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UAMS Initiates Clinical for Breast Cancer Vaccine

October 24th, 2011 - Little Rock, AR – The University of Arkansas for Medical Sciences (UAMS) announces the start of a Phase 1 clinical trial to study the safety of a novel vaccine to prevent the recurrence of breast cancer.

 

UAMS has three research subjects enrolled in the Phase 1 clinical trial and plans on completing the trial sometime in 2012 after studying the safety of the vaccine in up to 18 research subjects. After the safety testing phase is completed, UAMS expects to conduct another clinical trial using the vaccine on up to 50 research subjects.

 

The vaccine was developed by Thomas Kieber-Emmons, Ph.D., professor of pathology and holder of the Josetta Wilkins Chair of Breast Cancer Research at the Winthrop P. Rockefeller Cancer Institute at UAMS. His research has been federally funded since 1992.

 

Here’s how the vaccine would work: The surface of a cancer cell is covered with carbohydrates. If the vaccine could trigger an immune response to carbohydrates, it would destroy the cancer cells. But it is difficult to get the immune system to recognize carbohydrates on cancer cells.

 

So Kieber-Emmons used a chemical compound called a peptide to mimic a carbohydrate in hopes that the body would create an immune response to the peptide that then cross-reacts with the carbohydrate on the tumor cell and destroys the cell.

 

“It’s not quite a bait and switch, but you’re trying to elicit a set of responses you just don’t see with carbohydrates. The true test will come during the clinical trial, but we anticipate our little deception will work to the advantage of breast cancer patients,” Kieber-Emmons said.

 

The successful effort to initiate the clinical evaluation of this novel approach to vaccine development involved a collaborative effort between the university and three well-known service providers – AmbioPharm Inc., a GMP-compliant manufacturer of peptide active pharmaceutical ingredients, Advantar Laboratories, a GMP-compliant laboratory offering analytical and formulation development services, and NextPharma Technologies, a contract manufacturer for clinical trial materials.

 

“The process of developing and manufacturing the vaccine required a very high level of interaction between UAMS, AmbioPharm, and Advantar over a two-year period,” Kieber-Emmons said.

 

UAMS, AmbioPharm,  Advantar and NextPharma conducted weekly production and development meetings throughout 2009 and 2010 to facilitate the development and manufacture of the material being used in the clinical trial.

 

Rich Kenley, Ph.D., Chief Executive Officer of Advantar Labs, said the partnership was able to initiate the Phase 1 trial rapidly and cost effectively. “We believe that the collaboration represents the optimal approach for translating leading-edge, innovative research into promising new therapies for important diseases.”

 

Jim Hampton, AmbioPharm executive vice president of business development and cGMP sales, said he is thrilled to see the vaccine make a successful entry into clinical trials. “The FDA had only a single question regarding the manufacturing section of the FDA submission.”

 

For additional information, visit http://www.advantarlabs.com or contact Brandon Griffin (858) 228-7788

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