• Accera Inc., of Broomfield, Colo., said data from its Phase II study of Ketasyn (AC-1202) in age-associated memory impairment showed that the drug has a positive and clinically meaningful effect on memory in older adults. The study enrolled 159 patients, who received either Ketasyn or placebo for 90 days, followed by a two-week washout period, and then were evaluated through a battery of neuropsychometric tests that measure various aspects of memory and cognition. Consistent with earlier findings from Alzheimer's disease studies, subjects who did not have the APOE4 genotype responded particularly well to treatment. The company intends to begin a pivotal Phase III study in early 2008 in mild-to-moderate Alzheimer's patients.

• Ambrilia Biopharma Inc., of Montreal, reported positive top-line results from the first clinical study of its prolonged-release formulation of octreotide (C2L) in acromegalic patients. Data from a single-dose administration of C2L in eight patients indicated that C2L normalizes the major marker for acromegaly, insulin-like growth factor-1, and suppresses high-growth hormone plasma levels. No serious adverse events were seen. Ambrilia said earlier this week that it had completed patient recruitment in a pivotal Phase III trial of the product in that indication.

• ImClone Systems Inc., of New York, said it began enrollment in a Phase II trial of IMC-A12, an anti-insulin-like growth factor-1 receptor monoclonal antibody, to treat advanced prostate cancer. The single-arm, open-label study of IMC-A12 will enroll 30 asymptomatic, chemotherapy-naive patients with metastatic androgen-independent prostate cancer. The trial is designed to evaluate the efficacy, safety and pharmacology of IMC-A12 administered every two weeks by intravenous infusion. The antibody is designed to inhibit insulin-like growth factors I and II from binding to and activating the receptor, thus blocking a signaling pathway that enhances tumor cell proliferation and survival.

• Lorus Therapeutics Inc., of Toronto, completed a proof-of-concept trial of GTI-2040 in acute myeloid leukemia, and expanded the program in that indication with the initiation of a Phase II trial of GTI-2040 and high-dose Ara-C in refractory and relapsed AML. The Phase II trial will evaluate efficacy as well as intracellular target activities and pharmacological synergies between the two agents. Lorus expects the new trial to be completed by the end of 2008. The proof-of-concept study demonstrated safety and showed promising clinical responses in patients, Lorus said. Moreover, the clinical responses correlated with down-regulation of R2, the cellular target of the antisense agent GTI-2040. Complete results from that trial are expected to be presented later in a scientific publication.

• Orexo AB, of Stockholm, Sweden, said it began Phase I trials of its product for nocturia and on-demand treatment of urinary incontinence, OX 19 (sublingual desmopressin). It has developed several formulations of the product and now is beginning clinical testing of the lead formulation. The bioavailability trial, which is taking place in Sweden, is expected to be completed by the end of the year.

• Orthogen AG, of Dusseldorf, Germany, said its Orthokine therapy produced better results over six months than cortisone treatment in a trial in disc-related back pain. Results of the randomized, prospective, double-blind trial were published in Spine. The company tested the effect of the endogenous protective proteins produced using the Orthokine procedure. Proteins are isolated from the blood of the patient and stimulated to produce IL-1Ra and other cytokine antagonists and growth factors. After processing in a laboratory, the protein solution is isolated and prepared as an injection. The 84-patient study was conducted in Germany. Orthokine is used in Europe, but not approved in the U.S. by the FDA.

• Pharmaxis Ltd., of Sydney, Australia, said it Phase III B301 study of Bronchitol for treating bronchiectasis met its two primary efficacy endpoints: quality of life and mucus clearance. The 362-patient study demonstrated a highly significant improvement in quality of life based on patient questionnaires, and a significant difference in mucus clearance at 12 weeks vs. placebo (p<0.001). The trial was conducted in Australia, New Zealand and the UK. Bronchitol is administered by inhalation to the patient's lungs. Earlier this month, Pharmaxis requested a special protocol assessment review with the FDA regarding a U.S. Phase III trial of Bronchitol.

• Prolexys Pharmaceuticals Inc., of Salt Lake City, said it began its first-in-humans Phase I trial of PRLX 93936. The open-label trial is designed to evaluate safety, pharmacokinetics, pharmacodynamics and dosing in up to 36 patients with advanced solid tumors. PRLX 93936 is a structural analogue of a compound called erastin, in-licensed by Prolexys from the MIT/ Whitehead Institute in January 2005. The small molecule PRLX 93936 is about 100 times more potent and 1,000 times more soluble than erastin, the company said.