• Adventrx Pharmaceuticals Inc., of San Diego, said it will stop enrolling patients in its Phase III trial of CoFactor in first-line treatment metastatic colorectal cancer, upon advice from its data safety monitoring board, which cited a slow accrual rate and the fact that analysis of Phase IIb data showed no significant differences between the treatment arm and control arm with regard to either safety or efficacy. Results of the Phase IIb trial, reported last month, showed that CoFactor missed its endpoint of reducing serious hematological or gastrointestinal adverse events associated with the chemotherapy drug 5-fluorouracil (5-FU) when compared to leucovorin. Overall survival data from the Phase IIb study and data from the Phase III study are expected in the second quarter of 2008. Adventrx said it will continue an ongoing Phase II trial of CoFactor in advanced breast cancer, in which 5-FU is administered as a bolus, and anticipates completing enrollment in that study around the end of the year. (See BioWorld Today, Oct. 2, 2007.)

• Arpida Ltd., of Basel, Switzerland, reported additional data on iclaprim, showing that the intravenously administered antibiotic demonstrated linear, predictable and gender-independent pharmacokinetic characteristics in a clinically relevant dose range. Results also showed that the drug was safe and well tolerated in clinical studies. Further results showed that the addition of antifungal drug ketoconazole did not affect the pharmacokinetics of iclaprim. Those data were presented at the clinical pharmacology meeting in Kiel, Germany.

• CV Therapeutics Inc., of Palo Alto, Calif., said data from a Phase I study of CVT-6883, an adenosine A2B antagonist, showed that the drug was safe and well tolerated at a range of doses in healthy volunteers. CV retains worldwide rights to the drug, which has shown preclinical activity in several disease areas, including chronic pulmonary diseases such as asthma, chronic obstructive pulmonary disease and pulmonary fibrosis.

• GeoVax Labs Inc., of Atlanta, reported Phase I data from its HIV/AIDS vaccines, showing that both the DNA and MVA vaccines demonstrated safety and immunogenicity following the delivery of four full doses. CD4 T-cell and CD8 T-cell responses were evident both in the one-tenth dose and the full-dose vaccine recipients. Antibody responses to the envelop glycoprotein increased following the fourth vaccination and were present in 88 percent of the full-dose participants. The 36-participant full-dose study is the second in a series of four Phase I trials to test GeoVax's vaccines, which are designed to express more than 50 percent of the AIDS virus protein components to stimulate an anti-HIV immune response.

• Gilead Sciences Inc., of Foster City, Calif., reported 48-week data from two Phase III trials of Viread (tenofovir disoproxil fumarate) in adult patients with chronic hepatitis B virus infection, showing that patients receiving Viread experienced superior efficacy results compared to those receiving Hepsera, Gilead's approved HBV drug. In Study 102, which tested Viread against Hepsera in HBeAb-negative patients, 71 percent in the Viread arm had a complete response vs. 49 percent in the Hepsera arm. In Study 103, which involved HBeAg-positive HBV patients, 67 percent of those receiving Viread showed a complete response compared to 12 percent receiving Hepsera. Those updated data were presented at the liver disease meeting in Boston. Gilead reported top-line results from those trials in June. (See BioWorld Today, June 8, 2007.)

• IDM Pharma Inc., of Irvine, Calif., reported updated results from a Phase II trial of melanoma vaccine Uvidem, showing that the drug induced immune response and was well tolerated in patients with advanced disease. Nine of 33 patients (30 percent) have demonstrated evidence of clinical benefit, with duration of response ranging from 7.2 to 29.7 months. To date, none of the patients who had an objective response, measured using RECIST criteria, have relapsed, and the survival rate at 12 months is 67 percent. Further data showed that 18 of 29 evaluated patients (62 percent) showed a significant increase in TAA-specific cytokine-producing cells. In separate news, the company reported data from a Phase II study of its IDM2101 vaccine, which showed that it was well tolerated, induced broadly specific cytotoxic T-lymphocyte responses and showed a positive survival trend in non-small-cell lung cancer patients. Updated one-year survival in HLA-A2-positive patients treated with the IDM-2101 vaccine was 60 percent, compared to 49 percent in the group of patients who were HLA-A2-negative but otherwise comparable. Median survival in the IDM-2101 group was 17.3 months vs. 12 months in the comparator group.

