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Chinese pharmaceutical company forms alliance with American CRO.
Numerous US CROs now offer their services to American, European, and Japanese pharmaceutical companies conducting clinical trials in China. In a twist to this rising trend, American Oriental Bioengineering Inc. (AOBO), a Chinese pharmaceutical company, has formed an alliance to have an American CRO, Palm Beach Clinical Research Organization (Palm Beach CRO), conduct clinical trials of its drugs in the United States.
"We plan to develop one of our drug candidates in the United States. We would like to work with an American CRO to conduct our clinical study here," said Tom Du, MD, PhD, Chief Technology Officer at AOBO.
The agreement was formally signed at the 2011 US-China Trade and Economic Cooperation Forum on January 21, 2011. At the event, AOBO was the only Chinese pharmaceutical company to sign an agreement with an American company, and Palm Beach CRO was the only American CRO to sign an agreement with a Chinese pharmaceutical company.
"It's outstanding for Palm Beach CRO to be able to be chosen as the one and only CRO for AOBO," said Arthur Simon, PhD, President of Palm Beach CRO. "It's a major honor."
Based on this agreement, Palm Beach CRO will provide services such as site selection, protocol preparation, and data analysis, among other responsibilities.
Palm Beach CRO is currently conducting a Phase II study for a drug candidate for the treatment of overactive bladder with urge urinary incontinence and frequency (clinicaltrials.gov identifier NCT01294982).
According to Simon, sites have been chosen and enrollment is on schedule, with subjects being dosed at some sites.
"We expect clinical sites of the upmost highest levels, and to do clinical studies with physicians around the country at the highest level," said Simon. "The end result is to take the product to the next level—Phase III."
Palm Beach CRO hopes to have data ready by the third quarter of 2011.—Kayda Norman