oral mucositis – Page 3 – Oral Cancer News

SciClone announces topline results from Phase 2 clinical trial of SCV-07 for prevention of oral mucositis

Source: CNNMoney.com Author: press release SciClone Pharmaceuticals, Inc. today announced topline results from the company's phase 2 clinical trial of SCV-07 for the prevention of severe oral mucositis (OM) (World Health Organization, WHO scale, grades 3 to 4) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. This proof of concept study was intended to provide an estimate of SCV-07's treatment effect and guide further studies of SCV-07 in addressing this serious unmet medical need. Patients receiving the study's higher dose (0.1 mg/kg) of SCV-07 showed a trend towards delay to onset of severe OM, the study's primary endpoint. Patients in the low dose treatment arm (0.02 mg/kg) appeared to do worse than placebo, suggesting that the treatment effect is sensitive to dose. Additionally, SCV-07 was safe and well tolerated with no drug-related serious adverse events reported, indicating that there is potential to administer higher doses of SCV-07 in future clinical studies. Additional data analysis showed a more pronounced clinical benefit for patients in the high dose treatment arm when evaluating the delay to onset of ulcerative OM (WHO scale, grades 2 to 4), an expanded measure of OM. In this analysis, the low dose treatment arm appeared similar or slightly better than placebo. "We are encouraged that the trial provides an indication of a biological signal, in the high dose arm, for the pre-specified primary endpoint of the study," said Stephen T. Sonis, DMD, DMSc, Senior Physician, Brigham and Women's [...]

Oral Cancer Foundation News Team - A2010-04-01T19:51:55-07:00April, 2010|Oral Cancer News|

Access Pharmaceuticals provides update on MuGard commercial launch in North America

Source: money.cnn.com Author: press release Access Pharmaceuticals, Inc., today provided an update on its North American commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. Access intends to commercially launch MuGard in North America in the first quarter of 2010. Key strategic items pertaining to the launch include: Manufacturing: Access is currently working with its contract liquid manufacturer, Accupac, on initial clinical and stability batches, and expects to have initial commercial quantities available in 1Q 2010. Reimbursement: Access is working with outside regulatory consultants in developing and finalizing its reimbursement strategy as it pertains to third-party payors and Medicare/Medicaid. Clinical: Consistent with strategies employed by its global marketing partners, Access is working with key opinion leaders to develop a strategy for post-approval studies if and as needed. Access believes that its approved label indication and directions for use supports positioning MuGard as a preventative for oral mucositis caused by radiation and chemotherapy treatments, and provides for expansion into treatment of all types of oral wounds including aphthous ulcers, canker sores and traumatic ulcers, such as those caused by oral surgery. Marketing/Sales: Access has signed a deal with iMedicor to support online eMarketing efforts and education of oncologists, radiation oncologist and support staff as it pertains to oral mucositis and MuGard specifically. Access intends to build a hybrid, dedicated salesforce with oncology supportive care experience. Co-Promotion: Access continues to seek potential co-promotion arrangements with pharmaceutical and biotechnology companies in the [...]

Oral Cancer Foundation News Team - A2009-11-11T14:29:14-07:00November, 2009|Oral Cancer News|

MuGard data From UK study shows prevention of oral mucositis in head and neck cancer patients

Source: news.prnewswire.com Author: press release Access Pharmaceuticals Inc. announced today that its European partner, SpePharm, is collecting data from a post approval study of MuGard in head and neck cancer patients undergoing radiation treatment in the UK showing prevention of oral mucositis. In a multi-center study expected to enroll a total of 280 patients, patients are provided with seven weeks of MuGard therapy, and begin using MuGard one week prior to radiation treatment and then throughout the subsequent six weeks of planned therapy. The first 140 patients being treated in this assessment study have been enrolled and treated, and as of the time of the update, none of these patients have experienced any oral mucositis. "The initial feedback from SpePharm on their experience in the UK, with the first 140 patients in the assessment study, exceeds our most positive expectations," stated Jeffrey B. Davis, Access' President & CEO. "Normally, roughly 100% of patients undergoing radiation treatment for head and neck cancer experience some level of oral mucositis. This condition varies from a low level of discomfort and pain, up to Grades 3 and 4 which are debilitating to the point of patients discontinuing therapy. To see a result where all or substantially all of the patients using MuGard, and using it prophylactically, are not getting oral mucositis is extremely important with respect to treatment regimens. We believe the final data set will show that MuGard should be used prophylactically with all radiation or chemotherapy regimens that have the potential to [...]

