DARA Biosciences Enrolls Leading Oncology Centers in Breast Cancer Patient Registry

DARA Biosciences Enrolls Leading Oncology Centers in Breast Cancer Patient 
Registry 
CAPTURE: Compliance and Preference for Tamoxifen Registry Focuses on
Gaining Insights Into Aspects of Tamoxifen Therapy in Breast Cancer
Patients  
RALEIGH, NC and CHICAGO, IL  -- (Marketwired) -- 06/03/13 --  DARA
BioSciences, Inc. (NASDAQ: 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.  
CONTACTS: 
Media contact: 
David Connolly or Samantha Stenbeck 
LaVoie Group 
617-374-8800  
dconnolly@lavoiegroup.com 
sstenbeck@lavoiegroup.com  
Investor contact:
Jenene Thomas 
DARA Biosciences 
908-938-1475 
jthomas@darabio.com
 
 
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