• Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., completed the treatment phase of the Ampion-in-Knee trial. The three-arm, randomized, double-blind, Australian trial enrolled 60 patients with moderate to severe osteoarthritis of the knee and tested Ampion, a low molecular fraction of commercial albumin, in two combinations: with a steroid and lidocaine, and with a steroid and saline. The control arm was treated with a steroid, lidocaine and saline. Endpoints were pain perception as measured by the WOMAC pain scale and joint movement as measured by a goniometer. The endpoints were monitored at six, 24 and 72 hours after administration of the study drugs. The company expects to release the study results soon.

• Anadys Pharmaceuticals Inc., of San Diego, reported positive interim results and safety data from an ongoing Phase IIb study of setrobuvir plus the standard of care (SOC), pegylated interferon and ribavirin, in patients with genotype 1 hepatitis C. Of the subjects receiving the combination, 78 percent of treatment-naive patients and 76 percent of treatment-experienced patients had undetectable virus at Week 12, compared with 56 percent and 44 percent, respectively, for patients who received placebo plus SOC. Data through 24 weeks of dosing are expected by year-end. Setrobuvir, a non-nucleotide polymerase inhibitor, received fast-track status in the U.S. and is also being studied in combination with an undisclosed company's investigational antiviral. (See BioWorld Today, Aug. 9, 2011.)

• Baxter International Inc., of Deerfield, Ill., initiated a Phase III trial to evaluate the safety and effectiveness of BAX 111, a recombinant von Willebrand factor (rVWF), for the treatment and prevention of bleeding episodes in patients with von Willebrand disease. BAX 111 is the first recombinant von Willebrand product in clinical development.

• Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., said the independent data safety monitoring board (DSMB) for the Phase III SEAMLESS trial of sapacitabine in elderly patients with acute myeloid leukemia recommended that the study enter the randomized stage as planned. The DSMB review, mandated in a special protocol assessment, noted no safety or efficacy concerns. The board reviewed data from 46 subjects receiving oral sapacitabine capsules administered in alternating cycles with decitabine. Sapacitabine, a nucleoside analogue, also is being evaluated in Phase II trials in patients with hematological malignancies and solid tumors. Shares of Cyclacel (NASDAQ:CYCC) were up 11 cents, or 23 percent, closing at 57 cents Thursday. (See BioWorld Today, Oct. 6, 2010.)

• InnaVirVax, of Evry, France, received authorization from the French drug agency to start a Phase I/IIa study of its therapeutic vaccine VAC-3S for the treatment of HIV infections. VAC-3S is designed to fight the pathogenicity of the virus by blocking the decrease of the of CD4+ T lymphocytes count and to protect the immune system by reducing immune activation and inflammation. The dose-escalation study will enroll 24 HIV-infected patients under antiretroviral therapy.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., released results from two Phase III trials for Prolensa (bromfenac ophthalmic solution) that showed it was statistically significantly better than placebo in treating pain and inflammation associated with cataract surgery. In both studies, once-daily Prolensa met the primary efficacy endpoint of absence of ocular inflammation 14 days following surgery and the secondary efficacy endpoint of elimination of ocular pain one day post-surgery. There were no serious drug-related ocular or systemic adverse events. Because Prolensa has a lower concentration of the active ingredient in ISTA's Bromday, along with high efficacy and safety, the company plans to discontinue Bromday after the successful launch of Prolensa.

• Keryx Biopharmaceuticals Inc., of New York, reported Phase I/II combination activity of KRX-0401 (perifosine) in the treatment of advanced multiple myeloma patients. The data showed the combination of perifosine and bortezomib was active and well tolerated in patients previously treated with bortezomib. The survival data (median overall survival was 25 months) are encouraging, even in patients previously exposed to, and refractory to, bortezomib and immunomodulatory drugs. The results were published in the Oct. 11, 2011, online edition of the Journal of Clinical Oncology. Perifosine also is being evaluated in Phase III trials in multiple myeloma and refractory advanced colorectal cancer. (See BioWorld Today, March 10, 2011.)

• Telik Inc., of Palo Alto, Calif., initiated a Phase IIb trial evaluating Telintra (ezatiostat HCl) in patients with low to intermediate-1 IPSS risk, transfusion-dependent, nondeletion myelodysplastic syndrome, who have not been treated with hypomethylating agents such as Vidaza or Dacogen. The multicenter trial is intended to enroll up to 145 patients. The primary objective is to determine the hematologic improvement-erythroid response rate, as determined by clinically significant transfusion reduction or independence. Telintra is a modified glutathione analogue designed to stimulate the production of blood cells in the bone marrow.

• ViroMed Co. Ltd., of Seoul, South Korea, reported the results of a Phase I/II study that showed about 80 percent of the 12 subjects who received three different doses of VM202-DPN experienced a reduction in diabetic neuropathy pain (DPN). No adverse events were reported during the six- to 12-month follow-up period. While current DPN treatment options include analgesics for temporary pain relief and symptomatic treatments for short delay of symptoms, VM202-DPN aims at a cure by regenerating damaged nerve cells and nearby capillaries. The results of the U.S. study were presented at the BIO Korea 2011 Conference & Exhibition. ViroMed plans to apply by the end of the year to begin a Phase II study in the U.S. and is preparing for a Phase II study in South Korea.