• Immtech Pharmaceuticals Inc., of New York, completed its first exploratory malaria prevention trial of oral drug candidate pafuramidine, and said it intends to move forward with development of a prevention program. The trial was designed to determine whether the company should focus on commercializing a blood-stage or a liver-stage malaria prevention drug and provide information for Immtech to use in designing subsequent trials. Based on the results, the firm believes that continued treatment of travelers with pafuramidine for 30 days after travel will be protective against blood-stage malaria.

• Memory Pharmaceuticals Corp., of Montvale, N.J., reported positive top-line data from its Phase IIa trial of MEM 3454, a nicotinic alpha-7 receptor partial agonist, in 80 Alzheimer's disease patients over an eight-week treatment period. The primary endpoint was the change from baseline in the Quality of Episodic Secondary Memory factor score of the Cognitive Drug Research battery. In subjects receiving 5 mg and 15 mg of the drug at eight-hour post-dose time points, MEM 3454 demonstrated a statistically significant effect on the QESM compared to placebo. Both doses also achieved a statistically significant change in secondary endpoints, including other composite scores from the CDR battery. The company anticipates moving MEM 3454 into a second Phase IIa trial in cognitive impairment associated with schizophrenia in the near term.

• Pharmasset Inc., of Princeton, N.J., said results of a 14-day, Phase I monotherapy study of R7128 in chronic hepatitis C infection found the drug to be safe and well tolerated, with antiviral activity. R7128 is an oral prodrug of PSI-6130, a cytidine nucleoside analogue polymerase inhibitor of HCV, and is partnered with Basel, Switzerland-based F. Hoffmann-La Roche Ltd. The drug also is being tested in a four-week Phase I trial in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in up to 75 treatment-naïve patients chronically infected with HCV genotype 1.

• Poniard Pharmaceuticals Inc., of South San Francisco, started a Phase II trial of intravenous picoplatin in first-line metastatic colorectal cancer, with the aim of generating proof-of-concept data of the drug in combination with 5-fluorouracil and leucovorin, and to provide support for a Phase III trial. About 100 patients will be randomized to receive either picoplatin, a platinum-based chemotherapy agent, once every four weeks in combination with 5-FU and leucovorin in the FOLPI regimen or oxaliplatin in combination with 5-FU and leucovorin in the FOLFOX regimen. Efficacy and safety assessment will include objective tumor response, duration of response, progression-free survival, overall survival and assessment of peripheral neuropathy.

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, said it will continue its Phase III program of PI-88 without a special protocol assessment from the FDA, citing the need to begin the program as rapidly as possible. PI-88 recently received fast-track designation for the prevention of tumor recurrence after curative resection of primary liver cancer. Progen said, however, it intends to use FDA feedback from its SPA discussions to finalize the trial design and believes the trial will meet agency requirements. The Phase III study, expected to begin before the end of this year, will enroll about 600 patients with postoperative primary liver cancer.

• Romark Laboratories, of Tampa, Fla., reported results of a Phase II trial showing that 79 percent of interferon-naïve patients with chronic hepatitis C genotype 4 receiving the company's nitazoxanide, plus the standard of care, had a sustained virologic response 12 weeks following treatment vs. 43 percent of patients receiving standard of care without nitazoxanide. Patients in the nitazoxanide group did not experience relapse and reported no more side effects than patients in the control arm. The trial randomized 96 patients to receive either 48 weeks of standard care, 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon or 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus standard of care. Nitazoxanide is a small-molecule thiazolide that is designed to inhibit virus replication.

• SkyePharma plc, of London, completed a Phase III, long-term, open-label, safety study of Flutiform in asthma, and said that results are consistent with the safety database already accumulated on the product's individual constituents: fluticasone and formoterol. Results from the 472-patient trial will form part of the company's new drug application for Flutiform, anticipated in the second half of 2008.