• Auxilium Pharmaceuticals Inc., of Malvern, Pa., said retrospective data reported at the American Urological Association meeting in Anaheim, Calif., showed improvements in symptoms of decreased libido, energy levels and erectile function in 76 percent of hypogonadal men after switching brands of testosterone replacement gel therapy. Specifically, total testosterone levels increased significantly in patients who switched to Auxilium's Testim 1% (testosterone gel) following suboptimal response to Androgel 1% (testosterone gel, Solvay SA).

• BioLineRx Ltd., of Jerusalem, reported Phase I data at the American Psychiatric Association meeting in San Diego showing that BL-1020 was well tolerated and demonstrated biochemical evidence of dopamine blockade which is indicative of efficacy. A Phase II trial of the GABA-enhanced antipsychotic for schizophrenia is expected to begin at the end of next month.

• Celgene Corp., of Summit, N.J., reported Phase II data showing that CC-10004 (apremilast) achieved the primary endpoint after 12 weeks of treatment, with 24 percent of patients receiving the oral TNF antagonist twice daily achieving a score of 75 on the Psoriasis Area and Severity Index (PASI) compared to 10 percent of those on placebo. In addition, 57 percent of CC-10004 patients achieved a PASI-50 compared to 23 percent of placebo patients, and CC-10004 patients continued to improve over time. The company said it plans to advance the product's development across a broad range of inflammatory diseases.

• Cougar Biotechnology Inc., of Los Angeles, said Phase I/II data reported at the American Urological Association meeting in Anaheim, Calif., show that 60 percent of patients treated with CB7630 (abiraterone acetate) experienced a confirmed decline in prostate specific antigen (PSA) levels of greater than 50 percent, with a third experiencing PSA declines of greater than 90 percent. Also, 20 percent more experienced a decline in PSA that was less than 50 percent. Of 20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses in 11, with seven demonstrating ongoing stable disease and three experienced regressing bone disease.

• Cytogen Corp., of Princeton, N.J., reported outcomes data from a large cohort study at the American Urological Association meeting in Anaheim, Calif., demonstrating the value of the imaging product Prostascint (capromab pendetide) in predicting prognosis in prostate cancer. Prostate cancer-specific death rates were 10 times higher in patients with central abdominal uptake, a finding suggestive of metastatic disease, compared to those without central abdominal uptake (p=0.005), further reinforcing that Prostascint offers a level of accuracy and detail to prostate cancer imaging that can aid clinicians in defining patients' prognoses and treatment regimens.

• Enzo Biochem Inc., of New York, said interim data from two ongoing double-blind, placebo-controlled Phase II studies of Alequel suggested the approach induced clinical remissions and improved patients' quality of life compared to placebo. Alequel is an individualized oral immune regulation preparation consisting of an autologous protein-containing extract, individually prepared from mucosal tissue colon biopsies of the subject. The studies in 49 patients showed rates of remission and response nearly doubled in Alequel-treated patients. Enzo is enrolling additional patients in the trials.

• Inovio Biomedical Corp., of San Diego, announced that the first data from clinical trials of a DNA vaccine delivered using Inovio's electroporation approach were presented at the 3rd International Conference on DNA Vaccines in Malaga, Spain. Interim data from the Phase I/II prostate cancer study indicated that Inovio's electroporation delivery system was safe and well tolerated. Additionally, nine of 10 patients receiving the vaccine plus electroporation delivery achieved significant antibody responses compared to four of 10 patients receiving vaccine alone. The electroporation approach also is being studied in late-stage trials to improve delivery of cancer drugs. (See BioWorld Today, May 17, 2007.)

• Limerick NeuroSciences Inc., of South San Francisco, initiated its first company-sponsored, Phase I clinical trial of LNS 5310, its lead candidate based on a strategy of chemically modulating the bioavailability of existing drugs to reduce their neurotoxicity. A physician-sponsored, proof-of-concept study was completed late last year with LNS 5662, a flavonol PgP-modulator designed to minimize the side effects such as nausea and vomiting associated with the pain drug oxycodone.

• NanoBio Corp., of Ann Arbor, Mich., reported positive Phase I safety data on NB-002 for onychomycosis, a chronic persistent fungal infection of the nail bed. There were no drug-related adverse events, serious adverse events or discontinuations due to adverse events in any of the subjects treated. In addition, plasma drug levels were below the 1 ng/mL limit of detection at all time points. The product now is in Phase II.

• PDL BioPharma Inc., of Fremont, Calif., said long-term follow up data from Phase I and Phase I/II trials demonstrated that treatment with humanized monoclonal antibody Nuvion (visilizumab) on day 1 and day 2 was adequately tolerated and resulted in a sustained clinical response for up to 310 days in patients with intravenous steroid-refractory ulcerative colitis (IVSR-UC). The data, along with data indicating the potential of Nuvion in Crohn's disease, were presented at the Digestive Disease Week meeting in Washington. Nuvion is in Phase II/III for IVSR-UC and Phase II for Crohn's disease.

• Protherics plc, of London, said Phase IIa data reported at the Digestive Disease Week meeting in Washington showed that OncoGel improved dysphagia symptoms in nine oesophageal cancer patients. The symptoms remained unchanged for two patients, and tumor volumes decreased for eight of the 11 patients. The company plans to begin Phase IIb testing of the sustained-release formulation of paclitaxel in combination with chemoradiotherapy in the second half of this year.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said additional data from a Phase III registrational trial reported at the American Urological Association meeting in Anaheim, Calif., demonstrated a median time to pain progression of 66.1 weeks for the satraplatin arm compared with 22.3 weeks for placebo (p<0.001). Further, pain response rates were 24.2 percent for the 351-patient satraplatin arm compared with 13.8 percent for the 181-patient placebo arm (p=0.005). The double-blind, randomized, placebo-controlled study is evaluating satraplatin plus prednisone vs. placebo plus prednisone in 950 patients with hormone-refractory prostate cancer who have failed prior chemotherapy. Satraplatin is under priority review by the FDA, with an advisory committee review scheduled for July 24 and an action date set for Aug. 15.

• Topigen Pharmaceuticals Inc., of Montreal, reviewed data from a Phase II study of asthma drug TPI ASM8 at the American Thoracic Society Annual Meeting in Miami Beach, Fla. In the Phase II trial, the inhaled RNA-targeted drug demonstrated significant inhibitory effects on allergen-induced responses, inhibited the influx of eosinophil cells by nearly half, and halted the increase in total cells and neutrophils after an allergen challenge. Topigen is now conducting an expanded Phase II trial with TPI ASM8.

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