Oral mucositis relief

Amgen (http://www.amgentrials.com/) announced in January that recombinant human keratinocyte growth factor (rHu-KGF) decreased the duration and incidence of severe oral mucositis in a Phase III study of patients undergoing bone-marrow transplantation for haematological malignancies such as lymphoma, multiple myeloma and leukaemia.

Oral mucositis — inflammation and ulceration of the moist tissue that lines the mouth — occurs in approximately 40% of patients who receive chemotherapy or radiation therapy. Symptoms vary from pain and discomfort to an inability to take food or fluid, and patients are also prone to opportunistic mouth infections.

Amgen has been studying the ability of rHu-KGF to protect epithelial cells from injury caused by anticancer treatments. KGF stimulates the proliferation and development of epithelial cells, including the cells that line the gastrointestinal tract. Preliminary results from the randomized, double-blind trial, which is now closed to recruitment, showed a significant decrease in both the duration and incidence of severe mucositis. rHu-KGF was well tolerated in these patients.

Aesgen-14 (AES-14), developed by Aesgen, Inc. (www.aesgen.com), is also in Phase III clinical trials for oral mucositis. The therapy has recently been granted fast-track status from the US Food and Drug Administration, which expedites the regulatory review and approval process.

AES-14 is a mouth-rinse suspension that contains (L) glutamine in a proprietary vehicle that increases cellular glutamine uptake, and is used several times per day during chemotherapy. Randomized, placebo-controlled trials in the United States and elsewhere include patients with oral mucositis who are receiving chemotherapy for breast cancer. Preliminary data indicate that AES-14 significantly reduced the emergence, severity and duration of mucositis.

HPV risk revealed

Infection with human papillomavirus (HPV) is the main cause of cervical cancer, but little is known about the level of risk associated with different HPV types. More than 80 HPV types have been identified, but, so far, only 11 are consistently classified as high risk, and only types 16 and 18 are considered to be bona fide human carcinogens. In the 6 February issue of The New England Journal of Medicine, Nubia Muñoz et al. studied data from 11 case–control studies performed in nine countries. The studies involved 1,918 women with histologically confirmed squamous-cell cervical cancer and 1,928 control women. In addition to HPV types 16 and 18, the authors reported that 13 other types should be considered high risk and 3 types should be considered as “probably carcinogenic”.

In the study, cervical cells and tumour biopsy specimens were collected from untreated patients with newly diagnosed invasive or in situ squamous-cell cervical cancer. HPV DNA was detected in more than 90% of patients with cervical cancer and in roughly 15% of controls. The most common HPV types detected, in descending order of frequency, were types 16, 18, 45, 31, 33, 52, 58 and 35. Among controls, types 16, 18, 45, 31, 6, 58, 35 and 33 were the most common. The pooled odds ratio for cervical cancer associated with the presence of any HPV was 158.2. The association with the most and least common HPV types was similar, with odds ratios over 45. The findings indicate that an effective vaccine against the five most common HPV types could prevent almost 90% of cervical cancer cases worldwide.