• Corgentech Inc., of South San Francisco, completed patient enrollment in three Phase II trials of ALGRX 4975, one of three mid- to late-stage non-opioid pain management drugs the company is developing to evaluate its ability to reduce postsurgical pain. The three trials each enrolled about 40 patients who have either undergone gallbladder removal, hernia repair or total knee-replacement surgery. The two in gallbladder removal and hernia repair were each conducted at single sites, while the trial in knee replacement patients was conducted at two sites.

• CV Therapeutics Inc., of Palo Alto, Calif., said its study of Ranexa (ranolazine extended-release tablets) called MERLIN (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) TIMI-36 will continue as planned based on the results of an interim efficacy analysis. A statistically significant drug treatment effect on the rate of cardiovascular death (p<0.001) would have been needed for the data safety monitoring board to recommend stopping the study early. Preliminary results could be available in the fourth quarter or the first quarter of next year. (See BioWorld Today, Jan. 31, 2006.)

• Debiopharm SA, of Lausanne, Switzerland, reported data at the Conference on Retroviruses and Opportunistic Infections in Denver, confirming Debio-025’s tolerability and safety at repeated oral doses in HIV-1 subjects. The double-blinded, placebo-controlled study also showed that the product was rapidly absorbed after administration, and anti-HIV-1 activity was observed in 11 of 36 subjects treated with Debio-025. Nine of them showed a viral load reduction lower or equal to 0.5 log¹⁰ and two a reduction higher to 1.0 log¹⁰.

• Gastrotech Pharma A/S, of Copenhagen, Denmark, began a Phase II study of GTP-200 in cancer cachexia patients. The study includes 30 patients with end-stage cancer and significant weight loss, who will be treated with daily injections of two dosages of GTP-200 for a total of eight weeks to evaluate its effect on body weight, body composition, appetite and quality of life. It is expected to be completed in the first quarter of next year. The trial follows a Phase I/II study that showed the treatment to be safe and effective on several endpoints, with specific findings to be unveiled the upcoming American Society of Clinical Oncology meeting.

• Halozyme Therapeutics Inc., of San Diego, and Baxter Healthcare Corp., of Deerfield, Ill., said results from a study called INFUSE-LR showed that the use of Hylenex preceding subcutaneous infusion of hypodermoclysis accelerated the flow rate by about fourfold vs. the subcutaneous infusion of hypodermoclysis with placebo, while causing less edema. Also, it was preferred by 92 percent of investigators and an equal amount of study subjects. Hylenex is a liquid injectable formulation that includes recombinant human hyaluronidase (rHuPH20), which is FDA-approved for use as a spreading agent to increase the absorption and dispersion of other injected drugs and for subcutaneous hydration.

• Insert Therapeutics Inc., of Pasadena, Calif., submitted an investigational new drug application to the FDA to begin a Phase I trial using its lead anticancer compound, IT-101, to treat patients with unresectable or metastatic solid tumors. The product is a combination of the company’s polymer technology, Cyclosert, and the cancer drug camptothecin. The study, which could begin next quarter, is designed to evaluate IT-101’s safety, pharmacokinetics and tolerability.

• Isis Pharmaceuticals Inc., of San Diego, said data to be reported at the Southwest Lipid Association’s inaugural meeting in San Antonio support an enhanced profile for ISIS 301012 in treating patients with cardiovascular disease. In addition to previously reported significant reductions in both apoB-100 and LDL-C, ISIS 301012 also reduced serum triglycerides, achieving a median reduction of 46 percent. A second-generation antisense drug, the product inhibits apoB-100.

• NeoPharm Inc., of Waukegan, Ill., said a proposed clinical trial of LEP-ETU (Liposomal Paclitaxel Easy to Use) could begin next quarter, at the earliest, pending resolution of an issue with the FDA. Both sides have been engaged in a dialogue to review the regulatory pathway for using section 505(b)(2) for the NeoLipid drug candidate, and the agency has advised that additional data are required to establish bioequivalence between LEP-ETU and Taxol. Already NeoPharm is in the planning phase for a meeting to discuss beginning a 100-patient efficacy trial to support approval under 505(b)(2). The company is preparing to submit the additional requested data in advance of its next FDA meeting, scheduled for the next quarter.

• Renovis Inc., of South San Francisco, said Phase III data published in the Feb. 8, 2006, issue of the New England Journal of Medicine showed a statistically significant reduction with NXY-059 vs. placebo on the primary outcome of stroke-related disability, as assessed on the Modified Rankin Scale (p=0.038 at 90 days). The findings come from the international SAINT I trial, which is being conducted by the product’s exclusive licensee, AstraZeneca AB, of London. Additional analysis showed a reduction in the disability of patients at both ends of the scale, with 4.4 percent more patients treated with NXY-059 (previously called Cerovive) becoming free of symptoms and 3.7 percent more patients able to walk without help and being less dependent on others for bodily needs, compared to placebo.