• AEterna Zentaris Inc., of Quebec, disclosed additional positive top-line Phase I data for AN-152, a cytotoxic conjugate, in patients with gynecological and breast cancers. Data showed that the compound has a good safety profile and established the maximum tolerated dose at 267 mg/m(2), which will be used in a Phase II trial. Study results also provided a hint of efficacy as disease stabilization and regression of lesions were observed at the 160 mg/m(2) and 267 mg/m(2) dose levels.

• Antipodean Pharmaceuticals Inc., of San Francisco, completed enrollment in a Phase II study to evaluate MitoQ (mitoquinone) in Parkinson's disease. The trial is designed to randomize 128 patients into one of three treatment arms to compare MitoQ, administered at 40 mg or 80 mg once daily, to placebo. The primary endpoint is disease progression according to the Unified Parkinson's Disease Rating Scale.

• Arrow Therapeutics Ltd., of London, initiated a Phase I study of A-831, a small-molecule antiviral inhibitor of hepatitis C. The trial will evaluate the safety, tolerability and pharmacokinetics of single escalating doses of A-831 in healthy volunteers in the UK. A-831 is designed to target the NS5a protein.

• BioAxone Therapeutic Inc., of Montreal, reported positive interim results from a Phase I/IIa trial of Cethrin in acute spinal cord injury. Data showed that the treatment is safe and well tolerated when administered at four dose levels - 0.3 mg, 1 mg, 3 mg and 6 mg - and that the functional benefit might be dose dependent. After six weeks, 31 percent of patients recovered some sensory and/or motor function below the level of their injury and converted from complete injury to an incomplete injury. The 12-month study is evaluating 37 patients who suffered a complete thoracic or cervical injury, and the efficacy endpoint is designed to assess sensory and motor function as measured by the American Spinal Injury Association's scale. Cethrin is a recombinant protein delivered topically onto the spinal cord during decompression/stabilization surgery.

• BioMS Medical Corp., of Edmonton, Alberta, enrolled the first patients in its Phase II trial of MBP8298 in relapsing-remitting multiple sclerosis. The 215-patient study will test the drug against placebo over 15 months, followed by a 12-month open-label extension period. The study's objectives are to demonstrate the safety and efficacy of MBP8298 vs. placebo as measured by relapse rate, MRI activity and disease progression. MBP2898 also is in a pivotal Phase III trial for secondary progressive multiple sclerosis, with interim data anticipated in about 18 months.

• Draxis Health Inc., of Mississauga, Ontario, said its DraxImage radiopharmaceutical business unit received FDA approval to run two clinical trials using radioactive Iobenguane I-131 injection ([131] I-metaiodobenzylguanidine, or I-131 MIBG) for high-risk neuroblastoma. A Phase II study will evaluate I-131 MIBG when administered with intensive chemotherapy and autologous stem cell rescue in high-risk neuroblastoma, and a Phase I trial will test I-131 MIBG in combination with irinotecan and vincristine to determine safety and tolerability in patients with resistant/relapsed high-risk neuroblastoma. Both trials are expected to begin in December or early 2007.

• Genzyme Corp., of Cambridge, Mass., started treating patients in a Phase II trial of Clolar (clofarabine), the second pivotal study this year aimed at expanding the product label. The 109-patient CLASSIC II study aims at testing the safety and efficacy of the drug in previously untreated, older adults with acute myelogenous leukemia who are unlikely to benefit from standard induction therapy. The primary endpoint is overall response measured as either complete response or complete response with incomplete platelet recovery. Secondary endpoints include duration of remission, disease-free survival, overall survival, safety and 30-day mortality rate. The first pivotal trial, CLASSIC I, began enrolling patients earlier this year to compare the combination of Clolar and cytarabine to cytarabine alone.

• Halozyme Therapeutics Inc., of San Diego, completed enrollment of a clinical trial of Enhanze Technology, an enzyme-based drug delivery platform based on recombinant human PH20 hyaluronidase (rHuPH20). The study was designed to compare the pharmacokinetics, safety and tolerability of a large protein molecule therapeutics agent subcutaneously injected both with and without rHuPH20. If findings from the trial are supportive, the company might explore further use of rHUPH20 for administering large molecule agents.

• Kamada Ltd., of Ness Ziona, Israel, started Phase I trials of an inhaled formulation of its flagship drug, alpha 1-proteinase inhibitor (API), to examine the product's safety in 20 participants. Kamada also signed an agreement with PARI, a Germany-based aerosol therapy firm, for joint clinical development and marketing of API administered by inhalation. Terms of the collaboration were not disclosed. API is in development for congenital emphysema and cystic fibrosis.

• MannKind Corp., of Valencia, Calif., said the FDA cleared its investigational new drug application for its cancer immunotherapy program, and the company expects to begin a Phase I trial to test the immune response, safety and tolerability of a DNA vector with two synthetic peptides in subjects with solid malignancies, in a plasmid prime-peptide boost treatment. The study is designed to target two tumor-specific antigens: preferential antigen of melanoma (PRAME) and prostate-specific membrane antigen (PSMA). MannKind anticipates enrolling the first patient before the end of the year.

• Memory Pharmaceuticals Corp., of Montvale, N.J., completed enrollment in its ongoing Phase IIa trial of MEM 1003 in acute mania in bipolar disorder. Top-line results are expected in the first quarter of 2007. The 80-subject trial is designed to test MEM 1003 against placebo over a 21-day treatment period, followed by an optional open-label four-week treatment period. The primary outcome measure is the change in the Young Mania Rating Scale at 21 days. MEM 1003 is a neuronal L-type calcium channel modulator that also is in development for Alzheimer's disease.

• Pharmaxis Ltd., of Sydney, Australia, said the FDA designated Bronchitol as a fast-track product for cystic fibrosis, which could expedite regulatory review of the product. Bronchitol previously received orphan drug status in both the U.S. and Europe. The product is in Phase II and Phase III trials, and Pharmaxis anticipates completing a new drug application in 2008.

• Pro-Pharmaceuticals Inc., of Newton, Mass., began dosing patients in its Phase II program of Davanat as a first-line treatment for colorectal cancer. The trial will evaluate Davanat with Avastin (bevacizumab, Genentech Inc.), 5-fluorouracil and leucovorin in patients who have locally advanced, unresectable or metastatic colorectal cancer and are unable to tolerate intensive chemotherapy. The endpoint is tumor shrinkage. Pro-Pharmaceuticals is enrolling patients in two Phase II studies, with preliminary results expected in the first quarter of 2007.

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