• Acorda Therapeutics Inc., of Hawthorne, N.Y., began a second Phase III study of Fampridine-SR in multiple sclerosis. The study is expected to enroll about 200 patients at 35 MS clinical centers in the U.S. and Canada. The MS-F204 study, which is being conducted under a special protocol assessment from the FDA, will evaluate safety and the efficacy of Fampridine-SR in improving walking ability in MS patients. Acorda reported statistically significant results in a previous Phase III trial. (See BioWorld Today, Sept. 26, 2006.)
• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., said a Phase I trial of AN2728, a topical therapy under investigation for psoriasis, demonstrated tolerability, as well as activity comparable to existing topical treatments for psoriasis. The company said AN2728 suppresses the phosphodiesterase 4 enzyme, leading to TNF-alpha inhibition. The trial showed AN2728-treated plaques improved significantly compared with vehicle treatment (p<0.001), and efficacy was comparable to that seen with betamethasone and tacrolimus treatment.
• BioLineRx Ltd., of Jerusalem, submitted a request to a European regulatory agency to begin pilot Phase I/II trials of BL-1040, an absorbable implant to treat cardiac tissue damaged as the result of an acute myocardial infarction. The open-label study is expected to be conducted at sites Europe and Israel. The product is designed to provide mechanical support to damaged heart tissue after acute myocardial infarction in order improve cardiac function and survival.
• EntreMed Inc., of Rockville, Md., presented interim data from a Phase Ib trial demonstrating that the combination of Panzem NCD (2-methoxyestradiol) and Taxol (paclitaxel, Bristol-Myers Squibb Co.) caused one complete response, one partial response and one case of a 30 percent reduction in tumor volume out of 10 metastatic breast cancer patients treated. The combination also affected levels of HIF-1 regulated proteins and other biomarkers associated with chemotherapeutic resistance. Panzem NCD, an antiangiogenic drug, also is being studied in multiple Phase II cancer trials.
• Faust Pharmaceuticals SA, of Strasbourg, France, said Phase IIa trial results of its small-molecule glutamate release inhibitor, FP0011, demonstrated tolerability, as well as improved Parkinsonian symptoms and motor fluctuations. The trial included eight mid- to late-stage Parkinson's disease patients with L-dopa-induced motor complications. Data were being presented at the Movement Disorder Society congress in Istanbul, Turkey.
• Genta Inc., of Berkeley Heights, N.J., announced publication of preliminary clinical results showing Genasense (oblimersen sodium) injection can be administered safely by intermittent subcutaneous injection, as well as by brief intravenous infusion. Those regimens eventually may reduce or eliminate the current requirements for administering Genasense by continuous IV infusion. The data were published in proceedings of the meeting of the American Society of Clinical Oncology in Chicago.
• Isotechnika Inc., of Edmonton, Alberta, said it received approval from Polish regulators for participation in the ongoing Phase III European/Canadian trial of ISA247 in patients suffering from moderate to severe psoriasis. The company previously received approvals to begin the trial in 29 sites in Germany and Canada, where 283 patients already had been enrolled. Patient enrollment at 12 sites in Poland was expected to start immediately. The Phase II ESSENCE trial is a 24-week, randomized study comparing the product to placebo and cyclosporine.
• Movetis NV, of Turnhout, Belgium, initiated a Phase IIa trial of M0002 in ascites, an accumulation of fluid in the peritoneal cavity. M0002 is an orally active, selective vasopressin antagonist that inhibits water reabsorption from the kidneys without also causing high salt excretion. The company also said it has finalized manufacturing and met with European regulatory authorities about Resolor, its Phase III drug for chronic constipation. Additionally, Movetis completed preclinical toxicology work with M0003 and is planning to initiate a Phase II diabetic gastropathy trial around the end of the year.
• Protox Therapeutics Inc., of Vancouver, British Columbia, completed enrollment in a Phase I trial of PRX302 in localized, recurrent prostate cancer. Interim data disclosed in January showed that the drug is well tolerated and decreased PSA levels. Protox expects to report top-line data by mid-2007 and initiate a Phase II trial by year-end. PRX302, a targeted prodrug that converts into an anticancer agent in the presence of PSA, also is in a Phase I trial in benign prostatic hyperplasia.
• Surface Logix Inc., of Boston, initiated a Phase IIa trial of SLx-4090 in patients with dyslipidemia (abnormal levels of lipids in the bloodstream). The randomized, double-blind, placebo-controlled trial in 24 patients with dyslipidemia will investigate the drug's effect on reducing plasma lipid levels by preventing the intestinal absorption of cholesterol and triglycerides. SLx-4090 is an enterocyte-specific microsomal triglyceride transfer protein inhibitor.
• XTL Biopharmaceuticals Ltd., of Valley Cottage, N.Y., said a 56-patient Phase I trial of XTL-2125 in patients with chronic hepatitis C showed that HCV-RNA viral load reductions were not significantly different from those seen in the placebo group. XTL has decided to suspend further development of XTL-2125, an oral non-nucleoside hepatitis C virus polymerase inhibitor. The company's stock (NASDAQ:XTLB) fell 63 cents Wednesday, or 17.7 percent, to close at $2.90.