RALEIGH, NC and MIAMI, FL--(Marketwired - Jul 17, 2013) - The Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine in Miami, FL, is participating in CAPTURE (Compliance and Preference for Tamoxifen Registry) with DARA BioSciences, Inc., (
DARA announced the study at the American Society of Clinical Oncology (ASCO) annual meeting, in June, 2013.
The Sylvester Comprehensive Cancer Center is one of ten leading oncology centers now enrolling patients for 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.
"We are pleased to participate in this study, as the CAPTURE questionnaire explores patient preferences relative to their therapy," said Stefan Glück, MD, PhD, Sylvester Distinguished Professor of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine. "Therapies for breast cancer are long-term, and such courses of therapy pose adherence issues. CAPTURE data potentially could help clinicians improve patient care by learning more about patient preferences."
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.
Dr. Glück played a leading role in developing the CAPTURE study design and protocol in conjunction with DARA's Scientific Steering Committee, including Jivesh Sharma, MD, Presbyterian Hospital of Dallas, TX, and CEO of NEXGEN Oncology, Dallas. DARA expects to publish the CAPTURE data and to present it at scientific meetings.
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(R), 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(R), 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 Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine
Sylvester Comprehensive Cancer Center opened in 1992 to provide comprehensive cancer services to the South Florida community. Together with the 40-bed inpatient hospital, UMHC - University of Miami Hospital & Clinics, Sylvester/UMHC serves as the hub for cancer diagnosis and treatment for UHealth - University of Miami Health System. In 2003, Sylvester expanded its cancer services to patients in Broward and Palm Beach with the opening of Sylvester at Deerfield Beach. A third facility, Sylvester at Kendall, was opened in 2009 to serve patients in southern Miami-Dade county. Our fourth and newest facility, UHealth | Sylvester at Plantation, serves patients in Broward county and includes services such as infusion therapy, imaging, and laboratory services. Since its founding, Sylvester has transformed cancer research and treatment in South Florida and beyond.
Sylvester handles 1,100 inpatient admissions annually, performs more than 2,400 surgical procedures, and treats more than 4,100 new cancer patients. All Sylvester physicians are on the faculty of the Miller School of Medicine, South Florida's only academic medical center.
Today there are more than 305,000 outpatient visits at the cancer center and more than 250 physicians and scientists working together to realize Harcourt Sylvester Jr.'s vision of a comprehensive cancer center. In addition, Sylvester physicians and scientists are engaged in approximately 168 clinical trials and receive more than $49 million annually in research grants.
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.