Adventrx Pharmaceuticals, Inc. has received clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) to begin an international Phase IIb randomized controlled clinical trial using CoFactor with 5-fluorouracil (5-FU) in metastatic colorectal cancer in the United Kingdom.

The Company expects to begin patient enrolment for this trial by the end of April 2005. The trial will be conducted at clinical sites in the European Union (EU) and countries outside of the EU following regulatory and ethics approval in each country.

"This clearance comes on the heels of meeting our primary clinical endpoint for response rate with our ongoing US CoFactor Phase II trial in metastatic colorectal cancer," Evan M. Levine, president and CEO of Adventrx said adding, "This is an important step in the overall late stage clinical development of CoFactor and we look forward to launching this Phase IIb trial in the UK and other countries involved. We also look forward to launching two Phase III pivotal trials for CoFactor; one for metastatic colorectal cancer in the US; and one for pancreatic cancer in Europe."

This Phase IIb study is an international, multi-center, open label, randomized, controlled clinical trial to evaluate the safety and efficacy of treatment with CoFactor plus 5-FU in patients with metastatic colorectal carcinoma.

Adventrx has filed for clearance to initiate a Phase III trial in the US with CoFactor in metastatic colorectal cancer and currently plans to file in the first half of this year for clearance to initiate an EU-based Phase III study in pancreatic cancer.

CoFactor is a folate-based biomodulator developed to enhance the activity of the widely used cancer chemotherapeutic, 5-FU. Data from previous clinical trials in Europe have demonstrated clinical benefit and improved overall median survival in patients with advanced tumours, including colorectal, pancreatic and breast.