DARA BioSciences Presents Results of Breast Cancer CAPTURE Registry at NCCN® 19th Annual Conference: Advancing the Standard of Cancer Care™

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-

Business Wire

RALEIGH, N.C.--(BUSINESS WIRE)--

DARA BioSciences, Inc. (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:

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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.

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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.

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Media Contact:
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Corporate Contact:
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Jenene Thomas, 908-938-1475
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