RALEIGH, N.C.--(BUSINESS WIRE)--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, today announced the launch of a smartphone app to provide cancer patients an educational resource to help improve oral care and management of oral mucositis. This is being accompanied by the release of a list of “Top 10 Oral Care Tips” < http://gelclair.com/top-10-oral-hygiene-tips > for Cancer Patients.
(Editor’s note: Top 10 Oral Hygiene Tips video file and individual photos are available for download and web use.)
The Oral Mucositis Care app, available for iPhone and Android devices, provides educational resources and tips for patients about managing oral mucositis, a common and often intensely painful side effect occurring in cancer patients who undergo radiation and chemotherapy. The app offers patients helpful tips, a reference guide to good oral hygiene and ways to help manage the pain and discomfort of oral mucositis.
“Oral mucositis causes significant discomfort and pain in many patients, and may delay or interrupt cancer treatment,” said David J. Drutz, M.D., DARA BioSciences' Chief Executive Officer and Chief Medical Officer. “We designed this application to be a resource for patients and their care givers to help them manage and hopefully improve symptoms of oral mucositis.”
It is estimated there are more than 50,000 Americans diagnosed with head and neck cancer each year, and research shows that up to 100 percent of patients who receive radiotherapy for head and neck cancers develop oral mucositis. Additionally, oral mucositis develops in 30 to 75 percent of patients who receive chemotherapy for any kind of cancer. Oral mucositis is diagnosed in approximately 400,000 patients in the United States each year.
“The painful symptoms of oral mucositis, which often limit a patient’s ability to eat, drink and talk comfortably, have the potential to derail a prescribed course of radiation or chemotherapy,” said Elizabeth Feldman, DMD, MS, a maxillofacial prosthodontist and dental oncologist at UF Health Cancer Center-Orlando Health. “Educating patients about proper oral hygiene techniques and treatment options for painful oral mucositis symptoms is vitally important to improve their care and wellbeing.”
Dr. Feldman consulted with DARA in the development of the oral mucositis patient app.
According to the Oral Cancer Foundation (OCF), a non-profit organization that provides information, patient support, sponsorship of research and advocacy related to oral cancers, oral mucositis is considered the “most common, debilitating complication” of cancer treatments. “That’s especially true of chemotherapy and radiation,” said Brian Hill, a stage 4 oral cancer survivor and founder and executive director of the OCF. “In addition to severe pain and nutritional problems as a result of the inability to eat, the severe open sores in the mucosa can increase the risk of infection.”
The release of Oral Mucositis Care follows the 15th annual recognition of April as Oral Cancer Awareness month, a national effort encouraging dental practices to offer free oral cancer screenings to people in their communities to help catch oral cancer in its earliest and most treatable stage. Organizations such as the Academy of General Dentistry (AGD), the American Academy of Oral and Maxillofacial Pathology (AAOMP), the American Academy of Oral Medicine (AAOM), the American Academy of Periodontology (AAP), the American Association of Oral and Maxillofactial Surgeons (AAOMS), the American Dental Association (ADA), and the American Dental Hygienists’’ Association (ADHA) have all joined OCF in supporting this important campaign.
DARA BioSciences last year reintroduced Gelclair®, an FDA-approved bioadherent oral rinse gel for treating the pain that accompanies oral mucositis (OM). Gelclair is the most clinically studied and published of all oral gel devices approved for oral mucositis in the United States. In clinical trials, Gelclair has been demonstrated to rapidly and effectively relieve pain. To download the app, visit the iTunes Store or Google Play and search for “Oral Mucositis Care.” The app will also be available on www.Gelclair.com. For optimal performance, the latest software versions are recommended.
About Oral Mucositis
Oral Mucositis (OM) is an acute inflammation and ulceration of the surface of the mouth and throat in cancer patients caused by chemotherapy and radiation treatment, which disrupt rapidly dividing epithelial progenitor cells. It is estimated that approximately 400,000 cases of OM are diagnosed annually. OM can be an intensely painful condition that often leads to difficulties swallowing food and fluids, potentially leading to dehydration and malnutrition. OM can also lead to delays in cancer treatments, through chemotherapy dose reductions, breaks in radiation treatment, cessation of cancer therapy, hospitalization and reliance on parenteral nutrition. OM is seen most often in patients receiving radiation therapy for head and neck cancer, and in patients receiving high-dose chemotherapy conditioning prior to hematopoietic stem cell transplantation. However, any patient receiving cancer treatment is at risk.
