• Accentia Biopharmaceuticals Inc., of Tampa, Fla., said it will begin patient enrollment this month for Phase III of SinuNase (intranasal lavage of 0.01% amphotericin B), which has received fast-track status from the FDA, for severe chronic sinusitis refractory to sinus surgery. The trial is to be a 16-week, double-blind comparison with 300 patients randomized between SinuNase and placebo, with the primary endpoint of resolution of key symptoms of chronic sinusitis.

• Allos Therapeutics Inc., of Westminster, Colo., said updated results of its Phase II study of Efaproxyn (efaproxiral) in patients with unresectable non-small-cell lung cancer who are receiving sequential chemoradiotherapy showed that patients receiving Efaproxyn exhibited superior survival compared to patients in a Phase III radiation therapy oncology group study. Median survival of patients in the Efaproxyn study was 20.6 months vs. 13.3 months in the radiation study. Results were presented at the 48th annual meeting of the American Society for Therapeutic Radiology and Oncology in Philadelphia.

• Amgen Inc., of Thousand Oaks, Calif., said results from a Phase II study of AMG 706, an oral, targeted VEGF receptor inhibitor, showed encouraging activity in patients with advanced high-dose imatinib-resistant gastrointestinal stromal tumors. The RECIST assessment of 120 evaluable patients demonstrated a clinical benefit rate of 27 percent (3 percent partial response plus 24 percent durable stable response at or above 22 weeks). The median progression-free survival was 16 weeks, with a 26-week progression-free survival of 27 percent and median survival of 59 weeks. Data were presented at the Connective Tissue Oncology Society meeting in Venice, Italy.

• BioMimetic Therapeutics Inc., of Franklin, Tenn., said interim results of its first orthopedic trial in Canada of GEM OS1 Bone Graft in foot and ankle fusions showed that 85 percent of patients had some degree of fusion by 12 weeks, and 67 percent achieved greater than 50 percent osseous bridging as measured in CT scans. Results were presented at the Dewar Orthopaedic Society Meeting in Toronto.

• Cell Therapeutics Inc., of Seattle, temporarily suspended enrollment in its lung cancer trial of Xyotax (paclitaxel poliglumex) called PIONEER, pending follow-up data on recently enrolled patients. A data safety monitoring board recommended the stoppage to allow data to mature and assess differences in early-cycle deaths observed between arms of the study. While most of the deaths were attributed to disease progression, more complete data are required to analyze the difference. All patients currently in the trial will continue to be treated. In addition, the study will be amended to focus on the primary efficacy endpoint of survival in women with normal estrogen levels, the patient subset that demonstrated the greatest survival benefit in the STELLAR trials.

• CombinatoRx Inc., of Cambridge, Mass., reported positive preliminary results of its Phase II trial of CRx-102 in rheumatoid arthritis. Results of the trial, which compared CRx-102 plus a disease-modifying anti-rheumatic drug (DMARD) to placebo plus DMARD, demonstrated statistically significant improvements on primary and secondary endpoints in the CRx-102 arm. In patients treated with the drug, the ACR20 response rate was 63 percent at day 42 vs. 30 percent in the control arm. CRx-102 is an oral combination candidate containing the cardiovascular agent dipyridamole and a low dose of prednisolone. Shares of CombinatoRx (NASDAQ:CRXX) jumped 17.7 percent on the news, gaining $1.25 Monday to close at $8.30.

• Epeius Biotechnologies Corp., of San Marino, Calif., said published clinical data showed the safety and single-agent efficacy of Rexin-G against chemotherapy-resistant cancers. Data from three studies involving patients with various chemo-resistant tumor types showed an 83 percent progressive tumor reduction and/or necrosis in the first trial in metastatic pancreatic cancer patients; a 64 percent objective tumor response in the second trial of patients with metastatic breast, colon, uterine, muscle and vocal cord cancer; and tumor reduction and/or necrosis in all three patients in a third trial who received a mathematically calculated optimal dose of Rexin-G. Those results were published in the International Journal of Oncology.

• Generex Biotechnology Corp., of Toronto, entered an agreement with the Lebanese-Canadian Hospital in Beirut to conduct the first clinical trial of the Antigen Express synthetic avian influenza vaccine. The vaccine is based upon simple peptide-synthesis technology, as opposed to the traditional egg-based vaccines, and preclinical studies suggest it could be used with traditional vaccines to extend their utility, as well as to prevent mortality associated with H5N1 infection when used alone.

• ImClone Systems Inc., of New York, and Bristol-Myers Squibb Co., also of New York, reported results from two Phase III trials of Erbitux (cetuximab) in metastatic colorectal cancer patients. The first trial, which compared Erbitux plus best supportive care to best supportive care alone in 572 patients with refractory disease, met its primary endpoint of overall survival. Data from the second study, which evaluated Erbitux plus irinotecan vs. irinotecan alone in 1,300 patients whose disease was not responding to first-line oxaliplatin-based chemotherapy, failed to meet its primary survival endpoint. Results, however, showed that the drug met the secondary endpoints of progression-free survival and response rate. Further analysis of the results is expected.

