• 4SC AG, of Planegg-Martinsried, Germany, reported results from its Phase IIa study of SC12267 in rheumatoid arthritis, which showed that the drug was safe and well tolerated. Data also confirmed dose-dependent trends in efficacy, in accordance with ACR20 responses (a measure for the reduction of RA symptoms of at least 20 percent). About 47 percent of patients in the 35-mg dose group showed an ACR20 response compared to 33 percent in the placebo group. The company said data also indicated a positive trend in efficacy for patients who had received treatment with other disease-modifying anti-rheumatic drugs prior to the trial.

• Amarin Corp. plc, of London, started a Phase I trial in volunteers to evaluate the co-administration of ultra-pure ethyl EPA and niacin in niacin-induced flushing. Niacin is an approved treatment for dyslipidemia but carries a side effect of flushing. Amarin believes that by using ultra-pure EPA and niacin together, both HDL and triglycerides can be managed. The trial is part of Amarin's cardiovascular development program.

• ArQule Inc., of Woburn, Mass., said symptomatic and asymptomatic QTc prolongation, a measure of cardiac function, was observed in a Phase I dose-escalation trial of ARQ 171, a second-generation product in the company's E2F-1 cancer therapy program. Those observations were made based on EKGs from patients who received doses of the drug from 380 mg to 760 mg per meter squared. As a result, the company will review EKGs from patients previously treated at lower doses before making a further decision on whether to continue the trial. ArQule anticipates analysis of QTc prolongation data to be completed between the end of 2007 and early 2008.

• Bavarian Nordic A/S, of Kvistgard, Denmark, successfully completed a Phase II trial of Imvamune, a third-generation smallpox vaccine, in 745 healthy subjects, who received either one or two doses of the drug. The company said those results will help advance the product into Phase III registration trials, which are needed for approval. Data from the Phase II study, along with additional Phase II data of Imvamune in immune-compromised subjects, are necessary for obtaining emergency use authorization (EUA). Bavarian anticipates approval on its EUA application in the second half of 2008.

• Cytos Biotechnology AG, of Zurich, Switzerland, started two Phase II trials of Immunodrug CYT003-QbG10, an immunotherapeutic product for allergic diseases. The first study is designed to evaluate increasing doses of CYT003-QbG10 monotherapy in 64 patients with perennial allergic rhinoconjunctivitis due to house dust mite and/or cat allergy, while the second trial will involve 100 patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy. In both studies, efficacy will be evaluated by means of the conjunctival provocation test. First results are expected in the middle of 2008.

• ImClone Systems Inc., of New York, reported data suggesting that patients with unresectable, metastatic colorectal cancer (mCRC) refractory to systemic chemotherapy can achieve substantial regression of their liver metastases with Erbitux (cetuximab), which can increase their potential as candidates for complete surgical resection. After a median follow-up of 16 months, 23 of 25 patients (92 percent) who underwent surgical resection were alive and 10 patients (40 percent) were disease-free. Median overall survival and progression-free survival from initiation of Erbitux therapy were 20 months and 13 months, respectively, in patients with unresectable mCRC refractory to conventional therapy. Data were published in the Journal of Clinical Oncology.

• LifeCycle Pharma A/S, of Horsholm, Denmark, started a Phase I trial of LCP-Siro, which contains the immunosuppressant sirolimus (Rapamune, Wyeth), in healthy volunteers. The company's goal is to create a candidate with increased bioavailability and reduced dosing compared to sirolimus, an FDA-approved drug for preventing organ rejection after transplantation and for treating certain autoimmune diseases. LifeCycle anticipates Phase I data in 2008.

• Plethora Solutions Holdings plc, of London, said preliminary analysis of Phase II data confirmed positive clinical effect and safety of PSD503 as a front-line therapy in stress urinary incontinence. Early data in 12 patients showed that the drug produced a 44 percent overall reduction in leakage, as measured from pad weight, compared to an 11 percent increase in pad weight in the placebo group. PSD503 is a metered dose, topical gel formulation of phenylephrine.

• Prana Biotechnology Ltd., of Melbourne, Australia, said the data safety monitoring board completed its third and final review of an ongoing Phase IIa trial of PBT2 in Alzheimer's disease patients and confirmed that the study is safe to continue. The review included 59 patients, and the board concluded that no treatment-related serious adverse events or withdrawals have been noted. Prana completed trial enrollment and randomization in September and anticipates reporting study results in the first quarter of 2008. The trial's primary outcome measure is safety and tolerability, though data also will report the effect of PBT on cerebrospinal fluid and blood biomarkers directly associated with the etiology of Alzheimer's disease.

• Sucampo Pharma Ltd., of Tokyo, a Japanese subsidiary of Sucampo Pharmaceuticals Inc., initiated a Phase IIb study in Japan to evaluate lubiprostone in adult chronic idiopathic constipation. The study is expected to enroll about 160 patients who will be randomized to receive one of three twice-daily doses of lubiprostone (8 mcg, 16 mcg and 24 mcg capsule) or placebo over 14 days. The primary endpoint will be the number of spontaneous bowel movements after one week of treatment. Sucampo co-markets lubiprostone in the U.S. as Amitiza.

• Supratek Pharma Inc., of Montreal, received a special protocol assessment from the FDA for a Phase III trial to compare SP1049C plus best supportive care vs. best supportive care alone in patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction and stomach who have failed adjuvant or first- or second-line chemotherapy. SP1049C is a nanomedicine candidate based on Supratek's Biotransport polymer technology. It is composed of poloxamers and cytotoxic drug doxorubicin and has shown in preclinical and early clinical development to have a higher efficacy against chemo-resistant tumors in which the original drug is inactive. SP1049C has orphan drug designation in esophageal carcinoma.