About Gelclair® (Bioadherent oral rinse gel)
Gelclair® is an easy-to-use bioadherent oral rinse gel indicated for the management and relief of pain of various etiologies, including oral mucositis/stomatitis, irritation due to oral surgery, ulcers caused by braces or ill-fitting dentures, certain systemic diseases, and for diffuse aphthous ulcers. Gelclair® has a unique hyaluronic acid – based formulation and does not contain alcohol, thereby reducing the risk of painful burning and drying. Gelclair® has been broadly studied, demonstrating rapid and effective relief of pain, improvement in patients’ ability to eat and drink and reducing the need for rescue analgesics. DARA has exclusive U.S. commercial rights to Gelclair® through a license with The Helsinn Group in Switzerland.
Gelclair® Important Safety Information
Do not use Gelclair® if there is a known or suspected hypersensitivity to any of its ingredients. No adverse effects have been reported in clinical trials, although post marketing reports have included infrequent complaints of burning sensation in the mouth. Do not eat or drink for at least 30-60 minutes following treatment. If Gelclair® is swallowed accidently, no adverse effects are anticipated.
For additional information, including a copy of the Full Prescribing Information, please visit our web site at www.gelclair.com
About DARA BioSciences, Inc.
DARA BioSciences, Inc. of Raleigh, North Carolina, is an oncology supportive care specialty pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help patients with cancer adhere to their therapy and manage side effects arising from their cancer treatments.
In addition to Gelclair®, DARA holds exclusive U.S. marketing rights to Soltamox® (tamoxifen citrate) oral solution, the only liquid form of tamoxifen, indicated for the treatment of metastatic breast cancer, the 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 women at high risk for breast cancer. Soltamox® offers an option to patients who prefer or need a liquid form of tamoxifen. DARA licensed the U.S. rights to Soltamox® from UK-based Rosemont Pharmaceuticals, Ltd.
Under an agreement with Innocutis, DARA also markets Bionect® (hyaluronic acid sodium salt, 0.2%) a topical treatment for skin irritation and burns associated with radiation therapy, in U.S. oncology/radiology markets. Bionect® is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritation of the skin, and first and second degree burns.
DARA is focused on expanding its portfolio of oncology supportive care products in the United States, via in-licensing and/or partnering of complementary late-stage and approved products. In addition, the company wishes to identify a strategic partner for the clinical development of KRN5500, currently in Phase 2 for the treatment of chronic, treatment refractory, chemotherapy-induced peripheral neuropathy (CCIPN). The FDA has granted KRN5500 orphan drug status for the treatment of CCIPN and designated it as a Fast Track Drug.
In January 2014, DARA kicked off its new partnership with Alamo Pharma Services, a subsidiary of Mission Pharmacal, in deploying a dedicated 20-person national sales team in the U.S. oncology market. In addition to promoting DARA's products Soltamox® (tamoxifen citrate oral solution), Gelclair® and Bionect®, this specialized oncology supportive care sales team also will provide clinicians with access to three Mission Pharmacal products: Ferralet® 90 (for iron deficiency anemia), BINOSTO® (alendronate sodium effervescent tablet indicated for the treatment of osteoporosis), and Aquoral® (for chemotherapy/radiation therapy-induced dry mouth).
Important Safety Information and full Prescribing Information for Mission Pharmacal’s products may be found at: www.Ferralet.com, www.Binosto.com, and www.Aquoral.com.
For more information please visit our web site at www.darabio.com.
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 Boxed 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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The full Prescribing Information for Soltamox is available at www.soltamox.com/prescribing-information.
Bionect® Important Safety Information
Do not administer Bionect® to patients with known hypersensitivity to any of the ingredients in this product. Do not use concomitantly with disinfectants containing quaternary ammonium salts. Each tube of Bionect® should be used by only one person to reduce the risk of cross infection. Prolonged use may give rise to sensitization.
The full prescribing information for Bionect® is available at www.bionect.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, Soltamox, Bionect or other products given that DARA only recently hired 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.
