Combination of targeted therapy, chemotherapy, showed promise in Phase I trial
AURORA, Colo. – The University of Colorado Cancer Center is enrolling patients in a clinical trial for a new treatment for advanced pancreatic cancer that showed promise in early clinical trials.
“Pancreatic cancer remains of the most difficult to treat,” says Wells Messersmith, MD, FACP, director of the University of Colorado Cancer Center gastrointestinal medical oncology at University of Colorado Hospital. “In fact it has the highest mortality rate of all major cancers, with only six percent of patients surviving more than five years from diagnosis. People with advanced disease live only a few months after diagnosis, and there hasn’t been much improvement in survival over the past 40 years. That’s why this new treatment is exciting.”
The new oral treatment, IPI-926 from Infinity Pharmaceuticals, Inc., takes a new approach—blocking the Hedgehog pathway. Scientists think this pathway plays a key role in passing information to adult stem cells that regulate tissue regeneration, and that if the pathway breaks down, diseases like cancer occur.
The Phase 1b/2 clinical trial is for patients with previously untreated pancreatic cancer that has spread beyond the initial tumor site (metastatic disease). Patients enrolled in the trial will be treated with a combination of IPI-926 and Gemzar® (gemcitabine), a chemotherapy drug used to treat advanced pancreatic cancer.
In a Phase I study, a single daily dose of IPI-926 was well-tolerated and resulted in clinical activity in patients with basal cell carcinoma. The new trial will first aim to determine the recommended combined therapy dose for a multi-center, randomized, double-blind Phase 2 study, which will evaluate overall survival, progression-free survival, time to progression and overall response.
“Clinical trials that evaluate potential new treatments for pancreatic cancer, like this study with IPI-926, represent important efforts and potentially promising clinical advances to find more effective ways to better treat patients and make a meaningful difference in their lives,” says Messersmith, associate professor of medical oncology at the University of Colorado School of Medicine. “There are many patients in Denver, in Colorado and in the Rocky Mountain region who are waiting for an alternative, and we are hopeful that our efforts will have a positive impact.”
About 43,140 Americans will be diagnosed with pancreatic cancer this year and 36,800 will die from the disease, according to the American Cancer Society website, http://cancer.org. About 430 Coloradoans died from the disease in 2009, the website said.
Clinical Contact Information
For information about the Colorado arm of this clinical trial, please contact Stacy Grolnic, UCCC Phase I Team Coordinator, at 720-848-0655 or [email protected].
About the University of Colorado Cancer Center
The University of Colorado Cancer Center is the Rocky Mountain region’s only National Cancer Institute-designated comprehensive cancer center. NCI has given only 40 cancer centers this designation, deeming membership as “the best of the best.” Headquartered on the University of Colorado Denver Anschutz Medical Campus, UCCC is a consortium of three state universities (Colorado State University, University of Colorado at Boulder and University of Colorado Denver) and five institutions (The Children’s Hospital, Denver Health, Denver VA Medical Center, National Jewish Health and University of Colorado Hospital). Together, our 440+ members are working to ease the cancer burden through cancer care, research, education and prevention and control. Learn more at www.uccc.info.
About Infinity Pharmaceuticals, Inc.
Infinity (NASDAQ: INFI) is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity’s programs in the inhibition of the Hsp90 chaperone system, the Hedgehog pathway, fatty acid amide hydrolase and phosphoinositide-3-kinase are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company’s website at http://www.infi.com.
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Contact: Lynn Clark, 303-724-3160, [email protected]