CAPTURE: (Compliance And Preference For
Tamoxifen Registry)
NEW FINDINGS FOR ONCOLOGISTS TREATING BREAST
CANCER
- A Large, Multi-Center Breast Cancer Patient
Survey-
-Findings Detail New Patient Insights Regarding
Tamoxifen Adherence and Potential for a Liquid Form of Tamoxifen to
Improve Long-Term Compliance-
DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive
care pharmaceutical company dedicated to providing health care
professionals a synergistic portfolio of medicines to help cancer
patients adhere to their therapy and manage side effects arising
from their cancer treatment announced today that the Company is
presenting data from its abstract titled “CAPTURE (Compliance and
Preference for Tamoxifen Registry) patient survey reveals potential
strategies to improve long-term adherence to TAM based on choice:
Results of a large internet-based survey”, at the National
Comprehensive Cancer Network® (NCCN®) 19th Annual Conference:
Advancing the Standard of Cancer Care™ - March 13 -15, 2014 in
Hollywood, FL.
The abstract is being presented during General Poster Session
One on March 13, 2014 by lead author, Stefan Glück MD, PhD, FRCPC,
Sylvester Distinguished Professor, Department of Medicine, Division
of Hematology/Oncology, Sylvester Comprehensive Cancer Center in
the University of Miami’s Miller School of Medicine and within the
University of Miami Health System (UHealth).
“CAPTURE’s Scientific Steering Committee designed the trial with
the goal of understanding patient-reported adherence to tamoxifen
tablets, formulation preference and degree of swallowing
difficulty,” said David J. Drutz, MD, DARA’s Chief Executive
Officer and Chief Medical Officer. “We have achieved this goal and
are confident that CAPTURE’s key findings will provide invaluable
information to the oncology community to help advance clinical
practice and improve adherence to tamoxifen therapy. Sub-optimal
adherence remains an important challenge for many physicians and
patients and providing therapeutic options to patients may be an
important tool to encourage patients to take an active role in
their long-term treatment.”
CAPTURE STUDY DESIGN
CAPTURE was designed as a 36-question Internet-based survey for
patients with breast cancer who were taking tamoxifen tablets, as
treatment or adjuvant therapy, to quantify adherence, patient
preference for an oral liquid formulation of tamoxifen and the
prevalence of swallowing difficulties in tamoxifen patients with
breast cancer. The CAPTURE (Compliance and Preference for Tamoxifen
Registry) survey was administered by health care professionals to
626 patients in 17 US-based cancer treatment centers and included a
validated measure of swallowing difficulties, the EAT-10 tool.
Female patients 18 years and older with a diagnosis of breast
cancer who were currently taking either adjuvant or therapeutic TAM
tablets were included in the survey.
CAPTURE STUDY KEY
FINDINGS
- Breast cancer patient adherence to
tamoxifen tablet therapy is less than optimal, consistent with
previous publications; 14% of patients enrolled in CAPTURE
self-reported that they miss 2 or more tamoxifen doses each
month.
- Eight percent of patients were
identified with swallowing difficulties as assessed by scoring
greater than 2 on the Eating Assessment Tool (EAT-10).
- Seven percent of respondents believe
that a liquid form of tamoxifen would help them achieve long-term
compliance with tamoxifen therapy and 22 percent of respondents
indicated a willingness to try a liquid formulation of
tamoxifen.
“Findings from this well-designed, IRB-approved survey indicate
adherence to tamoxifen remains an important issue for practicing
clinicians to discuss with their patients,” said Dr. Glück.
“Results also indicate that nearly 1 in 10 patients (7%) believe
that having a liquid formulation of tamoxifen as an option would
help improve long-term compliance with tamoxifen therapy. Providing
patients with the right medicine, in a delivery form that is best
for the individual, is a standard of care that should be employed
to ensure best practice.”
Tamoxifen is indicated for the treatment of metastatic breast
cancer, adjuvant treatment of breast cancer, the reduction of risk
of invasive breast cancer in women with ductal carcinoma in situ,
and to reduce breast cancer incidence in high risk women.
Currently, more than 1.9 million prescriptions of tamoxifen are
written annually in the United States. Between 31 and 61 percent of
patients fail to complete their prescribed course of treatment,
thereby diminishing its benefits in reducing the risk of breast
cancer and breast cancer recurrence.
About DARA BioSciences,
Inc.
