• Introgen Therapeutics Inc., of Austin, Texas, said Phase I/II data showed that intratumoral administration of Advexin in patients with advanced esophageal cancer was found to be safe, feasible and clinically active. Nine of 10 patients had local tumor responses of stable disease, and overall one-year survival was 60 percent. These results were published in Cancer Science.

• Synthetic Blood International Inc., of Costa Mesa, Calif., began a Phase II trial to evaluate the safety and biological effects of Oxycyte, its perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute, in patients with traumatic brain injury. The primary purpose of the eight-patient, open-label, proof-of-concept study is to demonstrate Oxycyte’s ability to increase brain oxygen tension and favorably affect other brain chemistries that impact clinical outcome in patients suffering severe head injury. Also, the study will assess the safety of Oxycyte when given by intravenous infusion.

• Targeted Genetics Corp., of Seattle, received FDA clearance to amend the clinical protocol of its ongoing Phase I trial of tgAAC94 in patients with inflammatory arthritis. As amended, the protocol now includes a higher dose and increases the number of patients targeted for enrollment from 40 to 120. Under the amended protocol, the study now is designated a Phase I/II trial and is more focused, as previously it was testing two dose levels of tgAAC94 in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.

• Valeant Pharmaceuticals International Inc., of Costa Mesa, Calif., reported 48-week results from a Phase II study of pradefovir, showing that 10 mg, 20 mg and 30 mg of the oral antiviral compound had a statistically superior viral load reduction compared to 10 mg of Hepsera (adefovir dipivoxil, from Gilead Sciences Inc.). Valeant is evaluating the safety and efficacy of pradefovir for compensated chronic hepatitis B. Pradefovir, a prodrug of adefovir, was licensed from Metabasis Therapeutics Inc., of San Diego.

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