• Advaxis Inc., of North Brunswick, N.J., filed an investigational new drug application for a Phase II study of Lovaxin C, its lead candidate in cervical intraepithelial neoplasia, set to start this summer. The company successfully completed a Phase I trial overseas. Lovaxin C, a Listeria vaccine candidate, is designed to target HPV-associated cancers, such as cervical and head and neck.
• Basilea Basilea pharmaceutica Ltd., of Basel, Switzerland, said results from a Phase III study show that ceftobiprole demonstrated high cure rates in patients at risk for poor outcomes. The drug was effective in 93 percent of the clinically evaluable patients ages 75 and older (vs. 86 percent for the comparator), and the cure rate in patients with Class IV and Class V severity was 90 percent for ceftobiprole vs. 85 percent for the comparator. Patients with systemic inflammatory response syndrome were cured in 85 percent of cases with ceftobiprole and 87 percent for comparator. Those data were presented at the American Thoracic Society meeting in Toronto.
• BioMarin Pharmaceutical Inc., of Novato, Calif., said the first patient started treatment in its Phase I study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) in phenylketonuria. The study, which is designed to assess single, subcutaneous injections of PEG-PAL, is expected to conclude enrollment of 35 PKC patients in the fourth quarter. BioMarin said it believes the drug might be able to reduce blood Phe levels and help patients who do not respond to Kuvan (sapropterin dihydrochloride), the company's approved PKU product.
• Centocor Inc., of Horsham, Pa., said data from a new analysis of the Active Ulcerative Colitis Trials (ACT 1 and ACT 2) showed that at week eight, more than 60 percent of patients with moderately to severely active ulcerative colitis receiving Remicade (infliximab) achieved clinical response regardless of disease duration. Investigators also reported significant improvements maintained at week 30, with nearly half of Remicade-treated patients having a clinical response. Those findings were presented at the Digestive Disease Week meeting in San Diego.
• Ceragenix Pharmaceuticals Inc., of Denver, reported positive results from a study comparing EpiCeram to Elidel (pimecrolimus 1 percent) cream in mild to moderate pediatric atopic dermatitis. The 38-patient study showed that both products produced significant improvements in patients' conditions after four weeks of treatment and showed no statistically significant differences between the groups as measured by EASI (Eczema Area and Severity Index) scores at day 28. However, there was a statistically significant difference in median EASI score reduction at week two, with Elidel showing fast improvement at that time, but Ceragenix said the slower response to EpiCeram could be attributable to the relatively small amounts of EpiCeram that were applied.
• Dynogen Pharmaceuticals Inc., of Waltham, Mass., reported positive results from its Phase IIa trial of DDP733 (pumosetrag), showing that it demonstrated a statistically significant improvement over placebo in the endpoint of overall subject global assessment in irritable bowel syndrome with constipation. DDP733 achieved a benefit in overall IBS relief in 54 percent of subjects in the 1.4 mg dose group, compared to 15 percent in the placebo arm. Data were presented at the Digestive Disease Week meeting in San Diego. Also at that conference, Dynogen reported results from a Phase IIa trial of DDP225, showing statistically significant improvement in relief of abdominal pain or discomfort associated with IBS with diarrhea. The 1-mg dose of the drug demonstrated a benefit over placebo, 71 percent vs. 25 percent.
• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said data from its Phase I study of PEG-SN38 in heavily pretreated patients with solid tumors and lymphoma showed that the drug was well tolerated and that multiple patients treated with a median of five prior regimens, including patients who had progressed on irinotecan, had prolonged stable disease. Results from a separate Phase Ib study of recombinant mannose-binding lectin (EZN-2232) showed that the drug continues to be safe and well tolerated in multiple myeloma patients undergoing high-dose chemotherapy. Those results and others will be presented at the American Society of Clinical Oncology meeting in Chicago.
• Eisai Corp., of Woodcliff Lake, N.J., a subsidiary of Eisai Co., Ltd., of Tokyo, said study results showed that patients with Lennox-Gastaut syndrome treated with rufinamide, its investigational anti-epileptic agent, as an adjunctive therapy experienced more than 40 percent fewer drop attacks than patients who received placebo. The median percentage reduction in total seizure frequency from baseline was greater in the rufinamide group (32.7 percent) vs. the placebo group (11.7 percent), and the rufinamide-treated patients had 42.5 percent median percentage reduction in tonic-atonic seizure (drop attack) frequency per 28 days from baseline, compared to a 1.4 percent increase in placebo-treated patients. Data were published in Neurology.
• Gilead Sciences Inc., of Foster City, Calif., reported results of a post hoc analysis of data collected during the ARIES-1, ARIES-2 and ARIES-3 studies of Letairis in pulmonary arterial hypertension patients with primarily WHO functional Class II or III symptoms showed that, at week 48, the six-minute walk distance for patients who received Letairis for the length of the study (ABS/ABS) was +47 meters, compared to 33 meters for the patients who crossed over to Letairis treatment after 12 weeks of placebo (PLB/ABS). At one year of treatment, the probability of no clinical worsening was 84 percent in the ABS/ABS group compared to 76 percent in the PLB/ABS group. Those data were presented at the American Thoracic Society conference in Toronto.