DARA BioSciences Inc. of Raleigh, North Carolina, is an oncology
supportive care pharmaceutical company dedicated to providing
healthcare professionals a synergistic portfolio of medicines to
help cancer patients adhere to their therapy and manage side
effects arising from their cancer treatments.
Tamoxifen Important Safety
Information
Tamoxifen citrate is contraindicated in women who require
concomitant coumadin-type anticoagulant therapy, in women with a
history of deep vein thrombosis or pulmonary embolus, and in women
with known hypersensitivity to the drug or any of its
ingredients.
Serious and life-threatening events associated with tamoxifen in
the risk reduction setting (women at high risk for cancer and women
with DCIS) include uterine malignancies, stroke and pulmonary
embolism.
The most common adverse reactions to tamoxifen treatment are
(incidence ≥ 20%) hot flashes, fluid retention, vaginal discharge,
vaginal bleeding, vasodilatation, nausea, irregular menses, weight
loss, and musculoskeletal events.
Tamoxifen carries the following Black Box Warning:
****************************************************************************************************************
WARNING – For Women with Ductal Carcinoma in Situ (DCIS) and
Women at High Risk for Breast Cancer: Serious and
life-threatening events associated with tamoxifen in the risk
reduction setting (women at high risk for cancer and women with
DCIS) include uterine malignancies, stroke and pulmonary embolism.
Incidence rates for these events were estimated from the NSABP P-1
trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in
Breast Cancer Incidence In High Risk Women). Uterine
malignancies consist of both endometrial adenocarcinoma (incidence
rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for
placebo) and uterine sarcoma (incidence rate per 1,000 women-years
of 0.17 for tamoxifen vs. 0.0 for placebo)*. For stroke, the
incidence rate per 1,000 women-years was 1.43 for tamoxifen vs.
1.00 for placebo**. For pulmonary embolism, the incidence rate per
1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies
were fatal. Health care providers should discuss the potential
benefits versus the potential risks of these serious events with
women at high risk of breast cancer and women with DCIS considering
tamoxifen to reduce their risk of developing breast cancer. The
benefits of tamoxifen outweigh its risks in women already diagnosed
with breast cancer.
*Updated long-term follow-up data (median length of follow-up is
6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the
Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing
Information. **See Table 3 under CLINICAL PHARMACOLOGY, Clinical
Studies in Prescribing Information.
***********************************************************************************************************
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, and are subject to risks and
uncertainties. These statements are based on the current
expectations, estimates, forecasts and projections regarding
management’s beliefs and assumptions. In some cases, you can
identify forward looking statements by terminology such as “may,”
“will,” “should,” “hope,” “expects,” “intends,” “plans,”
“anticipates,” “contemplates,” “believes,” “estimates,” “predicts,”
“projects,” “potential,” “continue,” and other similar terminology
or the negatives of those terms. 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 February 4, 2014, and
DARA's other filings with the SEC from time to time. Those factors
include risks and uncertainties relating to DARA's current cash
position and its need to raise additional capital in order to be
able to continue to fund its operations; the stockholder dilution
that may result from capital raising efforts and the exercise or
conversion, as applicable, of DARA's outstanding options, warrants
and convertible preferred stock; full-ratchet anti-dilution
protection afforded investors in prior financing transactions that
may restrict or prohibit DARA's ability to raise capital on terms
favorable to the Company and its current stockholders; DARA's
limited operating history which may make it difficult to evaluate
DARA's business and future viability; DARA's ability to timely
commercialize and generate revenues or profits from Soltamox,
Gelclair, Bionect or other products given that DARA only recently
retained its initial sales force and DARA's lack of history as a
revenue-generating company; DARA's ability to achieve the desired
results from the agreements with Mission and Alamo; FDA and other
regulatory risks relating to DARA's ability to market Soltamox,
Soltamox, Bionect or other products in the United States or
elsewhere; DARA's ability to in-license and/or partner products;
the current regulatory environment in which DARA sells its
products; the market acceptance of those products; dependence on
partners and third-party manufacturers; successful performance
under collaborative and other commercial agreements; DARA's ability
to retain its managerial personnel and to attract additional
personnel; potential product liability risks that could exceed
DARA's liability coverage; potential risks related to healthcare
fraud and abuse laws; competition; the strength of DARA's
intellectual property, the intellectual property of others and any
asserted claims of infringement, 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 Contact:LaVoie
GroupDavid Connolly,
617-374-8800dconnolly@lavoiegroup.comorCorporate Contact:DARA BioSciencesJenene
Thomas, 908-938-1475jthomas@darabio.com
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