Oral Cancer Foundation News Team - A2009-07-23T13:14:45-07:00July, 2009|Oral Cancer News|

Oral spray reduces mouth sores

Source: patient.cancerconsultants.com Author: staff Among patients treated with radiation therapy for head and neck cancer, mouth sores (oral mucositis) were reduced by use of an oral spray containing epidermal growth factor (EGF). These results were published in Cancer. Mouth sores are one of the most common and serious complications of radiation therapy for head and neck cancer. Mouth sores are painful, interfere with eating and drinking, and can also lead to infection. If they become severe enough they may require a reduction or delay in cancer treatment. Epidermal growth factor (EGF) is a protein that plays several important roles in the body, including wound healing and tissue growth. To evaluate the use of an EGF-containing oral spray for the treatment of mouth sores, researchers in Korea conducted a Phase II clinical trial among 113 patients with head and neck cancer. The most common sites of cancer among the study participants were the nasopharynx, oropharynx, and oral cavity. All of the patients were treated with radiation therapy with or without chemotherapy. In addition, patients were assigned to receive one of three doses of the EGF oral spray or a placebo. The spray was used twice a day through week five of radiation therapy. Patients were considered to have responded to the EGF spray or placebo if they had no mucositis or only mild mucositis at weeks 4 and 5 of radiation therapy. Response rate among patients in the placebo group was 37%. Response rates among patients in the EGF spray groups [...]

Oral Cancer Foundation News Team - A2009-07-22T05:23:02-07:00July, 2009|Oral Cancer News|

Topical EGF may decrease severe mucositis in patients with head and neck cancer receiving radiotherapy

Source: professional.cancerconsultants.com Author: staff Researchers from Korea have reported that recombinant epidermal growth factor (EGF) delivered as a spray twice daily may decrease the severity of severe mucositis in patients undergoing radiotherapy with or without chemotherapy for head and neck cancer. The details of this study appeared in an early online publication on June 9, 2009 in Cancer.[1] Oral mucositis is a frequent clinical problem in patients receiving chemotherapy and/or radiation therapy. Mucositis can be a severe dose-limiting toxicity, especially in patients receiving high-dose chemotherapy. Keritonocyte growth factor (Kepivance®) has been approved for prevention of mucositis in patients undergoing autologous stem cell transplantation. Other methods of treating or preventing oral mucositis include oral antiseptics, cryotherapy, laser therapy, L-glutamine (Saforis® and velafermin). Previous studies of antiseptic, antibiotic, and antifungal mouth washes and lozenges have revealed no dramatic effects, but two recent randomized trials suggested a limited role for topical antibiotic and antifungal treatment of mucositis. This multicenter trial enrolled 113 patients who were receiving definitive chemoradiotherapy or adjuvant radiotherapy. Patients were randomly allocated to a placebo group or to a group receiving three doses of EGF. Responders were defined as patients who had an RTOG grade of 2 or lower at the fourth- and fifth-week examinations. By this criteria 64% of patients receiving a 50-microgram dose of EGF responded compared with 37% in the control group. These authors concluded: “The EGF spray may have potential benefit for oral mucositis in patients undergoing RT for head and neck cancer. Phase 3 studies [...]

Oral Cancer Foundation News Team - A2009-07-08T05:12:37-07:00July, 2009|Oral Cancer News|

Improvements for patients with oral mucositis

Source: cancerfocus.net Author: staff New data show that Caphosol® (www.caphosol.com), an advanced electrolyte solution, significantly limits the occurrence and severity of oral mucositis (OM) in cancer patients undergoing chemotherapy and radiation therapy. The data, which contain the final results from a prospective observational study sponsored by EUSA Pharma, were presented today at the 50th annual meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO), and demonstrate that Caphosol use is associated with high levels of medication compliance and patient and physician satisfaction. The latest findings expand upon 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. "Oral mucositis is a common, debilitating side effect of chemotherapy and radiation therapy, resulting from erosion of epithelial cells in the oral cavity (cells lining the surface of the throat and esophagus) during therapy," said principal investigator Marilyn L. Haas, PhD, RN, CNS, ANP-C, Nurse Practitioner, Carolina Clinical Consultant. "Patients with oral mucositis often experience severe pain, difficulty eating and swallowing, and greater susceptibility to infection. The registry data suggests that CAPHOSOL, a supersaturated electrolyte oral rinse, has a significant positive impact on the occurrence and severity of oral mucositis, and is highly regarded by patients and physicians." Dr. Haas and colleagues reported data from 68 patients with head and neck (HN) cancer enrolled in an open-label, observational registry maintained at 26 treatment centers in the U.S. The patients were considered at high risk of developing [...]

Oral Cancer Foundation News Team - A2008-09-28T21:23:42-07:00September, 2008|Oral Cancer News|