• Aegera Therapeutics, of Montreal, said it has initiated four new clinical oncology studies for AEG35156, a second generation anti-sense therapeutic targeting the X-Linked Inhibitor of Apoptosis, a key member of the Inhibitor of Apoptosis protein family. Aegera has initiated an open-label Phase II study in acute myeloid leukemia with AEG35156 given in combination with ara-C and idarubicin. The study is being performed at six sites across North America. Three other multicenter open-label Phase I/II studies have been initiated with AEG35156 in pancreatic cancer, advanced breast cancer and advanced non-small cell lung cancer. In the studies, AEG35156 will be combined with current standard-of-care chemotherapeutics.

• Allon Therapeutics Inc., of Vancouver, British Columbia, has completed enrollment in its Phase II trial evaluating AL-108 as a treatment for Alzheimer's disease. The trial has progressed ahead of schedule and is expected to be the first of Allon's three Phase II efficacy trials to report top-line data, with results expected in the first quarter of next year. The 150 subject Phase II trial is a multicenter, double-blind, randomized, placebo-controlled, multiple-dose study to evaluate the safety, tolerability and effect on cognitive function of AL-108 after 12 weeks of intranasal administration in patients with amnestic mild cognitive impairment, the precursor to Alzheimer's.

• CardioVascular BioTherapeutics Inc., of Las Vegas, finished a Phase I wound healing trial aimed at evaluating the safety and tolerability of the company's protein-based drug candidate CVBT-141B, formulated with human fibroblast growth factor-1, in patients suffering from either diabetic or venous stasis ulcers. FGF-1 was applied topically in eight subjects at a single site and was found to be well tolerated. FGF-1 offers the possibility of improved dermal ulcer healing by the promotion of new blood vessel growth in the wound bed, the company said.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, has completed recruitment of its Phase I/II clinical study using its lead compound CTCE-9908 in late-stage cancer patients. Dosing is expected to be completed by the end of October with results reported by the end of the year. The study involves testing CTCE-9908 in up to 30 patients with late-stage cancers to evaluate safety and preliminary efficacy. The trial includes patients with cancers such as breast, lung, prostate and ovarian.

• Columbia Laboratories Inc., of Livingston, N.J., said data showed, for the first time, a positive association between the use of vaginal progesterone and infants' overall health at birth. Babies born to women with high-risk pregnancies treated with Prochieve 8 percent progesterone gel appear to be less likely to need intensive care than babies born to mothers treated with placebo. The Phase III data are published in the October issue of Ultrasound in Obstetrics & Gynecology, the official publication of the International Society of Ultrasound in Obstetrics and Gynecology.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., has initiated a clinical trial of ISIS 325568, thus earning a $5 million development milestone from Ortho-McNeil Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson. The collaboration between Isis and OMI, announced Sept. 13, includes the licensing of two second-generation antisense drugs, ISIS 325568 and ISIS 377131, both of which are novel approaches for treating metabolic disease. ISIS 325568 was designed to selectively inhibit the production of glucagon receptor and has demonstrated improved glucose control in animal models of Type II diabetes.

• NicOx SA, of Sophia Antipolis, France, said its collaboration with Grupo Ferrer International, of Barcelona, Spain, has yielded promising clinical results, including Phase I results with NCX 1022, a nitric oxide-releasing derivative of hydrocortisone for skin disorders. Results were offered at the 21st World Congress of Dermatology in Buenos Aires.

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