• MedImmune Inc., of Gaithersburg, Md., said preliminary Phase III results showed that Numax met its primary endpoint of non-inferiority by reducing the incidence of hospitalizations caused by respiratory syncytial virus (RSV) in infants at high risk for serious RSV disease by 26 percent compared to Synagis (palivizumab), its marketed drug in this indication (p<0.01). The pivotal data also indicated that Numax showed superiority over Synagis in a secondary endpoint by reducing the incidence of RSV-specific, medically attended outpatient lower respiratory infections by about 52 percent. The randomized, double-blind study involved about 6,600 high-risk infants in 24 countries. In the trial, the overall RSV attack rate was 1.4 percent for infants receiving Numax compared to 1.9 percent for those who received Synagis. The company is hoping to bring Numax, the next generation of its top-selling drug Synagis, to the market in 2008. The trial began two years ago. (See BioWorld Today, Nov. 2, 2004.)

• Migenix Inc., of Vancouver, British Columbia, said top-line Phase II data demonstrated proof of concept and evidence of clinical benefit using the oral alpha-glucosidase inhibitor, celgosivir (MX-3253), in combination with pegylated interferon and ribavirin compared to treatment with those two agents alone in patients with chronic hepatitis C virus genotype 1 infections who were characterized as nonresponders to prior therapy with optimized pegylated interferon plus ribavirin. That is considered one of the most difficult to treat patient populations. Going forward, the company is working to provide a data package to Schering-Plough Corp., of Kenilworth, N.J., for its exclusive review under a license option agreement, and to complete a Phase II celgosivir combination study in treatment-naive patients, which began enrolling patients last month.

• Neurochem Inc., of Laval, Quebec, said it received recommendations from both the North American and European Data Safety Monitoring Boards to continue its two Phase III trials of Alzhemed (tramiprosate) in Alzheimer's disease. In the North American study, 542 of the planned 1,052 patients with mild to moderate Alzheimer's have completed 18 months of treatment, and the trial is expected to be completed in January. The European trial is expected to complete enrollment of 930 patients this fall.

• Novelos Therapeutics Inc., of Newton, Mass., began a pivotal Phase III trial of its lead product, NOV-002, in advanced non-small-cell lung cancer. The randomized, open-label study is being conducted under a special protocol assessment to test the small molecule in combination with first-line chemotherapy, paclitaxel and carboplatin, compared to those two agents alone. It will include 840 patients in 10 countries, and enrollment was expected to be completed in the first quarter of 2008. The study's primary efficacy endpoint is a measure of improvement in median overall survival. NOV-002 is based on oxidized glutathione that acts as a chemoprotectant and immunomodulator.

• Palatin Technologies Inc., of Cranbury, N.J., and King Pharmaceuticals Inc., of Bristol, Tenn., reported positive Phase IIb results showing bremelanotide to be an effective treatment for erectile dysfunction. In one study, four of the five doses evaluated had clinically and statistically significant changes in the primary efficacy endpoint, the Erectile Function domain of the International Index of Erectile Function, relative to placebo. In a second study, doses of 12.5 mg and 15 mg also produced clinically and statistically significant changes on the same endpoint.

• Poniard Pharmaceuticals Inc., of South San Francisco, said positive interim data from its ongoing Phase II trial of picoplatin in patients with small-cell lung cancer have led it to develop plans to begin a pivotal Phase III trial in the first half of next year. The early findings showed a median overall survival of 26.7 weeks in the 72 evaluable patients treated with picoplatin, better than the typical 16- to 20-week median survival in patients who receive second-line chemotherapy. The trial includes lung cancer patients with platinum-refractory disease or platinum-resistant or platinum-sensitive disease who have progressed within six months after receiving first-line therapy. Poniard, which expects to enroll about 400 patients in its Phase III trial to test survival as its primary endpoint, plans to file a new drug application in 2009.

• Samaritan Pharmaceuticals Inc., of Las Vegas, submitted an investigational new drug application to evaluate its lead compound, Caprospinol (SP-233), for Alzheimer's disease. Preclinical studies have shown that the product targets and binds to the beta amyloid protein, washing out beta amyloid plaque from the brain.

• Valera Pharmaceuticals Inc., of Cranbury, N.J., said it will begin a clinical study with John Hopkins University in Baltimore of VP004, a subcutaneous implant that uses its Hydron technology to deliver naltrexone, for opioid addiction. An investigational new drug application for VP004, which was submitted to the FDA in June, has been accepted. Patient screening will begin Nov. 8. An open-label study of the implant will involve about 12 healthy volunteers who have a history of opioid abuse.

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