BREAKING NEWS:

First Study Targeting Colorectal Cancer Stem Cells to Begin

SCHAUMBURG, Ill., Jul 06, 2012 (BUSINESS WIRE) -- The Gateway for Cancer Research(SM) (announces an exciting new Gateway-funded phase II study using ADAPT therapy for treatment of metastatic colorectal cancer based on a 2010 AACR presentation by Dr. Lin and his collaborators.

The clinical trial, being led by Dr. Edward Lin, a medical oncologist at the University of Washington, Fred Hutchinson Cancer Research Center and an accomplished researcher and expert in gastrointestinal cancers, is the first to specifically target colon cancer stem cells.

The study will use a unique combination drug therapy of Capecitabine (a chemotherapy drug) and Celecoxib (an FDA approved arthritis medication) to "wake up" and to "kill" colon cancer stem cells. The treatment works by activating cancer stem cells that hibernate during chemotherapy--a chief cause of treatment failure--so they can be destroyed. The proper sequence is necessary to consistently kill the dormant cells. The ADAPT concept was proposed by Drs. Lin and Linheng Li, a prominent stem cell biologist.

It is a very powerful drug combination with good preliminary results. Pilot studies have shown significantly increased survival rates compared with conventional therapy. Of 124 treated patients, 40% of those treated with this protocol achieved complete remission or near remission with a median survival of 93.7 months and only 1/3 of the patients had surgical removal of the metastasis.

The average length of survival for stage IV colorectal cancer patients on conventional treatment is about 20-24 months and 46 months for complete responders.

"A lot of patients we didn't expect to see live, are living and thriving," says Dr. Lin. It also allows a good quality of life for patients. "The treatment is offering an immediate benefit to today's cancer patients. 95% of participants are out and about in their daily lives, doing what they need to do without skipping a beat." Thomas Oberdorf, a 5-year colorectal cancer survivor who benefitted from Dr.

Lin's treatment protocol is grateful.

"As a stage IV colorectal cancer patient, I hoped to live another two years to see my daughter through to age 11. Thanks to Dr. Lin's treatment protocol, I am healthy and am hoping for another 50 years," said Oberdorf who did not miss a beat as CFO of a large organization during the course of his treatment.

The drug combination allowed a good quality of life for most patients. An independent randomized phase III study also showed that celecoxib reduced capecitabine induced hand foot syndrome that was observed by Dr. Lin.

Tiffany Heigle, a stage IV colon cancer patient when she first met with Dr. Lin, credits him for 10 years of survival and precious time with her family.

"Because of Dr. Lin's new treatment approach, I can enjoy being a mom to my 18-year-old freshman in college and my 15-year-old freshman in high school," says Heigle." I have been allowed to see them grow up due to this research." Colorectal cancer is the number 3 killer and an estimated 1.2 million people around the globe have the disease. More than 70,000 deaths per year in the US alone are attributed to colorectal cancer and for patients with stage IV disease; five year survival is under 10% with current treatments. Surgery remains the only treatment that yielded long term survival and this may be changed by the current study.

The clinical trial is inclusive and invites a broad range of patients and colorectal cancer stages with the goal to duplicate the success observed in the clinic. If successful, this treatment protocol has the potential to save many lives per year world wide.

Dr. Lin notes that The Gateway and he share the philosophy of putting patients at the center of everything that they do. "It is a privilege and pleasure to work with Gateway," said Dr. Lin. "Everyone on the team is passionate about the cause, keenly aware of issues, and working toward solutions." Dr. Lin is excited at the prospect of further testing the treatment protocol with The Gateway's support and expanding the trial to other tumors and making it available globally. "The Gateway has provided seed funding that will help this study continue and hopefully help the vision expand so the treatment is available to many more patients," continued Lin.