• Accentia Biopharmaceuticals Inc., of Tampa, Fla., said it has evidence that most, if not all, cases of chronic sinusitis are due to a fungal-induced inflammation, as originally proposed by investigators at the Mayo Clinic. The data were collected as part of the company's ongoing pivotal Phase III trial of SinuNase, an intranasal formulation of the antifungal amphotericin B.

• Adventrx Pharmaceuticals Inc., of San Diego, said it received confirmation from the FDA regarding its proposed 505(b)(2) new drug application regulatory path for ANX-514 (docetaxel emulsion). The FDA has indicated that data from a single study of about 28 patients that demonstrated the bioequivalence of ANX-514 and docetaxel is sufficient to support filing of an NDA. The company plans to start the bioequivalence trial later this year, a study that would evaluate safety and compare blood levels of docetaxel following a single dose of ANX-514 or Taxotere in patients with advanced cancers.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., said a human bioequivalence study of a new formulation of CH-1504 identified doses to be used in a Phase II evaluation in the treatment of rheumatoid arthritis. Results indicated that 1 mg of the new formulation was comparable to 15 mg of the original formulation used during previous Phase I evaluations of CH-1504. Based on the results, Chelsea intends to proceed with its upcoming Phase II trial in rheumatoid arthritis using 0.25 mg, 0.5 mg and 1.0 mg of the antifolate in lieu of the previously planned dosages. Chelsea expects to initiate that trial in the fourth quarter at sites in Europe and Canada.

• Cytogen Corp., of Princeton, N.J., reported publication of data demonstrating the value of Prostascint (capromab pendetide) in predicting outcomes for patients with prostate cancer. The study evaluated 341 patients who were imaged with Prostascint in the 1990s, and whose images showed a localization pattern known as central abdomen uptake, a finding suggestive of metastatic disease, as compared to those without such findings. In the study, prostate cancer-specific death rates were 10 times higher in patients with CAU than in patients without CAU (p=0.005). Data appeared in the current issue of Urology.

• EntreMed Inc., of Rockville, Md., reported presentation of interim results from a Phase II study of MKC-1 in patients with metastatic breast cancer. Results from the first stage of the single-agent study demonstrated the small-molecule cell-cycle inhibitor was well tolerated without evidence of cumulative toxicity in anthracycline/taxane-refractory metastatic breast cancer patients. Of the 35 evaluable patients, one complete response, two partial responses and three stable diseases of greater than four months were observed. The study has proceeded to the second stage and is continuing to enroll up to 53 evaluable patients to confirm safety and assess the extent of objective responses.

• IntelGenx Technologies Corp., of St. Laurent, Quebec, said its SL tablet technology will be included in the Phase I study of CAT 310, a cannabinoid-based neuropathic pain product being developed by Cannasat Therapeutics Inc., of Toronto. Health Canada has approved the study, for which enrollment is expected to begin in early October. IntelGenx's SL tablet delivery system is intended to improve the bioavailability of the active ingredients in CAT 310, and create a rapid onset of action.

• Kosan Biosciences Inc., of Hayward, Calif., presented updated data from a Phase I trial, showing that alvespimycin, its second-generation Hsp90 inhibitor, demonstrated antitumor activity and tolerability in combination with trastuzumab (Herceptin) in patients with refractory HER2-positive metastatic breast cancer, and in patients with refractory ovarian cancer who were progressing on standard chemotherapy. Clinical benefit was observed in 42 percent of evaluable patients (eight of 19) with HER2-positive metastatic breast cancer. It is expanding the Phase I trial to include paclitaxel in the regimen, to establish a safety profile and lay the groundwork for a potential larger Phase II/III trial. It also expects to start a Phase II monotherapy trial in newly diagnosed HER2-positive patients later this year.

• Lev Pharmaceuticals Inc., of New York, announced positive results from its pivotal Phase III clinical trial of Cinryze, a C1 inhibitor, for the prophylactic treatment of hereditary angioedema (HAE). The study results showed that the primary endpoint was achieved, showing a clinically and statistically significant reduction in the number of HAE attacks. In the 24-week, double-blind, placebo controlled study, 24 patients were randomly assigned to one of two treatment groups: 12 weeks of Cinryze treatment followed by 12 weeks of placebo or 12 weeks of placebo treatment followed by 12 weeks of Cinryze. Patients received twice-weekly doses of Cinryze or placebo. The primary endpoint was met with a 53 percent reduction in the number of attacks in the Cinryze group (p<0.0001). Secondary endpoints also showed highly significant differences in favor of Cinryze, including a 66 percent reduction in days of swelling (p<0.0001) and decreases in the average severity of attacks (p=0.0008) and average duration of attacks (p=0.0004). Based on the results, Lev said it will amend its biologics license application to seek an expanded indication for Cinryze to include the prevention of HAE attacks. Cinryze is being developed as a replacement therapy for both the acute and prophylactic treatment of HAE.

