• Amazon Biotech Inc., of New York, signed an interim letter of agreement with the Immunology Clinic of New York to conduct a Phase I/II, randomized, double-blind, placebo-controlled study to test the safety and efficacy of its botanical drug product, AMZ0026, in pre-symptomatic HIV-positive patients undergoing no other anti-retroviral therapies. The company is negotiating with other investigative sites, including hospital clinics, to participate in the study.

• Biovest International Inc., of Worcester, Mass., received approval from the Russian Ministry of Health and Social Development to recruit patients for its ongoing Phase III trial of BiovaxID in indolent follicular non-Hodgkin's lymphoma. The approval adds 14 clinical sites to the study, and Biovest anticipates recruiting up to 175 patients from those sites over the next 18 months.

• Cell Genesys Inc., of South San Francisco, said enrollment has opened for an expanded multicenter Phase I trial of CG0070 to evaluate escalating multiple-dose regimens of CG0070 in patients with recurrent bladder cancer. The expanded trial was prompted by encouraging interim safety and efficacy data for single-dose administration of CG0070 and will include up to 45 additional patients who have failed previous therapy with Bacillus Calmette-Guerin, the current standard therapy. CG0070 is being developed through a global alliance with Novartis AG, of Basel, Switzerland.

• Innovive Pharmaceuticals Inc., of New York, began a Phase I trial of INNO-406 in patients resistant to Gleevec (imatinib, from Novartis AG) or intolerant Philadelphia-positive leukemias. Positive (Ph+) leukemias include chronic myeloid leukemia in chronic, accelerated or blastic phases (CML-CP, CML-AP, CML-BP, respectively). The study is expected to enroll up to 100 patients.

• Novelos Therapeutics Inc., of Newton, Mass., said Dana-Farber/Partners Cancer Care enrolled the first patient in a Phase II trial of NOV-002 in combination with carboplatin in platinum-resistant ovarian cancer patients. The primary objective of the open-label, single-arm Phase II trial will be to determine the tumor response rate in a cohort of women with platinum-resistant ovarian cancer after treatment with NOV-002 and carboplatin. Up to 25 women will be enrolled and may receive up to six cycles of NOV-002 and carboplatin. Interim results are expected in early 2007.

• Oncolytics Biotech Inc., of Calgary, Alberta, received a letter of approval from the UK Medicines and Healthcare products Regulatory Agency for its clinical trial application to begin a Phase II trial to evaluate the antitumor effects of intratumoral administration of Reolysin in combination with low-dose radiation in 40 patients with advanced cancers. The trial will be an open-label, single-arm, multicenter study of Reolysin delivered via intratumoral injection to patients during treatment with low-dose radiotherapy.

• Replidyne Inc., of Louisville, Colo., started a Phase I trial of its topical anti-infective drug candidate, REP8839, being developed for skin and wound infections and the prevention of S. aureus infections including methicillin-resistant S. aureus infections in hospital settings. REP8839 is being developed in combination with the topical antibiotic mupirocin. The study will examine various concentrations of REP8839 alone and in combination with mupirocin vs. a placebo control in 110 healthy adults.

• Topigen Pharmaceuticals Inc., of Montreal, said preliminary Phase II data indicated that inhaled TPI-ASM8 demonstrated protection in early and late-stage allergic responses in asthma patients. The company touted the findings as the first demonstration of efficacy with an RNA-targeting drug in respiratory patients, including substantial reductions of eosinophil cell levels and suppression of target gene expression. Also, inhaled TPI-ASM8 was safe and well tolerated. The drug consists of two modified antisense oligonucleotides designed to reduce the recruitment and persistence of chronic inflammatory cells.

• UCB SA, of Brussels, Belgium, reported positive Phase II data showing that Cimzia (certolizumab pegol, CDP870) met its co-primary endpoints in reducing psoriasis following 12 weeks of treatment. Patients who received 200-mg doses of the new anti-tumor necrosis factor therapy had a 74.6 percent reduction in their Psoriasis Area and Severity Index score, and those on 400-mg doses had an 82.8 percent reduction. Those results were statistically significant (p<0.001) compared to placebo patients, who exhibited a 6.8 percent reduction. Cimzia was well tolerated, with adverse events as expected for an anti-TNF treatment. Already, the product is under FDA and European review for approval in treating Crohn's disease.