, ...
Transformation Abstract Encryption and privacy in the cloud is a daunting yet essential task for both security practitioners and application developers, especially as applications continue moving to the cloud at an exponential rate. What are some best practices and processes for enterprises to follow that balance both security and ease of use requirements? What technologies are available to empower enterprises with code, data and key protection from cloud providers, system administrators, inside...
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
In his session at 21st Cloud Expo, Raju Shreewastava, founder of Big Data Trunk, provided a fun and simple way to introduce Machine Leaning to anyone and everyone. He solved a machine learning problem and demonstrated an easy way to be able to do machine learning without even coding. Raju Shreewastava is the founder of Big Data Trunk (www.BigDataTrunk.com), a Big Data Training and consulting firm with offices in the United States. He previously led the data warehouse/business intelligence and Bi...
Nicolas Fierro is CEO of MIMIR Blockchain Solutions. He is a programmer, technologist, and operations dev who has worked with Ethereum and blockchain since 2014. His knowledge in blockchain dates to when he performed dev ops services to the Ethereum Foundation as one the privileged few developers to work with the original core team in Switzerland.
Contextual Analytics of various threat data provides a deeper understanding of a given threat and enables identification of unknown threat vectors. In his session at @ThingsExpo, David Dufour, Head of Security Architecture, IoT, Webroot, Inc., discussed how through the use of Big Data analytics and deep data correlation across different threat types, it is possible to gain a better understanding of where, how and to what level of danger a malicious actor poses to an organization, and to determin...
Cloud-enabled transformation has evolved from cost saving measure to business innovation strategy -- one that combines the cloud with cognitive capabilities to drive market disruption. Learn how you can achieve the insight and agility you need to gain a competitive advantage. Industry-acclaimed CTO and cloud expert, Shankar Kalyana presents. Only the most exceptional IBMers are appointed with the rare distinction of IBM Fellow, the highest technical honor in the company. Shankar has also receive...
Digital Transformation and Disruption, Amazon Style - What You Can Learn. Chris Kocher is a co-founder of Grey Heron, a management and strategic marketing consulting firm. He has 25+ years in both strategic and hands-on operating experience helping executives and investors build revenues and shareholder value. He has consulted with over 130 companies on innovating with new business models, product strategies and monetization. Chris has held management positions at HP and Symantec in addition to ...
Traditional IT, great for stable systems of record, is struggling to cope with newer, agile systems of engagement requirements coming straight from the business. In his session at 18th Cloud Expo, William Morrish, General Manager of Product Sales at Interoute, will outline ways of exploiting new architectures to enable both systems and building them to support your existing platforms, with an eye for the future. Technologies such as Docker and the hyper-convergence of computing, networking and...