• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said its antiviral RNAi drug ALN-RSV01 was well tolerated and demonstrated statistically significant antiviral activity against respiratory syncytial virus (RSV) infection in a Phase II trial. ALN-RSV01 was delivered via inhalation in the double-blind, placebo-controlled, randomized 88-patient study. Complete data will be presented at a scientific meeting next month.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., initiated a Phase II trial comparing the efficacy and tolerability of CH-1504 to methotrexate in rheumatoid arthritis. CH-1504 is a nonmetabolized antifolate designed to avoid the kidney and liver toxicities associated with methotrexate. The double-blind, 200-patient trial will compare CH-1504 dosed daily at 0.25 mg, 0.5 mg and 1 mg to weekly 20-mg doses of methotrexate, with a primary endpoint of ACR 20 response after 12 weeks.

• EntreMed Inc., of Rockville, Md., started a Phase II study of MKC-1, a cell cycle inhibitor, in recurrent or resistant epithelial ovarian cancer and advanced endometrial cancer patients. The trial's primary objective is to determine the antitumor activity of the drug when administered orally as a single agent in platinum- or taxane-refractory cancer patients. Safety, response duration in patients with an objective response and progression-free survival also will be assessed. The study will be a two-arm parallel group design with each group having two stages.

• Genaera Corp., of Plymouth Meeting, Pa., said the FDA cleared its investigational new drug application seeking to begin clinical trials with trodusquemine (MSI-1436) in Type II diabetes. Trodusquemine, which regulates insulin and leptin receptor signaling by inhibiting protein tyrosine phosphatase 1B (PTP-1B), also is being studied in a Phase I obesity trial.

• Generex Biotechnology Corp., of Worcester, Mass., received Ukraine regulatory clearance to begin a Phase III trial of Oral-lyn, its liquid insulin spray for Type I diabetes. The company previously received non-objection letters from regulatory authorities in Canada and the U.S. regarding the trial. The six-month, 750-patient study will compare Oral-lyn to standard injectable insulin with a primary endpoint of lowering hemoglobin A1C (HbA1C). Oral-lyn is approved in Ecuador and India. (See BioWorld Today, June 27, 2007.)

• ImmunoVaccine Technologies Inc., of Halifax, Nova Scotia, said it met with Health Canada's regulatory affairs division to discuss requirements for Phase I testing, in which IVT plans to combine antigens with its vaccine-enhancement technology, the VacciMax platform. The company will be in a U.S. Phase I trial, as a result of its December acquisition of Immunotope Inc., of Doylestown, Pa. (See BioWorld Today, Dec. 11, 2007.)

• Nventa Biopharmaceuticals Corp., of San Diego, completed enrollment and initiated dosing of the third cohort of patients in its Phase I trial of HspE7 in cervical dysplasia, a precursor to cervical cancer. HspE7 is a therapeutic vaccine targeting human papillomavirus-related diseases. The Phase I study is expected to enroll up to 24 patients in five cohorts, each receiving increasing doses of the vaccine and/or adjuvant.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said Indian authorities cleared its protocol for a Phase II trial of bavituximab plus chemotherapy in breast cancer. The 46-patient trial will evaluate the ability of bavituximab combined with carboplatin and paclitaxel to affect overall response rate. Bavituximab is a monoclonal antibody that binds phosphatidylserine, a phospholipid exposed in tumor blood vessels. It is being studied in other Phase I solid tumor trials, and additional Phase II trials are planned.

• Sequenom Inc., of San Diego, said the institutional review board at San Diego-based Sharp HealthCare approved the protocol for a screening study to clinically assess the company's noninvasive cell-free fetal nucleic acid SEQureDx technology for detecting fetal aneuploidy, including Down syndrome. The screening technology is designed to extract fetal nucleic acid material from a blood specimen collected from the mother to determine the genetic status of the fetus.

• Tercica Inc., of Brisbane, Calif., started dosing the first patient in a Phase II trial testing the combination of South San Francisco-based Genentech Inc.'s recombinant human growth hormone Nutropin AQ (somatropin [rDNA origin]) and Tercica's recombinant insulin-like growth factor-1 Increlex (mecasermin [rDNA origin] injection). The primary objective is to assess the efficacy, measured as first-year height velocity, and safety of three different combination regimens compared to growth hormone alone in short stature associated with IGF-1 deficiency. The study will enroll about 100 patients, and Tercica anticipates completing enrollment in mid-2009. Tercica and Genentech began collaborating on a combination product in July 2007 in short stature, as well as for adult growth hormone deficiency and potentially other metabolic disorders. Under the terms, Genentech has rights to opt in to development programs for both products through the completion of Phase II. (See BioWorld Today, July 12, 2007.)