• Access Pharmaceuticals Inc., of Dallas, began a new clinical study involving its DACH platinum polymer therapeutic, AP5346, in patients with head and neck cancer. The study’s goal is to demonstrate the ability of the tumor-targeting polymer system to deliver more platinum to tumors than can be attained with oxaliplatin, the approved DACH platinum compound.

• Amgen Inc., of Thousand Oaks, Calif., said Phase II data demonstrated twice-yearly injections of denosumab (previously AMG 162), a RANK ligand inhibitor, significantly increased bone mineral density in the total hip, lumbar spine, distal 1/3 radius and total body compared to placebo. Results of the one-year study appeared in the Feb. 23 issue of the New England Journal of Medicine. Data results also included an open-label Fosamax (alendronate) arm of the same clinical trial.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., initiated a randomized Phase II study of Actilon (CPG 10101) for the treatment of patients with chronic hepatitis C infection. The trial is expected to enroll 90 adults with genotype 1 hepatitis C virus who have failed previous therapy with the current standard of care. Coley expects preliminary data to be available in the second half of 2006.

• Genzyme Corp., of Cambridge, Mass., ceased to enroll new patients in its Phase II trial that is testing whether autologous skeletal myoblasts can be used to reverse damage done to cardiac muscle following a heart attack or to safely halt a patient’s further progression of heart failure. The trial’s data monitoring committee recommended this step after concluding that there is a low likelihood that the trial would result in the hypothesized improvements in heart function. The company intends to follow all 95 patients who have been enrolled to date, and it will conduct an analysis of all efficacy and safety once the trial is complete.

• Javelin Pharmaceuticals Inc., of San Diego, reported final results from a Phase IIb study of Rylomine (intranasal morphine) in 187 patients with moderate-to-severe postsurgical pain. In addition to meeting the study’s primary endpoint of a linear dose-response for pain relief over four hours as compared to placebo, secondary endpoint results showed statistically superior pain relief compared to placebo for the two highest dose levels of Rylomine and intravenous morphine 7.5 mg. The data were presented at the 22^nd Annual Meeting of the American Academy of Pain Medicine in San Diego.

• Jazz Pharmaceuticals Inc., of Palo Alto, Calif., said patients with fibromyalgia syndrome treated with Xyrem (sodium oxybate) in a Phase II trial experienced significant pain relief. The eight-week study examined two dosages of Xyrem (at 4.5 g per day or 6 g per day) compared to placebo in 188 patients. Results were presented at the annual meeting of the American Academy of Pain Management in San Diego.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., reported that the latest internal review of safety data for its ongoing Phase II trial of NX-1207 revealed no serious drug side effects. NX-1207, in development to treat benign prostatic hyperplasia, has completed two Phase I and II trials with results showing an average of 23 percent prostate shrinkage in one month with minimal side effects.

• Prima Biomed Ltd., of Melbourne, Australia, said its Phase IIa trial of CancerVac for ovarian cancer has completed recruitment. If results are positive, Prima plans to start a pivotal trial in ovarian cancer that could lead to the launch of the product in Australia. The company’s partner outside of Australia, Biomira Inc., of Edmonton, Alberta, will review the final report to decide whether to exercise its right to in-license CancerVac.

• Ziopharm Oncology Inc., of New York, dosed the first patient in a Phase I/II trial with ZIO-201 (isophosphoramide mustard), its alkylating drug to treat cancer. ZIO-201 is the active metabolite of ifosfamide, an existing drug for sarcoma that often is limited by its toxicity. Data from an ongoing Phase I study suggest that Ziopharm’s product could be given at much higher doses than ifosfamide. The company also expects to conduct Phase II studies of ZIO-201 in adult and pediatric sarcoma, and an exploratory Phase II trial in lymphoma.