HOUSTON, June 26, 2008 - New data show that use of CAPHOSOL® (www.caphosol.com), an advanced oral electrolyte solution, resulted in both favorable impact on rates and severity of oral mucositis (OM) in cancer patients undergoing chemotherapy and radiation therapy. The data, which were presented today at the 20th International Symposium of the Multinational Association of Supportive Care in Cancer (MASCC) and the International Society of Oral Oncology (ISOO), also demonstrate that CAPHOSOL use is associated with low use of pain medication and high levels of patient and physician satisfaction.
The findings add to the growing body of evidence of the benefits of CAPHOSOL in the management of OM and related symptoms in patients with various types of cancer.
"Our research suggests that CAPHOSOL, a supersaturated electrolyte oral rinse, has a significant positive impact on the incidence and severity oral mucositis, a common side effect of chemotherapy and radiation therapy," commented principal investigator Marilyn L. Haas, PhD, RN, CNS, ANP-C, Nurse Practitioner, Mountain Radiation Oncology, Asheville, N.C. "This extremely debilitating condition results from erosion of epithelial cells in the oral cavity (cells lining the surface of the throat and esophagus) during therapy, and often causes severe pain, difficulty eating and swallowing, and greater susceptibility to infection. For cancer patients at high risk of oral mucositis, CAPHOSOL can be an important component of treatment."
Dr. Haas and colleagues reported data from an open-label, non-randomized observational study, called the Caphosol Oral Mucositis Follow-up Observational Registry Trial (COMFORT). The study enrolled 218 patients at high risk of developing OM. Most of the patients were Caucasian (84 percent) and female (60 percent). The most common malignancies among the participants were breast cancer (31 percent), head and neck cancer (31 percent) and colorectal cancer (11 percent). All patients in the study received CAPHOSOL administered as an oral rinse four-to-10 times daily for an average of six-to-eight weeks beginning the first day of treatment. Data were reported for 170 (78 percent) of patients who had completed follow-up at the time the data were analyzed.
Compliance was high, with patients rinsing at least once on 96 percent of days. Overall, patients rinsed between two and six times per day for 90 percent of their days on the study. Low rates of OM were noted with 60 percent having no OM (Grade 0), 20 percent with grade I and 15 percent with grade II. Only 5 percent and 1 percent developed grades III and IV OM. In general, rates and severity of OM were higher in patients with cancers of the head and neck and those receiving combination chemotherapy and radiation therapy. No pain medication was required in 54 percent of patients, while opiates were used by 25 percent and other non-opioid medications (including NSAIDS) by 21 percent of patients.
Patient satisfaction was high, with 52 percent very satisfied, 29 percent satisfied, 13 percent only slightly satisfied and 3 percent not satisfied. Physician assessment of efficacy was: excellent (54 percent), good (16 percent), satisfactory (18 percent), not satisfactory (2 percent) and not evaluable (10 percent).
The use of Caphosol also had a favorable impact on the severity of OM: Mild OM (Grade 0/1) was found in more than 90 percent of chemotherapy patients and 40 percent of head and neck cancer patients. Severe OM (Grade 3/4) was found in only 1-2 percent of chemotherapy patients and 18 percent of head and neck cancer patients (with only one patient at Grade 4).
"The patients in this study had cancer treatments that put them at high risk of developing oral mucositis, which at high grades results in severe pain and diminished quality of life," said Dr. Haas. "It was therefore quite encouraging to observe the low use of pain medication and high levels of satisfaction among CAPHOSOL users, as well as the high ratings of efficacy by the physicians. It appears, then, that CAPHOSOL can be a highly useful tool in the management of chemoradiation-induced oral mucositis."
Oral Mucositis: A Common and Debilitating Condition
Oral complications including mucositis and salivary gland dysfunction are common and often debilitating side effects of cancer therapy. OM is estimated to affect more than 400,000 cancer patients each year. OM affects approximately 40 percent of cancer patients who receive chemotherapy, more than 70 percent of those undergoing conditioning therapy for bone marrow transplantation, and virtually all patients receiving radiation therapy for head and neck cancer.
Oral mucositis usually manifests itself within seven to 14 days after initiation of therapy. Initial signs and symptoms include redness, swelling and ulceration of the mucosa. Oral mucositis can cause mouth pain, xerostomia (dryness of the mouth or throat), difficulty eating and drinking, as well as difficulty with speech; these effects can significantly impact a patient's weight, mood and physical functioning. Severe ulceration may cause breaks in the mucosa, which can then become susceptible to oral opportunistic infections, possibly resulting in bacteremia (the presence of bacteria in the blood), sepsis (the presence of pathogenic microorganisms in the blood) or other potentially fatal complications. The economic impact of mucositis can be significant, as the need for prolonged hospital stays, nutritional therapy and treatments for pain and infection can drive up the costs of therapy.
CAPHOSOL is an advanced electrolyte solution indicated as an adjunct to standard oral care in treating OM caused by radiation or high dose chemotherapy. CAPHOSOL, a U.S. patented prescription medical device, is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent. Patients restricted to a low sodium diet should consult their physician before use. Patients should avoid eating or drinking at least 15 minutes after use.
As part of its commitment to advancing the treatment and care of cancer patients, Cytogen launched CARE OM™ (www.careom.com) a Web-based education and support center for patients and caregivers seeking to learn more about OM and CAPHOSOL. In addition to oral mucositis educational material and support information, visitors to CARE OM can also download an OM brochure or request it by mail. For more information about CAPHOSOL, visit www.caphosol.com or call (800) 833-3533.
About EUSA Pharma Inc.
EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, pain control and critical care products. The company currently has nine products on the global market, including Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy, ProstaScint® for imaging the extent and spread of prostate cancer, Quadramet® for the treatment of pain in patients whose cancer has spread to the bones, Erwinase® and Kidrolase® for the treatment of acute lymphoblastic leukemia, the antibiotic surgical implant Collatamp® G, and Rapydan®, a rapid-onset anesthetic patch which recently received Europe-wide approval. EUSA also has several products in late-stage development, notably Collatamp® G topical, a gentamicin impregnated collagen sponge for the prevention and treatment of infected skin ulcers, and CollaRx® bupivacaine implant* for local post-surgical pain control.
Founded in 2006, EUSA Pharma is supported by a consortium of leading life science capital investors, comprising TVM Capital, Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV Life Sciences, NeoMed and NovaQuest. Since its foundation, the company has raised over $275 million, and completed several significant transactions, including the acquisitions of Cytogen Corporation, Talisker Pharma Ltd, the French biopharmaceutical company OPi SA and the European antibiotic and pain control business of Innocoll Pharmaceuticals Inc. As part of its rapid growth strategy the company has established commercial infrastructure in the US, a pan-European presence covering over 20 countries and a wider distribution network in a further 25 territories. EUSA Pharma plans to continue its aggressive program of acquisitions and in-licensing within its specialist areas of medical and geographic focus, in line with its ambitious target to create a rapidly growing $1 billion company by the beginning of the next decade.
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