University of Miami's Sylvester Comprehensive Cancer Center Announces Participation in DARA BioSciences Breast Cancer Patients

University of Miami's Sylvester Comprehensive Cancer Center Announces 
Participation in DARA BioSciences Breast Cancer Patients for CAPTURE
Registry 
DARA BioSciences Studying Patient Adherence to Tamoxifen Therapy
Through CAPTURE: Compliance and Preference for Tamoxifen Registry 
RALEIGH, NC and MIAMI, FL -- (Marketwired) -- 07/17/13 --  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., (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.  
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(R) (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 Glueck, 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. Glueck 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(R), 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(R),
Soltamox(R), Gelclair(R) 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
dconnolly@lavoiegroup.com 
sstenbeck@lavoiegroup.com  
Corporate Contact:
Jenene Thomas
DARA BioSciences
908-938-1475
jthomas@darabio.com