Patients with Stage II and Stage III Colon Cancer Treated with 5-FU-Based Adjuvant Therapy after 1995 Have Improved Overall Survival

(BUSINESS WIRE)--ASCO Abstract Number: 3616 - Patients with stage III colon cancer treated with 5-FU-based chemotherapy after complete surgical removal of their tumor after 1995 had improved overall survival with no change in time to recurrence compared to patients treated before 1995. In contrast, patients with stage II colon cancer treated after 1995 had longer time to recurrence and time from recurrence to death compared to those patients treated prior to 1995, according to Mayo Clinic and Gr Hospitalier Pitie-Salpetriere, Paris, researchers. They will present the study’s findings on June 4-8, 2010, at the 2010 American Society of Clinical Oncology Annual Meeting in Chicago.

“By combining information from 21 cancer treatment trials for patients with stage II and stage III colon cancer, our analysis determined that those patients treated after 1995 had improved overall survival,” says Dan Sargent, Ph.D., Mayo Clinic biostatistician, North Central Cancer Treatment Group (NCCTG) statistician and senior author on the study.

The analysis compared patient data from more than 18,000 patients with stage II and stage III colon cancer treated with 5-FU-based chemotherapy after their primary tumor had been surgically removed for the time period 1978-1995 versus 1996-2007.

“Patients with stage II colon cancer treated after 1995 had had longer time to recurrence, possibly due to improvements in surgery and pathology” says Dr. Sargent. “In addition, after 1995, both stage II and stage III colon cancer patients treated after surgery with the same 5-FU-based chemotherapy after surgery had improved overall survival. This finding provides evidence to support previous findings that access to new medical therapies introduced in the mid-1990s as well as the expanded use of surgery for patients recurrent disease have meaningfully improving overall survival for patients treated in this setting.”

The findings arise from analysis of combined data collected within an expanded database by the Adjuvant Colon Cancer End Points (ACCENT) Group, a consortium of scientists. The ACCENT database includes data from more than 33,500 patients from the United States, Canada, Australia and Europe. ACCENT, chaired by Dr. Sargent, is supported by the North Central Cancer Treatment Group.

Dr. Sargent conducted the analysis on the expanded database in concert with an international team of scientists participating in ACCENT including Qian Shi, Ph.D. and Brian Bot, from Mayo Clinic; Thierry Andre, M.D., Gr Hospitalier Pitie-Salpetriere; Greg Yothers, M.D., NSABP Statistical Center, Pittsburgh; Daniel Haller, M.D., Abramson Cancer Center, University of Pittsburgh; Eric Van Cutsem, M.D., Ph.D., University Hospital Gasthuisberg/Leuven; James Cassidy, M.D., Glasgow University; Jacqueline Benedetti, Ph.D., Fred Hutchinson Cancer Research Center, Seattle; and Michael O’Connell, M.D., National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, NSABP Operations Center, Pittsburgh.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

APRISO™ Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis

(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today (October 31) announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for APRISO™ (mesalamine) extended-release capsules 0.375 g. APRISO is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults. APRISO is the first and only mesalamine product approved by the FDA for once-a-day dosing for the maintenance of remission of ulcerative colitis. Additionally, APRISO is the first and only 5-ASA with Intellicor™ extended release delivery technology. The Company expects to launch APRISO to physicians during the first quarter of 2009. APRISO is patent protected until 2018.

Bill Forbes, Pharm. D., Vice President, Research and Development, and Chief Development Officer, Salix, stated, “APRISO is an important new once-daily treatment option that encourages compliance in ulcerative colitis patients and provides effective long-term protection from ulcerative colitis flare-ups. A major goal of UC therapy is to prevent relapse which may decrease the risk of disease progression. APRISO accomplishes this goal through the combination of an enteric pH-dependent coating which provides for a delayed release starting at a pH of 6.0 and a polymer matrix core, which provides for extended release. This patented delivery technology is designed to distribute the active ingredient beginning in the small bowel and continuing throughout the colon. Previous generation pH-dependent 5-ASA treatment options provide for release of the active ingredient starting at a pH of 7.0. According to published data, many people never reach a pH of 7.0 in their small or large intestine. APRISO represents a new and important advancement in 5-ASA drug delivery.”

The approval is based on results from two randomized, double-blind, placebo-controlled multi-center, multi-national studies totaling 562 adults in remission from ulcerative colitis. The studies showed that APRISO was more effective than placebo in maintaining long-term remission for six months. In both studies, the proportion of patients who remained relapse-free at six months was greater for APRISO than for placebo.

In these studies APRISO offered clinically-proven efficacy in extending both remission and relief of UC symptoms:

* Maintained remission for six months in 7 out of 10 UC patients in two clinical trials and
* Sustained improvement in rectal bleeding and bowel movement frequency.

APRISO’s patented Intellicor™ delivery system is the first and only to combine delayed and extended 5-ASA release.

* Unlike tablets, APRISO’s gelatin outer capsule quickly dissolves in the stomach to disperse microgranules into the digestive tract.
* Next, a delayed-release coating on the microgranules dissolves at pH 6.0 or higher.
* Last, an inner polymer matrix core controls the extended release of mesalamine to provide drug distribution throughout affected areas.

About Mesalamine Granules

APRISO™ is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older. APRISO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates, or to any of the components of APRISO capsules. The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame, equivalent to 0.56 mg of phenylalanine. In two well-controlled clinical trials, the most common treatment-related adverse events occurring in greater than 3% of adult patients taking 1.5 g/day of APRISO (versus placebo) were headache (11% vs 8%), diarrhea (8% vs 7%), upper abdominal pain (5% vs 3%), nausea (4% vs 3%), nasopharyngitis (4% vs 3%), influenza and influenza-like illness (4% vs 4%) and sinusitis (3% vs 3%).

Salix acquired rights to market APRISO in the U.S. from Dr. Falk Pharma GmbH of Freiburg, Germany. Mesalamine granules have been approved in Germany since 2001 for the treatment of symptoms related to inflammatory bowel disease. In addition, consistent with the FDA-approved labeling, once-daily dosing of mesalamine granules is currently approved via the mutual recognition procedure in Austria, Belgium, Denmark, Finland, Greece, Ireland, Luxemburg, Netherlands, Norway, Portugal, Sweden, Spain and the UK.

About Ulcerative Colitis

Ulcerative colitis is a chronic inflammatory disease of the colon or large intestine. The inflammation usually begins in the rectum and lower colon, but it may also involve the entire colon. Because the inflammation makes the colon empty frequently, symptoms typically include diarrhea (sometimes accompanied by blood) and often abdominal pain. About five percent of people with ulcerative colitis will develop colorectal cancer.

Patients with ulcerative colitis may experience periods of remission (times when the symptoms go away) that can last for months or years. However, most patients’ symptoms eventually return. Active therapy is treatment given to treat ulcerative colitis symptoms when they are active. Maintenance therapy refers to treatment given to patients to enable them to stay in remission, and to maintain their health in a disease-free, or limited-disease, state. Maintenance medications must be taken for a prolonged period of time.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page