RALEIGH, NC and CHICAGO, IL--(Marketwired - June 03, 2013) - DARA BioSciences, Inc. (DARA), a specialty pharmaceutical company focused on oncology supportive care products, announced today that the Company has enrolled eight U.S. oncology centers in its IRB-approved breast cancer patient registry study, CAPTURE (Compliance and Preference for Tamoxifen Registry). The 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.
DARA announced the study today at the American Society of Clinical Oncology (ASCO) annual meeting. DARA and its distribution partner, ONCO360, a leader in oncology pharmacy services, are located at Booth #12121.
Patient enrollment and recruitment for CAPTURE is underway. Up to 20 cancer centers in the United States and 620 patients are targeted for participation in this study. 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.
The CAPTURE registry questionnaire asks patients about their adherence to prescribed tamoxifen therapy, whether they have a preference for a liquid form of the medication (Soltamox, tamoxifen citrate oral solution) or tamoxifen tablets and if they have any swallowing difficulties.
CAPTURE was developed in conjunction with DARA's Scientific Steering Committee, including two recognized leaders in the fields of oncology and breast cancer, Stefan Glück, M.D., Ph.D., Sylvester Distinguished Professor of Medicine, Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami, FL; and Jivesh Sharma, M.D., Presbyterian Hospital of Dallas, TX, and CEO of NEXGEN Oncology, Dallas.
"Soltamox is a new option for breast cancer patients requiring tamoxifen, and CAPTURE is an important initiative that will provide a compendium of data from a large cohort of patients to support physicians who prescribe tamoxifen. I believe key findings from this study will enable health care providers to better understand the complexities of patient adherence and the patient's preference or need for a liquid form of tamoxifen to potentially assist in long term tamoxifen compliance," Dr. Stefan Glück, Professor of Medicine said.
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.
The Company expects to publish the CAPTURE data and to present it at scientific meetings. DARA also plans to share the results with clinicians in order to help them understand challenges facing patients with breast cancer, with the ultimate goal of treatment optimization and improved adherence.
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.
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.