Tennessee Oncology Announces Participation in DARA BioSciences Breast Cancer
DARA BioSciences Studying Patient Adherence to Tamoxifen Therapy
Through CAPTURE: Compliance and Preference for Tamoxifen Registry
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(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.
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(R) is bioequivalent to
tamoxifen and has the same indications. See full prescribing
CAPTURE's key objectives are to:
-- Understand patient preference for tamoxifen tablets or an oral
tamoxifen liquid solution: Some patients may prefer one dosag
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
-- 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
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
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 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(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 produc
ts, 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.
David Connolly or Samantha Stenbeck
Director of Marketing
Carol Fite Lynn
(615) 297-7717, ext. 100
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