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., presented data from a prospective analysis of images from the Zemiva Phase IIb trial using its recently validated Normals reference database. Zemiva (iodofiltic acid I-123 or BMIPP) is being studied in emergency departments to rapidly detect acute coronary syndrome and evaluate cardiac ischemia. Data demonstrated Zemiva compared favorably to published performance parameters of approved cardiac blood flow tracers.

• Neoprobe Corp., of Dublin, Ohio, provided updated information from Phase II evaluation of Lymphoseek. The study in 80 patients with either melanoma or breast cancer showed an overall lymph node identification rate of 95 percent, beating the 90 percent study objective. The company said it has begun activities to prepare for Phase III testing of Lymphoseek, a radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure known as intraoperative lymphatic mapping.

• Neose Technologies Inc., of Horsham, Pa., said dosing began in its Phase II trial of NE-180 in renal patients. NE-180 is a long-acting, GlycoPEGylated erythropoietin being developed for treating anemia in adult cancer patients with nonmyeloid malignancies receiving chemotherapy, and for treating anemia associated with chronic kidney disease in dialysis and nondialysis patients. A Phase II trial in patients with chemotherapy-induced anemia began earlier this year. The trial will enroll up to 60 patients with anemia associated with chronic renal failure. It is an open-label, ascending-dose study to evaluate safety, tolerability and dose responses of NE-180 administered subcutaneously.

• Nventa Biopharmaceuticals Corp., of San Diego, initiated a Phase I trial to assess the safety and tolerability of a new HspE7 product, dosed with an adjuvant, in 24 patients with cervical intraepithelial neoplasia. The study of the therapeutic vaccine will evaluate safety and tolerability, as well as T-cell and B-cell-specific human papillomavirus-E7 immune responses.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., submitted a clinical protocol with regulators in India for an open-label Phase II safety and efficacy trial of bavituximab in combination with paclitaxel and carboplatin in patients with metastatic breast cancer. Up to 15 patients will be enrolled initially, and the study will be expanded up to 46 patients if promising results are observed in the first cohort. The primary endpoint is overall response rates. Secondary objectives include time to tumor progression, duration of response, overall patient survival and safety parameters. Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine.

• Pharmasset Inc., of Princeton, N.J., presented positive safety, tolerability, pharmacokinetic and food-effect data following single ascending doses of R7128, a prodrug of PSI- 6130, an oral cytidine nucleoside analogue polymerase inhibitor of hepatitis C virus. The study included 46 healthy volunteers. The product is being developed through a collaboration with F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Pharmasset's stock (NASDAQ:VRUS) gained $1.60 Monday, or 15.4 percent, to close at $12.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said treatment with rilonacept (IL-1 Trap) demonstrated a statistically significant reduction in patient pain scores in a single-blind, controlled study of 10 patients with chronic active gout. In the study, for which safety was the primary endpoint measure, treatment with rilonacept generally was well tolerated. After six weeks of Interleukin-1 Trap treatment, 70 percent of patients achieved at least a 50 percent improvement in their pain scores; none of the patients achieved a 50 percent improvement during the placebo run-in period. Other efficacy measures also were improved.

• TorreyPines Therapeutics Inc., of La Jolla, Calif., completed its third Phase I trial of NGX267, in clinical development for the treatment of cognitive impairment associated with schizophrenia. The compound, a functionally selective muscarinic agonist, was found to be safe and well tolerated when given orally to 60 healthy male volunteers in Belgium once daily for four consecutive days. In two previous Phase I trials, NGX267, administered as single oral doses, was shown to be well tolerated in healthy young adult males, as well as in healthy elderly males and females. TorreyPines plans to initiate a Phase II dose-ranging trial in CIAS during the first half of 2008.

• XenoPort Inc., of Santa Clara, Calif., said a Phase I trial demonstrated sustained levels of XP19986 over 24 hours and enabled identification of suitable doses for further clinical studies of XP19986, a transported prodrug of R-baclofen. The placebo-controlled, dose-escalating, repeat-dose trial of XP19986 formulated in a sustained-release tablet was conducted in 48 healthy adult volunteers. XenoPort plans to start a Phase II trial of that drug formulation later this year in patients with gastroesophageal reflux disease, and a Phase II trial of a different formulation in patients with spasticity.

• XTL Biopharmaceuticals Ltd., of Valley Cottage, N.Y., initiated a Phase IIb trial of Bicifadine, a serotonin and norepinephrine reuptake inhibitor, for the treatment of diabetic neuropathic pain. The randomized, double-blind, placebo-controlled study will compare two doses of Bicifadine to placebo in about 330 patients in the U.S., Europe and India. The primary endpoint is in reduction of pain at week 14.

• Ziopharm Oncology Inc., of New York, said it began dosing patients in a U.S. Phase I trial of its oral formulation of darinaparsin (ZIO-101) to treat solid tumors. The company also initiated patient treatment in a U.S. Phase I trial of the oral formulation of indibulin (ZIO-301) in solid tumors. Darinaparsin is a small-molecule organic arsenic agent designed to induce cell-cycle arrest and cell death. Indibulin is a synthetic antimitotic agent designed to bind to tubulin, destabilize microtubule polymerization and arrest tumor cell growth at the G2/M phase.

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