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Mucositis

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April 12, 2010

SciClone reported positive results from a phase II trial of SCV-07 for the prevention of severe oral mucositis (OM). This U.S.-based, randomized, double-blind, placebo-controlled study enrolled 59 subjects receiving radio-chemotherapy for the treatment of head and neck cancer. The subjects received either placebo, SCV-07 at a dose of 0.02 mg/kg, or SCV-07 at a dose of 0.1 mg/kg. The treatment period was approximately seven weeks, with a follow-up visit approximately 30 days following the last day of radiation therapy. The primary efficacy endpoint was delay of onset of severe OM. The subjects who received the higher dose (0.1 mg/kg) of SCV-07 showed a trend towards delay to onset. Those in the low dose treatment arm appeared to do worse than placebo, suggesting a dose-related treatment effect. SCV-07 was safe and well tolerated with no drug-related serious adverse events reported.

October 15, 2007

CuraGen released negative results from a phase II trial of velafermin for the treatment of oral mucositis. This randomized, double-blind, placebo-controlled study enrolled 390 subjects on high dose chemotherapy, in the United States. The subjects received a single infusion of either placebo or one of three dose levels of velafermin (10 mcg/kg, 30 mcg/kg or 60 mcg/kg) administered 24 hours after an autologous bone marrow transplantation. The primary endpoint was the reduction in incidence of severe oral mucositis in the subjects receiving 30 mcg/kg compared to placebo. While treatment was deemed to be safe and well tolerated, the primary endpoint was not met. Based on the results, CuraGen has decided to discontinue the development of velafermin.

March 6, 2006

Algeta announced positive results of a phase II study, dubbed (BC1-02), of Alpharadin (radium-223), for the treatment of bone metastases related to hormone-refractory prostate cancer (HRPC) at the ASCO Prostate Cancer Symposium. The trial met its primary efficacy endpoint, with Alpharadin significantly decreasing bone-alkaline phosphatase, a bone-turnover biomarker compared to placebo at 4 months (p<0.001). Efficacy was also noted in reducing secondary markers of bone turnover, including the S-PINP bone formation marker and the S-CTX-I and S-ICTP bone resorption markers. Prostate-specific antigen levels were also reduced. This double-blind placebo-controlled study enrolled 64 patients with bone metastases due to HRPC at 11 sites in Norway, Sweden and the UK. Additional 12 month data, including figures on long-term safety and survival, were expected in the second half of 2006.

Alizyme has issued positive result of a phase IIa trial of ATL-104, for the treatment of oral mucositis related to chemotherapy. Results from the study indicated that all 3 doses of the drug reduced mean duration of WHO Grade 2-4 mucositis (3.2 to 4.5 days) relative to placebo (5.9 days). Subgroup analysis indicated that serious Grade 3-4 mucositis was also reduced for all 3 doses (2.4 to 3.1 days, vs. 5.4 days). Secondary efficacy data were also positive, including efficacy on the WCCNR scale, reduced incidence of oral ulceration and pain, and duration of time patients were unable to take solids by mouth. This randomized, double-blind, multi-center study enrolled 64 patients undergoing chemotherapy across 8 sites in the UK, who received 1 of 3 dose regimens of the drug or placebo prior to autologous peripheral stem cell transplantation.

Spectrum Pharmaceuticals announced positive results of a phase I trial of satraplatin for the treatment of solid tumors at the 2006 ASCO Prostate Cancer Symposium in San Francisco. Trial data yielded a positive overall safety profile, with no significant cardio, renal, liver or neurological toxicities. Overall toxicities, including nausea, vomiting and diarrhea, were mild to moderate in nature, and effectively controlled with prophylactic anti-emetic therapy. Preliminary efficacy data yielded a 1 partial response and 2 cases of stable disease. Administration of the drug with a high-fat meal was shown to reduce peak plasma drug concentration by approximately 20%. The study enrolled 17 heavily pretreated patients with advanced solid tumors.

February 9, 2004

Human Genome Sciences reported negative results from a phase II trial investigating repifermin, also known as keratinocyte growth factor-2 (KGF-2) for the treatment of cancer therapy-induced mucositis. Results demonstrated the study did not meet its primary endpoint. Data showed that the percentage of subjects treated repifermin (75 mcg/kg), who experienced Grade two to four mucositis was not statistically significantly different from placebo. Repifermin was well tolerated with a safety profile similar to placebo. The study was designed to show a 40% relative reduction in the incidence of Grade two to four mucositis. The single-center, double-blind, crossover, dose-escalation trial enrolled 92 subjects with multiple myeloma, scheduled to receive stem cell transplantation. No other clinical trials of repifermin are underway or are planned in any indication.

February 3, 2003

Amgen reported positive results from a phase III trial investigating rHu-KGF, a natural keratinocyte growth factor for the treatment of oral mucositis as a complication of cancer treatments. Preliminary results from the randomized, double blind trial were positive on all endpoints showing a highly significant decrease in both the duration and incidence of severe mucositis. In addition, results showed that the drug was well tolerated. The study enrolled subjects who underwent bone marrow transplantation treatment for hematologic malignancies such as lymphoma, multiple myeloma, and leukemia.

January 27, 2003

Amgen reported positive results from a phase III trial investigating rHu-KGF, a natural keratinocyte growth factor for the treatment of oral mucositis as a complication of cancer treatments. Preliminary results from the randomized, double blind trial were positive on all endpoints showing a highly significant decrease in both the duration and incidence of severe mucositis. In addition, results showed that the drug was well tolerated. The study enrolled subjects who underwent bone marrow transplantation treatment for hematologic malignancies such as lymphoma, multiple myeloma, and leukemia.

October 7, 2002

Preliminary results of a phase III trial of Intrabiotic Pharmaceuticals' iseganan HCL in subjects undergoing high dose chemotherapy showed that the trial did not meet its primary endpoint of reducing oral mucositis. Though well tolerated, the results indicated that there was no significant difference between the 43% of iseganan subjects and 37% of placebo subjects who did not develop severe oral mucositis. There was also no significant difference between iseganan and placebo subjects in the reduction of pain, swallowing difficulty, proportion of subjects who developed oral muscositis and narcotic use. As a result of these findings, Intrabiotics is discontinuing development of iseganan for the treatment of severe oral mucositis.

August 12, 2002

The results of a phase I trial of OC-1012 for the treatment of mucositis, a serious side effect of chemotherapy and head and neck radiation therapy, showed no safety issues with the compound. In addition, OC-1012 positively changed the mucositis profile over time. Subjects in the trial were bone marrow transplant patients undergoing chemotherapy treatment. OC-1012 is being developed by OraPharma.