• ImClone Systems Inc., of New York, said the initial stage of a series of Phase I/II trials of IMC-A12 in advanced pancreatic cancer patients opened for enrollment. IMC-A12 is a fully human, IgG1 anti-insulin-like growth factor-1 receptor monoclonal antibody. The study, which will evaluate the drug in combination with gemcitabine and erlotinib (Tarceva, Genentech Inc. and OSI Pharmaceuticals Inc.), is one of at least 10 Phase I and Phase II trials sponsored by a division of the National Cancer Institute.
• KAI Pharmaceuticals Inc., of South San Francisco, started enrollment in a Phase I study of KAI-1678, an isozyme-selective inhibitor of the epsilon protein kinase C pathway that has shown effectiveness in reducing pain responses in preclinical models. The study will evaluate the drug in healthy males in Australia and is expected to be completed this quarter.
• NPS Pharmaceuticals Inc., of Bedminster, N.J., said Phase III data showed that Gattex (teduglutide) was generally well tolerated and effective in reducing the parenteral nutrition requirements of short bowel syndrome patients, with the lower dose findings showing statistical significance vs. placebo. Results from the 83-patient trial indicated that 46 percent of patients who received low-dose Gattex responded and achieved a highly statistically significant reduction in PN compared to placebo. Two low-dose patients gained independence from and discontinued PN by week 16, and a third high-dose patient discontinued PN at the end of treatment. Data were reported at the Digestive Disease Week meeting in San Diego. NPS is finalizing a protocol for a Phase III confirmatory study, expected to start in the third quarter.
• Omeros Corp., of Seattle, started enrolling patients in a Phase I study of OMS201, a pharmacosurgery product candidate for use during urological surgery. The trial will involve at least 24 patients undergoing unilateral ureteroscopic removal of stones with a maximum diameter of 12 mm located in the renal-collecting system or ureter. OMS201 is one of four programs in the company's Pharmacosurgery platform, which is designed to combine therapeutic agents to act simultaneously at multiple discrete targets to preemptively block the molecular-signaling and biochemical cascade caused by surgical trauma and to provide clinical benefits both during and after surgery.
• Palatin Technologies Inc., of Cranbury, N.J., started dosing in a Phase IIa study of PL-3994, a long-acting natriuretic peptide receptor A agonist, in patients with controlled hypertension. The trial will include up to five cohorts and as many as 35 subjects who will be placed on a controlled diet and be monitored for 24 hours prior to receiving a single dose of PL-3994 or placebo with blood pressures and laboratory values monitored for 24 hours. Results of that study are expected to assist in the design of a Phase II study in patients with episodes of hypertensive urgency planned for later this year.
• Precision Therapeutics Inc., of Pittsburgh, reported that use of the ChemoFx Assay, a cell-based test designed to examine the response of a specific patient's tumor to various chemotherapies, correlated with significantly longer overall survival in patients with primary ovarian cancer. Patients who received treatment determined by ChemoFx to lead to the best tumor response had an overall survival 1.4 times longer than those receiving a treatment shown by ChemoFx to be nonresponsive. Analyses also found that nearly two-third of patients' tumors were more responsive to a treatment identified by ChemoFx than to treatment they actually received.
• Qiagen NV, of Hilden, Germany, said long-term data published in Cancer showed that women screened only with a human papillomavirus DNA test are half as likely to develop moderate to severe cervical disease over the next six years as those who get only conventional cytology. Qiagen markets the digene HPV test in the U.S. and Europe.
• Salix Pharmaceuticals Ltd., of Morrisville, N.C., said data from a Phase IIb trial of rifaximin, a nonabsorbed gut-selective antibiotic for diarrhea-associated irritable bowel syndrome, showed that patients receiving the drug demonstrated statistically greater clinical improvement in both co-primary endpoints of adequate relief of global IBS symptoms and bloating compared to placebo. Improvements were sustained for 12 weeks of follow-up, despite cessation of therapy after 14 days. Those data were presented at the Digestive Disease Week meeting in San Diego.
• Synta Pharmaceuticals Corp., of Lexington, Mass, and GlaxoSmithKline plc, of London, reported positive Phase II data showing that elesclomol (formerly STA-4783) produced a statistically significant improvement in progression-free survival in patients with Stage IV metastatic melanoma compared to paclitaxel alone. Data from that retrospective subgroup analysis will be presented at the upcoming American Society of Clinical Oncology meeting in Chicago.
• Targanta Therapeutics Corp., of Cambridge, Mass., said enrollment has been completed in its Phase II SIMPLIFI (Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections) trial of antibiotic oritavancin. The company expects to lock the database and analyze results over the next few months to determine whether to pursue Phase III registrational trials for infrequent dosing of oritavancin in cSSSIs. The drug is under FDA review for cSSSI, with an action date of Dec. 8.