|By Marketwired .||
|August 9, 2013 08:00 AM EDT||
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.
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