• Amarillo Biosciences Inc., of Amarillo, Texas, announced that four clinical sites are ready to enroll patients in a Phase II study to test low-dose interferon alpha lozenges administered orally to HIV-positive subjects with oral warts.

• Durect Corp., of Cupertino, Calif., completed Phase I trials with a new product, DUR-843, which is intended to treat a persistent pain condition. The company said DUR-843 has the potential to provide advantages over existing pain medications, but did not disclose details about the delivery method.

• Genmab A/S, of Copenhagen, Denmark, started a Phase II study of HuMax-CD20 (ofatumumab) in combination with fludarabine and cyclophosphamide to treat chronic lymphocytic leukemia in previously untreated patients. Fifty-six patients will be enrolled in the study. Genmab also disclosed more positive data in the HuMax-CD20 Phase I/II study to treat patients with relapsed or refractory CLL. An objective response rate of 50 percent (13 of 26 evaluable patients) was observed in patients treated at the highest dose level (2,000 mg). That included one nodular partial remission confirmed by CT scan and one patient who qualified as nPR but had residual lymphadenopathy revealed by CT. Responders include one additional patient compared to previously reported data.

• Helix BioPharma Corp., of Aurora, Ontario, started patient enrollment in a Phase II trial of topical interferon alpha-2b for the treatment of ano-genital warts associated with human papillomavirus infection. The trial is taking place in Sweden and will assess the efficacy and safety of the product compared with placebo. It will enroll 120 patients.

• Immtech Pharmaceuticals Inc., of New York, started a Phase II trial in the U.S. with its oral drug candidate, pafuramidine maleate, as a prophylaxis to prevent malaria for travelers to endemic regions. The study protocol was reviewed by the FDA and has been approved by the institutional review board of a major U.S. medical center.

• Introgen Therapeutics Inc., of Austin, Texas, said expanded p53 biomarker studies confirmed with high statistical significance the survival benefit of Advexin therapy in patients with abnormal p53 function. The new results showed that patients with the abnormal p53 biomarker in recurrent squamous cell carcinoma of the head and neck were most likely to have a survival benefit from their use of Advexin. Introgen is preparing to start the analyses of Phase III data in support of its registration of Advexin.

• Memory Pharmaceuticals Corp., of Montvale, N.J., said the FDA completed its review of the investigational new drug application for MEM 3454 and released the clinical hold. The Phase IIa trial with MEM 3454 in Alzheimer's disease will start during the first quarter of 2007. (See BioWorld Today, Oct. 18, 2006.)

• NicOx SA, of Sophia Antipolis, France, said the FDA provided feedback on the requirements for long-term safety data needed for the submission of the NDA for naproxcinod (HCT 3012), telling the company that a large clinical cardiovascular outcomes study would not be required at the time of NDA submission. Naproxcinod is in Phase III trials for the signs and symptoms of osteoarthritis. Separately, the firm disclosed top-line results from a pharmacodynamic clinical study using ambulatory blood pressure monitoring, which demonstrated a differentiated and favorable 24-hour blood pressure profile for naproxcinod, compared to naproxen, in hypertensive subjects after two weeks. The trial results showed a 2 mm Hg difference in both the average systolic and diastolic blood pressure in favor of naproxcinod, in terms of the mean change from baseline as measured by ABPM, but the difference did not reach statistical significance for systolic blood pressure, the primary endpoint of the trial (p=0.101). Statistical significance was achieved for diastolic blood pressure, which was an important secondary endpoint (p=0.007).

• Vernalis plc, of Winnersh, UK, started a Phase I trial of V24343, a cannabinoid-1 antagonist, as a potential treatment for obesity, Type II diabetes and related disorders.

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